title: Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)(Codified version)

text:
               20.9.2008

               EN

               Official Journal of the European Union

               L 253/1

      COMMISSION DIRECTIVE 2008/84/EC
   of 27 August 2008
   laying down specific purity criteria on food additives other than colours and sweeteners
   (Text with EEA relevance)
   (Codified version)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   Whereas:

               (1)

               Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (4).

               (3)

               It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

               (4)

               Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

               (6)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in Annex I to this Directive.
   Article 2
   Directive 96/77/EC, as amended by the Directives listed in Annex II, part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law set out in Annex II, part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 27 August 2008.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 40, 11.2.1989, p. 27.

      (2)  OJ L 339, 30.12.1996, p. 1.

      (3)  See Annex II, part A.

      (4)  OJ L 61, 18.3.1995, p. 1.

      ANNEX I
      Ethylene oxide may not be used for sterilising purposes in food additives.
      E 170 (i) CALCIUM CARBONATE
      Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1).
      E 200 SORBIC ACID

                     Definition

                  Chemical name

                  Sorbic acid

                  Trans, trans-2,4-hexadienoic acid

                  Einecs

                  203-768-7

                  Chemical formula

                  C6H8O2

                  Molecular weight

                  112,12

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 oC

                     Identification

                              A.

                              Melting range

                  Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator

                              B.

                              Spectrometry

                  An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm

                              C.

                              Positive test for double bonds

                              D.

                              Sublimation point

                  80 oC

                     Purity

                  Water content

                  Not more than 0,5 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,2 %

                  Aldehydes

                  Not more than 0,1 % (as formaldehyde)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 202 POTASSIUM SORBATE

                     Definition

                  Chemical name

                  Potassium sorbate

                  Potassium (E, E)-2,4-hexadienoate

                  Potassium salt of trans, trans 2,4-hexadienoic acid

                  Einecs

                  246-376-1

                  Chemical formula

                  C6H7O2K

                  Molecular weight

                  150,22

                  Assay

                  Content not less than 99 % on the dried basis

                     Description

                  White crystalline powder showing no change in colour after heating for 90 minutes at 105 oC

                     Identification

                              A.

                              Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator

                              B.

                              Positive tests for potassium and for double bonds

                     Purity

                  Loss on drying

                  Not more than 1,0 % (105 oC, 3h)

                  Acidity or alkalinity

                  Not more than about 1,0 % (as sorbic acid or K2CO3)

                  Aldehydes

                  Not more than 0,1 %, calculated as formaldehyde

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 203 CALCIUM SORBATE

                     Definition

                  Chemical name

                  Calcium sorbate

                  Calcium salts of trans, trans-2,4-hexadienoic acid

                  Einecs

                  231-321-6

                  Chemical formula

                  C12H14O4Ca

                  Molecular weight

                  262,32

                  Assay

                  Content not less than 98 % on the dried basis

                     Description

                  Fine white crystalline powder not showing any change in colour after heating at 105 oC for 90 minutes

                     Identification

                              A.

                              Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator

                              B.

                              Positive tests for calcium and for double bonds

                     Purity

                  Loss on drying

                  Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator

                  Aldehydes

                  Not more than 0,1 % (as formaldehyde)

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 210 BENZOIC ACID

                     Definition

                  Chemical name

                  Benzoic acid

                  Benzenecarboxylic acid

                  Phenylcarboxylic acid

                  Einecs

                  200-618-2

                  Chemical formula

                  C7H6O2

                  Molecular weight

                  122,12

                  Assay

                  Content not less than 99,5 % on the anhydrous basis

                     Description

                  White crystalline powder

                     Identification

                              A.

                              Melting range

                  121,5 oC to 123,5 oC

                              B.

                              Positive sublimation test and test for benzoate

                     Purity

                  Loss on drying

                  Not more than 0,5 % after drying for three hours over sulphuric acid

                  pH

                  About 4 (solution in water)

                  Sulphated ash

                  Not more than 0,05 %

                  Chlorinated organic compounds

                  Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid

                  Readily oxidisable substances

                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

                  Readily carbonisable substances

                  A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (3), 0,3 ml of ferric chloride TSC (4), 0,1 ml of copper sulphate TSC (5) and 4,4 ml of water

                  Polycyclic acids

                  On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 211 SODIUM BENZOATE

                     Definition

                  Chemical name

                  Sodium benzoate

                  Sodium salt of benzenecarboxylic acid

                  Sodium salt of phenylcarboxylic acid

                  Einecs

                  208-534-8

                  Chemical formula

                  C7H5O2Na

                  Molecular weight

                  144,11

                  Assay

                  Not less than 99 % of C7H5O2Na, after drying at 105 oC for four hours

                     Description

                  A white, almost odourless, crystalline powder or granules

                     Identification

                              A.

                              Solubility

                  Freely soluble in water, sparingly soluble in ethanol

                              B.

                              Melting range for benzoic acid

                  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after drying in a sulphuric acid desiccator

                              C.

                              Positive tests for benzoate and for sodium

                     Purity

                  Loss on drying

                  Not more than 1,5 % after drying at 105 oC for four hours

                  Readily oxidisable substances

                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

                  Polycyclic acids

                  On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

                  Chlorinated organic compounds

                  Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

                  Degree of acidity or alkalinity

                  Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 212 POTASSIUM BENZOATE

                     Definition

                  Chemical name

                  Potassium benzoate

                  Potassium salt of benzenecarboxylic acid

                  Potassium salt of phenylcarboxylic acid

                  Einecs

                  209-481-3

                  Chemical formula

                  C7H5KO2·3H2O

                  Molecular weight

                  214,27

                  Assay

                  Content not less than 99 % C7H5KO2 after drying at 105 oC to constant weight

                     Description

                  White crystalline powder

                     Identification

                              A.

                              Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator

                              B.

                              Positive tests for benzoate and for potassium

                     Purity

                  Loss on drying

                  Not more than 26,5 %, determined by drying at 105 oC

                  Chlorinated organic compounds

                  Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

                  Readily oxidisable substances

                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

                  Readily carbonisable substances

                  A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

                  Polycyclic acids

                  On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

                  Degree of acidity or alkalinity

                  Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 213 CALCIUM BENZOATE

                     Synonyms

                  Monocalcium benzoate

                     Definition

                  Chemical name

                  Calcium benzoate

                  Calcium dibenzoate

                  Einecs

                  218-235-4

                  Chemical formula

                  Anhydrous:

                  C14H10O4Ca

                  Monohydrate:

                  C14H10O4Ca· H2O

                  Trihydrate:

                  C14H10O4Ca· 3H2O

                  Molecular weight

                  Anhydrous:

                  282,31

                  Monohydrate:

                  300,32

                  Trihydrate:

                  336,36

                  Assay

                  Content not less than 99 % after drying at 105 oC

                     Description

                  White or colourless crystals, or white powder

                     Identification

                              A.

                              Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator

                              B.

                              Positive tests for benzoate and for calcium

                     Purity

                  Loss on drying

                  Not more than 17,5 % determined by drying at 105 oC to constant weight

                  Water insoluble matter

                  Not more than 0,3 %

                  Chlorinated organic compounds

                  Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids

                  Readily oxidisable substances

                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

                  Readily carbonisable substances

                  Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

                  Polycyclic acids

                  On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid

                  Degree of acidity or alkalinity

                  Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 214 ETHYL p-HYDROXYBENZOATE

                     Synonyms

                  Ethylparaben

                  Ethyl p-oxybenzoate

                     Definition

                  Chemical name

                  Ethyl-p-hydroxybenzoate

                  Ethyl ester of p-hydroxybenzoic acid

                  Einecs

                  204-399-4

                  Chemical formula

                  C9H10O3

                  Molecular weight

                  166,8

                  Assay

                  Content not less than 99,5 % after drying for two hours at 80 oC

                     Description

                  Almost odourless, small, colourless crystals or a white, crystalline powder

                     Identification

                              A.

                              Melting range

                  115 oC to 118 oC

                              B.

                              Positive test for p-hydroxybenzoate

                  Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid desiccator

                              C.

                              Positive test for alcohol

                     Purity

                  Loss on drying

                  Not more than 0,5 % after drying for two hours at 80 oC

                  Sulphated ash

                  Not more than 0,05 %

                     p-Hydroxybenzoic acid and salicylic acid

                  Not more than 0,35 % expressed as p-hydroxybenzoic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 215 SODIUM ETHYL p-HYDROXYBENZOATE

                     Definition

                  Chemical name

                  Sodium ethyl p-hydroxybenzoate

                  Sodium compound of the ethyl ester of p-hydroxybenzoic acid

                  Einecs

                  252-487-6

                  Chemical formula

                  C9H9O3Na

                  Molecular weight

                  188,8

                  Assay

                  Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis

                     Description

                  White, crystalline hygroscopic powder

                     Identification

                              A.

                              Melting range

                  115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator

                              B.

                              Positive test for p-hydroxybenzoate

                  Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC

                              C.

                              Positive test for sodium

                              D.

                              pH of a 0,1 % aqueous solution must be between 9,9 and 10,3

                     Purity

                  Loss on drying

                  Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator

                  Sulphated ash

                  37 to 39 %

                     p-Hydroxybenzoic acid and salicylic acid

                  Not more than 0,35 % expressed as p-hydroxybenzoic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 218 METHYL p-HYDROXYBENZOATE

                     Synonyms

                  Methylparaben

                  Methyl-p-oxybenzoate

                     Definition

                  Chemical name

                  Methyl p-hydroxybenzoate

                  Methyl ester of p-hydroxybenzoic acid

                  Einecs

                  243-171-5

                  Chemical formula

                  C8H8O3

                  Molecular weight

                  152,15

                  Assay

                  Content not less than 99 % after drying for two hours at 80 oC

                     Description

                  Almost odourless, small colourless crystals or white crystalline powder

                     Identification

                              A.

                              Melting range

                  125 oC to 128 oC

                              B.

                              Positive test for p-hydroxybenzoate

                  Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC after drying for two hours at 80 oC

                     Purity

                  Loss on drying

                  Not more than 0,5 %, after drying for two hours at 80 oC

                  Sulphated ash

                  Not more than 0,05 %

                     p-Hydroxybenzoic acid and salicylic acid

                  Not more than 0,35 % expressed as p-hydroxybenzoic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 219 SODIUM METHYL p-HYDROXYBENZOATE

                     Definition

                  Chemical name

                  Sodium methyl p-hydroxybenzoate

                  Sodium compound of the methylester of p-hydroxybenzoic acid

                  Chemical formula

                  C8H7O3Na

                  Molecular weight

                  174,15

                  Assay

                  Content not less than 99,5 % on the anhydrous basis

                     Description

                  White, hygroscopic powder

                     Identification

                              A.

                              The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 oC for two hours, have a melting range of 125 oC to 128 oC

                              B.

                              Positive test for sodium

                              C.

                              pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3

                     Purity

                  Water content

                  Not more than 5 % (Karl Fischer method)

                  Sulphated ash

                  40 % to 44,5 % on the anhydrous basis

                     p-Hydroxybenzoic acid and salicylic acid

                  Not more than 0,35 % expressed as p-hydroxybenzoic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 220 SULPHUR DIOXIDE

                     Definition

                  Chemical name

                  Sulphur dioxide

                  Sulphurous acid anhydride

                  Einecs

                  231-195-2

                  Chemical formula

                  SO2

                  Molecular weight

                  64,07

                  Assay

                  Content not less than 99 %

                     Description

                  Colourless, non-flammable gas with strong pungent suffocating odour

                     Identification

                              A.

                              Positive test for sulphurous substances

                     Purity

                  Water content

                  Not more than 0,05 %

                  Non-volatile residue

                  Not more than 0,01 %

                  Sulphur trioxide

                  Not more than 0,1 %

                  Selenium

                  Not more than 10 mg/kg

                  Other gases not normally present in the air

                  No trace

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 221 SODIUM SULPHITE

                     Definition

                  Chemical name

                  Sodium sulphite (anhydrous or heptahydrate)

                  Einecs

                  231-821-4

                  Chemical formula

                  Anhydrous:

                  Na2SO3

                  Heptahydrate:

                  Na2SO37H2O

                  Molecular weight

                  Anhydrous:

                  126,04

                  Heptahydrate:

                  252,16

                  Assay

                  Anhydrous:

                  Not less than 95 % of Na2SO3 and not less than 48 % of SO2

                  Heptahydrate:

                  Not less than 48 % of Na2SO3 and not less than 24 % of SO2

                     Description

                  White crystalline powder or colourless crystals

                     Identification

                              A.

                              Positive tests for sulphite and for sodium

                              B.

                              pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5

                     Purity

                  Thiosulphate

                  Not more than 0,1 % based on the SO2 content

                  Iron

                  Not more than 50 mg/kg based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 222 SODIUM BISULPHITE

                     Definition

                  Chemical name

                  Sodium bisulphite

                  Sodium hydrogen sulphite

                  Einecs

                  231-921-4

                  Chemical formula

                  NaHSO3 in aqueous solution

                  Molecular weight

                  104,06

                  Assay

                  Content not less than 32 % w/w NaHSO3

                     Description

                  A clear, colourless to yellow solution

                     Identification

                              A.

                              Positive tests for sulphite and for sodium

                              B.

                              pH of a 10 % aqueous solution between 2,5 and 5,5

                     Purity

                  Iron

                  Not more than 50 mg/kg of Na2SO3 based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 223 SODIUM METABISULPHITE

                     Synonyms

                  Pyrosulphite

                  Sodium pyrosulphite

                     Definition

                  Chemical name

                  Sodium disulphite

                  Disodium pentaoxodisulphate

                  Einecs

                  231-673-0

                  Chemical formula

                  Na2S2O5

                  Molecular weight

                  190,11

                  Assay

                  Content not less than 95 % Na2S2O5 and not less than 64 % of SO2

                     Description

                  White crystals or crystalline powder

                     Identification

                              A.

                              Positive tests for sulphite and for sodium

                              B.

                              pH of a 10 % aqueous solution between 4,0 and 5,5

                     Purity

                  Thiosulphate

                  Not more than 0,1 % based on the SO2 content

                  Iron

                  Not more than 50 mg/kg based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 224 POTASSIUM METABISULPHITE

                     Synonyms

                  Potassium pyrosulphite

                     Definition

                  Chemical name

                  Potassium disulphite

                  Potassium pentaoxo disulphate

                  Einecs

                  240-795-3

                  Chemical formula

                  K2S2O5

                  Molecular weight

                  222,33

                  Assay

                  Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate

                     Description

                  Colourless crystals or white crystalline powder

                     Identification

                              A.

                              Positive tests for sulphite and for potassium

                     Purity

                  Thiosulphate

                  Not more than 0,1 % based on the SO2 content

                  Iron

                  Not more than 50 mg/kg based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 226 CALCIUM SULPHITE

                     Definition

                  Chemical name

                  Calcium sulphite

                  Einecs

                  218-235-4

                  Chemical formula

                  CaSO3·2H2O

                  Molecular weight

                  156,17

                  Assay

                  Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2

                     Description

                  White crystals or white crystalline powder

                     Identification

                              A.

                              Positive tests for sulphite and for calcium

                     Purity

                  Iron

                  Not more than 50 mg/kg based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 227 CALCIUM BISULPHITE

                     Definition

                  Chemical name

                  Calcium bisulphite

                  Calcium hydrogen sulphite

                  Einecs

                  237-423-7

                  Chemical formula

                  Ca(HSO3)2

                  Molecular weight

                  202,22

                  Assay

                  6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]

                     Description

                  Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide

                     Identification

                              A.

                              Positive tests for sulphite and for calcium

                     Purity

                  Iron

                  Not more than 50 mg/kg based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 228 POTASSIUM BISULPHITE

                     Definition

                  Chemical name

                  Potassium bisulphite

                  Potassium hydrogen sulphite

                  Einecs

                  231-870-1

                  Chemical formula

                  KHSO3 in aqueous solution

                  Molecular weight

                  120,17

                  Assay

                  Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)

                     Description

                  Clear colourless aqueous solution

                     Identification

                              A.

                              Positive tests for sulphite and for potassium

                     Purity

                  Iron

                  Not more than 50 mg/kg based on the SO2 content

                  Selenium

                  Not more than 10 mg/kg based on the SO2 content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 230 BIPHENYL

                     Synonyms

                  Diphenyl

                     Definition

                  Chemical name

                  1,1′-biphenyl

                  Phenylbenzene

                  Einecs

                  202-163-5

                  Chemical formula

                  C12H10

                  Molecular weight

                  154,20

                  Assay

                  Content not less than 99,8 %

                     Description

                  White or pale yellow to amber crystalline solid having a characteristic odour

                     Identification

                              A.

                              Melting range

                  68,5 oC to 70,5 oC

                              B.

                              Distillation range

                  It distils completely within a 2,5 oC range between 252,5 oC and 257,5 oC

                     Purity

                  Benzene

                  Not more than 10 mg/kg

                  Aromatic amines

                  Not more than 2 mg/kg (as aniline)

                  Phenol derivatives

                  Not more than 5 mg/kg (as phenol)

                  Readily carbonisable substances

                  Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

                  Terphenyl and higher polyphenyl derivatives

                  Not more than 0,2 %

                  Polycyclic aromatic hydrocarbons

                  Absent

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 231 ORTHOPHENYLPHENOL

                     Synonyms

                  Orthoxenol

                     Definition

                  Chemical name

                  (1,1'-Biphenyl)-2-ol

                  2-Hydroxydiphenyl

                     o-Hydroxydiphenyl

                  Einecs

                  201-993-5

                  Chemical formula

                  C12H10O

                  Molecular weight

                  170,20

                  Assay

                  Content not less than 99 %

                     Description

                  White or slightly yellowish crystalline powder

                     Identification

                              A.

                              Melting range

                  56 oC to 58 oC

                              B.

                              Positive test for phenolate

                  An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution

                     Purity

                  Sulphated ash

                  Not more than 0,05 %

                  Diphenyl ether

                  Not more than 0,3 %

                     p-Phenylphenol

                  Not more than 0,1 %

                  1-Naphthol

                  Not more than 0,01 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 232 SODIUM ORTHOPHENYLPHENOL

                     Synonyms

                  Sodium orthophenylphenate

                  Sodium salt ofo-phenylphenol

                     Definition

                  Chemical name

                  Sodium orthophenylphenol

                  Einecs

                  205-055-6

                  Chemical formula

                  C12H9ONa· 4H2O

                  Molecular weight

                  264,26

                  Assay

                  Content not less than 97 % of C12H9ONa· 4H2O

                     Description

                  White or slightly yellowish crystalline powder

                     Identification

                              A.

                              Positive tests for phenolate and for sodium

                              B.

                              Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56 oC to 58 oC after drying in a sulphuric acid desiccator

                              C.

                              pH of a 2 % aqueous solution must be between 11,1 and 11,8

                     Purity

                  Diphenylether

                  Not more than 0,3 %

                     p-phenylphenol

                  Not more than 0,1 %

                  1-naphthol

                  Not more than 0,01 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 233 THIABENDAZOLE

                     Definition

                  Chemical name

                  4-(2-benzimidazolyl)thiazole

                  2-(4-thiazolyl)-1H-benzimidazole

                  Einecs

                  205-725-8

                  Chemical formula

                  C10H7N3S

                  Molecular weight

                  201,26

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  White, or almost white, odourless powder

                     Identification

                              A.

                              Melting range

                  296 oC to 303 oC

                              B.

                              Spectrometry

                  Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm

                     at 302 nm ± 2 nm: approximately 1 230

                     at 258 nm ± 2 nm: approximately 200

                     at 243 nm ± 2 nm: approximately 620

                  Ratio of absorption 243 nm/302 nm = 0,47 to 0,53

                  Ratio of absorption 258 nm/302 nm = 0,14 to 0,18

                     Purity

                  Water content

                  Not more than 0,5 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,2 %

                  Selenium

                  Not more than 3 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 234 NISIN

                     Definition

                  Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N

                  Einecs

                  215-807-5

                  Chemical formula

                  C143H230N42O37S7

                  Molecular weight

                  3 354 ,12

                  Assay

                  Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %

                     Description

                  White powder

                     Purity

                  Loss on drying

                  Not more than 3 % when dried to constant weight at 102 oC to 103 oC

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 235 NATAMYCIN

                     Synonyms

                  Pimaricin

                     Definition

                  Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis

                  Einecs

                  231-683-5

                  Chemical formula

                  C33H47O13N

                  Molecular weight

                  665,74

                  Assay

                  Content not less than 95 % on the anhydrous basis

                     Description

                  White to creamy-white crystalline powder

                     Identification

                              A.

                              Colour reactions

                  On adding a few crystals of natamycin on a spot plate, to a drop of:

                              —

                              concentrated hydrochloric acid, a blue colour develops,

                              —

                              concentrated phosphoric acid, a green colour develops,

                        which changes into pale red after a few minutes

                              B.

                              Spectrometry

                  A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm

                              C.

                              pH

                  5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)

                              D.

                              Specific rotation

                  [α]D
                     20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)

                     Purity

                  Loss on drying

                  Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)

                  Sulphated ash

                  Not more than 0,5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Microbiological criteria: total viable count

                  Not more than 100/g

            E 239 HEXAMETHYLENE TETRAMINE

                     Synonyms

                  Hexamine

                  Methenamine

                     Definition

                  Chemical name

                  1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine

                  Einecs

                  202-905-8

                  Chemical formula

                  C6H12N4

                  Molecular weight

                  140,19

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Colourless or white crystalline powder

                     Identification

                              A.

                              Positive tests for formaldehyde and for ammonia

                              B.

                              Sublimation point approximately 260 oC

                     Purity

                  Loss on drying

                  Not more than 0,5 % after drying at 105 oC in vacuum over P2O5 for two hours

                  Sulphated ash

                  Not more than 0,05 %

                  Sulphates

                  Not more than 0,005 % expressed as SO4

                  Chlorides

                  Not more than 0,005 % expressed as Cl

                  Ammonium salts

                  Not detectable

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 242 DIMETHYL DICARBONATE

                     Synonyms

                  DMDC

                  Dimethyl pyrocarbonate

                     Definition

                  Chemical name

                  Dimethyl dicarbonate

                  Pyrocarbonic acid dimethyl ester

                  Einecs

                  224-859-8

                  Chemical formula

                  C4H6O5

                  Molecular weight

                  134,09

                  Assay

                  Content not less than 99,8 %

                     Description

                  Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion

                     Identification

                              A.

                              Decomposition

                  After dilution positive tests for CO2 and methanol

                              B.

                              Melting point

                  17 oC

                  Boiling point

                  172 oC with decomposition

                              C.

                              Density 20 oC

                  Approximately 1,25 g/cm3

                              D.

                              Infrared spectrum

                  Maxima at 1 156 and 1 832 cm- 1

                     Purity

                  Dimethyl carbonate

                  Not more than 0,2 %

                  Chlorine, total

                  Not more than 3 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 249 POTASSIUM NITRITE

                     Definition

                  Chemical name

                  Potassium nitrite

                  Einecs

                  231-832-4

                  Chemical formula

                  KNO2

                  Molecular weight

                  85,11

                  Assay

                  Content not less than 95 % on the anhydrous basis (6)

                     Description

                  White or slightly yellow, deliquescent granules

                     Identification

                              A.

                              Positive tests for nitrite and for potassium

                              B.

                              pH of a 5 % solution:

                  Not less than 6,0 and not more than 9,0

                     Purity

                  Loss on drying

                  Not more than 3 % after drying for four hours over silica gel

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 250 SODIUM NITRITE

                     Definition

                  Chemical name

                  Sodium nitrite

                  Einecs

                  231-555-9

                  Chemical formula

                  NaNO2

                  Molecular weight

                  69,00

                  Assay

                  Content not less than 97 % on the anhydrous basis (7)

                     Description

                  White crystalline powder or yellowish lumps

                     Identification

                              A.

                              Positive tests for nitrite and for sodium

                     Purity

                  Loss on drying

                  Not more than 0,25 % after drying over silica gel for four hours

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 251 SODIUM NITRATE
      1.   SOLID SODIUM NITRATE

                     Synonyms

                  Chile saltpetre

                  Cubic or soda nitre

                     Definition

                  Chemical name

                  Sodium nitrate

                  Einecs

                  231-554-3

                  Chemical formula

                  NaNO3

                  Molecular weight

                  85,00

                  Assay

                  Content not less than 99 % after drying

                     Description

                  White crystalline, slightly hygroscopic powder

                     Identification

                              A.

                              Positive tests for nitrate and for sodium

                              B.

                              pH of a 5 % solution

                  Not less than 5,5 and more than 8,3

                     Purity

                  Loss on drying

                  Not more than 2 % after drying at 105 oC for four hours

                  Nitrites

                  Not more than 30 mg/kg expressed as NaNO2

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 251 SODIUM NITRATE
      2.   LIQUID SODIUM NITRATE

                     Definition

                  Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.

                  Chemical name

                  Sodium nitrate

                  Einecs

                  231-554-3

                  Chemical formula

                  NaNO3

                  Molecular weight

                  85,00

                  Assay

                  Content between 33,5 % and 40,0 % of NaNO3

                     Description

                  Clear colourless liquid

                     Identification

                              A.

                              Positive tests for nitrate and for sodium

                              B.

                              pH

                  Not less than 1,5 and not more than 3,5

                     Purity

                  Free nitric acid

                  Not more than 0,01 %

                  Nitrites

                  Not more than 10 mg/kg expressed as NaNO2

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 0,3 mg/kg

                  This specification refers to a 35 % aqueous solution

            E 252 POTASSIUM NITRATE

                     Synonyms

                  Chile saltpetre
                  Cubic or soda nitre

                     Definition

                  Chemical name

                  Potassium nitrate

                  Einecs

                  231-818-8

                  Chemical formula

                  KNO3

                  Molecular weight

                  101,11

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  White crystalline powder or transparent prisms having a cooling, saline, pungent taste

                     Identification

                              A.

                              Positive tests for nitrate and for potassium

                              B.

                              pH of a 5 % solution

                  Not less than 4,5 and not more than 8,5

                     Purity

                  Loss on drying

                  Not more than 1 % after drying at 105 oC for four hours

                  Nitrites

                  Not more than 20 mg/kg expressed as KNO2

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 260 ACETIC ACID

                     Definition

                  Chemical name

                  Acetic acid

                  Ethanoic acid

                  Einecs

                  200-580-7

                  Chemical formula

                  C2H4O2

                  Molecular weight

                  60,05

                  Assay

                  Content not less than 99,8 %

                     Description

                  Clear, colourless liquid having a pungent, characteristic odour

                     Identification

                              A.

                              Boiling point

                  118 oC at 760 mm pressure (of mercury)

                              B.

                              Specific gravity

                  About 1,049

                              C.

                              A one in three solution gives positive tests for acetate

                              D.

                              Solidification point

                  Not lower than 14,5 oC

                     Purity

                  Non-volatile residue

                  Not more than 100 mg/kg

                  Formic acid, formates and other oxidisable substances

                  Not more than 1 000 mg/kg expressed as formic acid

                  Readily oxidisable substances

                  Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 261 POTASSIUM ACETATE

                     Definition

                  Chemical name

                  Potassium acetate

                  Einecs

                  204-822-2

                  Chemical formula

                  C2H3O2K

                  Molecular weight

                  98,14

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour

                     Identification

                              A.

                              pH of a 5 % aqueous solution

                  Not less than 7,5 and not more than 9,0

                              B.

                              Positive tests for acetate and for potassium

                     Purity

                  Loss on drying

                  Not more than 8 % after drying at 150 oC for two hours

                  Formic acid, formates and other oxidisable substances

                  Not more than 1 000 mg/kg expressed as formic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 262 (i) SODIUM ACETATE

                     Definition

                  Chemical name

                  Sodium acetate

                  Einecs

                  204-823-8

                  Chemical formula

                  C2H3NaO2·nH2O (n = 0 or 3)

                  Molecular weight

                  Anhydrous:

                  82,03

                  Trihydrate:

                  136,08

                  Assay

                  Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis

                     Description

                  Anhydrous:

                  White, odourless, granular, hygroscopic powder

                  Trihydrate:

                  Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air

                     Identification

                              A.

                              pH of a 1 % aqueous solution

                  Not less than 8,0 and not more than 9,5

                              B.

                              Positive tests for acetate and for sodium

                     Purity

                  Loss on drying

                  Anhydrous:

                  Not more than 2 % (120 oC, 4 hours)

                  Trihydrate:

                  Between 36 and 42 % (120 oC, 4 hours)

                  Formic acid, formates and other oxidisable substances

                  Not more than 1 000 mg/kg expressed as formic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 262 (ii) SODIUM DIACETATE

                     Definition

                  Sodium diacetate is a molecular compound of sodium acetate and acetic acid

                  Chemical name

                  Sodium hydrogen diacetate

                  Einecs

                  204-814-9

                  Chemical formula

                  C4H7NaO4·nH2O (n = 0 or 3)

                  Molecular weight

                  142,09 (anhydrous)

                  Assay

                  Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate

                     Description

                  White, hygroscopic crystalline solid with an acetic odour

                     Identification

                              A.

                              pH of a 10 % aqueous solution

                  Not less than 4,5 and not more than 5,0

                              B.

                              Positive tests for acetate and for sodium

                     Purity

                  Water content

                  Not more than 2 % (Karl Fischer method)

                  Formic acid, formates and other oxidisable substances

                  Not more than 1 000 mg/kg expressed as formic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 263 CALCIUM ACETATE

                     Definition

                  Chemical name

                  Calcium acetate

                  Einecs

                  200-540-9

                  Chemical formula

                  Anhydrous:

                  C4H6O4Ca

                  Monohydrate:

                  C4H6O4Ca· H2O

                  Molecular weight

                  Anhydrous:

                  158,17

                  Monohydrate:

                  176,18

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder

                     Identification

                              A.

                              pH of a 10 % aqueous solution

                  Not less than 6,0 and not more than 9,0

                              B.

                              Positive tests for acetate and for calcium

                     Purity

                  Loss on drying

                  Not more than 11 % after drying (155 oC to constant weight, for the monohydrate)

                  Water insoluble matter

                  Not more than 0,3 %

                  Formic acid, formates and other oxidisable substances

                  Not more than 1 000 mg/kg expressed as formic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 270 LACTIC ACID

                     Definition

                  Chemical name

                  Lactic acid

                  2-Hydroxypropionic acid

                  1-Hydroxyethane-1-carboxylic acid

                  Einecs

                  200-018-0

                  Chemical formula

                  C3H6O3

                  Molecular weight

                  90,08

                  Assay

                  Content not less than 76 % and not more than 84 %

                     Description

                  Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically

                     Note:

                  Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid

                     Identification

                              A.

                              Positive test for lactate

                     Purity

                  Sulphated ash

                  Not more than 0,1 %

                  Chloride

                  Not more than 0,2 %

                  Sulphate

                  Not more than 0,25 %

                  Iron

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                     Note:

                  This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content

            E 280 PROPIONIC ACID

                     Definition

                  Chemical name

                  Propionic acid

                  Propanoic acid

                  Einecs

                  201-176-3

                  Chemical formula

                  C3H6O2

                  Molecular weight

                  74,08

                  Assay

                  Content not less than 99,5 %

                     Description

                  Colourless or slightly yellowish, oily liquid with a slightly pungent odour

                     Indentification

                              A.

                              Melting point

                  - 22 oC

                              B.

                              Distillation range

                  138,5 oC to 142,5 oC

                     Purity

                  Non-volatile residue

                  Not more than 0,01 % when dried at 140 oC to constant weight

                  Aldehydes

                  Not more than 0,1 % expressed as formaldehyde

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 281 SODIUM PROPIONATE

                     Definition

                  Chemical name

                  Sodium propionate

                  Sodium propanoate

                  Einecs

                  205-290-4

                  Chemical formula

                  C3H5O2Na

                  Molecular weight

                  96,06

                  Assay

                  Content not less than 99 % after drying for two hours at 105 oC

                     Description

                  White crystalline hygroscopic powder, or a fine white powder

                     Identification

                              A.

                              Positive tests for propionate and for sodium

                              B.

                              pH of a 10 % aqueous solution

                  Not less than 7,5 and not more than 10,5

                     Purity

                  Loss on drying

                  Not more than 4 % determined by drying for two hours at 105 oC

                  Water insolubles

                  Not more than 0,1 %

                  Iron

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 282 CALCIUM PROPIONATE

                     Definition

                  Chemical name

                  Calcium propionate

                  Einecs

                  223-795-8

                  Chemical formula

                  C6H10O4Ca

                  Molecular weight

                  186,22

                  Assay

                  Content not less than 99 %, after drying for two hours at 105 oC

                     Description

                  White crystalline powder

                     Identification

                              A.

                              Positive tests for propionate and for calcium

                              B.

                              pH of a 10 % aqueous solution

                  Between 6,0 and 9,0

                     Purity

                  Loss on drying

                  Not more than 4 %, determined by drying for two hours at 105 oC

                  Water insolubles

                  Not more than 0,3 %

                  Iron

                  Not more than 50 mg/kg

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 283 POTASSIUM PROPIONATE

                     Definition

                  Chemical name

                  Potassium propionate

                  Potassium propanoate

                  Einecs

                  206-323-5

                  Chemical formula

                  C3H5KO2

                  Molecular weight

                  112,17

                  Assay

                  Content not less than 99 % after drying for two hours at 105 oC

                     Description

                  White crystalline powder

                     Identification

                              A.

                              Positive tests for propionate and for potassium

                     Purity

                  Loss on drying

                  Not more than 4 %, determined by drying for two hours at 105 oC

                  Water-insoluble substances

                  Not more than 0,3 %

                  Iron

                  Not more than 30 mg/kg

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 284 BORIC ACID

                     Synonyms

                  Boracic acid

                  Orthoboric acid

                  Borofax

                     Definition

                  Einecs

                  233-139-2

                  Chemical formula

                  H3BO3

                  Molecular weight

                  61,84

                  Assay

                  Content not less than 99,5 %

                     Description

                  Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite

                     Identification

                              A.

                              Melting point

                  At approximately 171 oC

                              B.

                              Burns with a nice green flame

                              C.

                              pH of a 3,3 % aqueous solution

                  Between 3,8 and 4,8

                     Purity

                  Peroxides

                  No colour develops with added KI-solution

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 285 SODIUM TETRABORATE (BORAX)

                     Synonyms

                  Sodium borate

                     Definition

                  Chemical name

                  Sodium tetraborate

                  Sodium biborate

                  Sodium pyroborate

                  Anhydrous tetraborate

                  Einecs

                  215-540-4

                  Chemical formula

                  Na2B4O7

                  Na2B4O7·10H2O

                  Molecular weight

                  201,27

                     Description

                  Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water

                     Identification

                              A.

                              Melting range

                  Between 171 oC and 175 oC with decomposition

                     Purity

                  Peroxides

                  No colour develops with added KI-solution

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 290 CARBON DIOXIDE

                     Synonyms

                  Carbonic acid gas

                  Dry ice (solid form)

                  Carbonic anhydride

                     Definition

                  Chemical name

                  Carbon dioxide

                  Einecs

                  204-696-9

                  Chemical formula

                  CO2

                  Molecular weight

                  44,01

                  Assay

                  Content not less than 99 % v/v on the gaseous basis

                     Description

                  A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders

                     Identification

                              A.

                              Precipitation (Precipitate formation)

                  When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid

                     Purity

                  Acidity

                  915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)

                  Reducing substances, hydrogen phosphide and sulphide

                  915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution

                  Carbon monoxide

                  Not more than 10 μl/l

                  Oil content

                  Not more than 0,1 mg/l

            E 296 MALIC ACID

                     Synonyms

                  DL-Malic acid, pomalous acid

                     Definition

                  Chemical name

                  DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid

                  Einecs

                  230-022-8

                  Chemical formula

                  C4H6O5

                  Molecular weight

                  134,09

                  Assay

                  Content not less than 99,0 %

                     Description

                  White or nearly white crystalline powder or granules

                     Identification

                              A.

                              Melting range between 127 oC and 132 oC

                              B.

                              Positive test for malate

                              C.

                              Solutions of this substance are optically inactive in all concentrations

                     Purity

                  Sulphated ash

                  Not more than 0,1 %

                  Fumaric acid

                  Not more than 1,0 %

                  Maleic acid

                  Not more than 0,05 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 297 FUMARIC ACID

                     Definition

                  Chemical name

                  Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid

                  Einecs

                  203-743-0

                  Chemical formula

                  C4H4O4

                  Molecular weight

                  116,07

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  White crystalline powder or granules

                     Identification

                              A.

                              Melting range

                  286 oC-302 oC (closed capillary, rapid heating)

                              B.

                              Positive tests for double bonds and for 1,2-dicarboxylic acid

                              C.

                              pH of a 0,05 % solution at 25 oC

                  3,0-3,2

                     Purity

                  Loss on drying

                  Not more than 0,5 % (120 oC, 4h)

                  Sulphated ash

                  Not more than 0,1 %

                  Maleic acid

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 300 ASCORBIC ACID

                     Definition

                  Chemical name

                  L-ascorbic acid

                  Ascorbic acid

                  2,3-Didehydro-L-threo-hexono-1,4-lactone

                  3-Keto-L-gulofuranolactone

                  Einecs

                  200-066-2

                  Chemical formula

                  C6H8O6

                  Molecular weight

                  176,13

                  Assay

                  Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6

                     Description

                  White to pale yellow, odourless crystalline solid

                     Identification

                              A.

                              Melting range

                  Between 189 oC and 193 oC with decomposition

                              B.

                              Positive tests for ascorbic acid

                     Purity

                  Loss on drying

                  Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours

                  Sulphated ash

                  Not more than 0,1 %

                  Specific rotation

                  [α]D
                     20 between +20,5o and +21,5o (10 % w/v aqueous solution)

                  pH of a 2 % aqueous solution

                  Between 2,4 and 2,8

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 301 SODIUM ASCORBATE

                     Definition

                  Chemical name

                  Sodium ascorbate

                  Sodium L-ascorbate

                  2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate

                  3-Keto-L-gulofurano-lactone sodium enolate

                  Einecs

                  205-126-1

                  Chemical formula

                  C6H7O6Na

                  Molecular weight

                  198,11

                  Assay

                  Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na

                     Description

                  White or almost white, odourless crystalline solid which darkens on exposure to light

                     Identification

                              A.

                              Positive tests for ascorbate and for sodium

                     Purity

                  Loss on drying

                  Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours

                  Specific rotation

                  [α]D
                     20 between + 103o and + 106o (10 % w/v aqueous solution)

                  pH of 10 % aqueous solution

                  Between 6,5 and 8,0

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 302 CALCIUM ASCORBATE

                     Definition

                  Chemical name

                  Calcium ascorbate dihydrate

                  Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate

                  Einecs

                  227-261-5

                  Chemical formula

                  C12H14O12Ca· 2H2O

                  Molecular weight

                  426,35

                  Assay

                  Content not less than 98 % on a volatile matter-free basis

                     Description

                  White to slightly pale greyish-yellow odourless crystalline powder

                     Identification

                              A.

                              Positive tests for ascorbate and for calcium

                     Purity

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Specific rotation

                  [α]D
                     20 between + 95o and + 97o (5 % w/v aqueous solution)

                  pH of 10 % aqueous solution

                  Between 6,0 and 7,5

                  Volatile matter

                  Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 304 (i) ASCORBYL PALMITATE

                     Definition

                  Chemical name

                  Ascorbyl palmitate

                  L-ascorbyl palmitate

                  2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate

                  6-palmitoyl-3-keto-L-gulofuranolactone

                  Einecs

                  205-305-4

                  Chemical formula

                  C22H38O7

                  Molecular weight

                  414,55

                  Assay

                  Content not less than 98 % on the dried basis

                     Description

                  White or yellowish-white solid with a citrus-like odour

                     Identification

                              A.

                              Melting range

                  Between 107 oC and 117 oC

                     Purity

                  Loss on drying

                  Not more than 2,0 % after drying in a vacuum oven at 56 oC and 60 oC for one hour

                  Sulphated ash

                  Not more than 0,1 %

                  Specific rotation

                  [α]D
                     20 between + 21o and + 24o (5 % w/v in methanol solution)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 304 (ii) ASCORBYL STEARATE

                     Definition

                  Chemical name

                  Ascorbyl stearate

                  L-ascorbyl stearate

                  2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate

                  6-stearoyl-3-keto-L-gulofuranolactone

                  Einecs

                  246-944-9

                  Chemical formula

                  C24H42O7

                  Molecular weight

                  442,6

                  Assay

                  Content not less than 98 %

                     Description

                  White or yellowish, white solid with a citrus-like odour

                     Identification

                              A.

                              Melting point

                  About 116 oC

                     Purity

                  Loss on drying

                  Not more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC for one hour

                  Sulphated ash

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 306 TOCOPHEROL-RICH EXTRACT

                     Definition

                  Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols

                  Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols

                  Molecular weight

                  430,71 (d-α-tocopherol)

                  Assay

                  Content not less than 34 % of total tocopherols

                     Description

                  Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form

                     Identification

                              A.

                              By suitable gas liquid chromatographic method

                              B.

                              Solubility tests

                  Insoluble in water. Soluble in ethanol. Miscible in ether

                     Purity

                  Sulphated ash

                  Not more than 0,1 %

                  Specific rotation

                  [α]D
                     20 not less than + 20o

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 307 ALPHA-TOCOPHEROL

                     Synonyms

                  DL-α-Tocopherol

                     Definition

                  Chemical name

                  DL-5,7,8-Trimethyltocol

                  DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

                  Einecs

                  233-466-0

                  Chemical formula

                  C29H50O2

                  Molecular weight

                  430,71

                  Assay

                  Content not less than 96 %

                     Description

                  Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light

                     Identification

                              A.

                              Solubility tests

                  Insoluble in water, freely soluble in ethanol, miscible in ether

                              B.

                              Spectro-photometry

                  In absolute ethanol the maximum absorption is about 292 nm

                     Purity

                  Refractive index

                  n D
                     201,503-1,507

            Specific absorption
                      in ethanol

                     (292 nm) 72-76
                  (0,01 g in 200 ml of absolute ethanol)

                  Sulphated ash

                  Not more than 0,1 %

                  Specific rotation

                  [α]D
                     25 0o±0,05o (1 in 10 solution in chloroform)

                  Lead

                  Not more than 2 mg/kg

            E 308 GAMMA-TOCOPHEROL

                     Synonyms

                  dl-γ-Tocopherol

                     Definition

                  Chemical name

                  2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

                  Einecs

                  231-523-4

                  Chemical formula

                  C28H48O2

                  Molecular weight

                  416,69

                  Assay

                  Content not less than 97 %

                     Description

                  Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light

                     Identification

                              A.

                              Spectrometry

                  Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

                     Purity

            Specific absorption
                      in ethanol

                     (298 nm) between 91 and 97

                     (257 nm) between 5,0 and 8,0

                  Refractive index

                     1,503-1,507

                  Sulphated ash

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 309 DELTA-TOCOPHEROL

                     Definition

                  Chemical name

                  2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

                  Einecs

                  204-299-0

                  Chemical formula

                  C27H46O2

                  Molecular weight

                  402,7

                  Assay

                  Content not less than 97 %

                     Description

                  Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light

                     Identification

                              A.

                              Spectrometry

                  Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

                     Purity

            Specific absorption
                      in ethanol

                     (298 nm) between 89 and 95

                     (257 nm) between 3,0 and 6,0

                  Refractive index

                     1,500-1,504

                  Sulphated ash

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 310 PROPYL GALLATE

                     Definition

                  Chemical name

                  Propyl gallate

                  Propyl ester of gallic acid

                  n-propyl ester of 3,4,5-trihydroxybenzoic acid

                  Einecs

                  204-498-2

                  Chemical formula

                  C10H12O5

                  Molecular weight

                  212,20

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  White to creamy-white, crystalline, odourless solid

                     Identification

                              A.

                              Solubility tests

                  Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol

                              B.

                              Melting range

                  Between 146 oC and 150 oC after drying at 110 oC for four hours

                     Purity

                  Loss on drying

                  Not more than 1,0 % (110 oC, four hours)

                  Sulphated ash

                  Not more than 0,1 %

                  Free acid

                  Not more than 0,5 % (as gallic acid)

                  Chlorinated organic compound

                  Not more than 100 mg/kg (as C1)

            Specific absorption
                      in ethanol

                     (275 nm) not less than 485 and not more than 520

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 311 OCTYL GALLATE

                     Definition

                  Chemical name

                  Octyl gallate

                  Octyl ester of gallic acid

                  n-octyl ester of 3,4,5-trihydroxybenzoic acid

                  Einecs

                  213-853-0

                  Chemical formula

                  C15H22O5

                  Molecular weight

                  282,34

                  Assay

                  Content not less than 98 % after drying at 90 oC for six hours

                     Description

                  White to creamy-white odourless solid

                     Identification

                              A.

                              Solubility tests

                  Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol

                              B.

                              Melting range

                  Between 99 oC and 102 oC after drying at 90 oC for six hours

                     Purity

                  Loss on drying

                  Not more than 0,5 % (90 oC, six hours)

                  Sulphated ash

                  Not more than 0,05 %

                  Free acid

                  Not more than 0,5 % (as gallic acid)

                  Chlorinated organic compound

                  Not more than 100 mg/kg (as C1)

            Specific absorption
                      in ethanol

                     (275 nm) not less than 375 and not more than 390

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 312 DODECYL GALLATE

                     Synonyms

                  Lauryl gallate

                     Definition

                  Chemical name

                  Dodecyl gallate

                  n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid

                  Dodecyl ester of gallic acid

                  Einecs

                  214-620-6

                  Chemical formula

                  C19H30O5

                  Molecular weight

                  338,45

                  Assay

                  Content not less than 98 % after drying at 90 oC for six hours

                     Description

                  White or creamy-white odourless solid

                     Identification

                              A.

                              Solubility tests

                  Insoluble in water, freely soluble in ethanol and ether

                              B.

                              Melting range

                  Between 95 oC and 98 oC after drying at 90 oC for six hours

                     Purity

                  Loss on drying

                  Not more than 0,5 % (90 oC, six hours)

                  Sulphated ash

                  Not more than 0,05 %

                  Free acid

                  Not more than 0,5 % (as gallic acid)

                  Chlorinated organic compound

                  Not more than 100 mg/kg (as Cl)

            Specific absorption
                      in ethanol

                     (275 nm) not less than 300 and not more than 325

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 30 mg/kg

            E 315 ERYTHORBIC ACID

                     Synonyms

                  Isoascorbic acid

                  D-Araboascorbic acid

                     Definition

                  Chemical name

                  D-Erythro-hex-2-enoic acid γ-lactone

                  Isoascorbic acid

                  D-Isoascorbic acid

                  Einecs

                  201-928-0

                  Chemical formula

                  C6H8O6

                  Molecular weight

                  176,13

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  White to slightly yellow crystalline solid which darkens gradually on exposure to light

                     Identification

                              A.

                              Melting range

                  About 164 oC to 172 oC with decomposition

                              B.

                              Positive test for ascorbic acid/colour reaction

                     Purity

                  Loss on drying

                  Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours

                  Sulphated ash

                  Not more than 0,3 %

                  Specific rotation

                  [α]10 % (w/v) aqueous solution between -16,5o to -18,0o

                  Oxalate

                  To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

                  Lead

                  Not more than 2 mg/kg

            E 316 SODIUM ERYTHORBATE

                     Synonyms

                  Sodium isoascorbate

                     Definition

                  Chemical name

                  Sodium isoascorbate

                  Sodium D-isoascorbic acid

                  Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone

                  3-keto-D-gulofurano-lactone sodium enolate monohydrate

                  Einecs

                  228-973-9

                  Chemical formula

                  C6H7O6Na· H2O

                  Molecular weight

                  216,13

                  Assay

                  Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis

                     Description

                  White crystalline solid

                     Identification

                              A.

                              Solubility tests

                  Freely soluble in water, very slightly soluble in ethanol

                              B.

                              Positive test for ascorbic acid/colour reaction

                              C.

                              Positive test for sodium

                     Purity

                  Loss on drying

                  Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours

                  Specific rotation

                  [α]10 % (w/v) aqueous solution between + 95o and + 98o

                  pH of a 10 % aqueous solution

                  5,5 to 8,0

                  Oxalate

                  To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)

                     Synonyms

                  TBHQ

                     Definition

                  Chemical names

                  Tert-butyl-1,4-benzenediol

                  2-(1,1-Dimethylethyl)-1,4-benzenediol

                  Einecs

                  217-752-2

                  Chemical formula

                  C10H14O2

                  Molecular weight

                  166,22

                  Assay

                  Content not less than 99 % of C10H14O2

                     Description

                  White crystalline solid having a characteristic odour

                     Identification

                              A.

                              Solubility

                  Practically insoluble in water; soluble in ethanol

                              B.

                              Melting point

                  Not less than 126,5 oC

                              C.

                              Phenolics

                  Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced

                     Purity

                  Tertiary-Butyl-p-benzoquinone

                  Not more than 0,2 %

                  2,5-Di-tertiary-butyl hydroquinone

                  Not more than 0,2 %

                  Hydroxyquinone

                  Not more than 0,1 %

                  Toluene

                  Not more than 25 mg/kg

                  Lead

                  Not more than 2 mg/kg

            E 320 BUTYLATED HYDROXYANISOLE (BHA)

                     Synonyms

                  BHA

                     Definition

                  Chemical names

                  3-Tertiary-butyl-4-hydroxyanisole

                  A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole

                  Einecs

                  246-563-8

                  Chemical formula

                  C11H16O2

                  Formula weight

                  180,25

                  Assay

                  Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer

                     Description

                  White or slightly yellow crystals or waxy solid with a slight aromatic smell

                     Identification

                              A.

                              Solubility

                  Insoluble in water, freely soluble in ethanol

                              B.

                              Melting range

                  Between 48 °C and 63 °C

                              C.

                              Colour reaction

                  Passes test for phenol groups

                     Purity

                  Sulphated ash

                  Not more than 0,05 % after calcination at 800 ± 25 °C

                  Phenolic impurities

                  Not more than 0,5 %

            Specific absorption

                      (290 nm) not less than 190 and not more than 210
            Specific absorption

                      (228 nm) not less than 326 and not more than 345

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 321 BUTYLATED HYDROXYTOLUENE (BHT)

                     Synonyms

                  BHT

                     Definition

                  Chemical name

                  2,6-Ditertiary-butyl-p-cresol

                  4-Methyl-2,6-ditertiarybutylphenol

                  Einecs

                  204-881-4

                  Chemical formula

                  C15H24O

                  Molecular weight

                  220,36

                  Assay

                  Content not less than 99 %

                     Description

                  White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour

                     Identification

                              A.

                              Solubility tests

                  Insoluble in water and propane- 1,2-diol

                  Freely soluble in ethanol

                              B.

                              Melting point

                  At 70 oC

                              C.

                              Absorbance maximum

                  The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm

                     Purity

                  Sulphated ash

                  Not more than 0,005 %

                  Phenolic impurities

                  Not more than 0,5 %

            Specific absorption
                      in ethanol

                      (278 nm) not less than 81 and not more than 88

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 322 LECITHINS

                     Synonyms

                  Phosphatides

                  Phospholipids

                     Definition

                  Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides

                  Einecs

                  232-307-2

                  Assay

                              —

                              Lecithins: not less than 60,0 % of substances insoluble in acetone

                              —

                              Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone

                     Description

                              —

                              Lecithins: brown liquid or viscous semi-liquid or powder

                              —

                              Hydrolysed lecithins: light brown to brown viscous liquid or paste

                     Identification

                              A.

                              Positive tests for choline, for phosphorus and fatty acids

                              B.

                              Test for hydrolysed lecithin

                  To a 800 ml beaker add 500 ml of water (30 oC-35 oC). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g

                     Purity

                  Loss on drying

                  Not more than 2,0 % determined by drying at 105 oC for one hour

                  Toluene-insoluble matter

                  Not more than 0,3 %

                  Acid value

                              —

                              Lecithins: not more than 35 mg of potassium hydroxide per gram

                              —

                              Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram

                  Peroxide value

                  Equal to or less than 10

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 325 SODIUM LACTATE

                     Definition

                  Chemical name

                  Sodium lactate

                  Sodium 2-hydroxypropanoate

                  Einecs

                  200-772-0

                  Chemical formula

                  C3H5NaO3

                  Molecular weight

                  112,06 (anhydrous)

                  Assay

                  Content not less than 57 % and not more than 66 %

                     Description

                  Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour

                     Identification

                              A.

                              Positive test for lactate

                              B.

                              Positive test for sodium

                     Purity

                  Acidity

                  Not more than 0,5 % after drying expressed as lactic acid

                  pH of a 20 % aqueous solution

                  6,5 to 7,5

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Reducing substances

                  No reduction of Fehling's solution

                     Note:

                  This specification refers to a 60 % aqueous solution

            E 326 POTASSIUM LACTATE

                     Definition

                  Cheminal name

                  Potassium lactate

                  Potassium 2-hydroxypropanoate

                  Einecs

                  213-631-3

                  Chemical formula

                  C3H5O3K

                  Molecular weight

                  128,17 (anhydrous)

                  Assay

                  Content not less than 57 % and not more than 66 %

                     Description

                  Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour

                     Identification

                              A.

                              Ignition

                  Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added

                              B.

                              Colour reaction

                  Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact

                              C.

                              Positive tests for potassium and for lactate

                     Purity

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Acidity

                  Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required

                  Reducing substances

                  Potassium lactate solution shall not cause any reduction of Fehling's solution

                     Note:

                  This specification refers to a 60 % aqueous solution

            E 327 CALCIUM LACTATE

                     Definition

                  Chemical name

                  Calcium dilactate

                  Calcium dilactate hydrate

                  2-Hydroxypropanoic acid calcium salt

                  Einecs

                  212-406-7

                  Chemical formula

                  (C3H5O2)2 Ca· nH2O (n = 0-5)

                  Molecular weight

                  218,22 (anhydrous)

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  Almost odourless, white crystalline powder or granules

                     Identification

                              A.

                              Positive tests for lactate and for calcium

                              B.

                              Solubility tests

                  Soluble in water and practically insoluble in ethanol

                     Purity

                  Loss on drying

                  Determined by drying at 120 oC for four hours:

                              —

                              anhydrous: not more than 3,0 %

                              —

                              with 1 molecule of water: not more than 8,0 %

                              —

                              with 3 molecules of water: not more than 20,0 %

                              —

                              with 4,5 molecules of water: not more than 27,0 %

                  Acidity

                  Not more than 0,5 % of the dry matter expressed as lactic acid

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  pH of a 5 % solution

                  Between 6,0 and 8,0

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Reducing substances

                  No reduction of Fehling's solution

            E 330 CITRIC ACID

                     Definition

                  Chemical name

                  Citric acid

                  2-Hydroxy-1,2,3-propanetricarboxylic acid

                  β-Hydroxytricarballytic acid

                  Einecs

                  201-069-1

                  Chemical formula

                              (a)

                              C6H8O7 (anhydrous)

                              (b)

                              C6H8O7·H2O (monohydrate)

                  Molecular weight

                              (a)

                              192,13 (anhydrous)

                              (b)

                              210,15 (monohydrate)

                  Assay

                  Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis

                     Description

                  Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air

                     Identification

                              A.

                              Solubility tests

                  Very soluble in water; freely soluble in ethanol; soluble in ether

                     Purity

                  Water content

                  Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,05 % after calcination at 800 ± 25 oC

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

                  Oxalates

                  Not more than 100 mg/kg, expressed as oxalic acid, after drying

                  Readily carbonisable substances

                  Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 oC in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)

            E 331 (i) MONOSODIUM CITRATE

                     Synonyms

                  Monosodium citrate
                  Monobasic sodium citrate

                     Definition

                  Chemical name

                  Monosodium citrate

                  Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Chemical formula

                              (a)

                              C6H7O7Na (anhydrous)

                              (b)

                              C6H7O7Na· H2O (monohydrate)

                  Molecular weight

                              (a)

                              214,11 (anhydrous)

                              (b)

                              232,23 (monohydrate)

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Crystalline white powder or colourless crystals

                     Identification

                              A.

                              Positive tests for citrate and for sodium

                     Purity

                  Loss on drying

                  Determined by drying at 180 oC for four hours:

                              —

                              anhydrous: not more than 1,0 %

                              —

                              monohydrate: not more than 8,8 %

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 1 % aqueous solution

                  Between 3,5 and 3,8

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 331 (ii) DISODIUM CITRATE

                     Synonyms

                  Disodium citrate
                  Dibasic sodium citrate

                     Definition

                  Chemical name

                  Disodium citrate

                  Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Disodium salt of citric acid with 1,5 molecules of water

                  Einecs

                  205-623-3

                  Chemical formula

                  C6H6O7Na2·1,5H2O

                  Molecular weight

                  263,11

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Crystalline white powder or colourless crystals

                     Identification

                              A.

                              Positive tests for citrate and for sodium

                     Purity

                  Loss on drying

                  Not more than 13,0 % by drying at 180 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 1 % aqueous solution

                  Between 4,9 and 5,2

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 331 (iii) TRISODIUM CITRATE

                     Synonyms

                  Trisodium citrate
                  Tribasic sodium citrate

                     Definition

                  Chemical name

                  Trisodium citrate

                  Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form

                  Einecs

                  200-675-3

                  Chemical formula

                  Anhydrous:

                  C6H5O7Na3

                  Hydrated:

                  C6H5O7Na3·nH2O (n = 2 or 5)

                  Molecular weight

                  258,07 (anhydrous)

                  Assay

                  Not less than 99 % on the anhydrous basis

                     Description

                  Crystalline white powder or colourless crystals

                     Identification

                              A.

                              Positive tests for citrate and for sodium

                     Purity

                  Loss on drying

                  Determined by drying at 180 oC for four hours:

                              —

                              anhydrous:

                  not more than 1,0 %

                              —

                              dihydrate:

                  not more than 13,5 %

                              —

                              pentahydrate:

                  not more than 30,3 %

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 5 % aqueous solution

                  Between 7,5 and 9,0

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 332 (i) MONOPOTASSIUM CITRATE

                     Synonyms

                  Monopotassium citrate
                  Monobasic potassium citrate

                     Definition

                  Chemical name

                  Monopotassium citrate

                  Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Anhydrous monopotassium salt of citric acid

                  Einecs

                  212-753-4

                  Chemical formula

                  C6H7O7K

                  Molecular weight

                  230,21

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  White, hygroscopic, granular powder or transparent crystals

                     Identification

                              A.

                              Positive tests for citrate and for potassium

                     Purity

                  Loss on drying

                  Not more than 1,0 % determined by drying at 180 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 1 % aqueous solution

                  Between 3,5 and 3,8

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 332 (ii) TRIPOTASSIUM CITRATE

                     Synonyms

                  Tripotassium citrate
                  Tribasic potassium citrate

                     Definition

                  Chemical name

                  Tripotassium citrate

                  Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Monohydrated tripotassium salt of citric acid

                  Einecs

                  212-755-5

                  Chemical formula

                  C6H5O7K3·H2O

                  Molecular weight

                  324,42

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  White, hygroscopic, granular powder or transparent crystals

                     Identification

                              A.

                              Positive tests for citrate and for potassium

                     Purity

                  Loss on drying

                  Not more than 6,0 % determined by drying at 180 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 5 % aqueous solution

                  Between 7,5 and 9,0

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 333 (i) MONOCALCIUM CITRATE

                     Synonyms

                  Monocalcium citrate
                  Monobasic calcium citrate

                     Definition

                  Chemical name

                  Monocalcium citrate

                  Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Monohydrate monocalcium salt of citric acid

                  Chemical formula

                  (C6H7O7)2Ca· H2O

                  Molecular weight

                  440,32

                  Assay

                  Content not less than 97,5 % on the anhydrous basis

                     Description

                  Fine white powder

                     Identification

                              A.

                              Positive tests for citrate and for calcium

                     Purity

                  Loss on drying

                  Not more than 7,0 % determined by drying at 180 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 1 % aqueous solution

                  Between 3,2 and 3,5

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

                  Carbonates

                  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

            E 333 (ii) DICALCIUM CITRATE

                     Synonyms

                  Dicalcium citrate
                  Dibasic calcium citrate

                     Definition

                  Chemical name

                  Dicalcium citrate

                  Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Trihydrated dicalcium salt of citric acid

                  Chemical formula

                  (C6H7O7)2Ca2·3H2O

                  Molecular weight

                  530,42

                  Assay

                  Not less than 97,5 % on the anhydrous basis

                     Description

                  Fine white powder

                     Identification

                              A.

                              Positive tests for citrate and for calcium

                     Purity

                  Loss on drying

                  Not more than 20,0 % determined by drying at 180 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

                  Carbonates

                  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

            E 333 (iii) TRICALCIUM CITRATE

                     Synonyms

                  Tricalcium citrate
                  Tribasic calcium citrate

                     Definition

                  Chemical name

                  Tricalcium citrate

                  Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

                  Tetrahydrated tricalcium salt of citric acid

                  Einecs

                  212-391-7

                  Chemical formula

                  (C6H6O7)2Ca3·4H2O

                  Molecular weight

                  570,51

                  Assay

                  Not less than 97,5 % on the anhydrous basis

                     Description

                  Fine white powder

                     Identification

                              A.

                              Positive tests for citrate and for calcium

                     Purity

                  Loss on drying

                  Not more than 14,0 % determined by drying at 180 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

                  Carbonates

                  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

            E 334 L(+)-TARTARIC ACID

                     Definition

                  Chemical name

                  L-tartaric acid

                  L-2,3-dihydroxybutanedioic acid

                  d-α, β-dihydroxysuccinic acid

                  Einecs

                  201-766-0

                  Chemical formula

                  C4H6O6

                  Molecular weight

                  150,09

                  Assay

                  Content not less than 99,5 % on the anhydrous basis

                     Description

                  Colourless or translucent crystalline solid or white crystalline powder

                     Identification

                              A.

                              Melting range

                  Between 168 oC and 170 oC

                              B.

                              Positive test for tartrate

                     Purity

                  Loss on drying

                  Not more than 0,5 % (over P2O5, three hours)

                  Sulphated ash

                  Not more than 1 000 mg/kg after calcination at 800 ± 25 oC

                  Specific optical rotation of a 20 % w/v aqueous solution

                  [α] 20
                     D between +11,5o and +13,5o

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

            E 335 (i) MONOSODIUM TARTRATE

                     Synonyms

                  Monosodium salt of L-(+)-tartaric acid

                     Definition

                  Chemical name

                  Monosodium salt of L-2,3-dihydroxybutanedioic acid

                  Monohydrated monosodium salt of L-(+)-tartaric acid

                  Chemical formula

                  C4H5O6Na· H2O

                  Molecular weight

                  194,05

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Transparent colourless crystals

                     Identification

                              A.

                              Positive tests for tartrate and for sodium

                     Purity

                  Loss on drying

                  Not more than 10,0 % determined by drying at 105 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 335 (ii) DISODIUM TARTRATE

                     Definition

                  Chemical name

                  Disodium L-tartrate

                  Disodium (+)-tartrate

                  Disodium (+)-2,3-dihydroxybutanedioic acid

                  Dihydrated disodium salt of L-(+)-tartaric acid

                  Einecs

                  212-773-3

                  Chemical formula

                  C4H4O6Na2·2H2O

                  Molecular weight

                  230,8

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Transparent, colourless crystals

                     Identification

                              A.

                              Positive tests for tartrate and for sodium

                              B.

                              Solubility tests

                  1 gram is insoluble in 3 ml of water. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 17,0 % determined by drying at 150 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of a 1 % aqueous solution

                  Between 7,0 and 7,5

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 336 (i) MONOPOTASSIUM TARTRATE

                     Synonyms

                  Monobasic potassium tartrate

                     Definition

                  Chemical name

                  Anhydrous monopotassium salt of L-(+)-tartaric acid

                  Monopotassium salt of L-2,3-dihydroxybutanedioic acid

                  Chemical formula

                  C4H5O6K

                  Molecular weight

                  188,16

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  White crystalline or granulated powder

                     Identification

                              A.

                              Positive tests for tartrate and for potassium

                              B.

                              Melting point

                  230 oC

                     Purity

                  pH of a 1 % aqueous solution

                  3,4

                  Loss on drying

                  Not more than 1,0 % determined by drying at 105 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 336 (ii) DIPOTASSIUM TARTRATE

                     Synonyms

                  Dibasic potassium tartrate

                     Definition

                  Chemical name

                  Dipotassium salt of L-2,3-dihydroxybutanedioic acid

                  Dipotassium salt with half a molecule of water of L-(+)-tartaric acid

                  Einecs

                  213-067-8

                  Chemical formula

                  C4H4O6K2·1/2H2O

                  Molecular weight

                  235,2

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  White crystalline or granulated powder

                     Identification

                              A.

                              Positive tests for tartrate and for potassium

                     Purity

                  pH of a 1 % aqueous solution

                  Between 7,0 and 9,0

                  Loss on drying

                  Not more than 4,0 % determined by drying at 150 oC for four hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 337 POTASSIUM SODIUM TARTRATE

                     Synonyms

                  Potassium sodium L-(+)-tartrate

                  Rochelle salt

                  Seignette salt

                     Definition

                  Chemical name

                  Potassium sodium salt of L-2,3-dihydroxybutanedioic acid

                  Potassium sodium L-(+)-tartrate

                  Einecs

                  206-156-8

                  Chemical formula

                  C4H4O6KNa· 4H2O

                  Molecular weight

                  282,23

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Colourless crystals or white crystalline powder

                     Identification

                              A.

                              Positive tests for tartrate, for potassium and for sodium

                              B.

                              Solubility tests

                  1 gram is soluble in 1 ml of water, insoluble in ethanol

                              C.

                              Melting range

                  Between 70 and 80 oC

                     Purity

                  Loss on drying

                  Not more than 26,0 % and not less than 21,0 % determined by drying at 150 oC for three hours

                  Oxalates

                  Not more than 100 mg/kg expressed as oxalic acid, after drying

                  pH of 1 % aqueous solution

                  Between 6,5 and 8,5

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 338 PHOSPHORIC ACID

                     Synonyms

                  Orthophosphoric acid

                  Monophosphoric acid

                     Definition

                  Chemical name

                  Phosphoric acid

                  Einecs

                  231-633-2

                  Chemical formula

                  H3PO4

                  Molecular weight

                  98,00

                  Assay

                  Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.

                     Description

                  Clear, colourless, viscous liquid

                     Identification

                              A.

                              Positive tests for acid and for phosphate

                     Purity

                  Volatile acids

                  Not more than 10 mg/kg (as acetic acid)

                  Chlorides

                  Not more than 200 mg/kg (expressed as chlorine)

                  Nitrates

                  Not more than 5 mg/kg (as NaNO3)

                  Sulphates

                  Not more than 1 500 mg/kg (as CaSO4)

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                     Note:
                  This specification refers to a 75 % aqueous solution

            E 339 (i) MONOSODIUM PHOSPHATE

                     Synonyms

                  Monosodium monophosphate

                  Acid monosodium monophosphate

                  Monosodium orthophosphate

                  Monobasic sodium phosphate

                  Sodium dihydrogen monophosphate

                     Definition

                  Chemical name

                  Sodium dihydrogen monophosphate

                  Einecs

                  231-449-2

                  Chemical formula

                  Anhydrous: NaH2PO4

                  Monohydrate: NaH2PO4 · H2O

                  Dihydrate: NaH2PO4 · 2H2O

                  Molecular weight

                  Anhydrous: 119,98

                  Monohydrate: 138,00

                  Dihydrate: 156,01

                  Assay

                  After drying at 60 oC for one hour and then at 105 oC for four hours, contains not less than 97 % of NaH2PO4

                  P2O5 content

                  Between 58,0 % and 60,0 % on the anhydrous basis

                     Description

                  A white odourless, slightly deliquescent powder, crystals or granules

                     Identification

                              A.

                              Positive tests for sodium and for phosphate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol or ether

                              C.

                              pH of a 1 % solution

                  Between 4,1 and 5,0

                     Purity

                  Loss on drying

                  The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60 oC for one hour, then at 105 oC for four hours

                  Water-insoluble substances

                  Not more than 0,2 % on the anhydrous basis

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 339 (ii) DISODIUM PHOSPHATE

                     Synonyms

                  Disodium monophosphate

                  Secondary sodium phosphate

                  Disodium orthophosphate

                  Acid disodium phosphate

                     Definition

                  Chemical name

                  Disodium hydrogen monophosphate

                  Disodium hydrogen orthophosphate

                  Einecs

                  231-448-7

                  Chemical formula

                  Anhydrous: Na2HPO4

                  Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12)

                  Molecular weight

                  141,98 (anhydrous)

                  Assay

                  After drying at 40 oC for three hours and subsequently at 105 oC for five hours, contains not less than 98 % of Na2HPO4

                  P2O5 content

                  Between 49 % and 51 % on the anhydrous basis

                     Description

                  Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals

                     Identification

                              A.

                              Positive tests for sodium and for phosphate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 8,4 and 9,6

                     Purity

                  Loss on drying

                  When dried at 40 oC for three hours and then at 105 oC for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %

                  Water-insoluble substances

                  Not more than 0,2 % on the anhydrous basis

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 339 (iii) TRISODIUM PHOSPHATE

                     Synonyms

                  Sodium phosphate

                  Tribasic sodium phosphate

                  Trisodium orthophosphate

                     Definition

                  Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains 1/4 molecule of NaOH

                  Chemical name

                  Trisodium monophosphate

                  Trisodium phosphate

                  Trisodium orthophosphate

                  Einecs

                  231-509-8

                  Chemical formula

                  Anhydrous: Na3PO4

                  Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12)

                  Molecular weight

                  163,94 (anhydrous)

                  Assay

                  Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 calculated on the ignited basis

                  P2O5 content

                  Between 40,5 % and 43,5 % on the anhydrous basis

                     Description

                  White odourless crystals, granules or crystalline powder

                     Identification

                              A.

                              Positive tests for sodium and for phosphate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 11,5 and 12,5

                     Purity

                  Loss on ignition

                  When dried at 120 oC for two hours and then ignited at about 800 oC for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %

                  Water insoluble substances

                  Not more than 0,2 % on the anhydrous basis

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 340 (i) MONOPOTASSIUM PHOSPHATE

                     Synonyms

                  Monobasic potassium phosphate

                  Monopotassium monophosphate

                  Potassium orthophosphate

                     Definition

                  Chemical name

                  Potassium dihydrogen phosphate

                  Monopotassium dihydrogen orthophosphate

                  Monopotassium dihydrogen monophosphate

                  Einecs

                  231-913-4

                  Chemical formula

                  KH2PO4

                  Molecular weight

                  136,09

                  Assay

                  Content not less than 98,0 % after drying at 105 oC for four hours

                  P2O5 content

                  Between 51,0 % and 53,0 % on the anhydrous basis

                     Description

                  Odourless, colourless crystals or white granular or crystalline powder, hygroscopic

                     Identification

                              A.

                              Positive tests for potassium and for phosphate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 4,2 and 4,8

                     Purity

                  Loss on drying

                  Not more than 2,0 % determined by drying at 105 oC for four hours

                  Water-insoluble substances

                  Not more than 0,2 % on the anhydrous basis

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 340 (ii) DIPOTASSIUM PHOSPHATE

                     Synonyms

                  Dipotassium monophosphate

                  Secondary potassium phosphate

                  Dipotassium acid phosphate

                  Dipotassium orthophosphate

                  Dibasic potassium phosphate

                     Definition

                  Chemical name

                  Dipotassium hydrogen monophosphate

                  Dipotassium hydrogen phosphate

                  Dipotassium hydrogen orthophosphate

                  Einecs

                  231-834-5

                  Chemical formula

                  K2HPO4

                  Molecular weight

                  174,18

                  Assay

                  Content not less than 98 % after drying at 105 oC for four hours

                  P2O5 content

                  Between 40,3 % and 41,5 % on the anhydrous basis

                     Description

                  Colourless or white granular powder, crystals or masses; deliquescent substance

                     Identification

                              A.

                              Positive tests for potassium and for phosphate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 8,7 and 9,4

                     Purity

                  Loss on drying

                  Not more than 2,0 % determined by drying at 105 oC for four hours

                  Water-insoluble substances

                  Not more than 0,2 % on the anhydrous basis

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 340 (iii) TRIPOTASSIUM PHOSPHATE

                     Synonyms

                  Potassium phosphate

                  Tribasic potassium phosphate

                  Tripotassium orthophosphate

                     Definition

                  Chemical name

                  Tripotassium monophosphate

                  Tripotassium phosphate

                  Tripotassium orthophosphate

                  Einecs

                  231-907-1

                  Chemical formula

                  Anhydrous: K3PO4

                  Hydrated: K3PO4 · nH2O (n = 1 or 3)

                  Molecular weight

                  212,27 (anhydrous)

                  Assay

                  Content not less than 97 % calculated on the ignited basis

                  P2O5 content

                  Between 30,5 % and 33,0 % on the ignited basis

                     Description

                  Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate

                     Identification

                              A.

                              Positive tests for potassium and for phosphate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 11,5 and 12,3

                     Purity

                  Loss on ignition

                  Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 oC for one hour and then ignite at about 800 oC ± 25 oC for 30 minutes

                  Water insoluble substances

                  Not more than 0,2 % on the anhydrous basis

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 341 (i) MONOCALCIUM PHOSPHATE

                     Synonyms

                  Monobasic calcium phosphate

                  Monocalcium orthophosphate

                     Definition

                  Chemical name

                  Calcium dihydrogen phosphate

                  Einecs

                  231-837-1

                  Chemical formula

                  Anhydrous: Ca(H2PO4)2

                  Monohydrate: Ca(H2PO4)2 · H2O

                  Molecular weight

                  234,05 (anhydrous)

                  252,08 (monohydrate)

                  Assay

                  Content not less than 95 % on the dried basis

                  P2O5 content

                  Between 55,5 % and 61,1 % on the anhydrous basis

                     Description

                  Granular powder or white, deliquescent crystals or granules

                     Identification

                              A.

                              Positive tests for calcium and for phosphate

                              B.

                              CaO content

                  Between 23,0 % and 27,5 % (anhydrous)

                  Between 19,0 % and 24,8 % (monohydrate)

                     Purity

                  Loss on drying

                  Not more than 14 % determined by drying at 105 oC for four hours (anhydrous)

                  Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate)

                  Loss on ignition

                  Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous)

                  Not more than 25,0 % determined by drying at 105 oC for one hour, then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate)

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 341 (ii) DICALCIUM PHOSPHATE

                     Synonyms

                  Dibasic calcium phosphate

                  Dicalcium orthophosphate

                     Definition

                  Chemical name

                  Calcium monohydrogen phosphate

                  Calcium hydrogen orthophosphate

                  Secondary calcium phosphate

                  Einecs

                  231-826-1

                  Chemical formula

                  Anhydrous: CaHPO4

                  Dihydrate: CaHPO4 · 2H2O

                  Molecular weight

                  136,06 (anhydrous)

                  172,09 (dihydrate)

                  Assay

                  Dicalcium phosphate, after drying at 200 oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4

                  P2O5 content

                  Between 50,0 % and 52,5 % on the anhydrous basis

                     Description

                  White crystals or granules, granular powder or powder

                     Identification

                              A.

                              Positive tests for calcium and for phosphate

                              B.

                              Solubility tests

                  Sparingly soluble in water. Insoluble in ethanol

                     Purity

                  Loss on ignition

                  Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 oC ± 25 oC for 30 minutes

                  Fluoride

                  Not more than 50 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 341 (iii) TRICALCIUM PHOSPHATE

                     Synonyms

                  Calcium phosphate, tribasic

                  Calcium orthophosphate

                  Pentacalcium hydroxy monophosphate

                  Calcium hydroxyapatite

                     Definition

                  Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5 · H2O

                  Chemical name

                  Pentacalcium hydroxy monophosphate

                  Tricalcium monophosphate

                  Einecs

                  235-330-6 (Pentacalcium hydroxy monophosphate)

                  231-840-8 (Calcium orthophosphate)

                  Chemical formula

                  Ca5(PO4)3· OH or Ca3(PO4)2

                  Molecular weight

                  502 or 310

                  Assay

                  Content not less than 90 % calculated on the ignited basis

                  P2O5 content

                  Between 38,5 % and 48,0 % on the anhydrous basis

                     Description

                  A white, odourless powder which is stable in air

                     Identification

                              A.

                              Positive tests for calcium and for phosphate

                              B.

                              Solubility

                  Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid

                     Purity

                  Loss on ignition

                  Not more than 8 % after ignition at 800 oC ± 25 oC, to constant weight

                  Fluoride

                  Not more than 50 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 343(i) MONOMAGNESIUM PHOSPHATE

                     Synonyms

                  Magnesiumdihydrogenphosphate

                  Magnesiumphosphate, monobasic

                  Monomagnesium orthophosphate

                     Definition

                  Chemical name

                  Monomagnesiumdihydrogenmonophosphate

                  Einecs

                  236-004-6

                  Chemical formula

                  Mg(H2PO4)2 · nH2O (where n = 0 to 4)

                  Molecular weight

                  218,30 (anhydrous)

                  Assay

                  Not less than 51,0 % after ignition

                     Description

                  White, odourless, crystalline powder, slightly soluble in water

                     Identification

                              A.

                              Positive test for magnesium and for phosphate

                              B.

                              MgO content

                  Not less than 21,5 % after ignition

                     Purity

                  Fluoride

                  Not more than 10 mg/kg (as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 343(ii) DIMAGNESIUM PHOSPHATE

                     Synonyms

                  Magnesiumhydrogenphosphate

                  Magnesiumphosphate, dibasic

                  Dimagnesium orthophosphate

                  Secondary magnesiumphosphate

                     Definition

                  Chemical name

                  Dimagnesiummonohydrogenmonophosphate

                  Einecs

                  231-823-5

                  Chemical formula

                  MgHPO4 · nH2O (where n = 0-3)

                  Molecular weight

                  120,30 (anhydrous)

                  Assay

                  Not less than 96 % after ignition

                     Description

                  White, odourless, crystalline powder, slightly soluble in water

                     Identification

                              A.

                              Positive test for magnesium and for phosphate

                              B.

                              MgO content:

                  Not less than 33,0 % calculated on an anhydrous basis

                     Purity

                  Fluoride

                  Not more than 10 mg/kg (as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 350 (i) SODIUM MALATE

                     Synonyms

                  Sodium salt of malic acid

                     Definition

                  Chemical name

                  Disodium DL-malate, disodium salt of hydroxybutanedioic acid

                  Chemical formula

                  Hemihydrate: C4H4Na2O5 · 1/2 H2O

                  Trihydrate: C4H4Na2O5 · 3H2O

                  Molecular weight

                  Hemihydrate: 187,05

                  Trihydrate: 232,10

                  Assay

                  Content not less than 98,0 % on the anhydrous basis

                     Description

                  White crystalline powder or lumps

                     Identification

                              A.

                              Positive tests for 1,2-dicarboxylic acid and for sodium

                              B.

                              Azo dye formation

                  Positive

                              C.

                              Solubility

                  Freely soluble in water

                     Purity

                  Loss on drying

                  Not more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130 oC, 4h) for the trihydrate

                  Alkalinity

                  Not more than 0,2 % as Na2CO3

                  Fumaric acid

                  Not more than 1,0 %

                  Maleic acid

                  Not more than 0,05 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 350 (ii) SODIUM HYDROGEN MALATE

                     Synonyms

                  Monosodium salt of DL-malic acid

                     Definition

                  Chemical name

                  Monosodium DL-malate, monosodium 2-DL-hydroxy succinate

                  Chemical formula

                  C4H5NaO5

                  Molecular weight

                  156,07

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  White powder

                     Identification

                              A.

                              Positive tests for 1,2-dicarboxylic acid and for sodium

                              B.

                              Azo dye formation

                  Positive

                     Purity

                  Loss on drying

                  Not more than 2,0 % (110 oC, 3h)

                  Maleic acid

                  Not more than 0,05 %

                  Fumaric acid

                  Not more than 1,0 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 351 POTASSIUM MALATE

                     Synonyms

                  Potassium salt of malic acid

                     Definition

                  Chemical name

                  Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid

                  Chemical formula

                  C4H4K2O5

                  Molecular weight

                  210,27

                  Assay

                  Content not less than 59,5 %

                     Description

                  Colourless or almost colourless aqueous solution

                     Identification

                              A.

                              Positive tests for 1,2-dicarboxylic acid and for potassium

                              B.

                              Azo dye formation

                  Positive

                     Purity

                  Alkalinity

                  Not more than 0,2 % as K2CO3

                  Fumaric acid

                  Not more than 1,0 %

                  Maleic acid

                  Not more than 0,05 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 352 (i) CALCIUM MALATE

                     Synonyms

                  Calcium salt of malic acid

                     Definition

                  Chemical name

                  Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid

                  Chemical formula

                  C4H5CaO5

                  Molecular weight

                  172,14

                  Assay

                  Content not less than 97,5 % on the anhydrous basis

                     Description

                  White powder

                     Identification

                              A.

                              Positive tests for malate, 1,2-dicarboxylic acid and for calcium

                              B.

                              Azo dye formation

                  Positive

                              C.

                              Solubility

                  Slightly soluble in water

                     Purity

                  Loss on drying

                  Not more than 2 % (100 oC, 3h)

                  Alkalinity

                  Not more than 0,2 % as CaCO3

                  Maleic acid

                  Not more than 0,05 %

                  Fumaric acid

                  Not more than 1,0 %

                  Fluoride

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 352 (ii) CALCIUM HYDROGEN MALATE

                     Synonyms

                  Monocalcium salt of DL-malic acid

                     Definition

                  Chemical name

                  Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate

                  Chemical formula

                  (C4H5O5)2Ca

                  Assay

                  Content not less than 97,5 % on the anhydrous basis

                     Description

                  White powder

                     Identification

                              A.

                              Positive tests for 1,2-dicarboxylic acid and for calcium

                              B.

                              Azo dye formation

                  Positive

                     Purity

                  Loss on drying

                  Not more than 2,0 % (110 oC, 3h)

                  Maleic acid

                  Not more than 0,05 %

                  Fumaric acid

                  Not more than 1,0 %

                  Fluoride

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 353 METATARTARIC ACID

                     Synonyms

                  Ditartaric acid

                     Definition

                  Chemical name

                  Metatartaric acid

                  Chemical formula

                  C4H6O6

                  Assay

                  Not less than 99,5 %

                     Description

                  Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel

                     Identification

                  A.

                  Very soluble in water and ethanol

                  B.

                  Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 oC, an intense violet coloration appears

                     Purity

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 354 CALCIUM TARTRATE

                     Synonyms

                  L-Calcium tartrate

                     Definition

                  Chemical name

                  Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate

                  Chemical formula

                  C4H4CaO6 · 2H2O

                  Molecular weight

                  224,18

                  Assay

                  Not less than 98,0 %

                     Description

                  Fine crystalline powder with a white or off-white colour

                     Identification

                              A.

                              Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids

                              B.

                              Specific rotation [α]20
                                 D

                  +7,0o to +7,4o (0,1 % in a 1N de HCl solution)

                              C.

                              pH of a 5 % slurry

                  Between 6,0 and 9,0

                     Purity

                  Sulphates (as H2SO4)

                  Not more than 1 g/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 355 ADIPIC ACID

                     Definition

                  Chemical name

                  Hexanedioic acid, 1,4-butanedicarboxylic acid

                  Einecs

                  204-673-3

                  Chemical formula

                  C6H10O4

                  Molecular weight

                  146,14

                  Assay

                  Content not less than 99,6 %

                     Description

                  White odourless crystals or crystalline powder

                     Identification

                              A.

                              Melting range

                  151,5 oC-154,0 oC

                              B.

                              Solubility

                  Slightly soluble in water. Freely soluble in ethanol

                     Purity

                  Water

                  Not more than 0,2 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 20 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 356 SODIUM ADIPATE

                     Definition

                  Chemical name

                  Sodium adipate

                  Einecs

                  231-293-5

                  Chemical formula

                  C6H8Na2O4

                  Molecular weight

                  190,11

                  Assay

                  Content not less than 99,0 % (on anhydrous basis)

                     Description

                  White odourless crystals or crystalline powder

                     Identification

                              A.

                              Melting range

                  151 oC-152 oC (for adipic acid)

                              B.

                              Solubility

                  Approximately 50 g/100 ml water (20 oC)

                              C.

                              Positive test for sodium

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 357 POTASSIUM ADIPATE

                     Definition

                  Chemical name

                  Potassium adipate

                  Einecs

                  242-838-1

                  Chemical formula

                  C6H8K2O4

                  Molecular weight

                  222,32

                  Assay

                  Content not less than 99,0 % (on anhydrous basis)

                     Description

                  White odourless crystals or crystalline powder

                     Identification

                              A.

                              Melting range

                  151 oC-152 oC (for adipic acid)

                              B.

                              Solubility

                  Approximately 60 g/100 ml water (20 oC)

                              C.

                              Positive test for potassium

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 363 SUCCINIC ACID

                     Definition

                  Chemical name

                  Butanedioic acid

                  Einecs

                  203-740-4

                  Chemical formula

                  C4H6O4

                  Molecular weight

                  118,09

                  Assay

                  Content no less than 99,0 %

                     Description

                  Colourless or white, odourless crystals

                     Identification

                              A.

                              Melting range

                  Between 185,0 oC and 190,0 oC

                     Purity

                  Residue on ignition

                  Not more than 0,025 % (800 oC, 15 min)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 380 TRIAMMONIUM CITRATE

                     Synonyms

                  Tribasic ammonium citrate

                     Definition

                  Chemical name

                  Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid

                  Einecs

                  222-394-5

                  Chemical formula

                  C6H17N3O7

                  Molecular weight

                  243,22

                  Assay

                  Content not less than 97,0 %

                     Description

                  White to off-white crystals or powder

                     Identification

                              A.

                              Positive tests for ammonium and for citrate

                              B.

                              Solubility

                  Freely soluble in water

                     Purity

                  Oxalate

                  Not more than 0,04 % (as oxalic acid)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE

                     Synonyms

                  Calcium disodium EDTA

                  Calcium disodium edetate

                     Definition

                  Chemical name

                  N, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium

                  Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate

                  Einecs

                  200-529-9

                  Chemical formula

                  C10H12O8CaN2Na2·2H2O

                  Molecular weight

                  410,31

                  Assay

                  Content not less than 97 % on the anhydrous basis

                     Description

                  White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic

                     Identification

                              A.

                              Positive tests for sodium and for calcium

                              B.

                              Chelating activity to metal ions positive

                              C.

                              pH of a 1 % solution between 6,5 and 7,5

                     Purity

                  Water content

                  5 to 13 % (Karl Fischer method)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 400 ALGINIC ACID

                     Definition

                  Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)

                  Einecs

                  232-680-1

                  Chemical formula

                  (C6H8O6)n

                  Molecular weight

                  10 000-600 000 (typical average)

                  Assay

                  Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200)

                     Description

                  Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless

                     Identification

                              A.

                              Solubility

                  Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate

                              B.

                              Calcium chloride precipitation test

                  To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum

                              C.

                              Ammonium sulphate precipitation test

                  To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch

                              D.

                              Colour reaction

                  Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple

                     Purity

                  pH of a 3 % suspension

                  Between 2,0 and 3,5

                  Loss on drying

                  Not more than 15 % (105 oC, 4 hours)

                  Sulphated ash

                  Not more than 8 % on the anhydrous basis

                  Sodium hydroxide (1 M solution)

                  Not more than 2 % on the anhydrous basis insoluble matter

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 500 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 401 SODIUM ALGINATE

                     Definition

                  Chemical name

                  Sodium salt of alginic acid

                  Chemical formula

                  (C6H7NaO6)n

                  Molecular weight

                  10 000-600 000 (typical average)

                  Assay

                  Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)

                     Description

                  Nearly odourless, white to yellowish fibrous or granular powder

                     Identification

                              A.

                              Positive test for sodium and alginic acid

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 4 hours)

                  Water-insoluble matter

                  Not more than 2 % on the anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 500 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 402 POTASSIUM ALGINATE

                     Definition

                  Chemical name

                  Potassium salt of alginic acid

                  Chemical formula

                  (C6H7KO6)n

                  Molecular weight

                  10 000-600 000 (typical average)

                  Assay

                  Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)

                     Description

                  Nearly odourless, white to yellowish fibrous or granular powder

                     Identification

                              A.

                              Positive test for potassium and for alginic acid

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 4 hours)

                  Water-insoluble matter

                  Not more than 2 % on the anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 500 colonies per gram

                  E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 403 AMMONIUM ALGINATE

                     Definition

                  Chemical name

                  Ammonium salt of alginic acid

                  Chemical formula

                  (C6H11NO6)n

                  Molecular weight

                  10 000 — 600 000 (typical average)

                  Assay

                  Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)

                     Description

                  White to yellowish fibrous or granular powder

                     Identification

                              A.

                              Positive test for ammonium and alginic acid

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 4 hours)

                  Sulphated ash

                  Not more than 7 % on the dried basis

                  Water-insoluble matter

                  Not more than 2 % on the anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 500 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 404 CALCIUM ALGINATE

                     Synonyms

                  Calcium salt of alginate

                     Definition

                  Chemical name

                  Calcium salt of alginic acid

                  Chemical formula

                  (C6H7Ca1/2O6)n

                  Molecular weight

                  10 000-600 000 (typical average)

                  Assay

                  Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)

                     Description

                  Nearly odourless, white to yellowish fibrous or granular powder

                     Identification

                              A.

                              Positive test for calcium and alginic acid

                     Purity

                  Loss on drying

                  Not more than 15,0 % (105 oC, 4 hours)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 500 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 405 PROPANE-1,2-DIOL ALGINATE

                     Synonyms

                  Hydroxypropyl alginate

                  1,2-propanediol ester of alginic acid

                  Propylene glycol alginate

                     Definition

                  Chemical name

                  Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule

                  Chemical formula

                  (C9H14O7)n (esterified)

                  Molecular weight

                  10 000-600 000 (typical average)

                  Assay

                  Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide

                     Description

                  Nearly odourless, white to yellowish brown fibrous or granular powder

                     Identification

                              A.

                              Positive test for 1,2-propanediol and alginic acid after hydrolysis

                     Purity

                  Loss on drying

                  Not more than 20 % (105 oC, 4 hours)

                  Total propane-1,2-diol content

                  Not less than 15 % and not more than 45 %

                  Free propane-1,2-diol content

                  Not more than 15 %

                  Water-insoluble matter

                  Not more than 2 % on the anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 500 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 406 AGAR

                     Synonyms

                  Gelose

                  Japan agar

                  Bengal, Ceylon, Chinese or Japanese isinglass

                  Layor Carang

                     Definition

                  Chemical name

                  Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the families Gelidiaceae and Sphaerococcaceae and related red algae of the class Rhodophyceae

                  Einecs

                  232-658-1

                  Assay

                  The threshold gel concentration should not be higher than 0,25 %

                     Description

                  Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose

                     Identification

                              A.

                              Solubility

                  Insoluble in cold water; soluble in boiling water

                     Purity

                  Loss on drying

                  Not more than 22 % (105 oC, 5 hours)

                  Ash

                  Not more than 6,5 % on the anhydrous basis determined at 550 oC

                  Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)

                  Not more than 0,5 % determined at 550 oC on the anhydrous basis

                  Insoluble matter (in hot water)

                  Not more than 1,0 %

                  Starch

                  Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced

                  Gelatin and other proteins

                  Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 oC. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes

                  Water absorption

                  Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 oC for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 407 CARRAGEENAN

                     Synonyms

                  Products of commerce are sold under different names such as:

                  Irish moss gelose

                  Eucheuman (from Eucheuma spp.)

                  Iridophycan (from Iridaea spp.)

                  Hypnean (from Hypnea spp.)

                  Furcellaran or Danish agar (from Furcellaria fastigiata)

                  Carrageenan (from Chondrus and Gigartina spp.)

                     Definition

                  Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded

                  Einecs

                  232-524-2

                     Description

                  Yellowish to colourless, coarse to fine powder which is practically odourless

                     Identification

                              A.

                              Positive tests for galactose, for anhydrogalactose and for sulphate

                     Purity

                  Methanol, ethanol propane-2-ol content

                  Not more than 0,1 % singly or in combination

                  Viscosity of a 1,5 % solution at 75 oC

                  Not less than 5 mPa.s

                  Loss on drying

                  Not more than 12 % (105 oC, four hours)

                  Sulphate

                  Not less than 15 % and not more than 40 % on the dried basis (as SO4)

                  Ash

                  Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC

                  Acid-insoluble ash

                  Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

                  Acid-insoluble matter

                  Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)

                  Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)

                  Not more than 5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 300 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 407a PROCESSED EUCHEUMA SEAWEED

                     Synonyms

                  PES (acronym for processed eucheuma seaweed)

                     Definition

                  Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded

                     Description

                  Tan to yellowish, coarse to fine powder which is practically odourless

                     Identification

                              A.

                              Positive tests for galactose, for anhydrogalactose and for sulphate

                              B.

                              Solubility

                  Forms cloudy viscous suspensions in water. Insoluble in ethanol

                     Purity

                  Methanol, ethanol, propane-2-ol content

                  Not more than 0,1 % singly or in combination

                  Viscosity of a 1,5 % solution at 75 oC

                  Not less than 5 mPa.s

                  Loss on drying

                  Not more than 12 % (105 oC, four hours)

                  Sulphate

                  Not less than 15 % and not more than 40 % on the dried basis (as SO4)

                  Ash

                  Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC

                  Acid-insoluble ash

                  Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

                  Acid-insoluble matter

                  Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)

                  Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)

                  Not more than 5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and moulds

                  Not more than 300 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 410 LOCUST BEAN GUM

                     Synonyms

                  Carob bean gum

                  Algaroba gum

                     Definition

                  Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan

                  Molecular weight

                  50 000-3 000 000

                  Einecs

                  232-541-5

                  Assay

                  Galactomannan content not less than 75 %

                     Description

                  White to yellowish-white, nearly odourless powder

                     Identification

                              A.

                              Positive tests for galactose mannose

                              B.

                              Microscopic examination

                  Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown

                              C.

                              Solubility

                  Soluble in hot water, insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 5 hours)

                  Ash

                  Not more than 1,2 % determined at 800 oC

                  Protein (N × 6,25)

                  Not more than 7 %

                  Acid-insoluble matter

                  Not more than 4 %

                  Starch

                  Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Ethanol and propane-2-ol

                  Not more than 1 %, single or in combination

            E 412 GUAR GUM

                     Synonyms

                  Gum cyamopsis

                  Guar flour

                     Definition

                  Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan

                  Einecs

                  232-536-0

                  Molecular weight

                  50 000-8 000 000

                  Assay

                  Galactomannan content not less than 75 %

                     Description

                  A white to yellowish-white, nearly odourless powder

                     Identification

                              A.

                              Positive tests for galactose and for mannose

                              B.

                              Solubility

                  Soluble in cold water

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 5 hours)

                  Ash

                  Not more than 1,5 % determined at 800 oC

                  Acid-insoluble matter

                  Not more than 7 %

                  Protein (N × 6,25)

                  Not more than 10 %

                  Starch

                  Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 413 TRAGACANTH

                     Synonyms

                  Tragacanth gum

                  Tragant

                     Definition

                  Tragacanth is a dried exudation obtained from the stems and branches of natural strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present

                  Molecular weight

                  Approximately 800 000

                  Einecs

                  232-252-5

                     Description

                  Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour

                     Identification

                              A.

                              Solubility

                  1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol

                     Purity

                  Negative test for Karaya gum

                  Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops

                  Loss on drying

                  Not more than 16 % (105 oC, 5 hours)

                  Total ash

                  Not more than 4 %

                  Acid insoluble ash

                  Not more than 0,5 %

                  Acid insoluble matter

                  Not more than 2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                     Salmonella spp.

                  Negative in 10 g

                     E. coli

                  Negative in 5 g

            E 414 ACACIA GUM

                     Synonyms

                  Gum arabic

                     Definition

                  Acacia gum is a dried exudation obtained from the stems and branches of natural strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid

                  Molecular weight

                  Approximately 350 000

                  Einecs

                  232-519-5

                     Description

                  Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.

                     Identification

                              A.

                              Solubility

                  1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 17 % (105 oC, 5 hours) for granular and not more than 10 % (105 oC, 4 hours) for spray-dried material

                  Total ash

                  Not more than 4 %

                  Acid insoluble ash

                  Not more than 0,5 %

                  Acid insoluble matter

                  Not more than 1 %

                  Starch or dextrin

                  Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced

                  Tannin

                  To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Hydrolysis products

                  Mannose, xylose and galacturonic acid are absent (determined by chromatography)

                     Salmonella spp.

                  Negative in 10 g

                     E. coli

                  Negative in 5 g

            E 415 XANTHAN GUM

                     Definition

                  Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral

                  Molecular weight

                  Approximately 1 000 000

                  Einecs

                  234-394-2

                  Assay

                  Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum

                     Description

                  Cream-coloured powder

                     Identification

                              A.

                              Solubility

                  Soluble in water. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 21/2 hours)

                  Total ash

                  Not more than 16 % on the anhydrous basis determined at 650 oC after drying at 105 oC for four hours

                  Pyruvic acid

                  Not less than 1,5 %

                  Nitrogen

                  Not more than 1,5 %

                  Ethanol and propan-2-ol

                  Not more than 500 mg/kg singly or in combination

                  Lead

                  Not more than 2 mg/kg

                  Total plate count

                  Not more than 5 000 colonies per gram

                  Yeast and mould

                  Not more than 300 colonies per gram

                     E. coli

                  Absent in 5 g

                     Salmonella spp.

                  Absent in 10 g

                     Xanthomonas campestris

                  Viable cells absent in 1 g

            E 416 KARAYA-GUM

                     Synonyms

                  Katilo

                  Kadaya

                  Gum sterculia

                     Sterculia

                  Karaya, gum karaya

                  Kullo

                  Kuterra

                     Definition

                  Karaya gum is a dried exudation from the stems and branches of natural strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid

                  Einecs

                  232-539-4

                     Description

                  Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid

                     Identification

                              A.

                              Solubility

                  Insoluble in ethanol

                              B.

                              Swelling in ethanol solution

                  Karaya gum swells in 60 % ethanol distinguishing it from other gums

                     Purity

                  Loss on drying

                  Not more than 20 % (105 oC, 5 hours)

                  Total ash

                  Not more than 8 %

                  Acid insoluble ash

                  Not more than 1 %

                  Acid insoluble matter

                  Not more than 3 %

                  Volatile acid

                  Not less than 10 % (as acetic acid)

                  Starch

                  Not detectable

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                     Salmonella spp.

                  Negative in 10 g

                     E. coli

                  Negative in 5 g

            E 417 TARA GUM

                     Definition

                  Tara gum is obtained by grinding the endosperm of the seeds of natural strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)

                  Einecs

                  254-409-6

                     Description

                  A white to white-yellow odourless powder

                     Identification

                              A.

                              Solubility

                  Soluble in water

                  Insoluble in ethanol

                              B.

                              Gel formation

                  To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed

                     Purity

                  Loss on drying

                  Not more than 15 %

                  Ash

                  Not more than 1,5 %

                  Acid insoluble matter

                  Not more than 2 %

                  Protein

                  Not more than 3,5 % (factor N × 5,7)

                  Starch

                  Not detectable

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 418 GELLAN GUM

                     Definition

                  Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt

                  Einecs

                  275-117-5

                  Molecular weight

                  Approximately 500 000

                  Assay

                  Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2

                     Description

                  An off-white powder

                     Identification

                              A.

                              Solubility

                  Soluble in water, forming a viscous solution.

                  Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 15 % after drying (105 oC, 21/2 hours)

                  Nitrogen

                  Not more than 3 %

                  Propane-2-ol

                  Not more than 750 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total plate count

                  Not more than 10 000 colonies per gram

                  Yeast and mould

                  Not more than 400 colonies per gram

                     E. coli

                  Negative in 5 g

                     Salmonella spp.

                  Negative in 10 g

            E 420(i) SORBITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Commission Directive 2008/60/EC (8).
      E 420(ii) SORBITOL SYRUP
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 421 MANNITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 422 GLYCEROL

                     Synonyms

                  Glycerin

                  Glycerine

                     Definition

                  Chemical names

                  1,2,3-propanetriol

                  Glycerol

                  Trihydroxypropane

                  Einecs

                  200-289-5

                  Chemical formula

                  C3H8O3

                  Molecular weight

                  92,10

                  Assay

                  Content not less than 98 % of glycerol on the anhydrous basis

                     Description

                  Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable

                     Identification

                              A.

                              Acrolein formation on heating

                  Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved

                              B.

                              Specific gravity (25/25 oC)

                  Not less than 1,257

                              C.

                              Refractive index [n]D20

                  Between 1,471 and 1,474

                     Purity

                  Water

                  Not more than 5 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,01 % determined at 800 ± 25 oC

                  Butanetriols

                  Not more than 0,2 %

                  Acrolein, glucose and ammonium compounds

                  Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 oC for five minutes. It neither becomes yellow nor emits an odour of ammonia

                  Fatty acids and esters

                  Not more than 0,1 % calculated as butyric acid

                  Chlorinated compounds

                  Not more than 30 mg/kg (as chlorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 425(i) KONJAC GUM

                     Definition

                  Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units

                  Molecular weight

                  The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000

                  Assay

                  Not less than 75 % carbohydrate

                     Description

                  A white to cream to light tan powder

                     Identification

                              A.

                              Solubility

                  Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0

                              B.

                              Gel formation

                  Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms

                              C.

                              Formation of heat-stable gel

                  Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed

                              D.

                              Viscosity (1 % solution)

                  Not less than 3 kgm-1s-1 at 25 oC

                     Purity

                  Loss on drying

                  Not more than 12 % (105 oC, 5 h)

                  Starch

                  Not more than 3 %

                  Protein

                  Not more than 3 % (N × 5,7)

                  Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample

                  Ether-soluble material

                  Not more than 0,1 %

                  Total ash

                  Not more than 5,0 % (800 oC, 3 to 4h)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 2 mg/kg

                     Salmonella spp.

                  Absent in 12,5 g

                     E. coli

                  Absent in 5 g

            E 425(ii) KONJAC GLUCOMANNAN

                     Definition

                  Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated

                  Molecular weight

                  500 000 to 2 000 000

                  Assay

                  Total dietary fibre: not less than 95 % on a dry weight basis

                     Description

                  White to slightly brownish fine particle size, free flowing and odourless powder

                     Identification

                              A.

                              Solubility

                  Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation

                              B.

                              Formation of heat-stable gel

                  Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed

                              C.

                              Viscosity (1 % solution)

                  Not less than 20 kgm-1s-1 at 25 oC

                     Purity

                  Loss on drying

                  Not more than 8 % (105 oC, 3h)

                  Starch

                  Not more than 1 %

                  Protein

                  Not more than 1,5 % (N × 5,7)

                  Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample

                  Ether-soluble material

                  Not more than 0,5 %

                  Sulphite (as SO2)

                  Not more than 4 mg/kg

                  Chloride

                  Not more than 0,02 %

                  50 % Alcohol-soluble

                  Not more than 2,0 % material

                  Total ash

                  Not more than 2,0 % (800 oC, 3 to 4h)

                  Lead

                  Not more than 1 mg/kg

                     Salmonella spp.

                  Absent in 12,5 g

                     E. coli

                  Absent in 5 g

            E 426 SOYBEAN HEMICELLULOSE

                     Definition

                  Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction

                  Chemical names

                  Water soluble soybean polysaccharides

                  Water soluble soybean fibre

                  Assay

                  Not less than 74 % carbohydrate

                     Description

                  Free flowing spray-dried white powder

                     Identification

                              A.

                              Solubility pH of 1 % solution

                  Soluble in hot and cold water without gel formation

                  5,5±1,5

                              B.

                              Viscosity of 10 % solution

                  Not more than 200 mPa.s

                     Purity

                  Loss on drying

                  Not more than 7 % (105 oC, 4h)

                  Protein

                  Not more than 14 %

                  Total ash

                  Not more than 9,5 % (600 oC, 4h)

                  Arsenic

                  Not more than 2 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Standard plate count

                  Not more than 3 000 colonies per gram

                  Yeast and mould

                  Not more than 100 colonies per gram

                     E. coli

                  Negative in 10 g

            E 431 POLYOXYETHYLENE (40) STEARATE

                     Synonyms

                  Polyoxyl (40) stearate

                  polyoxyethylene (40) monostearate

                     Definition

                  A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol

                  Assay

                  Content not less than 97,5 % on the anhydrous basis

                     Description

                  Cream-coloured flakes or waxy solid at 25 oC with a faint odour

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil

                              B.

                              Congealing range

                  39 oC-44 oC

                              C.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer method)

                  Acid value

                  Not more than 1

                  Saponification value

                  Not less than 25 and not more than 35

                  Hydroxyl value

                  Not less than 27 and not more than 40

                  1,4-Dioxane

                  Not more than 5 mg/kg

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Ethylene glycols (mono- and di-)

                  Not more than 0,25 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)

                     Synonyms

                  Polysorbate 20

                  Polyoxyethylene (20) sorbitan monolaurate

                     Definition

                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

                  Assay

                  Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis

                     Description

                  A lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether

                              B.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer method)

                  Acid value

                  Not more than 2

                  Saponification value

                  Not less than 40 and not more than 50

                  Hydroxyl value

                  Not less than 96 and not more than 108

                  1,4-dioxane

                  Not more than 5 mg/kg

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Ethylene glycols (mono- and di-)

                  Not more than 0,25 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)

                     Synonyms

                  Polysorbate 80

                  Polyoxyethylene (20) sorbitan monooleate

                     Definition

                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

                  Assay

                  Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis

                     Description

                  A lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether

                              B.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer method)

                  Acid value

                  Not more than 2

                  Saponification value

                  Not less than 45 and not more than 55

                  Hydroxyl value

                  Not less than 65 and not more than 80

                  1,4-dioxane

                  Not more than 5 mg/kg

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Ethylene glycols (mono- and di-)

                  Not more than 0,25 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)

                     Synonyms

                  Polysorbate 40

                  Polyoxyethylene (20) sorbitan monopalmitate

                     Definition

                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

                  Assay

                  Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis

                     Description

                  A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil

                              B.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer method)

                  Acid value

                  Not more than 2

                  Saponification value

                  Not less than 41 and not more than 52

                  Hydroxyl value

                  Not less than 90 and not more than 107

                  1,4-dioxane

                  Not more than 5 mg/kg

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Ethylene glycols (mono- and di-)

                  Not more than 0,25 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)

                     Synonyms

                  Polysorbate 60

                  Polyoxyethylene (20) sorbitan monostearate

                     Definition

                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

                  Assay

                  Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis

                     Description

                  A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils

                              B.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer method)

                  Acid value

                  Not more than 2

                  Saponification value

                  Not less than 45 and not more than 55

                  Hydroxyl value

                  Not less than 81 and not more than 96

                  1,4-dioxane

                  Not more than 5 mg/kg

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Ethylene glycols (mono- and di-)

                  Not more than 0,25 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)

                     Synonyms

                  Polysorbate 65

                  Polyoxyethylene (20) sorbitan tristearate

                     Definition

                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

                  Assay

                  Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis

                     Description

                  A tan-coloured, waxy solid at 25 oC with a faint characteristic odour

                     Identification

                              A.

                              Solubility

                  Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol

                              B.

                              Congealing range

                  29-33 oC

                              C.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

                     Purity

                  Water

                  Not more than 3 % (Karl Fischer method)

                  Acid value

                  Not more than 2

                  Saponification value

                  Not less than 88 and not more than 98

                  Hydroxyl value

                  Not less than 40 and not more than 60

                  1,4-dioxane

                  Not more than 5 mg/kg

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Ethylene glycols (mono- and di-)

                  Not more than 0,25 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 440 (i) PECTIN

                     Definition

                  Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol

                  Einecs

                  232-553-0

                  Assay

                  Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol

                     Description

                  White, light yellow, light grey or light brown powder

                     Identification

                              A.

                              Solubility

                  Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 12 % (105 oC, 2 hours)

                  Acid insoluble ash

                  Not more than 1 % (insoluble in approximately 3N hydrochloric acid)

                  Sulphur dioxide

                  Not more than 50 mg/kg on the anhydrous basis

                  Nitrogen content

                  Not more than 1,0 % after washing with acid and ethanol

                  Free methanol, ethanol and propane-2-ol

                  Not more than 1 %, singly or in combination, on the anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 440 (ii) AMIDATED PECTIN

                     Definition

                  Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol

                  Assay

                  Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol

                     Description

                  White, light yellow, light greyish or light brownish powder

                     Identification

                              A.

                              Solubility

                  Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 12 % (105 oC, 2 hours)

                  Acid-insoluble ash

                  Not more than 1 % (insoluble in approximately 3N hydrochloric acid)

                  Degree of amidation

                  Not more than 25 % of total carboxyl groups

                  Sulphur dioxide residue

                  Not more than 50 mg/kg on the anhydrous basis

                  Nitrogen content

                  Not more than 2,5 % after washing with acid and ethanol

                  Free methanol, ethanol and propane-2-ol

                  Not more than 1 % single or in combination, on a volatile matter-free basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 442 AMMONIUM PHOSPHATIDES

                     Synonyms

                  Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides

                     Definition

                  A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides

                  Assay

                  The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)

                     Description

                  Unctuous semi-solid

                     Identification

                              A.

                              Solubility

                  Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone

                              B.

                              Positive tests for glycerol, for fatty acid and for phosphate

                     Purity

                  Petroleum ether insoluble matter

                  Not more than 2,5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 444 SUCROSE ACETATE ISOBUTYRATE

                     Synonyms

                  SAIB

                     Definition

                  Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6

                  Einecs

                  204-771-6

                  Chemical name

                  Sucrose diacetate hexaisobutyrate

                  Chemical formulae

                  C40H62O19

                  Molecular weight

                  832-856 (approximate), C40H62O19: 846,9

                  Assay

                  Content not less than 98,8 % and not more than 101,9 % of C40H62O19

                     Description

                  A pale straw-coloured liquid, clear and free of sediment and having a bland odour

                     Identification

                              A.

                              Solubility

                  Insoluble in water. Soluble in most organic solvents

                              B.

                              Refractive index

                  [n]40
                     D: 1,4492-1,4504

                              C.

                              Specific gravity

                  [d]25
                     D: 1,141-1,151

                     Purity

                  Triacetin

                  Not more than 0,1 %

                  Acid value

                  Not more than 0,2

                  Saponification value

                  Not less than 524 and not more than 540

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 3 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 5 mg/kg

            E 445 GLYCEROL ESTERS OF WOOD ROSIN

                     Synonyms

                  Ester gum

                     Definition

                  A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation

                     Description

                  Hard, yellow to pale amber-coloured solid

                     Identification

                              A.

                              Solubility

                  Insoluble in water, soluble in acetone

                              B.

                              Infrared absorption spectrum

                  Characteristic of the compound

                     Purity

                  Specific gravity of solution

                  [d]20
                     25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5-176 oC, d20
                     4: 0,84)

                  Ring and ball softening range

                  Between 82 oC and 90 oC

                  Acid value

                  Not less than 3 and not more than 9

                  Hydroxyl value

                  Not less than 15 and not more than 45

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Test for absence of tall oil rosin (sulphur test)

                  When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin

            E 450 (i) DISODIUM DIPHOSPHATE

                     Synonyms

                  Disodium dihydrogen diphosphate

                  Disodium dihydrogen pyrophosphate

                  Sodium acid pyrophosphate

                  Disodium pyrophosphate

                     Definition

                  Chemical name

                  Disodium dihydrogen diphosphate

                  Einecs

                  231-835-0

                  Chemical formula

                  Na2H2P2O7

                  Molecular weight

                  221,94

                  Assay

                  Content not less than 95 % of disodium diphosphate

                  P2O5 Content

                  Not less than 63,0 % and not more than 64,5 %

                     Description

                  White powder or grains

                     Identification

                              A.

                              Positive tests for sodium and for phosphate

                              B.

                              Solubility

                  Soluble in water

                              C.

                              pH of a 1 % solution

                  Between 3,7 and 5,0

                     Purity

                  Loss on drying

                  Not more than 0,5 % (105 oC, four hours)

                  Water-insoluble matter

                  Not more than 1 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 450 (ii) TRISODIUM DIPHOSPHATE

                     Synonyms

                  Acid trisodium pyrophosphate

                  Trisodium monohydrogen diphosphate

                     Definition

                  Einecs

                  238-735-6

                  Chemical formula

                  Monohydrate: Na3HP2O7 · H2O

                  Anhydrous: Na3HP2O7

                  Molecular weight

                  Monohydrate: 261,95

                  Anhydrous: 243,93

                  Assay

                  Content not less than 95 % on the anhydrous basis

                  P2O5 content

                  Not less than 57 % and not more than 59 %

                     Description

                  White powder or grains, occurs anhydrous or as a monohydrate

                     Identification

                              A.

                              Positive tests for sodium and for phosphate

                              B.

                              Solubility

                  Soluble in water

                              C.

                              pH of a 1 % solution

                  Between 6,7 and 7,5

                     Purity

                  Loss on ignition

                  Not more than 4,5 % on the anhydrous compound

                  Not more than 11,5 % on the monohydrous basis

                  Loss on drying

                  Not more than 0,5 % (105 oC, four hours)

                  Water-insoluble matter

                  Not more than 0,2 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 450 (iii) TETRASODIUM DIPHOSPHATE

                     Synonyms

                  Tetrasodium pyrophosphate

                  Sodium pyrophosphate

                     Definition

                  Chemical name

                  Tetrasodium diphosphate

                  Einecs

                  231-767-1

                  Chemical formula

                  Anhydrous: Na4P2O7

                  Decahydrate: Na4P2O7 · 10H2O

                  Molecular weight

                  Anhydrous: 265,94

                  Decahydrate: 446,09

                  Assay

                  Content not less than 95 % of Na4P2O7 on the ignited basis

                  P2O5 content

                  Not less than 52,5 % and not more than 54,0 %

                     Description

                  Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air

                     Identification

                              A.

                              Positive tests for sodium and for phosphate

                              B.

                              Solubility

                  Soluble in water. Insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 9,8 and 10,8

                     Purity

                  Loss on ignition

                  Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105 oC for four hours, followed by ignition at 550 oC for 30 minutes

                  Water-insoluble matter

                  Not more than 0,2 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 450 (v) TETRAPOTASSIUM DIPHOSPHATE

                     Synonyms

                  Potassium pyrophosphate

                  Tetrapotassium pyrophosphate

                     Definition

                  Chemical name

                  Tetrapotassium diphosphate

                  Einecs

                  230-785-7

                  Chemical formula

                  K4P2O7

                  Molecular weight

                  330,34 (anhydrous)

                  Assay

                  Content not less than 95 % on the ignited basis

                  P2O5 content

                  Not less than 42,0 % and not more than 43,7 % on the anhydrous basis

                     Description

                  Colourless crystals or white, very hygroscopic powder

                     Identification

                              A.

                              Positive tests for potassium and for phosphate

                              B.

                              Solubility

                  Soluble in water, insoluble in ethanol

                              C.

                              pH of a 1 % solution

                  Between 10,0 and 10,8

                     Purity

                  Loss on ignition

                  Not more than 2 % after drying at 105 oC for four hours and then ignition at 550 oC for 30 minutes

                  Water-insoluble substances

                  Not more than 0,2 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 450 (vi) DICALCIUM DIPHOSPHATE

                     Synonyms

                  Calcium pyrophosphate

                     Definition

                  Chemical name

                  Dicalcium diphosphate

                  Dicalcium pyrophosphate

                  Einecs

                  232-221-5

                  Chemical formula

                  Ca2P2O7

                  Molecular weight

                  254,12

                  Assay

                  Content not less than 96 %

                  P2O5 content

                  Not less than 55 % and not more than 56 %

                     Description

                  A fine, white, odourless powder

                     Identification

                              A.

                              Positive tests for calcium and for phosphate

                              B.

                              Solubility

                  Insoluble in water. Soluble in dilute hydrochloric and nitric acids

                              C.

                              pH of a 10 % suspension in water

                  Between 5,5 and 7,0

                     Purity

                  Loss on ignition

                  Not more than 1,5 % at 800 oC ± 25 oC for 30 minutes

                  Fluoride

                  Not more than 50 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE

                     Synonyms

                  Acid calcium pyrophosphate

                  Monocalcium dihydrogen pyrophosphate

                     Definition

                  Chemical name

                  Calcium dihydrogen diphosphate

                  Einecs

                  238-933-2

                  Chemical formula

                  CaH2P2O7

                  Molecular weight

                  215,97

                  Assay

                  Content not less than 90 % on the anhydrous basis

                  P2O5 content

                  Not less than 61 % and not more than 64 %

                     Description

                  White crystals or powder

                     Identification

                              A.

                              Positive tests for calcium and for phosphate

                     Purity

                  Acid-insoluble matter

                  Not more than 0,4 %

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 451 (i) PENTASODIUM TRIPHOSPHATE

                     Synonyms

                  Pentasodium tripolyphosphate

                  Sodium tripolyphosphate

                     Definition

                  Chemical name

                  Pentasodium triphosphate

                  Einecs

                  231-838-7

                  Chemical formula

                  Na5O10P3 · nH2O (n = 0 or 6)

                  Molecular weight

                  367,86

                  Assay

                  Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)

                  P2O5 content

                  Not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)

                     Description

                  White, slightly hygroscopic granules or powder

                     Identification

                              A.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              B.

                              Positive tests for sodium and for phosphate

                              C.

                              pH of a 1 % solution

                  Between 9,1 and 10,2

                     Purity

                  Loss on drying

                  Anhydrous: Not more than 0,7 % (105 oC, one hour)

                  Hexahydrate: Not more than 23,5 % (60 oC, one hour, followed by drying at 105 oC, four hours)

                  Water-insoluble substances

                  Not more than 0,1 %

                  Higher polyphosphates

                  Not more than 1 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE

                     Synonyms

                  Pentapotassium tripolyphosphate

                  Potassium triphosphate

                  Potassium tripolyphosphate

                     Definition

                  Chemical name

                  Pentapotassium triphosphate

                  Pentapotassium tripolyphosphate

                  Einecs

                  237-574-9

                  Chemical formula

                  K5O10P3

                  Molecular weight

                  448,42

                  Assay

                  Content not less than 85 % on the anhydrous basis

                  P2O5 content

                  Not less than 46,5 % and not more than 48 %

                     Description

                  White, very hygroscopic powder or granules

                     Identification

                              A.

                              Solubility

                  Very soluble in water

                              B.

                              Positive tests for potassium and for phosphate

                              C.

                              pH of a 1 % solution

                  Between 9,2 and 10,5

                     Purity

                  Loss on ignition

                  Not more than 0,4 % (after drying at 105 oC, four hours, followed by ignition at 550 oC, 30 minutes)

                  Water-insoluble matter

                  Not more than 2 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 452 (i) SODIUM POLYPHOSPHATE
      1.   SOLUBLE POLYPHOSPHATE

                     Synonyms

                  Sodium hexametaphosphate

                  Sodium tetrapolyphosphate

                  Graham's salt

                  Sodium polyphosphates, glassy

                  Sodium polymetaphosphate

                  Sodium metaphosphate

                     Definition

                  Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0

                  Chemical name

                  Sodium polyphosphate

                  Einecs

                  272-808-3

                  Chemical formula

                  Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

                  Molecular weight

                  (102)n

                  Assay P2O5 content

                  Not less than 60 % and not more than 71 % on the ignited basis

                     Description

                  Colourless or white, transparent platelets, granules, or powders

                     Identification

                              A.

                              Solubility

                  Very soluble in water

                              B.

                              Positive tests for sodium and for phosphate

                              C.

                              pH of a 1 % solution

                  Between 3,0 and 9,0

                     Purity

                  Loss on ignition

                  Not more than 1 %

                  Water-insoluble matter

                  Not more than 0,1 %

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            2.   INSOLUBLE POLYPHOSPHATE

                     Synonyms

                  Insoluble sodium metaphosphate

                  Maddrell's salt

                  Insoluble sodium polyphosphate, IMP

                     Definition

                  Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5

                  Chemical name

                  Sodium polyphosphate

                  Einecs

                  272-808-3

                  Chemical formula

                  Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

                  Molecular weight

                  (102)n

                  P2O5 content

                  Not less than 68,7 % and not more than 70,0 %

                     Description

                  White crystalline powder

                     Identification

                              A.

                              Solubility

                  Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides

                              B.

                              Positive tests for sodium and for phosphate

                              C.

                              pH of 1 in 3 suspension in water

                  About 6,5

                     Purity

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 452 (ii) POTASSIUM POLYPHOSPHATE

                     Synonyms

                  Potassium metaphosphate

                  Potassium polymetaphosphate

                  Kurrol salt

                     Definition

                  Chemical name

                  Potassium polyphosphate

                  Einecs

                  232-212-6

                  Chemical formula

                  (KPO3)n

                  Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

                  Molecular weight

                  (118)n

                  P2O5 content

                  Not less than 53,5 % and not more than 61,5 % on the ignited basis

                     Description

                  Fine white powder or crystals or colourless glassy platelets

                     Identification

                              A.

                              Solubility

                  1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate

                              B.

                              Positive tests for potassium and for phosphate

                              C.

                              pH of a 1 % suspension

                  Not more than 7,8

                     Purity

                  Loss on ignition

                  Not more than 2 % (105 oC, four hours followed by ignition at 550 oC, 30 minutes)

                  Cyclic phosphate

                  Not more than 8 % on P2O5 content

                  Fluoride

                  Not more than 10 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 452(iii) SODIUM CALCIUM POLYPHOSPHATE

                     Synonym

                  Sodium calcium polyphosphate, glassy

                     Definition

                  Chemical name

                  Sodium calcium polyphosphate

                  Einecs

                  233-782-9

                  Chemical formula

                  (NaPO3)n CaO where n is typically 5

                  Assay

                  Not less than 61 % and not more than 69 % as P2O5

                     Description

                  White glassy crystals, spheres

                     Identification

                              A.

                              pH of a 1 % m/m slurry

                  Approximately 5 to 7

                              B.

                              CaO content

                  7 %-15 % m/m

                     Purity

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 452 (iv) CALCIUM POLYPHOSPHATE

                     Synonyms

                  Calcium metaphosphate

                  Calcium polymetaphosphate

                     Definition

                  Chemical name

                  Calcium polyphosphate

                  Einecs

                  236-769-6

                  Chemical formula

                  (CaP2O6)n

                  Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2

                  Molecular weight

                  (198)n

                  P2O5 content

                  Not less than 71 % and not more than 73 % on the ignited basis

                     Description

                  Odourless, colourless crystals or white powder

                     Identification

                              A.

                              Solubility

                  Usually sparingly soluble in water. Soluble in acid medium

                              B.

                              Positive tests for calcium and for phosphate

                              C.

                              CaO content

                  27 to 29,5 %

                     Purity

                  Loss on ignition

                  Not more than 2 % (105 oC, four hours followed by ignition at 550 oC, 30 minutes)

                  Cyclic phosphate

                  Not more than 8 % on P2O5 content

                  Fluoride

                  Not more than 30 mg/kg (expressed as fluorine)

                  Arsenic

                  Not more than 3 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 459 BETA-CYCLODEXTRIN

                     Definition

                  Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch

                  Chemical name

                  Cycloheptaamylose

                  Einecs

                  231-493-2

                  Chemical formula

                  (C6H10O5)7

                  Molecular weight

                  1 135

                  Assay

                  Content not less than 98,0 % of (C6H10O5)7 on an anhydrous basis

                     Description

                  Virtually odourless white or almost white crystalline solid

                     Identification

                              A.

                              Solubility

                  Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol

                              B.

                              Specific rotation

                  [α]25
                     D: + 160o to + 164o (1 % solution)

                     Purity

                  Water

                  Not more than 14 % (Karl Fischer method)

                  Other cyclodextrins

                  Not more than 2 % on an anhydrous basis

                  Residual solvents (toluene and trichloroethylene)

                  Not more than 1 mg/kg for each solvent

                  Sulphated ash

                  Not more than 0,1 %

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

            E 460 (i) MICROCRISTALLINE CELLULOSE

                     Synonyms

                  Cellulose gel

                     Definition

                  Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400

                  Chemical name

                  Cellulose

                  Einecs

                  232-674-9

                  Chemical formula

                  (C6H10O5)n

                  Molecular weight

                  About 36 000

                  Assay

                  Not less than 97 % calculated as cellulose on the anhydrous basis

                     Description

                  A fine white or almost white odourless powder

                     Identification

                              A.

                              Solubility

                  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution

                              B.

                              Colour reaction

                  To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced

                              C.

                              To be identified by IR spectroscopy

                              D.

                              Suspension test

                  Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears

                     Purity

                  Loss on drying

                  Not more than 7 % (105 oC, 3 hours)

                  Water-soluble matter

                  Not more than 0,24 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  pH of a 10 % suspension in water

                  The pH of the supernatant liquid is between 5,0 and 7,5

                  Starch

                  Not detectable

                  To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced

                  Particle size

                  Not less than 5 μm (not more than 10 % of particles of less than 5 μm)

                  Carboxyl groups

                  Not more than 1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 460 (ii) POWDERED CELLULOSE

                     Definition

                  Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials

                  Chemical name

                  Cellulose

                  Linear polymer of 1:4 linked glucose residues

                  Einecs

                  232-674-9

                  Chemical formula

                  (C6H10O5)n

                  Molecular weight

                  (162)n (n is predominantly 1 000 and greater)

                  Assay

                  Content not less than 92 %

                     Description

                  A white, odourless powder

                     Identification

                              A.

                              Solubility

                  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution

                              B.

                              Suspension test

                  Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settle and a supernatant liquid appears

                     Purity

                  Loss on drying

                  Not more than 7 % (105 oC, 3 hours)

                  Water-soluble matter

                  Not more than 1,0 %

                  Sulphated ash

                  Not more than 0,3 % determined at 800 ± 25 oC

                  pH of a 10 % suspension in water

                  The pH of the supernatant liquid is between 5,0 and 7,5

                  Starch

                  Not detectable

                  To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Particle size

                  Not less than 5 μm (not more than 10 % of particles of less than 5 μm)

            E 461 METHYL CELLULOSE

                     Synonyms

                  Cellulose methyl ether

                     Definition

                  Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups

                  Chemical name

                  Methyl ether of cellulose

                  Chemical formula

                  The polymers contain substituted anhydroglucose units with the following general formula:

                  C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:

                              —

                              H

                              —

                              CH3

                              —

                              or CH2CH3

                  Molecular weight

                  From about 20 000 to 380 000

                  Assay

                  Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)

                     Description

                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

                     Identification

                              A.

                              Solubility

                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution.

                  Insoluble in ethanol, ether and chloroform.

                  Soluble in glacial acetic acid

                     Purity

                  Loss on drying

                  Not more than 10 % (105 oC, 3 hours)

                  Sulphated ash

                  Not more than 1,5 % determined at 800 ± 25 oC

                  pH of a 1 % colloidal solution

                  Not less than 5,0 and not more than 8,0

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 462 ETHYL CELLULOSE

                     Synonyms

                  Cellulose ethyl ether

                     Definition

                  Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups

                  Chemical name

                  Ethyl ether of cellulose

                  Chemical formula

                  The polymers contain substituted anhydroglucose units with the following general formula:

                  C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:

                              —

                              H

                              —

                              CH2CH3

                  Assay

                  Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)

                     Description

                  Slightly hygroscopic white to off-white, odourless and tasteless powder

                     Identification

                              A.

                              Solubility

                  Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate

                              B.

                              Film forming test

                  Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable

                     Purity

                  Loss on drying

                  Not more than 3 % (105 oC, 2 hours)

                  Sulphated ash

                  Not more than 0,4 %

                  pH of a 1 % colloidal solution

                  Neutral to litmus

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 463 HYDROXYPROPYL CELLULOSE

                     Synonyms

                  Cellulose hydroxypropyl ether

                     Definition

                  Hydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups

                  Chemical name

                  Hydroxypropyl ether of cellulose

                  Chemical formula

                  The polymers contain substituted anhydroglucose units with the following general formula:

                  C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:

                              —

                              H

                              —

                              CH2CHOHCH3

                              —

                              CH2CHO(CH2CHOHCH3)CH3

                              —

                              CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3

                  Molecular weight

                  From about 30 000 to 1 000 000

                  Assay

                  Content not less than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis

                     Description

                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

                     Identification

                              A.

                              Solubility

                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether

                              B.

                              Gas chromatography

                  Determine the substituents by gas chromotography

                     Purity

                  Loss on drying

                  Not more than 10 % (105 oC, 3 hours)

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  pH of a 1 % colloidal solution

                  Not less than 5,0 and not more than 8,0

                  Propylene chlorohydrins

                  Not more than 0,1 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 464 HYDROXYPROPYL METHYL CELLULOSE

                     Definition

                  Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution

                  Chemical name

                  2-Hydroxypropyl ether of methylcellulose

                  Chemical formula

                  The polymers contain substituted anhydroglucose units with the following general formula:

                  C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:

                              —

                              H

                              —

                              CH3

                              —

                              CH2CHOHCH3

                              —

                              CH2CHO (CH2CHOHCH3) CH3

                              —

                              CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3

                  Molecular weight

                  From about 13 000 to 200 000

                  Assay

                  Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis

                     Description

                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

                     Identification

                              A.

                              Solubility

                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol

                              B.

                              Gas chromatography

                  Determine the substituents by gas chromatography

                     Purity

                  Loss on drying

                  Not more than 10 % (105 oC, 3 hours)

                  Sulphated ash

                  Not more than 1,5 % for products with viscosities of 50 mPa.s or above

                  Not more than 3 % for products with viscosities below 50 mPa.s

                  pH of a 1 % colloidal solution

                  Not less than 5,0 and not more than 8,0

                  Propylene chlorohydrins

                  Not more than 0,1 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 465 ETHYL METHYL CELLULOSE

                     Synonyms

                  Methylethylcellulose

                     Definition

                  Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups

                  Chemical name

                  Ethyl methyl ether of cellulose

                  Chemical formula

                  The polymers contain substituted anhydroglucose units with the following general formula:

                  C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:

                              —

                              H

                              —

                              CH3

                              —

                              CH2CH3

                  Molecular weight

                  From about 30 000 to 40 000

                  Assay

                  Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl

                     Description

                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

                     Identification

                              A.

                              Solubility

                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether

                     Purity

                  Loss on drying

                  Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 oC to constant weight)

                  Sulphated ash

                  Not more than 0,6 %

                  pH of a 1 % colloidal solution

                  Not less than 5,0 and not more than 8,0

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

            E 466 SODIUM CARBOXY METHYL CELLULOSE

                     Synonyms

                  Carboxy methyl cellulose

                  CMC

                  NaCMC

                  Sodium CMC

                  Cellulose gum

                     Definition

                  Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material

                  Chemical name

                  Sodium salt of the carboxymethyl ether of cellulose

                  Chemical formula

                  The polymers contain substituted anhydroglucose units with the following general formula:

                  C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:

                              —

                              H

                              —

                              CH2COONa

                              —

                              CH2COOH

                  Molecular weight

                  Higher than approximately 17 000 (degree of polymerisation approximately 100)

                  Assay

                  Content on the anhydrous basis not less than 99,5 %

                     Description

                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

                     Identification

                              A.

                              Solubility

                  Yields a viscous colloidal solution with water. Insoluble in ethanol

                              B.

                              Foam test

                  A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)

                              C.

                              Precipitate formation

                  To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)

                              D.

                              Colour reaction

                  Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:
                  To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface

                     Purity

                  Degree of substitution

                  Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit

                  Loss on drying

                  Not more than 12 % (105 oC to constant weight)

                  pH of a 1 % colloidal solution

                  Not less than 5,0 and not more than 8,5

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 20 mg/kg

                  Total glycolate

                  Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis

                  Sodium

                  Not more than 12,4 % on the anhydrous basis

            E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE

                     Synonyms

                  Cross-linked carboxymethyl cellulose

                  Cross-linked CMC

                  Cross-linked sodium CMC

                  Cross-linked cellulose gum

                     Definition

                  Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose

                  Chemical name

                  Sodium salt of the cross-linked carboxymethyl ether cellulose

                  Chemical formula

                  The polymers containing substituted anhydroglucose units with the general formula:

                  C6H7O2(OR1)(OR2)(OR3)

                  where R1, R2 and R3 may be any of the following:

                              —

                              H

                              —

                              CH2COONa

                              —

                              CH2COOH

                     Description

                  Slightly hygroscopic, white to off white, odourless powder

                     Identification

                  A.

                  Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass

                  B.

                  Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface

                  C.

                  It gives the reaction of sodium

                     Purity

                  Loss on drying

                  Not more than 6 % (105 oC, 3h)

                  Water solubles

                  Not more than 10 %

                  Degree of substitution

                  Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit

                  pH of 1 %

                  Not less than 5,0 and not more than 7,0

                  Sodium content

                  Not more than 12,4 % on anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE

                     Synonyms

                  Sodium carboxymethyl cellulose, enzymatically hydrolysed

                     Definition

                  Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)

                  Chemical name

                  Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed

                  Chemical formula

                  Sodium salts of polymers containing substituted anhydroglucose units with the general formula:

                  [C6H7O2(OH)x(OCH2COONa)y]n

                  where n is the degree of polymerisation

                  x = 1,50 to 2,80

                  y = 0,2 to 1,50

                  x + y = 3,0

                  (y = degree of substitution)

                  Formula weight

                  178,14 where y = 0,20

                  282,18 where y = 1,50

                  Macromolecules: Not less than 800 (n about 4)

                  Assay

                  Not less than 99,5 %, including mono- and disaccharides, on the dried basis

                     Description

                  White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder

                     Identification

                              A.

                              Solubility

                  Soluble in water, insoluble in ethanol

                              B.

                              Foam test

                  Vigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums

                              C.

                              Precipitate formation

                  To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum

                              D.

                              Colour reaction

                  Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface

                              E.

                              Viscosity (60 % solids)

                  Not less than 2,500 kgm-1s-1 at 25 oC corresponding to an average molecule weight of 5 000 D

                     Purity

                  Loss on drying

                  Not more than 12 % (105 oC to constant weight)

                  Degree of substitution

                  Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis

                  pH of a 1 % colloidal solution

                  Not less than 6,0 and not more than 8,5

                  Sodium chloride and sodium glycolate

                  Not more than 0,5 % singly or in combination

                  Residual enzyme activity

                  Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose

                  Lead

                  Not more than 3 mg/kg

            E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS

                     Definition

                  Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids

                  Assay

                  Content on the anhydrous basis not less than 95 %

                     Description

                  White or creamy white light powders, flakes or semi-solids

                     Identification

                              A.

                              Solubility

                  Sodium and potassium salts: soluble in water and ethanol calcium salts:

                  insoluble in water, ethanol and ether

                              B.

                              Positive tests for cations and for fatty acids

                     Purity

                  Sodium

                  Not less than 9 % and not more than 14 % expressed as Na2O

                  Potassium

                  Not less than 13 % and not more than 21,5 % expressed as K2O

                  Calcium

                  Not less than 8,5 % and not more than 13 % expressed as CaO

                  Unsaponifiable matter

                  Not more than 2 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Free alkali

                  Not more than 0,1 % expressed as NaOH

                  Matter insoluble in alcohol

                  Not more than 0,2 % (sodium and potassium salts only)

            E 470b MAGNESIUM SALTS OF FATTY ACIDS

                     Definition

                  Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids

                  Assay

                  Content on the anhydrous basis not less than 95 %

                     Description

                  White or creamy-white light powders, flakes or semi-solids

                     Identification

                              A.

                              Solubility

                  Insoluble in water, partially soluble in ethanol and ether

                              B.

                              Positive tests for magnesium and for fatty acids

                     Purity

                  Magnesium

                  Not less than 6,5 % and not more than 11 % expressed as MgO

                  Free alkali

                  Not more than 0,1 % expressed as MgO

                  Unsaponifiable matter

                  Not more than 2 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Glyceryl monostearate

                  Glyceryl monopalmitate

                  Glyceryl monooleate, etc.

                  Monostearin, monopalmitin, monoolein, etc.

                  GMS (for glyceryl monostearate)

                     Definition

                  Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol

                  Assay

                  Content of mono- and diesters: not less than 70 %

                     Description

                  The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads

                     Identification

                              A.

                              Infrared spectrum

                  Characteristic of a partial fatty acid ester of a polyol

                              B.

                              Positive tests for glycerol and for fatty acids

                              C.

                              Solubility

                  Insoluble in water, soluble in ethanol and toluene

                     Purity

                  Water content

                  Not more than 2 % (Karl Fischer method)

                  Acid value

                  Not more than 6

                  Free glycerol

                  Not more than 7 %

                  Polyglycerols

                  Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Total glycerol

                  Not less than 16 % and not more than 33 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Acetic acid esters of mono- and diglycerides

                  Acetoglycerides

                  Acetylated mono- and diglycerides

                  Acetic and fatty acid esters of glycerol

                     Definition

                  Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides

                     Description

                  Clear, mobile liquids to solids, from white to pale yellow in colour

                     Identification

                              A.

                              Positive tests for glycerol, for fatty acids and for acetic acid

                              B.

                              Solubility

                  Insoluble in water. Soluble in ethanol

                     Purity

                  Acids other than acetic and fatty acids

                  Not detectable

                  Free glycerol

                  Not more than 2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Total acetic acid

                  Not less than 9 % and not more than 32 %

                  Free fatty acids (and acetic acid)

                  Not more than 3 % estimated as oleic acid

                  Total glycerol

                  Not less than 14 % and not more than 31 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Lactic acid esters of mono- and diglycerides

                  Lactoglycerides

                  Mono- and diglycerides of fatty acids esterified with lactic acid

                     Definition

                  Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides

                     Description

                  Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour

                     Identification

                              A.

                              Positive tests for glycerol, for fatty acids and for lactic acid

                              B.

                              Solubility

                  Insoluble in cold water but dispersible in hot water

                     Purity

                  Acids other than lactic and fatty acids

                  Not detectable

                  Free glycerol

                  Not more than 2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Total lactic acid

                  Not less than 13 % and not more than 45 %

                  Free fatty acids (and lactic acid)

                  Not more than 3 % estimated as oleic acid

                  Total glycerol

                  Not less than 13 % and not more than 30 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Citrem

                  Citric acid esters of mono- and diglycerides

                  Citroglycerides

                  Mono- and diglycerides of fatty acids esterified with citric acid

                     Definition

                  Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide

                     Description

                  Yellowish or light brown liquids to waxy solids or semi-solids

                     Identification

                              A.

                              Positive tests for glycerol, for fatty acids and for citric acid

                              B.

                              Solubility

                  Insoluble in cold water

                  Dispersible in hot water

                  Soluble in oils and fats

                  Insoluble in cold ethanol

                     Purity

                  Acids other than citric and fatty acids

                  Not detectable

                  Free glycerol

                  Not more than 2 %

                  Total glycerol

                  Not less than 8 % and not more than 33 %

                  Total citric acid

                  Not less than 13 % and not more than 50 %

                  Sulphated ash (determined at 800 ± 25 oC)

                  Non-neutralised products: not more than 0,5 %

                  Partially or wholly neutralised products: not more than 10 %

                  Lead

                  Not more than 2 mg/kg

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Tartaric acid esters of mono- and diglycerides

                  Mono- and diglycerides of fatty acids esterified with tartaric acid

                     Definition

                  Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides

                     Description

                  Sticky viscous yellowish liquids to hard yellow waxes

                     Identification

                              A.

                              Positive tests for glycerol, for fatty acids and for tartaric acid

                     Purity

                  Acids other than tartaric and fatty acids

                  Not detectable

                  Free glycerol

                  Not more than 2 %

                  Total glycerol

                  Not less than 12 % and not more than 29 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Total tartaric acid

                  Not less than 15 % and not more than 50 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Diacetyltartaric acid esters of mono- and diglycerides

                  Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid

                  Diacetyltartaric and fatty acid esters of glycerol

                     Definition

                  Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids

                     Description

                  Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid

                     Identification

                              A.

                              Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid

                     Purity

                  Acids other than acetic, tartaric and fatty acids

                  Not detectable

                  Free glycerol

                  Not more than 2 %

                  Total glycerol

                  Not less than 11 % and not more than 28 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Total tartaric acid

                  Not less than 10 % and not more than 40 %

                  Total acetic acid

                  Not less than 8 % and not more than 32 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid

                     Definition

                  Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids

                     Description

                  Sticky liquids to solids, from white to pale-yellow in colour

                     Identification

                              A.

                              Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid

                     Purity

                  Acids other than acetic, tartaric and fatty acids

                  Not detectable

                  Free glycerol

                  Not more than 2 %

                  Total glycerol

                  Not less than 12 % and not more than 27 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Total acetic acid

                  Not less than 10 % and not more than 20 %

                  Total tartaric acid

                  Not less than 20 % and not more than 40 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 473 SUCROSE ESTERS OF FATTY ACIDS

                     Synonyms

                  Sucroesters

                  Sugar esters

                     Definition

                  Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation

                  Assay

                  Content not less than 80 %

                     Description

                  Stiff gels, soft solids or white to slightly greyish-white powders

                     Identification

                              A.

                              Positive tests for sugar for fatty acids

                              B.

                              Solubility

                  Sparingly soluble in water

                  Soluble in ethanol

                     Purity

                  Sulphated ash

                  Not more than 2 % determined at 800 ± 25 oC

                  Free sugar

                  Not more than 5 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Methanol

                  Not more than 10 mg/kg

                  Dimethylsulphoxide

                  Not more than 2 mg/kg

                  Dimethylformamide

                  Not more than 1 mg/kg

                  2-methyl-1-propanol

                  Not more than 10 mg/kg

                  Ethylacetate

                  Not more than 350 mg/kg, singly or in combination

                  Propane-2-ol

                  Prolyleneglycol

                  Methyl ethyl ketone

                  Not more than 10 mg/kg

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 474 SUCROGLYCERIDES

                     Synonyms

                  Sugar glycerides

                     Definition

                  Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol

                  Assay

                  Content not less than 40 % and not more than 60 % of sucrose fatty acid esters

                     Description

                  Soft solid masses, stiff gels or white to off-white powders

                     Identification

                              A.

                              Positive tests for sugar and for fatty acids

                              B.

                              Solubility

                  Insoluble in cold water

                  Soluble in ethanol

                     Purity

                  Sulphated ash

                  Not more than 2 % determined at 800 ± 25 oC

                  Free sugar

                  Not more than 5 %

                  Free fatty acids

                  Not more than 3 % estimated as oleic acid

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Methanol

                  Not more than 10 mg/kg

                  Dimethylformamide

                  Not more than 1 mg/kg

                  2-methyl-1-propanol

                  Not more than 10 mg/kg, single or in combination

                  Cyclohexane

                  Ethylacetate

                  Not more than 350 mg/kg, single or in combination

                  Propane-2-ol

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS

                     Synonyms

                  Polyglycerol fatty acid esters

                  Polyglycerin esters of fatty acid esters

                     Definition

                  Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol

                  Assay

                  Content of total fatty acid ester not less than 90 %

                     Description

                  Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids

                     Identification

                              A.

                              Positive tests for glycerol, for polyglycerols and for fatty acids

                              B.

                              Solubility

                  The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils

                     Purity

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  Acids other than fatty acids

                  Not detectable

                  Free fatty acids

                  Not more than 6 % estimated as oleic acid

                  Total glycerol and polyglycerol

                  Not less than 18 % and not more than 60 %

                  Free glycerol and polyglycerol

                  Not more than 7 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 476 POLYGLYCEROL POLYRICINOLEATE

                     Synonyms

                  Glycerol esters of condensed castor oil fatty acids

                  Polyglycerol esters of polycondensed fatty acids from castor oil

                  Polyglycerol esters of interesterified ricinoleic acid

                  PGPR

                     Definition

                  Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids

                     Description

                  Clear, highly viscous liquid

                     Identification

                              A.

                              Solubility

                  Insoluble in water and in ethanol.

                  Soluble in ether, hydrocarbons and halogenated hydrocarbons

                              B.

                              Positive tests for glycerol, polyglycerol and for ricinoleic acid

                              C.

                              Refractive index [n]65

                  Between 1,4630 and 1,4665

                     Purity

                  Polyglycerols

                  The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol

                  Hydroxyl value

                  Not less than 80 and not more than 100

                  Acid value

                  Not more than 6

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS

                     Synonyms

                  Propylene glycol esters of fatty acids

                     Definition

                  Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent

                  Assay

                  Content of total fatty acid ester not less than 85 %

                     Description

                  Clear liquids or waxy white flakes, beads or solids having a bland odour

                     Identification

                              A.

                              Positive tests for propylene glycol and for fatty acids

                     Purity

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  Acids other than fatty acids

                  Not detectable

                  Free fatty acids

                  Not more than 6 % estimated as oleic acid

                  Total propane-1,2-diol

                  Not less than 11 % and not more than 31 %

                  Free propane-1,2-diol

                  Not more than 5 %

                  Dimer and trimer of propylene glycol

                  Not more than 0,5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                                 Note:

                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).

            E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS

                     Synonyms

                  TOSOM

                     Definition

                  Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans

                     Description

                  Pale yellow to light brown a waxy or solid consistency

                     Identification

                              A.

                              Solubility

                  Insoluble in water. Soluble in hot oil or fat

                     Purity

                  Melting range

                  55-65 oC

                  Free fatty acids

                  Not more than 1,5 % estimated as oleic acid

                  Free glycerol

                  Not more than 2 %

                  Total fatty acids

                  83-90 %

                  Total glycerol

                  16-22 %

                  Fatty acid methyl esters, not forming adduct with urea

                  Not more than 9 % of total fatty acid methyl esters

                  Fatty acids, insoluble in petroleum ether

                  Not more than 2 % of total fatty acids

                  Peroxide value

                  Not more than 3

                  Epoxides

                  Not more than 0,03 % oxirane oxygen

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 481 SODIUM STEAROYL-2-LACTYLATE

                     Synonyms

                  Sodium stearoyl lactylate

                  Sodium stearoyl lactate

                     Definition

                  A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used

                  Chemical names

                  Sodium di-2-stearoyl lactate

                  Sodium di(2-stearoyloxy)propionate

                  Einecs

                  246-929-7

                  Chemical formula (major components)

                  C21H39O4Na

                  C19H35O4Na

                     Description

                  White or slightly yellowish powder or brittle solid with a characteristic odour

                     Identification

                              A.

                              Positive tests for sodium, for fatty acids and for lactic acid

                              B.

                              Solubility

                  Insoluble in water. Soluble in ethanol

                     Purity

                  Sodium

                  Not less than 2,5 % and not more than 5 %

                  Ester value

                  Not less than 90 and not more than 190

                  Acid value

                  Not less than 60 and not more than 130

                  Total lactic acid

                  Not less than 15 % and not more than 40 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 482 CALCIUM STEAROYL-2-LACTYLATE

                     Synonyms

                  Calcium stearoyl lactate

                     Definition

                  A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used

                  Chemical name

                  Calcium di-2-stearoyl lactate

                  Calcium di(2-stearoyloxy)propionate

                  Einecs

                  227-335-7

                  Chemical formula

                  C42H78O8Ca

                  C38H70O8Ca

                     Description

                  White or slightly yellowish powder or brittle solid with a characteristic odour

                     Identification

                              A.

                              Positive tests for calcium, for fatty acids and for lactid acid

                              B.

                              Solubility

                  Slightly soluble in hot water

                     Purity

                  Calcium

                  Not less than 1 % and not more than 5,2 %

                  Ester value

                  Not less than 125 and not more than 190

                  Total lactic acid

                  Not less than 15 % and not more than 40 %

                  Acid value

                  Not less than 50 and not more than 130

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 483 STEARYL TARTRATE

                     Synonyms

                  Stearyl palmityl tartrate

                     Definition

                  Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials

                  Chemical name

                  Distearyl tartrate

                  Dipalmityl tartrate

                  Chemical formula

                  C38H74O6 to C40H78O6

                  Molecular weight

                  627 to 655

                  Assay

                  Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180

                     Description

                  Cream-coloured unctuous solid (at 25 oC)

                     Identification

                              A.

                              Positive tests for tartare

                              B.

                              Melting range

                  Between 67 oC and 77 oC. After saponification the saturated long chain fatty alcohols have a melting range of 49 oC to 55 oC

                     Purity

                  Hydroxyl value

                  Not less than 200 and not more than 220

                  Acid value

                  Not more than 5,6

                  Total tartaric acid content

                  Not less than 18 % and not more than 35 %

                  Sulphated ash

                  Not more than 0,5 % determined at 800 ± 25 oC

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Unsaponifiable matter

                  Not less than 77 % and not more than 83 %

                  Iodine value

                  Not more than 4 (Wijs method)

            E 491 SORBITAN MONOSTEARATE

                     Definition

                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid

                  Einecs

                  215-664-9

                  Assay

                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

                     Description

                  Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 oC in mineral oil and ethyl acetate

                              B.

                              Congealing range

                  50-52 oC

                              C.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyol

                     Purity

                  Water

                  Not more than 2 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,5 %

                  Acid value

                  Not more than 10

                  Saponification value

                  Not less than 147 and not more than 157

                  Hydroxyl value

                  Not less than 235 and not more than 260

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 492 SORBITAN TRISTEARATE

                     Definition

                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid

                  Einecs

                  247-891-4

                  Assay

                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

                     Description

                  Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour

                     Identification

                              A.

                              Solubility

                  Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol

                              B.

                              Congealing range

                  47-50 oC

                              C.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyol

                     Purity

                  Water

                  Not more than 2 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,5 %

                  Acid value

                  Not more than 15

                  Saponification value

                  Not less than 176 and not more than 188

                  Hydroxyl value

                  Not less than 66 and not more than 80

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 493 SORBITAN MONOLAURATE

                     Definition

                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid

                  Einecs

                  215-663-3

                  Assay

                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

                     Description

                  Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour

                     Identification

                              A.

                              Solubility

                  Dispersible in hot and cold water

                              B.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of a polyol

                     Purity

                  Water

                  Not more than 2 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,5 %

                  Acid value

                  Not more than 7

                  Saponification value

                  Not less than 155 and not more than 170

                  Hydroxyl value

                  Not less than 330 and not more than 358

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 494 SORBITAN MONOOLEATE

                     Definition

                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate

                  Einecs

                  215-665-4

                  Assay

                  Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters

                     Description

                  Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water

                              B.

                              Iodine value

                  The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100

                     Purity

                  Water

                  Not more than 2 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,5 %

                  Acid value

                  Not more than 8

                  Saponification value

                  Not less than 145 and not more than 160

                  Hydroxyl value

                  Not less than 193 and not more than 210

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 495 SORBITAN MONOPALMITATE

                     Synonyms

                  Sorbitan palmitate

                     Definition

                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid

                  Einecs

                  247-568-8

                  Assay

                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

                     Description

                  Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour

                     Identification

                              A.

                              Solubility

                  Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water

                              B.

                              Congealing range

                  45-47 oC

                              C.

                              Infrared absorption spectrum

                  Characteristic of a partial fatty acid ester of polyol

                     Purity

                  Water

                  Not more than 2 % (Karl Fischer method)

                  Sulphate ash

                  Not more than 0,5 %

                  Acid value

                  Not more than 7,5

                  Saponification value

                  Not less than 140 and not more than 150

                  Hydroxyl value

                  Not less than 270 and not more than 305

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 500(i) SODIUM CARBONATE

                     Synonyms

                  Soda ash

                     Definition

                  Chemical name

                  Sodium carbonate

                  Einecs

                  207-838-8

                  Chemical formula

                  Na2CO3 · nH2O (n = 0, 1 or 10)

                  Molecular weight

                  106,00 (anhydrous)

                  Assay

                  Content not less than 99 % of Na2CO3 on the anhydrous basis

                     Description

                  Colourless crystals or white, granular or crystalline powder

                  The anhydrous form is hygroscopic, the decahydrate efflorescent

                     Identification

                              A.

                              Positive tests for sodium and for carbonate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 oC raising gradually to 300 oC, to constant weight)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 500(ii) SODIUM HYDROGEN CARBONATE

                     Synonyms

                  Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking soda

                     Definition

                  Chemical name

                  Sodium hydrogen carbonate

                  Einecs

                  205-633-8

                  Chemical formula

                  NaHCO3

                  Molecular weight

                  84,01

                  Assay

                  Content not less than 99 % on the anhydrous basis

                     Description

                  Colourless or white crystalline masses or crystalline powder

                     Identification

                              A.

                              Positive tests for sodium and for carbonate

                              B.

                              pH of a 1 % solution

                  Between 8,0 and 8,6

                              C.

                              Solubility

                  Soluble in water. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 0,25 % (over silica gel, 4h)

                  Ammonium salts

                  No odour of ammonia detectable after heating

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 500(iii) SODIUM SESQUICARBONATE

                     Definition

                  Chemical name

                  Sodium monohydrogen dicarbonate

                  Einecs

                  208-580-9

                  Chemical formula

                  Na2(CO)3 · NaHCO3 · 2H2O

                  Molecular weight

                  226,03

                  Assay

                  Content between 35,0 % and 38,6 % of NaHCO3 and between 46,4 % and 50,0 % of Na2CO3

                     Description

                  White flakes, crystals or crystalline powder

                     Identification

                              A.

                              Positive tests for sodium and for carbonate

                              B.

                              Solubility

                  Freely soluble in water

                     Purity

                  Sodium chloride

                  Not more than 0,5 %

                  Iron

                  Not more than 20 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 501(i) POTASSIUM CARBONATE

                     Definition

                  Chemical name

                  Potassium carbonate

                  Einecs

                  209-529-3

                  Chemical formula

                  K2CO3 · nH2O (n = 0 or 1,5)

                  Molecular weight

                  138,21 (anhydrous)

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  White, very deliquescent powder.

                  The hydrate occurs as small, white, translucent crystals or granules

                     Identification

                              A.

                              Positive tests for potassium and for carbonate

                              B.

                              Solubility

                  Very soluble in water. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 5 % (anhydrous) or 18 % (hydrate) (180 oC, 4h)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 501(ii) POTASSIUM HYDROGEN CARBONATE

                     Synonyms

                  Potassium bicarbonate, acid potassium carbonate

                     Definition

                  Chemical name

                  Potassium hydrogen carbonate

                  Einecs

                  206-059-0

                  Chemical formula

                  KHCO3

                  Molecular weight

                  100,11

                  Assay

                  Content not less than 99,0 % and not more than 101,0 % KHCO3 on the anhydrous basis

                     Description

                  Colourless crystals or white powder or granules

                     Identification

                              A.

                              Positive tests for potassium and for carbonate

                              B.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                     Purity

                  Loss on drying

                  Not more than 0,25 % (over silica gel, 4h)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 503(i) AMMONIUM CARBONATE

                     Definition

                  Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions

                  Chemical name

                  Ammonium carbonate

                  Einecs

                  233-786-0

                  Chemical formula

                  CH6N2O2, CH8N2O3 and CH5NO3

                  Molecular weight

                  Ammonium carbamate 78,06; ammonium carbonate 98,73; ammonium hydrogen carbonate 79,06

                  Assay

                  Content not less than 30,0 % and not more than 34,0 % of NH3

                     Description

                  White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide

                     Identification

                              A.

                              Positive tests for ammonium and for carbonate

                              B.

                              pH of a 5 % solution

                  about 8,6

                              C.

                              Solubility

                  Soluble in water

                     Purity

                  Non-volatile matter

                  Not more than 500 mg/kg

                  Chlorides

                  Not more than 30 mg/kg

                  Sulphate

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 503(ii) AMMONIUM HYDROGEN CARBONATE

                     Synonyms

                  Ammonium bicarbonate

                     Definition

                  Chemical name

                  Ammonium hydrogen carbonate

                  Einecs

                  213-911-5

                  Chemical formula

                  CH5NO3

                  Molecular weight

                  79,06

                  Assay

                  Content not less than 99,0 %

                     Description

                  White crystals or crystalline powder

                     Identification

                              A.

                              Positive tests for ammonium and for carbonate

                              B.

                              pH of a 5 % solution

                  about 8,0

                              C.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                     Purity

                  Non-volatile matter

                  Not more than 500 mg/kg

                  Chlorides

                  Not more than 30 mg/kg

                  Sulphate

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 504(ii) MAGNESIUM HYDROXIDE CARBONATE

                     Synonyms

                  Magnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxide

                     Definition

                  Chemical name

                  Magnesium carbonate hydroxide hydrated

                  Einecs

                  235-192-7

                  Chemical formula

                  4MgCO3Mg(OH)25H2O

                  Molecular weight

                  485

                  Assay

                  Mg content not less than 40,0 % and not more than 45,0 % calculated as MgO

                     Description

                  Light, white friable mass or bulky white powder

                     Identification

                              A.

                              Positive tests for magnesium and for carbonate

                              B.

                              Solubility

                  Practically insoluble in water. Insoluble in ethanol

                     Purity

                  Acid insoluble matter

                  Not more than 0,05 %

                  Water soluble matter

                  Not more than 1,0 %

                  Calcium

                  Not more than 1,0 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 507 HYDROCHLORIC ACID

                     Synonyms

                  Hydrogen chloride, muriatic acid

                     Definition

                  Chemical name

                  Hydrochloric acid

                  Einecs

                  231-595-7

                  Chemical formula

                  HCl

                  Molecular weight

                  36,46

                  Assay

                  Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HCl

                     Description

                  Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour

                     Identification

                              A.

                              Positive tests for acid and for chloride

                              B.

                              Solubility

                  Soluble in water and in ethanol

                     Purity

                  Total organic compounds

                  Total organic compounds (non-fluorine containing): not more than 5 mg/kg

                  Benzene: not more than 0,05 mg/kg

                  Fluorinated compounds (total): not more than 25 mg/kg

                  Non-volatile matter

                  Not more than 0,5 %

                  Reducing substances

                  Not more than 70 mg/kg (as SO2)

                  Oxidising substances

                  Not more than 30 mg/kg (as Cl2)

                  Sulphate

                  Not more than 0,5 %

                  Iron

                  Not more than 5 mg/kg

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 508 POTASSIUM CHLORIDE

                     Synonyms

                  Sylvine

                  Sylvite

                     Definition

                  Chemical name

                  Potassium chloride

                  Einecs

                  231-211-8

                  Chemical formulae

                  KCl

                  Molecular weight

                  74,56

                  Assay

                  Content not less than 99 % on the dried basis

                     Description

                  Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless

                     Identification

                              A.

                              Solubility

                  Freely soluble in water. Insoluble in ethanol

                              B.

                              Positive tests for potassium and for chloride

                     Purity

                  Loss on drying

                  Not more than 1 % (105 oC, 2 hours)

                  Sodium

                  Negative test

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

            E 509 CALCIUM CHLORIDE

                     Definition

                  Chemical name

                  Calcium chloride

                  Einecs

                  233-140-8

                  Chemical formula

                  CaCl2 · nH2O (n = 0,2 or 6)

                  Molecular weight

                  110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)

                  Assay

                  Content not less than 93,0 % on the anhydrous basis

                     Description

                  White, odourless, hygroscopic powder or deliquescent crystals

                     Identification

                              A.

                              Positive tests for calcium and for chloride

                              B.

                              Solubility

                  Anhydrous calcium chloride: freely soluble in water and ethanol

                  Dihydrate: freely soluble in water, soluble in ethanol

                  Hexahydrate: very soluble in water and ethanol

                     Purity

                  Magnesium and alkali salts

                  Not more than 5 % on the anhydrous basis

                  Fluoride

                  Not more than 40 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 511 MAGNESIUM CHLORIDE

                     Definition

                  Chemical name

                  Magnesium chloride

                  Einecs

                  232-094-6

                  Chemical formula

                  MgCl2 · 6H2O

                  Molecular weight

                  203,30

                  Assay

                  Content not less than 99,0 %

                     Description

                  Colourless, odourless, very deliquescent flakes or crystals

                     Identification

                              A.

                              Positive tests for magnesium and for chloride

                              B.

                              Solubility

                  Very soluble in water, freely soluble in ethanol

                     Purity

                  Ammonium

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 512 STANNOUS CHLORIDE

                     Synonyms

                  Tin chloride, tin dichloride

                     Definition

                  Chemical name

                  Stannous chloride dihydrate

                  Einecs

                  231-868-0

                  Chemical formula

                  SnCl2 · 2H2O

                  Molecular weight

                  225,63

                  Assay

                  Content not less than 98,0 %

                     Description

                  Colourless or white crystals

                  May have a slight odour of hydrochloric acid

                     Identification

                              A.

                              Positive tests for tin (II) and for chloride

                              B.

                              Solubility

                  Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water

                  Ethanol: soluble

                     Purity

                  Sulphate

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 513 SULPHURIC ACID

                     Synonyms

                  Oil of vitriol, dihydrogen sulphate

                     Definition

                  Chemical name

                  Sulphuric acid

                  Einecs

                  231-639-5

                  Chemical formula

                  H2SO4

                  Molecular weight

                  98,07

                  Assay

                  Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %

                     Description

                  Clear, colourless or slightly brown, very corrosive oily liquid

                     Identification

                              A.

                              Positive tests for acid and for sulphate

                              B.

                              Solubility

                  Miscible with water, with generation of much heat, also with ethanol

                     Purity

                  Ash

                  Not more than 0,02 %

                  Reducing matter

                  Not more than 40 mg/kg (as SO2)

                  Nitrate

                  Not more than 10 mg/kg (on H2SO4 basis)

                  Chloride

                  Not more than 50 mg/kg

                  Iron

                  Not more than 20 mg/kg

                  Selenium

                  Not more than 20 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 514(i) SODIUM SULPHATE

                     Definition

                  Chemical name

                  Sodium sulphate

                  Chemical formula

                  Na2SO4 · nH2O (n = 0 or 10)

                  Molecular weight

                  142,04 (anhydrous)

                  322,04 (decahydrate)

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  Colourless crystals or a fine, white, crystalline powder

                  The decahydrate is efflorescent

                     Identification

                              A.

                              Positive tests for sodium and for sulphate

                              B.

                              Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper

                     Purity

                  Loss on drying

                  Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °C

                  Selenium

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 514(ii) SODIUM HYDROGEN SULPHATE

                     Synonyms

                  Acid sodium sulphate, sodium bisulphate, nitre cake

                     Definition

                  Chemical name

                  Sodium hydrogen sulphate

                  Chemical formula

                  NaHSO4

                  Molecular weight

                  120,06

                  Assay

                  Content not less than 95,2 %

                     Description

                  White, odourless crystals or granules

                     Identification

                              A.

                              Positive tests for sodium and for sulphate

                              B.

                              Solutions are strongly acidic

                     Purity

                  Loss on drying

                  Not more than 0,8 %

                  Water insoluble

                  Not more than 0,05 %

                  Selenium

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 515(i) POTASSIUM SULPHATE

                     Definition

                  Chemical name

                  Potassium sulphate

                  Chemical formula

                  K2SO4

                  Molecular weight

                  174,25

                  Assay

                  Content not less than 99,0 %

                     Description

                  Colourless or white crystals or crystalline powder

                     Identification

                              A.

                              Positive tests for potassium and for sulphate

                              B.

                              pH of a 5 % solution

                  Between 5,5 and 8,5

                              C.

                              Solubility

                  Freely soluble in water, insoluble in ethanol

                     Purity

                  Selenium

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 515(ii) POTASSIUM HYDROGEN SULPHATE

                     Definition

                     Synonyms

                  Potassium bisulphate, potassium acid sulphate

                  Chemical name

                  Potassium hydrogen sulphate

                  Chemical formula

                  KHSO4

                  Molecular weight

                  136,17

                  Assay

                  Content not less than 99 %

                  Melting point

                  197 oC

                     Description

                  White deliquescent crystals, pieces or granules

                     Identification

                              A.

                              Positive test for potassium

                              B.

                              Solubility

                  Freely soluble in water, insoluble in ethanol

                     Purity

                  Selenium

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 516 CALCIUM SULPHATE

                     Synonyms

                  Gypsum, selenite, anhydrite

                     Definition

                  Chemical name

                  Calcium sulphate

                  Einecs

                  231-900-3

                  Chemical formula

                  CaSO4 · nH2O (n = 0 or 2)

                  Molecular weight

                  136,14 (anhydrous), 172,18 (dihydrate)

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  Fine, white to slightly yellowish-white odourless powder

                     Identification

                              A.

                              Positive tests for calcium and for sulphate

                              B.

                              Solubility

                  Slightly soluble in water, insoluble in ethanol

                     Purity

                  Loss on drying

                  Anhydrous: not more than 1,5 % (250 oC, constant weight)

                  Dihydrate: not more than 23 % (ibid.)

                  Fluoride

                  Not more than 30 mg/kg

                  Selenium

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 517 AMMONIUM SULPHATE

                     Definition

                  Chemical name

                  Ammonium sulphate

                  Einecs

                  231-984-1

                  Chemical formula

                  (NH4)2SO4

                  Molecular weight

                  132,14

                  Assay

                  Content not less than 99,0 % and not more than 100,5 %

                     Description

                  White powder, shining plates or crystalline fragments

                     Identification

                              A.

                              Positive tests for ammonium and for sulphate

                              B.

                              Solubility

                  Freely soluble in water, insoluble in ethanol

                     Purity

                  Loss on ignition

                  Not more than 0,25 %

                  Selenium

                  Not more than 30 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 520 ALUMINIUM SULPHATE

                     Synonyms

                  Alum

                     Definition

                  Chemical name

                  Aluminium sulphate

                  Einecs

                  233-135-0

                  Chemical formula

                  Al2(SO4)3

                  Molecular weight

                  342,13

                  Assay

                  Content not less than 99,5 % on the ignited basis

                     Description

                  White powder, shining plates or crystalline fragments

                     Identification

                              A.

                              Positive tests for aluminium and for sulphate

                              B.

                              pH of a 5 % solution 2,9 or above

                              C.

                              Solubility

                  Freely soluble in water, insoluble in ethanol

                     Purity

                  Loss on ignition

                  Not more than 5 % (500 oC, 3h)

                  Alkalies and alkaline earths

                  Not more than 0,4 %

                  Selenium

                  Not more than 30 mg/kg

                  Fluoride

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 521 ALUMINIUM SODIUM SULPHATE

                     Synonyms

                  Soda alum, sodium alum

                     Definition

                  Chemical name

                  Aluminium sodium sulphate

                  Einecs

                  233-277-3

                  Chemical formula

                  AlNa(SO4)2 · nH2O (n = 0 or 12)

                  Molecular weight

                  242,09 (anhydrous)

                  Assay

                  Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)

                     Description

                  Transparent crystals or white crystalline powder

                     Identification

                              A.

                              Positive tests for aluminium, for sodium and for sulphate

                              B.

                              Solubility

                  Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol

                     Purity

                  Loss on drying

                  Anhydrous form: not more than 10,0 % (220 oC, 16h)

                  Dodecahydrate: not more than 47,2 % (50 oC-55 oC, 1h then 200 oC, 16h)

                  Ammonium salts

                  No odour of ammonia detectable after heating

                  Selenium

                  Not more than 30 mg/kg

                  Fluoride

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 522 ALUMINIUM POTASSIUM SULPHATE

                     Synonyms

                  Potassium alum, potash alum

                     Definition

                  Chemical name

                  Aluminium potassium sulphate dodecahydrate

                  Einecs

                  233-141-3

                  Chemical formula

                  AlK(SO4)2 · 12 H2O

                  Molecular weight

                  474,38

                  Assay

                  Content not less than 99,5 %

                     Description

                  Large, transparent crystals or white crystalline powder

                     Identification

                              A.

                              Positive tests for aluminium, for potassium and for sulphate

                              B.

                              pH of a 10 % solution between 3,0 and 4,0

                              C.

                              Solubility

                  Freely soluble in water, insoluble in ethanol

                     Purity

                  Ammonium salts

                  No odour of ammonia detectable after heating

                  Selenium

                  Not more than 30 mg/kg

                  Fluoride

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 523 ALUMINIUM AMMONIUM SULPHATE

                     Synonyms

                  Ammonium alum

                     Definition

                  Chemical name

                  Aluminium ammonium sulphate

                  Einecs

                  232-055-3

                  Chemical formula

                  AlNH4(SO4)2 · 12 H2O

                  Molecular weight

                  453,32

                  Assay

                  Content not less than 99,5 %

                     Description

                  Large, colourless crystals or white powder

                     Identification

                              A.

                              Positive tests for aluminium, for ammonium and for sulphate

                              B.

                              Solubility

                  Freely soluble in water, soluble in ethanol

                     Purity

                  Alkali metals and alkaline earths

                  Not more than 0,5 %

                  Selenium

                  Not more than 30 mg/kg

                  Fluoride

                  Not more than 30 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 524 SODIUM HYDROXIDE

                     Synonyms

                  Caustic soda, lye

                     Definition

                  Chemical name

                  Sodium hydroxide

                  Einecs

                  215-185-5

                  Chemical formula

                  NaOH

                  Molecular weight

                  40,0

                  Assay

                  Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH

                     Description

                  White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate

                     Identification

                              A.

                              Positive tests for sodium

                              B.

                              A 1 % solution is strongly alkaline

                              C.

                              Solubility

                  Very soluble in water. Freely soluble in ethanol

                     Purity

                  Water insoluble and organic matter

                  A 5 % solution is completely clear and colourless to slightly coloured

                  Carbonate

                  Not more than 0,5 % (as Na2CO3)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 0,5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 525 POTASSIUM HYDROXIDE

                     Synonyms

                  Caustic potash

                     Definition

                  Chemical name

                  Potassium hydroxide

                  Einecs

                  215-181-3

                  Chemical formula

                  KOH

                  Molecular weight

                  56,11

                  Assay

                  Content not less than 85,0 % of alkali calculated as KOH

                     Description

                  White or nearly white pellets, flakes, sticks, fused masses or other forms

                     Identification

                              A.

                              Positive tests for potassium

                              B.

                              A 1 % solution is strongly alkaline

                              C.

                              Solubility

                  Very soluble in water. Freely soluble in ethanol

                     Purity

                  Water insoluble matter

                  A 5 % solution is completely clear and colourless

                  Carbonate

                  Not more than 3,5 % (as K2CO3)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 526 CALCIUM HYDROXIDE

                     Synonyms

                  Slaked lime, hydrated lime

                     Definition

                  Chemical name

                  Calcium hydroxide

                  Einecs

                  215-137-3

                  Chemical formula

                  Ca(OH)2

                  Molecular weight

                  74,09

                  Assay

                  Content not less than 92,0 %

                     Description

                  White powder

                     Identification

                              A.

                              Positive tests for alkali and for calcium

                              B.

                              Solubility

                  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

                     Purity

                  Acid insoluble ash

                  Not more than 1,0 %

                  Magnesium and alkali salts

                  Not more than 1,0 %

                  Barium

                  Not more than 300 mg/kg

                  Fluoride

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

            E 527 AMMONIUM HYDROXIDE

                     Synonyms

                  Aqua ammonia, strong ammonia solution

                     Definition

                  Chemical name

                  Ammonium hydroxide

                  Chemical formula

                  NH4OH

                  Molecular weight

                  35,05

                  Assay

                  Content not less than 27 % of NH3

                     Description

                  Clear, colourless solution, having an exceedingly pungent, characteristic odour

                     Identification

                              A.

                              Positive tests for ammonia

                     Purity

                  Non-volatile matter

                  Not more than 0,02 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 528 MAGNESIUM HYDROXIDE

                     Definition

                  Chemical name

                  Magnesium hydroxide

                  Einecs

                  215-170-3

                  Chemical formula

                  Mg(OH)2

                  Molecular weight

                  58,32

                  Assay

                  Content not less than 95,0 % on the anhydrous basis

                     Description

                  Odourless, white bulky powder

                     Identification

                              A.

                              Positive test for magnesium and for alkali

                              B.

                              Solubility

                  Practically insoluble in water and in ethanol

                     Purity

                  Loss on drying

                  Not more than 2,0 % (105 oC, 2h)

                  Loss on ignition

                  Not more than 33 % (800 oC to constant weight)

                  Calcium oxide

                  Not more than 1,5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

            E 529 CALCIUM OXIDE

                     Synonyms

                  Burnt lime

                     Definition

                  Chemical name

                  Calcium oxide

                  Einecs

                  215-138-9

                  Chemical formula

                  CaO

                  Molecular weight

                  56,08

                  Assay

                  Content not less than 95,0 % on the ignited basis

                     Description

                  Odourless, hard, white or greyish white masses of granules, or white to greyish powder

                     Identification

                              A.

                              Positive test for alkali and for calcium

                              B.

                              Heat is generated on moistening the sample with water

                              C.

                              Solubility

                  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

                     Purity

                  Loss on ignition

                  Not more than 10,0 % (ca 800 oC to constant weight)

                  Acid insoluble matter

                  Not more than 1,0 %

                  Barium

                  Not more than 300 mg/kg

                  Magnesium and alkali salts

                  Not more than 1,5 %

                  Fluoride

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

            E 530 MAGNESIUM OXIDE

                     Definition

                  Chemical name

                  Magnesium oxide

                  Einecs

                  215-171-9

                  Chemical formula

                  MgO

                  Molecular weight

                  40,31

                  Assay

                  Content not less than 98,0 % on the ignited basis

                     Description

                  A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml

                     Identification

                              A.

                              Positive test for alkali and for magnesium

                              B.

                              Solubility

                  Practically insoluble in water. Insoluble in ethanol

                     Purity

                  Loss on ignition

                  Not more than 5,0 % (ca 800 oC to constant weight)

                  Calcium oxide

                  Not more than 1,5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

            E 535 SODIUM FERROCYANIDE

                     Synonyms

                  Yellow prussiate of soda, sodium hexacyanoferrate

                     Definition

                  Chemical name

                  Sodium ferrocyanide

                  Einecs

                  237-081-9

                  Chemical formula

                  Na4Fe(CN)6 · 10 H2O

                  Molecular weight

                  484,1

                  Assay

                  Content not less than 99,0 %

                     Description

                  Yellow crystals or crystalline powder

                     Identification

                              A.

                              Positive test for sodium and for ferrocyanide

                     Purity

                  Free moisture

                  Not more than 1,0 %

                  Water insoluble matter

                  Not more than 0,03 %

                  Chloride

                  Not more than 0,2 %

                  Sulphate

                  Not more than 0,1 %

                  Free cyanide

                  Not detectable

                  Ferricyanide

                  Not detectable

                  Lead

                  Not more than 5 mg/kg

            E 536 POTASSIUM FERROCYANIDE

                     Synonyms

                  Yellow prussiate of potash, potassium hexacyanoferrate

                     Definition

                  Chemical name

                  Potassium ferrocyanide

                  Einecs

                  237-722-2

                  Chemical formula

                  K4Fe(CN)6· 3 H2O

                  Molecular weight

                  422,4

                  Assay

                  Content not less than 99,0 %

                     Description

                  Lemon yellow crystals

                     Identification

                              A.

                              Positive test for potassium and for ferrocyanide

                     Purity

                  Free moisture

                  Not more than 1,0 %

                  Water insoluble matter

                  Not more than 0,03 %

                  Chloride

                  Not more than 0,2 %

                  Sulphate

                  Not more than 0,1 %

                  Free cyanide

                  Not detectable

                  Ferricyanide

                  Not detectable

                  Lead

                  Not more than 5 mg/kg

            E 538 CALCIUM FERROCYANIDE

                     Synonyms

                  Yellow prussiate of lime, calcium hexacyanoferrate

                     Definition

                  Chemical name

                  Calcium ferrocyanide

                  Einecs

                  215-476-7

                  Chemical formula

                  Ca2Fe(CN)6 · 12H2O

                  Molecular weight

                  508,3

                  Assay

                  Content not less than 99,0 %

                     Description

                  Yellow crystals or crystalline powder

                     Identification

                              A.

                              Positive test for calcium and for ferrocyanide

                     Purity

                  Free moisture

                  Not more than 1,0 %

                  Water insoluble matter

                  Not more than 0,03 %

                  Chloride

                  Not more than 0,2 %

                  Sulphate

                  Not more than 0,1 %

                  Free cyanide

                  Not detectable

                  Ferricyanide

                  Not detectable

                  Lead

                  Not more than 5 mg/kg

            E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC

                     Synonyms

                  SALP

                     Definition

                  Chemical name

                  Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or

                  Trisodium dialuminium pentadecahydrogen octaphosphate (B)

                  Einecs

                  232-090-4

                  Chemical formula

                  NaAl3H14(PO4)8 · 4H2O (A)

                  Na3Al2H15(PO4)8 (B)

                  Molecular weight

                  949,88 (A)

                  897,82 (B)

                  Assay

                  Content not less than 95,0 % (both forms)

                     Description

                  White odourless powder

                     Identification

                              A.

                              Positive test for sodium, for aluminium and for phosphate

                              B.

                              pH

                  Acid to litmus

                              C.

                              Solubility

                  Insoluble in water. Soluble in hydrochloric acid

                     Purity

                  Loss on ignition

                  19,5 %-21,0 % (A) } (750 oC-800 oC, 2h)

                  15 %-16 % (B) } (750 oC-800 oC, 2h)

                  Fluoride

                  Not more than 25 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 4 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 551 SILICON DIOXIDE

                     Synonyms

                  Silica, silicium dioxide

                     Definition

                  Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water

                  Chemical name

                  Silicon dioxide

                  Einecs

                  231-545-4

                  Chemical formula

                  (SiO2)n

                  Molecular weight

                  60,08 (SiO2)

                  Assay

                  Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)

                     Description

                  White, fluffy powder or granules

                  Hygroscopic

                     Identification

                              A.

                              Positive test for silica

                     Purity

                  Loss on drying

                  Not more than 2,5 % (fumed silica, 105 oC, 2h)

                  Not more than 8,0 % (precipitated silica and silica gel, 105 oC, 2h)

                  Not more than 70 % (hydrous silica, 105 oC, 2h)

                  Loss on ignition

                  Not more than 2,5 % after drying (1 000 oC, fumed silica)

                  Not more than 8,5 % after drying (1 000 oC, hydrated forms)

                  Soluble ionisable salts

                  Not more than 5,0 % (as Na2SO4)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 552 CALCIUM SILICATE

                     Definition

                  Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2

                  Chemical name

                  Calcium silicate

                  Einecs

                  215-710-8

                  Assay

                  Content on the anhydrous basis:

                              —

                              as SiO2 not less than 50 % and not more than 95 %

                              —

                              as CaO not less than 3 % and not more than 35 %

                     Description

                  White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids

                     Identification

                              A.

                              Positive test for silicate and for calcium

                              B.

                              Forms a gel with mineral acids

                     Purity

                  Loss on drying

                  Not more than 10 % (105 oC, 2h)

                  Loss on ignition

                  Not less than 5 % and not more than 14 % (1 000 oC, constant weight)

                  Sodium

                  Not more than 3 %

                  Fluoride

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 553a(i) MAGNESIUM SILICATE

                     Definition

                  Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5

                  Assay

                  Content not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basis

                     Description

                  Very fine, white, odourless powder, free from grittiness

                     Identification

                              A.

                              Positive test for magnesium and for silicate

                              B.

                              pH of a 10 % slurry

                  Between 7,0 and 10,8

                     Purity

                  Loss on drying

                  Not more than 15 % (105 oC, 2h)

                  Loss on ignition

                  Not more than 15 % after drying (1 000 oC, 20 min)

                  Water soluble salts

                  Not more than 3 %

                  Free alkali

                  Not more than 1 % (as NaOH)

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 553a(ii) MAGNESIUM TRISILICATE

                     Definition

                  Chemical name

                  Magnesium trisilicate

                  Chemical formula

                  Mg2Si3O8 · xH2O (approximate composition)

                  Einecs

                  239-076-7

                  Assay

                  Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2 both on the ignited basis

                     Description

                  Fine, white powder, free from grittiness

                     Identification

                              A.

                              Positive test for magnesium and for silicate

                              B.

                              pH of a 5 % slurry

                  Between 6,3 and 9,5

                     Purity

                  Loss on ignition

                  Not less than 17 % and not more than 34 % (1 000 oC)

                  Water soluble salts

                  Not more than 2 %

                  Free alkali

                  Not more than 1 % (as NaOH)

                  Fluoride

                  Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 553b TALC

                     Synonyms

                  Talcum

                     Definition

                  Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite

                  Chemical name

                  Magnesium hydrogen metasilicate

                  Einecs

                  238-877-9

                  Chemical formula

                  Mg3(Si4O10)(OH)2

                  Molecular weight

                  379,22

                     Description

                  Light, homogeneous, white or almost white powder, greasy to the touch

                     Identification

                              A.

                              IR absorption

                  Characteristic peaks at 3 677, 1 018 and 669 cm-1

                              B.

                              X-ray diffraction

                  Peaks at 9,34/4,66/3,12 Å

                              C.

                              Solubility

                  Insoluble in water and ethanol

                     Purity

                  Loss on drying

                  Not more than 0,5 % (105 oC, 1h)

                  Acid-soluble matter

                  Not more than 6 %

                  Water-soluble matter

                  Not more than 0,2 %

                  Acid-soluble iron

                  Not detectable

                  Arsenic

                  Not more than 10 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 554 SODIUM ALUMINIUM SILICATE

                     Synonyms

                  Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate

                     Definition

                  Chemical name

                  Sodium aluminium silicate

                  Assay

                  Content on the anhydrous basis:

                              —

                              as SiO2 not less than 66,0 % and not more than 88,0 %

                              —

                              as Al2O3 not less than 5,0 % and not more than 15,0 %

                     Description

                  Fine white amorphous powder or beads

                     Identification

                              A.

                              Positive tests for sodium, for aluminium and for silicate

                              B.

                              pH of a 5 % slurry

                  Between 6,5 and 11,5

                     Purity

                  Loss on drying

                  Not more than 8,0 % (105 oC, 2h)

                  Loss on ignition

                  Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 oC, constant weight)

                  Sodium

                  Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 555 POTASSIUM ALUMINIUM SILICATE

                     Synonyms

                  Mica

                     Definition

                  Natural mica consists of mainly potassium aluminium silicate (muscovite)

                  Einecs

                  310-127-6

                  Chemical name

                  Potassium aluminium silicate

                  Chemical formulae

                  KAl2[AlSi3O10](OH)2

                  Molecular weight

                  398

                  Assay

                  Content not less than 98 %

                     Description

                  Light grey to white crystalline platelets or powder

                     Identification

                              A.

                              Solubility

                  Insoluble in water, diluted acids and alkali and organic solvents

                     Purity

                  Loss on drying

                  Not more than 0,5 % (105 oC, 2h)

                  Antimony

                  Not more than 20 mg/kg

                  Zinc

                  Not more than 25 mg/kg

                  Barium

                  Not more than 25 mg/kg

                  Chromium

                  Not more than 100 mg/kg

                  Copper

                  Not more than 25 mg/kg

                  Nickel

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 2 mg/kg

                  Lead

                  Not more than 10 mg/kg

            E 556 CALCIUM ALUMINIUM SILICATE

                     Synonyms

                  Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate

                     Definition

                  Chemical name

                  Calcium aluminium silicate

                  Assay

                  Content on the anhydrous basis:

                              —

                              as SiO2 not less than 44,0 % and not more than 50,0 %

                              —

                              as Al2O3 not less than 3,0 % and not more than 5,0 %

                              —

                              as CaO not less than 32,0 % and not more than 38,0 %

                     Description

                  Fine white, free-flowing powder

                     Identification

                              A.

                              Positive tests for calcium, for aluminium and for silicate

                     Purity

                  Loss on drying

                  Not more than 10,0 % (105 oC, 2h)

                  Loss on ignition

                  Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 oC, constant weight)

                  Fluoride

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 558 BENTONITE

                     Definition

                  Bentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite

                  Einecs

                  215-108-5

                  Chemical formula

                  (Al, Mg)8(Si4O10) 4(OH)8 · 12H2O

                  Molecular weight

                  819

                  Assay

                  Montmorillonite content not less than 80 %

                     Description

                  Very fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)

                     Identification

                              A.

                              Methylene blue test

                              B.

                              X-Ray diffraction

                  Characteristic peaks at 12,5/15 A

                              C.

                              IR absorption

                  Peaks at 428/470/530/1 110-1 020/3 750 — 3 400 cm-1

                     Purity

                  Loss on drying

                  Not more than 15,0 % (105 oC, 2h)

                  Arsenic

                  Not more than 2 mg/kg

                  Lead

                  Not more than 20 mg/kg

            E 559 ALUMINIUM SILICATE (KAOLIN)

                     Synonyms

                  Kaolin, light or heavy

                     Definition

                  Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption

                  Einecs

                  215-286-4 (kaolinite)

                  Chemical formula

                  Al2Si2O5(OH)4 (kaolinite)

                  Molecular weight

                  264

                  Assay

                  Content not less than 90 % (sum of silica and alumina, after ignition)

                  Silica (SiO2)

                  Between 45 % and 55 %

                  Alumina (Al2O3)

                  Between 30 % and 39 %

                     Description

                  Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes

                     Identification

                              A.

                              Positive tests for alumina and for silicate

                              B.

                              X-ray diffraction:

                  Characteristic peaks at 7,18/3,58/2,38/1,78 Å

                              C.

                              IR absorption:

                  Peaks at 3 700 and 3 620 cm-1

                     Purity

                  Loss on ignition

                  Between 10 and 14 % (1 000 oC, constant weight)

                  Water soluble matter

                  Not more than 0,3 %

                  Acid soluble matter

                  Not more than 2 %

                  Iron

                  Not more than 5 %

                  Potassium oxide (K2O)

                  Not more than 5 %

                  Carbon

                  Not more than 0,5 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 570 FATTY ACIDS

                     Definition

                  Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)

                  Chemical name

                  octanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1)

                  Assay

                  Not less than 98 % by chromatography

                     Description

                  A colourless liquid or white solid obtained from oils and fats

                     Identification

                              A.

                              Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight

                     Purity

                  Residue on ignition

                  Not more than 0,1 %

                  Unsaponifiable matter

                  Not more than 1,5 %

                  Water

                  Not more than 0,2 % (Karl Fischer method)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 1 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 574 GLUCONIC ACID

                     Synonyms

                  D-gluconic acid, dextronic acid

                     Definition

                  Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone

                  Chemical name

                  Gluconic acid

                  Chemical formula

                  C6H12O7 (gluconic acid)

                  Molecular weight

                  196,2

                  Assay

                  Content not less than 50,0 % (as gluconic acid)

                     Description

                  Colourless to light yellow, clear syrupy liquid

                     Identification

                              A.

                              Formation of phenylhydrazine derivative positive

                  Compound formed melts between 196 oC and 202 oC with decomposition

                     Purity

                  Residue on ignition

                  Not more than 1,0 %

                  Reducing matter

                  Not more than 0,75 % (as D-glucose)

                  Chloride

                  Not more than 350 mg/kg

                  Sulphate

                  Not more than 240 mg/kg

                  Sulphite

                  Not more than 20 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 575 GLUCONO-DELTA-LACTONE

                     Synonyms

                  Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone

                     Definition

                  Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones

                  Chemical name

                  D-Glucono-1,5-lactone

                  Einecs

                  202-016-5

                  Chemical formula

                  C6H10O6

                  Molecular weight

                  178,14

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  Fine, white, nearly odourless, crystalline powder

                     Identification

                              A.

                              Formation of phenylhydrazine derivative of gluconic acid positive

                  Compound formed melts between 196 oC and 202 oC with decomposition

                              B.

                              Solubility

                  Freely soluble in water. Sparingly soluble in ethanol

                              C.

                              Melting point

                  152 oC ± 2 oC

                     Purity

                  Water

                  Not more than 1,0 % (Karl Fischer method)

                  Reducing substances

                  Not more than 0,75 % (as D-glucose)

                  Lead

                  Not more than 2 mg/kg

            E 576 SODIUM GLUCONATE

                     Synonyms

                  Sodium salt of D-gluconic acid

                     Definition

                  Chemical name

                  Sodium D-gluconate

                  Einecs

                  208-407-7

                  Chemical formula

                  C6H11NaO7 (anhydrous)

                  Molecular weight

                  218,14

                  Assay

                  Content not less than 98,0 %

                     Description

                  White to tan, granular to fine, crystalline powder

                     Identification

                              A.

                              Positive test for sodium and for gluconate

                              B.

                              Solubility

                  Very soluble in water. Sparingly soluble in ethanol

                              C.

                              pH of a 10 % solution

                  Between 6,5 and 7,5

                     Purity

                  Reducing matter

                  Not more than 1,0 % (as D-glucose)

                  Lead

                  Not more than 2 mg/kg

            E 577 POTASSIUM GLUCONATE

                     Synonyms

                  Potassium salt of D-gluconic acid

                     Definition

                  Chemical name

                  Potassium D-gluconate

                  Einecs

                  206-074-2

                  Chemical formula

                  C6H11KO7 (anhydrous)

                  C6H11KO7 · H2O (monohydrate)

                  Molecular weight

                  234,25 (anhydrous)

                  252,26 (monohydrate)

                  Assay

                  Content not less than 97,0 % and not more than 103,0 % on dried basis

                     Description

                  Odourless, free flowing white to yellowish white, crystalline powder or granules

                     Identification

                              A.

                              Positive test for potassium and for gluconate

                              B.

                              pH of a 10 % solution

                  Between 7,0 and 8,3

                     Purity

                  Loss on drying

                  Anhydrous: not more than 3,0 % (105 oC, 4h, vacuum)
                  Monohydrate: not less than 6 % and not more than 7,5 % (105 oC, 4h, vacuum)

                  Reducing substances

                  Not more than 1,0 % (as D-glucose)

                  Lead

                  Not more than 2 mg/kg

            E 578 CALCIUM GLUCONATE

                     Synonyms

                  Calcium salt of D-gluconic acid

                     Definition

                  Chemical name

                  Calcium di-D-gluconate

                  Einecs

                  206-075-8

                  Chemical formula

                  C12H22CaO14 (anhydrous)

                  C12H22CaO14 · H2O (monohydrate)

                  Molecular weight

                  430,38 (anhydrous form)

                  448,39 (monohydrate)

                  Assay

                  Content not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basis

                     Description

                  Odourless, white crystalline granules or powder, stable in air

                     Identification

                              A.

                              Positive test for calcium and for gluconate

                              B.

                              Solubility

                  Soluble in water, insoluble in ethanol

                              C.

                              pH of a 5 % solution

                  Between 6,0 and 8,0

                     Purity

                  Loss on drying

                  Not more than 3,0 % (105 oC, 16h) (anhydrous)

                  Not more than 2,0 % (105 oC, 16h) (monohydrate)

                  Reducing substances

                  Not more than 1,0 % (as D-glucose)

                  Lead

                  Not more than 2 mg/kg

            E 579 FERROUS GLUCONATE

                     Definition

                  Chemical name

                  Ferrous di-D-gluconate dihydrate

                  Iron(II) di-gluconate dihydrate

                  Einecs

                  206-076-3

                  Chemical formulae

                  C12H22FeO14·2H2O

                  Molecular weight

                  482,17

                  Assay

                  Content not less than 95 % on the dried basis

                     Description

                  Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar

                     Identification

                              A.

                              Solubility

                  Soluble with slight heating in water. Practically insoluble in ethanol

                              B.

                              Positive test for ferrous ion

                              C.

                              Formation of phenylhy-drazine derivative of gluconic acid positive

                              D.

                              pH of a 10 % solution

                  Between 4 and 5,5

                     Purity

                  Loss on drying

                  Not more than 10 % (105 oC, 16 hours)

                  Oxalic acid

                  Not detectable

                  Iron (Fe III)

                  Not more than 2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Reducing substances

                  Not more than 0,5 % expressed as glucose

            E 585 FERROUS LACTATE

                     Synonyms

                  Iron(II) lactate

                  Iron(II) 2-hydroxy propanoate

                  Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)

                     Definition

                  Chemical name

                  Ferrous 2-hydroxy propanoate

                  Einecs

                  227-608-0

                  Chemical formulae

                  C6H10FeO6·xH2O (x = 2 or 3)

                  Molecular weight

                  270,02 (dihydrate)

                  288,03 (trihydrate)

                  Assay

                  Content not less than 96 % on the dried basis

                     Description

                  Greenish-white crystals or light green powder having a characteristic smell

                     Identification

                              A.

                              Solubility

                  Soluble in water. Practically insoluble in ethanol

                              B.

                              Positive test for ferrous ion and for lactate

                              C.

                              pH of a 2 % solution

                  Between 4 and 6

                     Purity

                  Loss on drying

                  Not more than 18 % (100 oC, under vacuum, approximately 700 mm Hg)

                  Iron (Fe III)

                  Not more than 0,6 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

            E 586 4-HEXYLRESORCINOL

                     Synonyms

                  4-Hexyl-1,3-benzenediol

                  Hexylresorcinol

                     Definition

                  Chemical name

                  4-Hexylresorcinol

                  Einecs

                  205-257-4

                  Chemical formula

                  C12H18O2

                  Molecular weight

                  197,24

                  Assay

                  Not less than 98 % on the dried basis

                     Description

                  White powder

                     Identification

                              A.

                              Solubility

                  Freely soluble in ether and acetone; very slightly soluble in water

                              B.

                              Nitric acid test

                  To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears

                              C.

                              Bromine test

                  To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution

                              D.

                              Melting range

                  62 to 67 oC

                     Purity

                  Acidity

                  Not more than 0,05 %

                  Sulphated ash

                  Not more than 0,1 %

                  Resorcinol and other phenols

                  Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced

                  Nickel

                  Not more than 2 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 3 mg/kg

            E 620 GLUTAMIC ACID

                     Synonyms

                  L-Glutamic acid, L-α-aminoglutaric acid

                     Definition

                  Chemical name

                  L-Glutamic acid, L-2-amino-pentanedioic acid

                  Einecs

                  200-293-7

                  Chemical formula

                  C5H9NO4

                  Molecular weight

                  147,13

                  Assay

                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis

                     Description

                  White crystals or crystalline powder

                     Identification

                              A.

                              Positive test for glutamic acid by thin layer chromatography

                              B.

                              Specific rotation [α]D20

                  Between +31,5o and +32,2o

                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

                              C.

                              pH of a saturated solution

                  Between 3,0 and 3,5

                     Purity

                  Loss on drying

                  Not more than 0,2 % (80 oC, 3h)

                  Sulphated ash

                  Not more than 0,2 %

                  Chloride

                  Not more than 0,2 %

                  Pyrrolidone carboxylic acid

                  Not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 621 MONOSODIUM GLUTAMATE

                     Synonyms

                  Sodium glutamate, MSG

                     Definition

                  Chemical name

                  Monosodium L-glutamate monohydrate

                  Einecs

                  205-538-1

                  Chemical formula

                  C5H8NaNO4 · H2O

                  Molecular weight

                  187,13

                  Assay

                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis

                     Description

                  White, practically odourless crystals or crystalline powder

                     Identification

                              A.

                              Positive test for sodium

                              B.

                              Positive test for glutamic acid by thin-layer chromatography

                              C.

                              Specific rotation [α]D
                                 20

                  Between +24,8o and +25,3o

                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

                              D.

                              pH of a 5 % solution

                  Between 6,7 and 7,2

                     Purity

                  Loss on drying

                  Not more than 0,5 % (98 oC, 5h)

                  Chloride

                  Not more than 0,2 %

                  Pyrrolidone carboxylic acid

                  Not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 622 MONOPOTASSIUM GLUTAMATE

                     Synonyms

                  Potassium glutamate, MPG

                     Definition

                  Chemical name

                  Monopotassium L-glutamate monohydrate

                  Einecs

                  243-094-0

                  Chemical formula

                  C5H8KNO4 · H2O

                  Molecular weight

                  203,24

                  Assay

                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis

                     Description

                  White, practically odourless crystals or crystalline powder

                     Identification

                              A.

                              Positive test for potassium

                              B.

                              Positive test for glutamic acid by thin-layer chromatog-raphy

                              C.

                              Specific rotation [α]D
                                 20

                  Between +22,5o and +24,0o

                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

                              D.

                              pH of a 2 % solution

                  Between 6,7 and 7,3

                     Purity

                  Loss on drying

                  Not more than 0,2 % (80 oC, 5h)

                  Chloride

                  Not more than 0,2 %

                  Pyrrolidone carboxylic acid

                  Not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 623 CALCIUM DIGLUTAMATE

                     Synonyms

                  Calcium glutamate

                     Definition

                  Chemical name

                  Monocalcium di-L-glutamate

                  Einecs

                  242-905-5

                  Chemical formula

                  C10H16CaN2O8 · x H2O (x = 0, 1, 2 or 4)

                  Molecular weight

                  332,32 (anhydrous)

                  Assay

                  Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis

                     Description

                  White, practically odourless crystals or crystalline powder

                     Identification

                              A.

                              Positive test for calcium

                              B.

                              Positive test for glutamic acid by thin-layer chromatog-raphy

                              C.

                              Specific rotation [α]D
                                 20

                  Between +27,4 and +29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

                     Purity

                  Water

                  Not more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)

                  Chloride

                  Not more than 0,2 %

                  Pyrrolidone carboxylic acid

                  Not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 624 MONOAMMONIUM GLUTAMATE

                     Synonyms

                  Ammonium glutamate

                     Definition

                  Chemical name

                  Monoammonium L-glutamate monohydrate

                  Einecs

                  231-447-1

                  Chemical formula

                  C5H12N2O4 · H2O

                  Molecular weight

                  182,18

                  Assay

                  Content not less than 99,0 % and not more 101,0 % on the anhydrous basis

                     Description

                  White, practically odourless crystals or crystalline powder

                     Identification

                              A.

                              Positive test for ammonium

                              B.

                              Positive test for glutamic acid by thin-layer chromatog-raphy

                              C.

                              Specific rotation [α]D
                                 20

                  Between +25,4o and +26,4o

                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

                              D.

                              pH of a 5 % solution

                  Between 6,0 and 7,0

                     Purity

                  Loss on drying

                  Not more than 0,5 % (50 oC, 4h)

                  Sulphated ash

                  Not more than 0,1 %

                  Pyrrolidone carboxylic acid

                  Not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 625 MAGNESIUM DIGLUTAMATE

                     Synonyms

                  Magnesium glutamate

                     Definition

                  Chemical name

                  Monomagnesium di-L-glutamate tetrahydrate

                  Einecs

                  242-413-0

                  Chemical formula

                  C10H16MgN2O8 · 4H2O

                  Molecular weight

                  388,62

                  Assay

                  Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis

                     Description

                  Odourless, white or off-white crystals or powder

                     Identification

                              A.

                              Positive test for magnesium

                              B.

                              Positive test for glutamic acid by thin-layer chromatog-raphy

                              C.

                              Specific rotation [α]D
                                 20

                  Between +23,8o and +24,4o

                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

                              D.

                              pH of a 10 % solution

                  Between 6,4 and 7,5

                     Purity

                  Water

                  Not more than 24 % (Karl Fischer)

                  Chloride

                  Not more than 0,2 %

                  Pyrrolidone carboxylic acid

                  Not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 626 GUANYLIC ACID

                     Synonyms

                  Guanylic acid

                     Definition

                  Chemical name

                  Guanosine-5'-monophosphoric acid

                  Einecs

                  201-598-8

                  Chemical formula

                  C10H14N5O8P

                  Molecular weight

                  363,22

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or white crystalline powder

                     Identification

                              A.

                              Positive test for ribose and for organic phosphate

                              B.

                              pH of a 0,25 % solution

                  Between 1,5 and 2,5

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

                     Purity

                  Loss on drying

                  Not more than 1,5 % (120 oC, 4h)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 627 DISODIUM GUANYLATE

                     Synonyms

                  Sodium guanylate, sodium 5'-guanylate

                     Definition

                  Chemical name

                  Disodium guanosine-5'-monophosphate

                  Einecs

                  221-849-5

                  Chemical formula

                  C10H12N5Na2O8P· x H2O (x = ca. 7)

                  Molecular weight

                  407,19 (anhydrous)

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or white crystalline powder

                     Identification

                              A.

                              Positive test for ribose, for organic phosphate, and for sodium

                              B.

                              pH of a 5 % solution

                  Between 7,0 and 8,5

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

                     Purity

                  Loss on drying

                  Not more than 25 % (120 oC, 4h)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 628 DIPOTASSIUM GUANYLATE

                     Synonyms

                  Potassium guanylate, potassium 5'-guanylate

                     Definition

                  Chemical name

                  Dipotassium guanosine-5'-monophosphate

                  Einecs

                  226-914-1

                  Chemical formula

                  C10H12K2N5O8P

                  Molecular weight

                  439,40

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or white crystalline powder

                     Identification

                              A.

                              Positive test for ribose, for organic phosphate, and for potassium

                              B.

                              pH of a 5 % solution

                  Between 7,0 and 8,5

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

                     Purity

                  Loss on drying

                  Not more than 5 % (120 oC, 4h)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 629 CALCIUM GUANYLATE

                     Synonyms

                  Calcium 5'-guanylate

                     Definition

                  Chemical name

                  Calcium guanosine-5'-monophosphate

                  Chemical formula

                  C10H12CaN5O8P· nH2O

                  Molecular weight

                  401,20 (anhydrous)

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, white or off-white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, for organic phosphate, and for calcium

                              B.

                              pH of a 0,05 % solution

                  Between 7,0 and 8,0

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

                     Purity

                  Loss on drying

                  Not more than 23,0 % (120 oC, 4h)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 630 INOSINIC ACID

                     Synonyms

                  5'-Inosinic acid

                     Definition

                  Chemical name

                  Inosine-5'-monophosphoric acid

                  Einecs

                  205-045-1

                  Chemical formula

                  C10H13N4O8P

                  Molecular weight

                  348,21

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, and for organic phosphate

                              B.

                              pH of a 5 % solution

                  Between 1,0 and 2,0

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

                     Purity

                  Loss on drying

                  Not more than 3,0 % (120 oC, 4h)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 631 DISODIUM INOSINATE

                     Synonyms

                  Sodium inosinate, sodium 5'-inosinate

                     Definition

                  Chemical name

                  Disodium inosine-5'-monophosphate

                  Einecs

                  225-146-4

                  Chemical formula

                  C10H11N4Na2O8P· H2O

                  Molecular weight

                  392,17 (anhydrous)

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, and for organic phosphate and for sodium

                              B.

                              pH of a 5 % solution

                  Between 7,0 and 8,5

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

                     Purity

                  Water

                  Not more than 28,5 % (Karl Fischer)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 632 DIPOTASSIUM INOSINATE

                     Synonyms

                  Potassium inosinate, potassium 5'-inosinate

                     Definition

                  Chemical name

                  Dipotassium inosine-5'-monophosphate

                  Einecs

                  243-652-3

                  Chemical formula

                  C10H11K2N4O8P

                  Molecular weight

                  424,39

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, and for organic phosphate and for potassium

                              B.

                              pH of a 5 % solution

                  Between 7,0 and 8,5

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

                     Purity

                  Water

                  Not more than 10,0 % (Karl Fischer)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 633 CALCIUM INOSINATE

                     Synonyms

                  Calcium 5'-inosinate

                     Definition

                  Chemical name

                  Calcium inosine-5'-monophosphate

                  Chemical formula

                  C10H11CaN4O8P· nH2O

                  Molecular weight

                  386,19 (anhydrous)

                  Assay

                  Content not less than 97,0 % on the anhydrous basis

                     Description

                  Odourless, colourless or white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, and for organic phosphate and for calcium

                              B.

                              pH of a 0,05 % solution

                  Between 7,0 and 8,0

                              C.

                              Spectrometry:

                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

                     Purity

                  Water

                  Not more than 23,0 % (Karl Fischer)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 634 CALCIUM 5'-RIBONUCLEOTIDE

                     Definition

                  Chemical name

                  Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate

                  Chemical formula

                  C10H11N4CaO8P· nH2O y

                  C10H12N5CaO8P· nH2O

                  Assay

                  Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis

                     Description

                  Odourless, white or nearly white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, and for organic phosphate and for calcium

                              B.

                              pH of a 0,05 % solution

                  Between 7,0 and 8,0

                     Purity

                  Water

                  Not more than 23,0 % (Karl Fischer)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 635 DISODIUM 5'-RIBONUCLEOTIDE

                     Synonyms

                  Sodium 5'-ribonucleotide

                     Definition

                  Chemical name

                  Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate

                  Chemical formula

                  C10H11N4Na2O8P · nH2O and

                  C10H12N5Na2O8P· nH2O

                  Assay

                  Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis

                     Description

                  Odourless, white or nearly white crystals or powder

                     Identification

                              A.

                              Positive test for ribose, and for organic phosphate and for sodium

                              B.

                              pH of a 5 % solution

                  Between 7,0 and 8,5

                     Purity

                  Water

                  Not more than 26,0 % (Karl Fischer)

                  Other nucleotides

                  Not detectable by thin-layer chromatography

                  Lead

                  Not more than 2 mg/kg

            E 640 GLYCINE AND ITS SODIUM SALT

                     Synonyms
                     (gly)

                  Aminoacetic acid, glycocoll

                     (Na salt)

                  Sodium glycinate

                     Definition

                  Chemical name (gly)

                  Aminoacetic acid

                  (Na salt)

                  Sodium glycinate

                  Chemical formula (gly)

                  C2H5NO2

                  (Na salt)

                  C2H5NO2 Na

                  Einecs (gly)

                  200-272-2

                  (Na salt)

                  227-842-3

                  Molecular weight (gly)

                  75,07

                  (Na salt)

                  98

                  Assay

                  Content not less than 98,5 % on the anhydrous basis

                     Description

                  White crystals or crystalline powder

                     Identification

                              A.

                              Positive test for amino acid (gly and Na salt)

                              B.

                              Positive test for sodium (Na salt)

                     Purity

                  Loss on drying (gly)

                  Not more than 0,2 % (105 oC, 3h)

                  (Na salt)

                  Not more than 0,2 % (105 oC, 3h)

                  Residue on ignition (gly)

                  Not more than 0,1 %

                  (Na salt)

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 650 ZINC ACETATE

                     Synonyms

                  Acetic acid, zinc salt, dihydrate

                     Definition

                  Chemical name

                  Zinc acetate dihydrate

                  Chemical formula

                  C4H6O4 Zn· 2H2O

                  Molecular weight

                  219,51

                  Assay

                  Content not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O

                     Description

                  Colourless crystals or fine, off-white powder

                     Identification

                              A.

                              Positive tests for acetate and for zinc

                              B.

                              pH of a 5 % solution

                  Between 6,0 and 8,0

                     Purity

                  Insoluble matter

                  Not more than 0,005 %

                  Chlorides

                  Not more than 50 mg/kg

                  Sulphates

                  Not more than 100 mg/kg

                  Alkalines and alkaline earths

                  Not more than 0,2 %

                  Organic volatile impurities

                  Passes test

                  Iron

                  Not more than 50 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 20 mg/kg

                  Cadmium

                  Not more than 5 mg/kg

            E 900 DIMETHYL POLYSILOXANE

                     Synonyms

                  Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone

                     Definition

                  Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO

                  Chemical name

                  Siloxanes and silicones, di-methyl

                  Chemical formula

                  (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3

                  Assay

                  Content of total silicon not less than 37,3 % and not more than 38,5 %

                     Description

                  Clear, colourless, viscous liquid

                     Identification

                              A.

                              Specific gravity (25o/25 oC)

                  Between 0,964 and 0,977

                              B.

                              Refractive index [n]D
                                 25

                  Between 1,400 and 1,405

                              C.

                              Infrared spectrum characteristic of the compound

                     Purity

                  Loss on drying

                  Not more than 0,5 % (150 oC, 4h)

                  Viscosity

                  Not less than 1,00 · 10-4 m2s-1 at 25 oC

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 901 BEESWAX

                     Synonyms

                  White wax, yellow wax

                     Definition

                  Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter

                  White beeswax is obtained by bleaching yellow beeswax

                  Einecs

                  232-383-7 (beeswax)

                     Description

                  Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour

                     Identification

                              A.

                              Melting range

                  Between 62 oC and 65 oC

                              B.

                              Specific gravity

                  About 0,96

                              C.

                              Solubility

                  Insoluble in water

                  Sparingly soluble in alcohol

                  Very soluble in chloroform and ether

                     Purity

                  Acid value

                  Not less than 17 and not more than 24

                  Saponification value

                  87-104

                  Peroxide value

                  Not more than 5

                  Glycerol and other polyols

                  Not more than 0,5 % (as glycerol)

                  Ceresin, paraffins and certain other waxes

                  Absent

                  Fats, Japan wax, rosin and soaps

                  Absent

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 902 CANDELILLA WAX

                     Definition

                  Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica

                  Einecs

                  232-347-0

                     Description

                  Hard, yellowish brown, opaque to translucent wax

                     Identification

                              A.

                              Specific gravity

                  About 0,983

                              B.

                              Melting range

                  Between 68,5 oC and 72,5 oC

                              C.

                              Solubility

                  Insoluble in water

                  Soluble in chloroform and toluene

                     Purity

                  Acid value

                  Not less than 12 and not more than 22

                  Saponification value

                  Not less than 43 and not more than 65

                  Glycerol and other polyols

                  Not more than 0,5 % (as glycerol)

                  Ceresin, paraffins and certain other waxes

                  Absent

                  Fats, Japan wax, rosin and soaps

                  Absent

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 903 CARNAUBA WAX

                     Definition

                  Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera

                  Einecs

                  232-399-4

                     Description

                  Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture

                     Identification

                              A.

                              Specific gravity

                  About 0,997

                              B.

                              Melting range

                  Between 82 oC and 86 oC

                              C.

                              Solubility

                  Insoluble in water

                  Partly soluble in boiling ethanol

                  Soluble in chloroform and diethyl ether

                     Purity

                  Sulphated ash

                  Not more than 0,25 %

                  Acid value

                  Not less than 2 and not more than 7

                  Ester value

                  Not less than 71 and not more than 88

                  Unsaponifiable matter

                  Not less than 50 % and not more than 55 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 904 SHELLAC

                     Synonyms

                  Bleached shellac, white shellac

                     Definition

                  Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)

                  Einecs

                  232-549-9

                     Description

                  Bleached shellac — off-white, amorphous, granular resin

                  Wax-free bleached shellac — light yellow, amorphous, granular resin

                     Identification

                              A.

                              Solubility

                  Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone

                              B.

                              Acid value

                  Between 60 and 89

                     Purity

                  Loss on drying

                  Not more than 6,0 % (40 oC, over silica gel, 15h)

                  Rosin

                  Absent

                  Wax

                  Bleached shellac: not more than 5,5 %

                  Wax-free bleached shellac: not more than 0,2 %

                  Lead

                  Not more than 2 mg/kg

            E 905 MICROCRYSTALLINE WAX

                     Synonyms

                  Petroleum wax

                     Definition

                  Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum

                     Description

                  White to amber, odourless wax

                     Identification

                              A.

                              Solubility

                  Insoluble in water, very slightly soluble in ethanol

                              B.

                              Refractive Index

                  n D
                     1001,434-1,448

                     Purity

                  Molecular weight

                  Average not less than 500

                  Viscosity at 100 oC

                  Not less than 1,1 · 10-5 m2s-1

                  Residue on ignition

                  Not more than 0,1 %

                  Carbon number at 5 % distillation point

                  Not more than 5 % of molecules with carbon number less than 25

                  Colour

                  Passes test

                  Sulphur

                  Not more than 0,4 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 3 mg/kg

                  Polycyclic aromatic compounds

                  The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:

                  nm

                  Maximum absorbance per cm path length

                  280-289

                  0,15

                  290-299

                  0,12

                  300-359

                  0,08

                  360-400

                  0,02

            E 907 HYDROGENATED POLY-1-DECENE

                     Synonyms

                  Hydrogenated polydec-1-ene

                  Hydrogenated poly-alpha-olefin

                     Definition

                  Chemical formula

                  C10nH20n+2 where n = 3-6

                  Molecular weight

                  560 (average)

                  Assay

                  Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:

                  C30: 13-37 %

                  C40: 35-70 %

                  C50: 9-25 %

                  C60: 1-7 %

                     Description

                     Identification

                              A.

                              Solubility

                  Insoluble in water; slightly soluble in ethanol; soluble in toluene

                              B.

                              Burning

                  Burns with a bright flame and a paraffin-like characteristic smell

                     Purity

                  Viscosity

                  Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 oC

                  Compounds with carbon number less than 30

                  Not more than 1,5 %

                  Readily carbonisable substances

                  After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour

                  Nickel

                  Not more than 1 mg/kg

                  Lead

                  Not more than 1 mg/kg

            E 912 MONTAN ACID ESTERS

                     Definition

                  Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol

                  Chemical name

                  Montan acid esters

                     Description

                  Almost white to yellowish flakes, powder, granules or pellets

                     Identification

                              A.

                              Density (20 oC)

                  Between 0,98 and 1,05

                              B.

                              Drop point

                  Greater than 77 oC

                     Purity

                  Acid value

                  Not more than 40

                  Glycerol

                  Not more than 1 % (by gas chromatography)

                  Other polyols

                  Not more than 1 % (by gas chromatography)

                  Other wax types

                  Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

                  Arsenic

                  Not more than 2 mg/kg

                  Chromium

                  Not more than 3 mg/kg

                  Lead

                  Not more than 2 mg/kg

            E 914 OXIDISED POLYETHYLENE WAX

                     Definition

                  Polar reaction products from mild oxidation of polyethylene

                  Chemical name

                  Oxidised polyethylene

                     Description

                  Almost white flakes, powder, granules or pellets

                     Identification

                              A.

                              Density (20 oC)

                  Between 0,92 and 1,05

                              B.

                              Drop point

                  Greater than 95 oC

                     Purity

                  Acid value

                  Not more than 70

                  Viscosity at 120 oC

                  Not less than 8,1 · 10-5 m2s-1

                  Other wax types

                  Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

                  Oxygen

                  Not more than 9,5 %

                  Chromium

                  Not more than 5 mg/kg

                  Lead

                  Not more than 2 mg/kg

            E 920 L-CYSTEINE

                     Definition

                  L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance

                  Einecs

                  200-157-7 (anhydrous)

                  Chemical formula

                  C3H7NO2S· HCl· n H20 (where n = 0 or 1)

                  Molecular weight

                  157,62 (anhydrous)

                  Assay

                  Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis

                     Description

                  White powder or colourless crystals

                     Identification

                              A.

                              Solubility

                  Freely soluble in water and in ethanol

                              B.

                              Melting range

                  Anhydrous form melts at about 175 oC

                              C.

                              Specific rotation

                  [α]20
                     D: between +5,0o and +8,0o or

                  [α]25
                     D: between +4,9o and 7,9o

                     Purity

                  Loss on drying

                  Between 8,0 % and 12,0 %

                  Not more than 2,0 % (anhydrous form)

                  Residue on ignition

                  Not more than 0,1 %

                  Ammonium-ion

                  Not more than 200 mg/kg

                  Arsenic

                  Not more than 1,5 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 927b CARBAMIDE

                     Synonyms

                  Urea

                     Definition

                  Einecs

                  200-315-5

                  Chemical formula

                  CH4N2O

                  Molecular weight

                  60,06

                  Assay

                  Content not less than 99,0 % on the anhydrous basis

                     Description

                  Colourless to white, prismatic, crystalline powder or small, white pellets

                     Identification

                              A.

                              Solubility

                  Very soluble in water

                  Soluble in ethanol

                              B.

                              Precipitation with nitric acid

                  To pass the test a white, crystalline precipitate is formed

                              C.

                              Colour reaction

                  To pass the test a reddish-violet colour is produced

                              D.

                              Melting range

                  132 oC to 135 oC

                     Purity

                  Loss on drying

                  Not more than 1,0 % (105 oC, 1h)

                  Sulphated ash

                  Not more than 0,1 %

                  Ethanol-insoluble matter

                  Not more than 0,04 %

                  Alkalinity

                  Passes test

                  Ammonium-ion

                  Not more than 500 mg/kg

                  Biuret

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 938 ARGON

                     Definition

                  Chemical name

                  Argon

                  Einecs

                  231-147-0

                  Chemical formula

                  Ar

                  Molecular weight

                  40

                  Assay

                  Not less than 99 %

                     Description

                  Colourless, odourless, non-flammable gas

                     Purity

                  Water

                  Not more than 0,05 %

                  Methane and other hydrocarbons calculated as methane

                  Not more than 100 μl/l

            E 939 HELIUM

                     Definition

                  Chemical name

                  Helium

                  Einecs

                  231-168-5

                  Chemical formula

                  He

                  Molecular weight

                  4

                  Assay

                  Not less than 99 %

                     Description

                  Colourless, odourless, non-flammable gas

                     Purity

                  Water

                  Not more than 0,05 %

                  Methane and other hydrocarbons calculated as methane

                  Not more than 100 μl/l

            E 941 NITROGEN

                     Definition

                  Chemical name

                  Nitrogen

                  Einecs

                  231-783-9

                  Chemical formula

                  N2

                  Molecular weight

                  28

                  Assay

                  Not less than 99 %

                     Description

                  Colourless, odourless, non-flammable gas

                     Purity

                  Water

                  Not more than 0,05 %

                  Carbon monoxide

                  Not more than 10 μl/l

                  Methane and other hydrocarbons calculated as methane

                  Not more than 100 μl/l

                  Nitrogen dioxide and nitrogen oxide

                  Not more than 10 μl/l

                  Oxygen

                  Not more than 1 %

            E 942 NITROUS OXIDE

                     Definition

                  Chemical name

                  Nitrous oxide

                  Einecs

                  233-032-0

                  Chemical formula

                  N2O

                  Molecular weight

                  44

                  Assay

                  Not less than 99 %

                     Description

                  Colourless, non-flammable gas, sweetish odour

                     Purity

                  Water

                  Not more than 0,05 %

                  Carbon monoxide

                  Not more than 30 μl/l

                  Nitrogen dioxide and nitrogen oxide

                  Not more than 10 μl/l

            E 943a BUTANE

                     Synonyms

                  n-Butane

                     Definition

                  Chemical name

                  Butane

                  Chemical formula

                  CH3CH2CH2CH3

                  Molecular weight

                  58,12

                  Assay

                  Content not less than 96 %

                     Description

                  Colourless gas or liquid with mild, characteristic odour

                     Identification

                              A.

                              Vapour pressure

                  108,935 kPa at 20 oC

                     Purity

                  Methane

                  Not more than 0,15 % v/v

                  Ethane

                  Not more than 0,5 % v/v

                  Propane

                  Not more than 1,5 % v/v

                  Isobutane

                  Not more than 3,0 % v/v

                  1,3-butadiene

                  Not more than 0,1 % v/v

                  Moisture

                  Not more than 0,005 %

            E 943b ISOBUTANE

                     Synonyms

                  2-methyl propane

                     Definition

                  Chemical name

                  2-methyl propane

                  Chemical formula

                  (CH3)2CH CH3

                  Molecular weight

                  58,12

                  Assay

                  Content not less than 94 %

                     Description

                  Colourless gas or liquid with mild, characteristic odour

                     Identification

                              A.

                              Vapour pressure

                  205,465 kPa at 20 oC

                     Purity

                  Methane

                  Not more than 0,15 % v/v

                  Ethane

                  Not more than 0,5 % v/v

                  Propane

                  Not more than 2,0 % v/v

                  n-Butane

                  Not more than 4,0 % v/v

                  1,3-butadiene

                  Not more than 0,1 % v/v

                  Moisture

                  Not more than 0,005 %

            E 944 PROPANE

                     Definition

                  Chemical name

                  Propane

                  Chemical formula

                  CH3CH2CH3

                  Molecular weight

                  44,09

                  Assay

                  Content not less than 95 %

                     Description

                  Colourless gas or liquid with mild, characteristic odour

                     Identification

                              A.

                              Vapour pressure

                  732,910 kPa at 20 oC

                     Purity

                  Methane

                  Not more than 0,15 % v/v

                  Ethane

                  Not more than 1,5 % v/v

                  Isobutane

                  Not more than 2,0 % v/v

                  n-Butane

                  Not more than 1,0 % v/v

                  1,3-butadiene

                  Not more than 0,1 % v/v

                  Moisture

                  Not more than 0,005 %

            E 948 OXYGEN

                     Definition

                  Chemical name

                  Oxygen

                  Einecs

                  231-956-9

                  Chemical formula

                  O2

                  Molecular weight

                  32

                  Assay

                  Not less than 99 %

                     Description

                  Colourless, odourless, non-flammable gas

                     Purity

                  Water

                  Not more than 0,05 %

                  Methane and other hydrocarbons calculated as methane

                  Not more than 100 μl/l

            E 949 HYDROGEN

                     Definition

                  Chemical name

                  Hydrogen

                  Einecs

                  215-605-7

                  Chemical formula

                  H2

                  Molecular weight

                  2

                  Assay

                  Content not less than 99,9 %

                     Description

                  Colourless, odourless, highly flammable gas

                     Purity

                  Water

                  Not more than 0,005 % v/v

                  Oxygen

                  Not more than 0,001 % v/v

                  Nitrogen

                  Not more than 0,75 % v/v

            E 950 ACESULFAME K
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 951 ASPARTAME
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 953 ISOMALT
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 957 THAUMATIN
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 959 NEOHESPERIDINE DIHYDROCHALCONE
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 965(i) MALTITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 965(ii) MALTITOL SYRUP
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 966 LACTITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 967 XYLITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 999 QUILLAIA EXTRACT

                     Synonyms

                  Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract

                     Definition

                  Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components

                     Description

                  Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution

                     Identification

                              A.

                              pH of a 2,5 % solution

                  Between 4,5 and 5,5

                     Purity

                  Water

                  Not more than 6,0 % (Karl Fischer method) (powder form only)

                  Arsenic

                  Not more than 2 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

            E 1103 INVERTASE

                     Definition

                  Invertase is produced from Saccharomyces cerevisiae

                  Systematic name

                  β-D-Fructofuranoside fructohydrolase

                  Enzyme Commission No

                  EC 3.2.1.26

                  Einecs

                  232-615-7

                     Purity

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Cadmium

                  Not more than 0,5 mg/kg

                  Total bacterial count

                  Not more than 50 000/g

                     Salmonella spp.

                  Absent by test in 25 g

                  Coliforms

                  Not more than 30/g

                     E. coli

                  Absent by test in 25 g

            E 1105 LYSOZYME

                     Synonyms

                  Lysozyme hydrochloride

                  Muramidase

                     Definition

                  Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride

                  Chemical name

                  Enzyme Commission (EC) No: 3.2.1.17

                  Einecs

                  232-620-4

                  Molecular weight

                  About 14 000

                  Assay

                  Content not less than 950 mg/g on the anhydrous basis

                     Description

                  White, odourless powder having a slightly sweet taste

                     Identification

                              A.

                              Isoelectric point 10,7

                              B.

                              pH of a 2 % aqueous solution between 3,0 and 3,6

                              C.

                              Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm

                     Purity

                  Water content

                  Not more than 6,0 % (Karl Fischer method) (powder form only)

                  Residue on ignition

                  Not more than 1,5 %

                  Nitrogen

                  Not less than 16,8 % and not more than 17,8 %

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 10 mg/kg

                  Microbiological criteria

                  Total bacterial count

                  Not more than 5 × 104 col/g

                     Salmonellae

                  Absent in 25 g

                     Staphylococcus aureus

                  Absent in 1 g

                     Escherichia coli

                  Absent in 1 g

            E 1200 POLYDEXTROSE

                     Synonyms

                  Modified polydextroses

                     Definition

                  Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose

                  Assay

                  Content not less than 90 % of polymer on the ash free and anhydrous basis

                     Description

                  White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution

                     Identification

                              A.

                              Positive tests for sugar and for reducing sugar

                              B.

                              pH of a 10 % solution

                  Between 2,5 and 7,0 for polydextrose

                  Between 5,0 and 6,0 for polydextrose-N

                     Purity

                  Water

                  Not more than 4,0 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,3 % (polydextrose)

                  Not more than 2,0 % (polydextrose N)

                  Nickel

                  Not more than 2 mg/kg for hydrogenated polydextroses

                  1,6-Anhydro-D-glucose

                  Not more than 4,0 % on the ash-free and the dried basis

                  Glucose and sorbitol

                  Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately

                  Molecular weight limit

                  Negative test for polymers of molecular weight greater than 22 000

                  5-Hydroxy-methylfurfural

                  Not more than 0,1 % (polydextrose)

                  Not more than 0,05 % (polydextrose-N)

                  Lead

                  Not more than 0,5 mg/kg

            E 1201 POLYVINYLPYRROLIDONE

                     Synonyms

                  Povidone

                  PVP

                  Soluble polyvinylpyrrolidone

                     Definition

                  Chemical name

                  Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

                  Chemical formula

                  (C6H9NO)n

                  Molecular weight

                  Not less than 25 000

                  Assay

                  Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis

                     Description

                  White or nearly white powder

                     Identification

                              A.

                              Solubility

                  Soluble in water and in ethanol. Insoluble in ether

                              B.

                              pH of a 5 % solution

                  Between 3,0 and 7,0

                     Purity

                  Water

                  Not more than 5 % (Karl Fischer)

                  Total ash

                  Not more than 0,1 %

                  Aldehyde

                  Not more than 500 mg/kg (as acetaldehyde)

                  Free-N-vinylpyrrolidone

                  Not more than 10 mg/kg

                  Hydrazine

                  Not more than 1 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 1202 POLYVINYLPOLYPYRROLIDONE

                     Synonyms

                  Crospovidone

                  Cross linked polyvidone

                  Insoluble polyvinylpyrrolidone

                     Definition

                  Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination

                  Chemical name

                  Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

                  Chemical formula

                  (C6H9NO)n

                  Assay

                  Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis

                     Description

                  A white hygroscopic powder with a faint, non-objectionable odour

                     Identification

                              A.

                              Solubility

                  Insoluble in water, ethanol and ether

                              B.

                              pH of a 1 % suspension in water

                  Between 5,0 and 8,0

                     Purity

                  Water

                  Not more than 6 % (Karl Fischer)

                  Sulphated ash

                  Not more than 0,4 %

                  Water-soluble matter

                  Not more than 1 %

                  Free-N-vinylpyrrolidone

                  Not more than 10 mg/kg

                  Free-N, N'-divinyl-imidazolidone

                  Not more than 2 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 1204 PULLULAN

                     Definition

                  Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography

                  Einecs

                  232-945-1

                  Chemical formula

                  (C6H10O5)x

                  Assay

                  Not less than 90 % of glucan on the dried basis

                     Description

                  White to off-white odourless powder

                     Identification

                              A.

                              Solubility

                  Soluble in water, practically insoluble in ethanol

                              B.

                              pH of 10 % solution

                  5,0 to 7,0

                              C.

                              Precipitation with polyethylene glycol 600

                  Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed

                              D.

                              Depoly-merisation with pullulanase

                  Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution

                     Purity

                  Loss on drying

                  Not more than 6 % (90 oC, pressure not more than 50 mm Hg, 6 h)

                  Mono-, di- and oligosaccharides

                  Not more than 10 % expressed as glucose

                  Viscosity

                  100 to 180 mm2/s (10 % w/w aqueous solution at 30 oC)

                  Lead

                  Not more than 1 mg/kg

                  Yeast and moulds

                  Not more than 100 colonies per gram

                  Coliforms

                  Absent in 25 g

                  Salmonella

                  Absent in 25 g

            E 1404 OXIDISED STARCH

                     Definition

                  Oxidised starch is starch treated with sodium hypochlorite

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Carboxyl groups

                  Not more than 1,1 %

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1410 MONOSTARCH PHOSPHATE

                     Definition

                  Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Residual phosphate

                  Not more than 0,5 % (as P) for wheat or potato starch

                  Not more than 0,4 % (as P) for other starches

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1412 DISTARCH PHOSPHATE

                     Definition

                  Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Residual phosphate

                  Not more than 0,5 % (as P) for wheat or potato starch

                  Not more than 0,4 % (as P) for other starches

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1413 PHOSPHATED DISTARCH PHOSPHATE

                     Definition

                  Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Residual phosphate

                  Not more than 0,5 % (as P) for wheat or potato starch

                  Not more than 0,4 % (as P) for other starches

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1414 ACETYLATED DISTARCH PHOSPHATE

                     Definition

                  Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Acetyl groups

                  Not more than 2,5 %

                  Residual phosphate

                  Not more than 0,14 % (as P) for wheat or potato starch

                  Not more than 0,04 % (as P) for other starches

                  Vinyl acetate

                  Not more than 0,1 mg/kg

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1420 ACETYLATED STARCH

                     Synonyms

                  Starch acetate

                     Definition

                  Acetylated starch is starch esterified with acetic anhydride or vinyl acetate

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Acetyl groups

                  Not more than 2,5 %

                  Vinyl acetate

                  Not more than 0,1 mg/kg

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1422 ACETYLATED DISTARCH ADIPATE

                     Definition

                  Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Acetyl groups

                  Not more than 2,5 %

                  Adipate groups

                  Not more than 0,135 %

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1440 HYDROXYPROPYL STARCH

                     Definition

                  Hydroxypropyl starch is starch etherified with propylene oxide

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Hydroxypropyl groups

                  Not more than 7,0 %

                  Propylene chlorohydrin

                  Not more than 1 mg/kg

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE

                     Definition

                  Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Hydroxypropyl groups

                  Not more than 7,0 %

                  Residual phosphate

                  Not more than 0,14 % (as P) for wheat or potato starch

                  Not more than 0,04 (as P) for other starches

                  Propylene chlorohydrin

                  Not more than 1 mg/kg

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1450 STARCH SODIUM OCTENYL SUCCINATE

                     Synonyms

                  SSOS

                     Definition

                  Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Octenylsuccinyl groups

                  Not more than 3 %

                  Octenylsuccinic acid residue

                  Not more than 0,3 %

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1451 ACETYLATED OXIDISED STARCH

                     Definition

                  Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 15,0 % for cereal starch

                  Not more than 21,0 % for potato starch

                  Not more than 18,0 % for other starches

                  Carboxyl groups

                  Not more than 1,3 %

                  Acetyl groups

                  Not more than 2,5 %

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

            E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE

                     Synonyms

                  SAOS

                     Definition

                  Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate

                     Description

                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                     Identification

                              A.

                              If not pregelatinised: by microscopic observation

                              B.

                              Iodine staining positive (dark blue to light red colour)

                     Purity (all values expressed on an anhydrous basis except for loss on drying)

                  Loss on drying

                  Not more than 21,0 %

                  Octenylsuccinyl groups

                  Not more than 3 %

                  Octenylsuccinic acid residue

                  Not more than 0,3 %

                  Sulphur dioxide

                  Not more than 50 mg/kg for modified cereal starches

                  Not more than 10 mg/kg for the other modified starches, unless otherwise specified

                  Arsenic

                  Not more than 1 mg/kg

                  Lead

                  Not more than 2 mg/kg

                  Mercury

                  Not more than 0,1 mg/kg

                  Aluminium

                  Not more than 0,3 %

            E 1505 TRIETHYL CITRATE

                     Synonyms

                  Ethyl citrate

                     Definition

                  Chemical name

                  Triethyl-2-hydroxypropan-1,2,3-tricarboxylate

                  Einecs

                  201-070-7

                  Chemical formula

                  C12H20O7

                  Molecular weight

                  276,29

                  Assay

                  Content not less than 99,0 %

                     Description

                  Odourless, practically colourless, oily liquid

                     Identification

                              A.

                              Specific gravity

                  d25
                     25: 1,135-1,139

                              B.

                              Refractive index

                  [n]D
                     20: 1,439-1,441

                     Purity

                  Water

                  Not more than 0,25 % (Karl Fischer method)

                  Acidity

                  Not more than 0,02 % (as citric acid)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 1517 GLYCERYL DIACETATE

                     Synonyms

                  Diacetin

                     Definition

                  Glyceryl diacetate consist predominantly of a mixture of the 1,2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters

                  Chemical names

                  Glyceryl diacetate

                  1, 2, 3-propanetriol diacetate

                  Chemical formula

                  C7H12O5

                  Molecular weight

                  176,17

                  Assay

                  Not less than 94,0 %

                     Description

                  Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour

                     Identification

                              A.

                              Solubility

                  Soluble in water. Miscible with ethanol

                              B.

                              Positive tests for glycerol and acetate

                              C.

                              Specific gravity

                  d20
                     20: 1,175-1,195

                              D.

                              Boiling range

                  Between 259 and 261 oC

                     Purity

                  Total ash

                  Not more than 0,02 %

                  Acidity

                  Not more than 0,4 % (as ascetic acid)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 1518 GLYCERYL TRIACETATE

                     Synonyms

                  Triacetin

                     Definition

                  Chemical name

                  Glyceryl triacetate

                  Einecs

                  203-051-9

                  Chemical formula

                  C9H14O6

                  Molecular weight

                  218,21

                  Assay

                  Content not less than 98,0 %

                     Description

                  Colourless, somewhat oily liquid having a slightly fatty odour

                     Identification

                              A.

                              Positive tests for acetate and for glycerol

                              B.

                              Refractive index

                  Between 1,429 and 1,431 at 25 oC

                              C.

                              Specific gravity (25 oC/25 oC)

                  Between 1,154 and 1,158

                              D.

                              Boiling range

                  Between 258 and 270 oC

                     Purity

                  Water

                  Not more than 0,2 % (Karl Fischer method)

                  Sulphated ash

                  Not more than 0,02 % (as citric acid)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

            E 1519 BENZYL ALCOHOL

                     Synonyms

                  Phenylcarbinol

                  Phenylmethyl alcohol

                  Benzenemethanol

                  Alpha-hydroxytoluene

                     Definition

                  Chemical names

                  Benzyl alcohol

                  Phenylmethanol

                  Chemical formula

                  C7H8O

                  Molecular weight

                  108,14

                  Assay

                  Not less than 98,0 %

                     Description

                  Colourless, clear liquid with a faint, aromatic odour

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethanol and ether

                              B.

                              Refractive index

                  [n]D
                     20: 1,538-1,541

                              C.

                              Specific gravity

                  d25
                     25: 1,042-1,047

                              D.

                              Positive test for peroxides

                     Purity

                  Distillation range

                  Not less than 95 % v/v distils between 202 and 208 oC

                  Acid value

                  Not more than 0,5

                  Aldehydes

                  Not more than 0,2 % v/v (as bezaldehyde)

                  Lead

                  Not more than 5 mg/kg

            E 1520 PROPANE-1,2-DIOL

                     Synonyms

                  Propylene glycol

                     Definition

                  Chemical names

                  1,2-dihydroxypropane

                  Einecs

                  200-338-0

                  Chemical formula

                  C3H8O2

                  Molecular weight

                  76,10

                  Assay

                  Content not less than 99,5 % on the anhydrous basis

                     Description

                  Clear, colourless, hygroscopic, viscous liquid

                     Identification

                              A.

                              Solubility

                  Soluble in water, ethanol and acetone

                              B.

                              Specific gravity

                  d20
                     20: 1,035-1,040

                              C.

                              Refractive index

                  [n]20
                     D: 1,431-1,433

                     Purity

                  Distillation range

                  99 % v/v distils between 185 oC-189 oC

                  Sulphated ash

                  Not more than 0,07 %

                  Water

                  Not more than 1,0 % (Karl Fischer method)

                  Lead

                  Not more than 5 mg/kg

            POLYETHYLENE GLYCOL 6000

                     Synonyms

                  PEG 6000

                  Macrogol 6000

                     Definition

                  Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000

                  Chemical formula

                  (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140)

                  Molecular weight

                  5 600-7 000

                  Assay

                  Not less than 90,0 % and not more than 110,0 %

                     Description

                  A white or almost white solid with a waxy or paraffin-like appearance

                     Identification

                              A.

                              Solubility

                  Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils

                              B.

                              Melting range

                  Between 55 oC and 61 oC

                     Purity

                  Viscosity

                  Between 0,220 and 0,275 kgm-1s-1 at 20 oC

                  Hydroxyl value

                  Between 16 and 22

                  Sulphated ash

                  Not more than 0,2 %

                  Ethylene oxide

                  Not more than 0,2 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 5 mg/kg

         (1)  OJ L 226, 22.9.1995, p. 1.

         (2)  Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.

         (3)  Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml.

         (4)  Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.

         (5)  Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml.

         (6)  When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.

         (7)  When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.

         (8)  OJ L 158, 18.6.2008, p. 17.

      ANNEX II
      PART A
      Repealed Directive with list of its successive amendments

         (referred to in Article 2)

                  Commission Directive 96/77/EC

                              Commission Directive 98/86/EC

                              Commission Directive 2000/63/EC

                              Commission Directive 2001/30/EC

                              Commission Directive 2002/82/EC

                              Commission Directive 2003/95/EC

                              Commission Directive 2004/45/EC

                              Commission Directive 2006/129/EC

                  (OJ L 339, 30.12.1996, p. 1)

                              (OJ L 334, 9.12.1998, p. 1)

                              (OJ L 277, 30.10.2000, p. 1)

                              (OJ L 146, 31.5.2001, p. 1)

                              (OJ L 292, 28.10.2002, p. 1)

                              (OJ L 283, 31.10.2003, p. 71)

                              (OJ L 113, 20.4.2004, p. 19)

                              (OJ L 346, 9.12.2006, p. 15)

            PART B
      List of time-limits for transposition into national law

         (referred to in Article 2)

                  Directive

                  Time-limit for transposition

                  96/77/EC

                  1 July 1997 (1)

                  98/86/EC

                  1 July 1999 (2)

                  2000/63/EC

                  31 March 2001 (3)

                  2001/30/EC

                  1 June 2002 (4)

                  2002/82/EC

                  31 August 2003

                  2003/95/EC

                  1 November 2004 (5)

                  2004/45/EC

                  1 April 2005 (6)

                  2006/129/EC

                  15 February 2008

         (1)  According to Article 3(2) of Directive 96/77/EC, products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.

         (2)  According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted.

         (3)  According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply with this Directive may be marketed until stocks are exhausted.

         (4)  According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted.

         (5)  According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted.

         (6)  According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted.

      ANNEX III
      Correlation table

                  Directive 96/77/EC

                  This Directive

                  Article 1

                  Article 1

                  Article 2

                  —

                  Article 3

                  —

                  —

                  Article 2

                  Article 4

                  Article 3

                  Article 5

                  Article 4

                  Annex

                  Annex I

                  —

                  Annex II

                  —

                  Annex III