title: Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version) (Text with EEA relevance)

text:
               10.1.2009

               EN

               Official Journal of the European Union

               L 6/20

      COMMISSION DIRECTIVE 2008/128/EC
   of 22 December 2008
   laying down specific purity criteria concerning colours for use in foodstuffs
   (Codified version)
   (Text with EEA relevance)
   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 authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   Whereas:

               (1)

               Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs (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 colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (4).

               (3)

               It is necessary to take into account the specifications and analytical techniques for colours 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 colours mentioned in Directive 94/36/EC are set out in Annex I hereto.
   Article 2
   Directive 95/45/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 of the Directives 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 that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 22 December 2008.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 40, 11.2.1989, p. 27.

      (2)  OJ L 226, 22.9.1995, p. 1.

      (3)  See Annex II, Part A.

      (4)  OJ L 237, 10.9.1994, p. 13.

      ANNEX I
      A.   GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS

                     Definition

                  Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.

                  HCl insoluble matter

                  Not more than 0,5 %

                  Ether extractable matter

                  Not more than 0,2 % (under neutral conditions)
                  Specific purity criteria for the corresponding colours are applicable.

            B.   SPECIFIC CRITERIA OF PURITY

                  E 100 CURCUMIN

                     Synonyms

                  CI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane

                     Definition

                  Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of natural strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occuring in turmeric may be present.
                  Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane.

                  Class

                  Dicinnamoylmethane

                  Colour Index No

                  75300

                  Einecs

                  207-280-5

                  Chemical names

                              I

                              1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione

                              II

                              1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione

                              III

                              1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione

                  Chemical formula

                              I

                              C21H20O6

                              II

                              C20H18O5

                              III

                              C19H16O4

                  Molecular weight

                              I.

                              368,39

                              II.

                              338,39

                              III.

                              308,39

                  Assay

                  Content not less than 90 % total colouring matters
                  E1 cm
                     1 %1 607 at ca 426 nm in ethanol

                     Description

                  Orange-yellow crystalline powder

                  Identification

                              A.

                              Spectrometry

                  Maximum in ethanol at ca 426 nm

                              B.

                              Melting Range

                  179 °C-182 °C

                  Purity

                  Solvent residues

                  Ethylacetate
                  Acetone
                  n-butanol
                  Methanol
                  Ethanol
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 101 (i) RIBOFLAVIN

                     Synonyms

                  Lactoflavin

                  Class

                  Isoalloxazine

                  Einecs

                  201-507-1

                  Chemical names

                  7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione
                  7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine

                  Chemical formula

                  C17H20N4O6

                  Molecular weight

                  376,37

                  Assay

                  Content not less than 98 % on the anhydrous basis
                  E1 cm
                     1 % 328 at ca 444 nm in aqueous solution

                     Description

                  Yellow to orange-yellow crystalline powder, with slight odour

                  Identification

                              A.

                              Spectrometry

                  The ratio A375/A267 is between 0,31 and 0,33
                  The ratio A444/A267 is between 0,36 and 0,39

                  in aqueous solution

                  Maximum in water at ca 444 nm

                              B.

                              Specific rotation

                  [α]D20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution

                  Purity

                  Loss on drying

                  Not more than 1,5 % after drying at 105 °C for 4 hrs

                  Sulfated ash

                  Not more than 0,1 %

                  Primary aromatic amines

                  Not more than 100 mg/kg (calculated as aniline)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE

                     Synonyms

                  Riboflavin-5′-phosphate sodium

                     Definition

                  These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate

                  Class

                  Isoalloxazine

                  Einecs

                  204-988-6

                  Chemical names

                  Monosodium
                  (2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate;
                  monosodium salt of 5′-monophosphate ester of riboflavin

                  Chemical formula

                              For the dihydrate form

                              :

                              C17H20N4NaO9P·2H2O

                              For the anhydrous form

                              :

                              C17H20N4NaO9P

                  Molecular weight

                  541,36

                  Assay

                  Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2O
                  E1 cm
                     1 % 250 at ca 375 nm in aqueous solution

                     Description

                  Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste

                  Identification

                              A.

                              Spectrometry

                  The ratio A375/A267 is between 0,30 and 0,34
                  The ratio A444/A267 is between 0,35 and 0,40

                  in aqueous solution

                  Maximum in water at ca 444 nm

                              B.

                              Specific rotation

                  [α]D20 between + 38° and + 42° in a 5 molar HCl solution

                  Purity

                  Loss on drying

                  Not more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form

                  Sulfated ash

                  Not more than 25 %

                  Inorganic phosphate

                  Not more than 1,0 % (calculated as PO4 on the anhydrous basis)

                  Subsidiary colouring matters

                              Riboflavin (free)

                              :

                              Not more than 6 %

                              Riboflavine diphosphate

                              :

                              Not more than 6 %

                  Primary aromatic amines

                  Not more than 70 mg/kg (calculated as aniline)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 102 TARTRAZINE

                     Synonyms

                  CI Food Yellow 4

                     Definition

                  Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  19140

                  Einecs

                  217-699-5

                  Chemical names

                  Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate

                  Chemical formula

                  C16H9N4Na3O9S2

                  Molecular weight

                  534,37

                  Assay

                  Content not less than 85 % total colouring matters calculated as the sodium salt
                  E1 cm
                     1 % 530 at ca 426 nm in aqueous solution

                     Description

                  Light orange powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 426 nm

                              B.

                              Yellow solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 1,0 %

                  Organic compounds other than colouring matters:

                              4-hydrazinobenzene sulfonic acid

                              4-aminobenzene-1-sulfonic acid

                              5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid

                              4,4′-diazoaminodi(benzene sulfonic acid)

                              Tetrahydroxysuccinic acid

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 104 QUINOLINE YELLOW

                     Synonyms

                  CI Food Yellow 13

                     Definition

                  Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Chinophthalone

                  Colour Index No

                  47005

                  Einecs

                  305-897-5

                  Chemical name

                  The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)

                  Chemical formula

                  C18H9N Na2O8S2 (principal component)

                  Molecular weight

                  477,38 (principal component)

                  Assay

                  Content not less than 70 % total colouring matters calculated as the sodium salt
                  Quinoline Yellow shall have the following composition:
                  Of the total colouring matters present:

                              —

                              not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates

                              —

                              not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates

                              —

                              not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate

                        E1 cm
                     1 % 865 (principal component) at ca 411 nm in aqueous acetic acid solution

                     Description

                  Yellow powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm

                              B.

                              Yellow solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 4,0 %

                  Organic compounds other than colouring matters:

                              2-methylquinoline

                              2-methylquinoline-sulfonic acid

                              Phthalic acid

                              2,6-dimethyl quinoline

                              2,6-dimethyl quinoline sulfonic acid

                  Total not more than 0,5 %

                  2-(2-quinolyl)indan-1,3-dione

                  Not more than 4 mg/kg

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 110 SUNSET YELLOW FCF

                     Synonyms

                  CI Food Yellow 3, Orange Yellow S

                     Definition

                  Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  15985

                  Einecs

                  220-491-7

                  Chemical names

                  Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate

                  Chemical formula

                  C16H10N2Na2O7S2

                  Molecular weight

                  452,37

                  Assay

                  Content not less than 85 % total colouring matters calculated as the sodium salt
                  E1 cm
                     1 % 555 at ca 485 nm in aqueous solution at pH 7

                     Description

                  Orange-red powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 485 nm at pH 7

                              B.

                              Orange solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 5,0 %

                  1-(Phenylazo)-2-naphthalenol (Sudan I)

                  Not more than 0,5 mg/kg

                  Organic compounds other than colouring matters:

                              4-aminobenzene-1-sulfonic acid

                              3-hydroxynaphthalene-2,7-disulfonic acid

                              6-hydroxynaphthalene-2-sulfonic acid

                              7-hydroxynaphthalene-1,3-disulfonic acid

                              4,4′-diazoaminodi(benzene sulfonic acid)

                              6,6′-oxydi(naphthalene-2-sulfonic acid)

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  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 120 COCHINEAL, CARMINIC ACID, CARMINES

                     Definition

                  Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa.
                  The colouring principle is carminic acid.
                  Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.
                  In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.
                  Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.

                  Class

                  Anthraquinone

                  Colour Index No

                  75470

                  Einecs

                  Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4

                  Chemical names

                  7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid

                  Chemical formula

                  C22H20O13 (carminic acid)

                  Molecular weight

                  492,39 (carminic acid)

                  Assay

                  Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.

                     Description

                  Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.

                  Identification

                  Spectrometry

                  Maximum in aqueous ammonia solution at ca 518 nm
                  Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid

                  Purity

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 122 AZORUBINE, CARMOISINE

                     Synonyms

                  CI Food Red 3

                     Definition

                  Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  14720

                  Einecs

                  222-657-4

                  Chemical name

                  Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate

                  Chemical formula

                  C20H12N2Na2O7S2

                  Molecular weight

                  502,44

                  Assay

                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  E1 cm
                     1 % 510 at ca 516 nm in aqueous solution

                     Description

                  Red to maroon powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 516 nm

                              B.

                              Red solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 2,0 %

                  Organic compounds other than colouring matters:

                              4-aminonaphthalene-1-sulfonic acid

                              4-hydroxynaphthalene-1-sulfonic acid

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 123 AMARANTH

                     Synonyms

                  CI Food Red 9

                     Definition

                  Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  16185

                  Einecs

                  213-022-2

                  Chemical name

                  Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate

                  Chemical formula

                  C20H11N2Na3O10S3

                  Molecular weight

                  604,48

                  Assay

                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  E1 cm
                     1 % 440 at ca 520 nm in aqueous solution

                     Description

                  Reddish-brown powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 520 nm

                              B.

                              Red solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 3,0 %

                  Organic compounds other than colouring matters:

                              4-aminonaphthalene-1-sulfonic acid

                              3-hydroxynaphthalene-2,7-disulfonic acid

                              6-hydroxynaphthalene-2-sulfonic acid

                              7-hydroxynaphthalene-1,3-disulfonic acid

                              7-hydroxynaphthalene-1,3-6-trisulfonic acid

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 124 PONCEAU 4R, COCHINEAL RED A

                     Synonyms

                  CI Food Red 7, New Coccine

                     Definition

                  Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  16255

                  Einecs

                  220-036-2

                  Chemical name

                  Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate

                  Chemical formula

                  C20H11N2Na3O10S3

                  Molecular weight

                  604,48

                  Assay

                  Content not less than 80 % total colouring matters, calculated as the sodium salt.
                  E1 cm
                     1 % 430 at ca 505 nm in aqueous solution

                     Description

                  Reddish powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 505 nm

                              B.

                              Red solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 1,0 %

                  Organic compounds other than colouring matters:

                              4-aminonaphthalene-1-sulfonic acid

                              7-hydroxynaphthalene-1,3-disulfonic acid

                              3-hydroxynaphthalene-2,7-disulfonic acid

                              6-hydroxynaphthalene-2-sulfonic acid

                              7-hydroxynaphthalene-1,3-6-trisulfonic acid

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 127 ERYTHROSINE

                     Synonyms

                  CI Food Red 14

                     Definition

                  Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Xanthen

                  Colour Index No

                  45430

                  Einecs

                  240-474-8

                  Chemical name

                  Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate

                  Chemical formula

                  C20H6I4Na2O5.H2O

                  Molecular weight

                  897,88

                  Assay

                  Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt
                  E1 cm
                     1 %1 100 at ca 526 nm in aqueous solution at pH 7

                     Description

                  Red powder or granules.

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 526 nm at pH 7

                              B.

                              Red solution in water

                  Purity

                  Inorganic iodides calculated as sodium iodide

                  Not more than 0,1 %

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters (except fluorescein)

                  Not more than 4,0 %

                  Fluorescein

                  Not more than 20 mg/kg

                  Organic compounds other than colouring matters:

                  Tri-iodoresorcinol

                  Not more than 0,2 %

                  2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acid

                  Not more than 0,2 %

                  Ether extractable matter

                  From a solution of pH from 7 through 8, not more than 0,2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  Aluminium Lakes

                  The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only.

                  E 128 RED 2G

                     Synonyms

                  CI Food Red 10, Azogeranine

                     Definition

                  Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  18050

                  Einecs

                  223-098-9

                  Chemical name

                  Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate

                  Chemical formula

                  C18H13N3Na2O8S2

                  Molecular weight

                  509,43

                  Assay

                  Content not less than 80 % total colouring matters, calculated as the sodium salt
                  E1 cm
                     1 % 620 at ca 532 nm in aqueous solution

                     Description

                  Red powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 532 nm

                              B.

                              Red solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 2,0 %

                  Organic compounds other than colouring matters:

                              5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid

                              5-amino-4-hydroxynaphthalene-2,7-disulfonic acid

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 129 ALLURA RED AC

                     Synonyms

                  CI Food Red 17

                     Definition

                  Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Monoazo

                  Colour Index No

                  16035

                  Einecs

                  247-368-0

                  Chemical name

                  Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate

                  Chemical formula

                  C18H14N2Na2O8S2

                  Molecular weight

                  496,42

                  Assay

                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  E1 cm
                     1 % 540 at ca 504 nm in aqueous solution at pH 7

                     Description

                  Dark red powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 504 nm

                              B.

                              Red solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 3,0 %

                  Organic compounds other than colouring matters:

                  6-hydroxy-2-naphthalene sulfonic acid, sodium salt

                  Not more than 0,3 %

                  4-amino-5-methoxy-2-methylbenezene sulfonic acid

                  Not more than 0,2 %

                  6,6-oxybis (2-naphthalene sulfonic acid) disodium salt

                  Not more than 1,0 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  From a solution of pH 7, not more than 0,2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 131 PATENT BLUE V

                     Synonyms

                  CI Food Blue 5

                     Definition

                  Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium sulfate as the principal uncoloured components.
                  The potassium salt is also permitted.

                  Class

                  Triarylmethane

                  Colour Index No

                  42051

                  Einecs

                  222-573-8

                  Chemical names

                  The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt

                  Chemical formula

                  Calcium compound: C27H31N2O7S2Ca

                  Sodium compound: C27H31N2O7S2Na

                  Molecular weight

                  Calcium compound: 579,72
                  Sodium compound: 582,67

                  Assay

                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  E1 cm
                     1 %2 000 at ca 638 nm in aqueous solution at pH 5

                     Description

                  Dark-blue powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at 638 nm at pH 5

                              B.

                              Blue solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 2,0 %

                  Organic compounds other than colouring matters:

                              3-hydroxy benzaldehyde

                              3-hydroxy benzoic acid

                              3-hydroxy-4-sulfobenzoic acid

                              N,N-diethylamino benzene sulfonic acid

                  Total not more than 0,5 %

                  Leuco base

                  Not more than 4,0 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  From a solution of pH 5 not more than 0,2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 132 INDIGOTINE, INDIGO CARMINE

                     Synonyms

                  CI Food Blue 1

                     Definition

                  Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Indigoid

                  Colour Index No

                  73015

                  Einecs

                  212-728-8

                  Chemical names

                  Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate

                  Chemical formula

                  C16H8N2Na2O8S2

                  Molecular weight

                  466,36

                  Assay

                  Content not less than 85 % total colouring matters, calculated as the sodium salt;
                  disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 %
                  E1 cm
                     1 % 480 at ca 610 nm in aqueous solution

                     Description

                  Dark-blue powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 610 nm

                              B.

                              Blue solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 %

                  Organic compounds other than colouring matters:

                              Isatin-5-sulfonic acid

                              5-sulfoanthranilic acid

                              Anthranilic acid

                  Total not more than 0,5 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 133 BRILLIANT BLUE FCF

                     Synonyms

                  CI Food Blue 2

                     Definition

                  Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Triarylmethane

                  Colour Index No

                  42090

                  Einecs

                  223-339-8

                  Chemical names

                  Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate

                  Chemical formula

                  C37H34N2Na2O9S3

                  Molecular weight

                  792,84

                  Assay

                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  E1 cm
                     1 %1 630 at ca 630 nm in aqueous solution

                     Description

                  Reddish-blue powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 630 nm

                              B.

                              Blue solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 6,0 %

                  Organic compounds other than colouring matters:

                  Sum of 2-, 3- and 4-formyl benzene sulfonic acids

                  Not more than 1,5 %

                  3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid

                  Not more than 0,3 %

                  Leuco base

                  Not more than 5,0 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % at pH 7

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 140 (i) CHLOROPHYLLS

                     Synonyms

                  CI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin

                     Definition

                  Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

                  Class

                  Porphyrin

                  Colour Index No

                  75810

                  Einecs

                  Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4

                  Chemical names

                  The major colouring principles are:

                              Phytyl (132
                                 R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)

                              Phytyl (132
                                 R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)

                  Chemical formula

                  Chlorophyll a (magnesium complex): C55H72MgN4O5

                  Chlorophyll a: C55H74N4O5

                  Chlorophyll b (magnesium complex): C55H70MgN4O6

                  Chlorophyll b: C55H72N4O6

                  Molecular weight

                  Chlorophyll a (magnesium complex): 893,51
                  Chlorophyll a: 871,22
                  Chlorophyll b (magnesium complex): 907,49
                  Chlorophyll b: 885,20

                  Assay

                  Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %
                  E1 cm
                     1 % 700 at ca 409 nm in chloroform

                     Description

                  Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesium

                  Identification

                  Spectrometry

                  Maximum in chloroform at ca 409 nm

                  Purity

                  Solvent residues

                  Acetone
                  Methyl Ethyl ketone
                  Methanol
                  Ethanol
                  Propan-2-ol
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: Not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 140 (ii) CHLOROPHYLLINS

                     Synonyms

                  CI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorophyllin

                     Definition

                  The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium.
                  Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

                  Class

                  Porphyrin

                  Colour Index No

                  75815

                  Einecs

                  287-483-3

                  Chemical names

                  The major colouring principles in their acid forms are:

                              —

                              3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)
                              and

                              —

                              3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)

                        Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.
                  Magnesium complexes may also be present.

                  Chemical formula

                  Chlorophyllin a (acid form): C34H34N4O5

                  Chlorophyllin b (acid form): C34H32N4O6

                  Molecular weight

                  Chlorophyllin a: 578,68
                  Chlorophyllin b: 592,66
                  Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.

                  Assay

                  Content of total chlorophyllins is not less than 95 % of the sample dried at ca 100 °C for 1 hour.
                  E1 cm
                     1 % 700 at ca 405 nm in aqueous solution at pH 9
                  E1 cm
                     1 % 140 at ca 653 nm in aqueous solution at pH 9

                     Description

                  Dark green to blue/black powder

                  Identification

                  Spectrometry

                  Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm

                  Purity

                  Solvent residues

                  Acetone
                  Methyl ethyl ketone
                  Methanol
                  Ethanol
                  Propan-2-ol
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS

                     Synonyms

                  CI Natural Green 3, Copper Chlorophyll, Copper Phaeophytin

                     Definition

                  Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

                  Class

                  Porphyrin

                  Colour Index No

                  75815

                  Einecs

                  Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5

                  Chemical names

                  [Phytyl (132
                     R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)
                  [Phytyl (132
                     R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)

                  Chemical formula

                  Copper chlorophyll a: C55H72Cu N4O5

                  Copper chlorophyll b: C55H70Cu N4O6

                  Molecular weight

                  Copper chlorophyll a: 932,75
                  Copper chlorophyll b: 946,73

                  Assay

                  Content of total copper chlorophylls is not less than 10 %.
                  E1 cm
                     1 % 540 at ca 422 nm in chloroform
                  E1 cm
                     1 % 300 at ca 652 nm in chloroform

                     Description

                  Waxy solid ranging in colour from blue green to dark green depending on the source material

                  Identification

                  Spectrometry

                  Maximum in chloroform at ca 422 nm and at ca 652 nm

                  Purity

                  Solvent residues

                  Acetone
                  Methyl ethyl ketone
                  Methanol
                  Ethanol
                  Propan-2-ol
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Copper ions

                  Not more than 200 mg/kg

                  Total copper

                  Not more than 8,0 % of the total copper phaeophytins

                  E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS

                     Synonyms

                  Sodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5

                     Definition

                  The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralized to form the salts of potassium and/or sodium.
                  Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.

                  Class

                  Porphyrin

                  Colour Index No

                  75815

                  Einecs

                  Chemical names

                  The major colouring principles in their acid forms are:
                  3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a)
                  and
                  3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)

                  Chemical formula

                  Copper chlorophyllin a (acid form): C34H32Cu N4O5

                  Copper chlorophyllin b (acid form): C34H30Cu N4O6

                  Molecular weight

                  Copper chlorophyllin a: 640,20
                  Copper chlorophyllin b: 654,18
                  Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.

                  Assay

                  Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.
                  E1 cm
                     1 % 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5
                  E1 cm
                     1 % 145 at ca 630 nm in aqueous phosphate buffer at pH 7,5

                     Description

                  Dark green to blue/black powder

                  Identification

                  Spectrometry

                  Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nm

                  Purity

                  Solvent residues

                  Acetone
                  Methyl ethyl ketone
                  Methanol
                  Ethanol
                  Propan-2-ol
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Copper ions

                  Not more than 200 mg/kg

                  Total copper

                  Not more than 8,0 % of the total copper chlorophyllins

                  E 142 GREEN S

                     Synonyms

                  CI Food Green 4, Brilliant Green BS

                     Definition

                  Green S consists essentially of sodium N-[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.
                  Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Triarylmethane

                  Colour Index No

                  44090

                  Einecs

                  221-409-2

                  Chemical names

                  Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium;
                  Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).

                  Chemical formula

                  C27H25N2NaO7S2

                  Molecular Weight

                  576,63

                  Assay

                  Content not less than 80 % total colouring matters calculated as the sodium salt
                  E1 cm
                     1 %1 720 at ca 632 nm in aqueous solution

                     Description

                  Dark blue or dark green powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 632 nm

                              B.

                              Blue or green solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 1,0 %

                  Organic compounds other than colouring matters:

                  4,4′-bis(dimethylamino)-benzhydryl alcohol

                  Not more than 0,1 %

                  4,4′-bis(dimethylamino)-benzophenone

                  Not more than 0,1 %

                  3-hydroxynaphthalene-2,7-disulfonic acid

                  Not more than 0,2 %

                  Leuco base

                  Not more than 5,0 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 150a PLAIN CARAMEL

                     Definition

                  Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.

                  Einecs

                  232-435-9

                     Description

                  Dark brown to black liquids or solids

                  Purity

                  Colour bound by DEAE cellulose

                  Not more than 50 %

                  Colour bound by phosphoryl cellulose

                  Not more than 50 %

                  Colour intensity (1)

                  0,01-0,12

                  Total nitrogen

                  Not more than 0,1 %

                  Total sulphur

                  Not more than 0,2 %

                  Arsenic

                  Not more than 1 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 25 mg/kg

                  E 150b CAUSTIC SULPHITE CARAMEL

                     Definition

                  Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.

                  Einecs

                  232-435-9

                     Description

                  Dark brown to black liquids or solids

                  Purity

                  Colour bound by DEAE cellulose

                  More than 50 %

                  Colour intensity (1)

                  0,05-0,13

                  Total nitrogen

                  Not more than 0,3 % (2)

                  Sulphur dioxide

                  Not more than 0,2 % (2)

                  Total sulphur

                  0,3-3,5 % (2)

                  Sulphur bound by DEAE cellulose

                  More than 40 %

                  Absorbance ratio of colour bound by DEAE cellulose

                  19-34

                  Absorbance ratio
                  (A 280/560)

                  Greater than 50

                  Arsenic

                  Not more than 1 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 25 mg/kg

                  E 150c AMMONIA CARAMEL

                     Definition

                  Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.

                  Einecs

                  232-435-9

                     Description

                  Dark brown to black liquids or solids

                  Purity

                  Colour bound by DEAE cellulose

                  Not more than 50 %

                  Colour bound by phosphoryl cellulose

                  More than 50 %

                  Colour intensity (1)

                  0,08-0,36

                  Ammoniacal nitrogen

                  Not more than 0,3 % (2)

                  4-methylimidazole

                  Not more than 250 mg/kg (2)

                  2-acetyl-4-tetrahydroxy-butylimidazole

                  Not more than 10 mg/kg (2)

                  Total sulphur

                  Not more than 0,2 % (2)

                  Total nitrogen

                  0,7-3,3 % (2)

                  Absorbance ratio of colour bound by phosphoryl cellulose

                  13-35

                  Arsenic

                  Not more than 1 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 25 mg/kg

                  E 150d SULPHITE AMMONIA CARAMEL

                     Definition

                  Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).

                  Einecs

                  232-435-9

                     Description

                  Dark brown to black liquids or solids

                  Purity

                  Colour bound by DEAE cellulose

                  More than 50 %

                  Colour intensity (1)

                  0,10-0,60

                  Ammoniacal nitrogen

                  Not more than 0,6 % (2)

                  Sulphur dioxide

                  Not more than 0,2 % (2)

                  4-methylimidazole

                  Not more than 250 mg/kg (2)

                  Total nitrogen

                  0,3-1,7 % (2)

                  Total sulphur

                  0,8-2,5 % (2)

                  Nitrogen/sulphur ratio of alcohol precipitate

                  0,7-2,7

                  Absorbance ratio of alcohol precipitate (3)

                  8-14

                  Absorbance ratio (A 280/560)

                  Not more than 50

                  Arsenic

                  Not more than 1 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 25 mg/kg

                  E 151 BRILLIANT BLACK BN, BLACK PN

                     Synonyms

                  CI Food Black 1

                     Definition

                  Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Bisazo

                  Colour Index No

                  28440

                  Einecs

                  219-746-5

                  Chemical names

                  Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate

                  Chemical formula

                  C28H17N5Na4O14S4

                  Molecular weight

                  867,69

                  Assay

                  Content not less than 80 % total colouring matters calculated as the sodium salt
                  E1 cm
                     1 % 530 at ca 570 nm in solution

                     Description

                  Black powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water at ca 570 nm

                              B.

                              Black-bluish solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 10 % (expressed on the dye content)

                  Organic compounds other than colouring matters:

                              4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid

                              4-amino-5-hydroxynaphthalene-1,7-disulfonic acid

                              8-aminonaphthalene-2-sulfonic acid

                              4,4′-diazoaminodi-(benzenesulfonic acid)

                  Total not more than 0,8 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % under neutral conditions

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 153 VEGETABLE CARBON

                     Synonyms

                  Vegetable black

                     Definition

                  Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonised at high temperatures. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.

                  Colour Index No

                  77266

                  Einecs

                  215-609-9

                  Chemical names

                  Carbon

                  Chemical formula

                  C

                  Molecular weight

                  12,01

                  Assay

                  Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis

                     Description

                  Black powder, odourless and tasteless

                  Identification

                              A.

                              Solubility

                  Insoluble in water and organic solvents

                              B.

                              Burning

                  When heated to redness it burns slowly without a flame

                  Purity

                  Ash (Total)

                  Not more than 4,0 % (ignition temperature: 625 °C)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  Polyaromatic hydrocarbons

                  The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1 000 ml of 0,01 M sulphuric acid.

                  Loss on drying

                  Not more than 12 % (120 °C, 4 hrs)

                  Alkali soluble matter

                  The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless

                  E 154 BROWN FK

                     Synonyms

                  CI Food Brown 1

                     Definition

                  Brown FK consists essentially of a mixture of:

                              I

                              sodium 4-(2,4-diaminophenylazo) benzenesulfonate

                              II

                              sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate

                              III

                              disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

                              IV

                              disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

                              V

                              disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)

                              VI

                              trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)

                        and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.
                  Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted.

                  Class

                  Azo (a mixture of mono-, bis- and trisazo colours)

                  Einecs

                  Chemical names

                  A mixture of:

                              I

                              sodium 4-(2,4-diaminophenylazo) benzenesulfonate

                              II

                              sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate

                              III

                              disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

                              IV

                              disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)

                              V

                              disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)

                              VI

                              trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)

                  Chemical formula

                              I

                              C12H11N4NaO3S

                              II

                              C13H13N4NaO3S

                              III

                              C18H14N6Na2O6S2

                              IV

                              C18H14N6Na2O6S2

                              V

                              C19H16N6Na2O6S2

                              VI

                              C24H17N8Na3O9S3

                  Molecular weight

                              I

                              314,30

                              II

                              328,33

                              III

                              520,46

                              IV

                              520,46

                              V

                              534,47

                              VI

                              726,59

                  Assay

                  Content not less than 70 % total colouring matters
                  Of the total colouring matters present the proportions of the components shall not exceed:

                              I

                              26 %

                              II

                              17 %

                              III

                              17 %

                              IV

                              16 %

                              V

                              20 %

                              VI

                              16 %

                     Description

                  Red-brown powder or granules

                  Identification

                  Orange to reddish solution

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 3,5 %

                  Organic compounds other than colouring matters:

                  4-aminobenzene-1-sulfonic acid

                  Not more than 0,7 %

                  m-phenylenediamine and 4-methyl-m-phenylenediamine

                  Not more than 0,35 %

                  Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamine

                  Not more than 0,007 % (calculated as aniline)

                  Ether extractable matter

                  From a solution of pH 7, not more than 0,2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 155 BROWN HT

                     Synonyms

                  CI Food Brown 3

                     Definition

                  Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulfate as the principal uncoloured components.
                  Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.

                  Class

                  Bisazo

                  Colour Index No

                  20285

                  Einecs

                  224-924-0

                  Chemical names

                  Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)

                  Chemical formula

                  C27H18N4Na2O9S2

                  Molecular Weight

                  652,57

                  Assay

                  Content not less than 70 % total colouring matters calculated as the sodium salt.
                  E1 cm
                     1 % 403 at ca 460 nm in aqueous solution at pH 7

                     Description

                  Reddish-brown powder or granules

                  Identification

                              A.

                              Spectrometry

                  Maximum in water of pH 7 at ca 460 nm

                              B.

                              Brown solution in water

                  Purity

                  Water insoluble matter

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Not more than 10 % (TLC method)

                  Organic compounds other than colouring matters:

                  4-aminonaphthalene-1-sulfonic acid

                  Not more than 0,7 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (calculated as aniline)

                  Ether extractable matter

                  Not more than 0,2 % in a solution of pH 7

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 160a (i) MIXED CAROTENES

            1.   Plant carotenes

                     Synonyms

                  CI Food Orange 5

                     Definition

                  Mixed carotenes are obtained by solvent extraction of natural strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.
                  The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
                  Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (4), dichloromethane and carbon dioxide.

                  Class

                  Carotenoid

                  Colour Index No

                  75130

                  Einecs

                  230-636-6

                  Chemical formula

                  Beta-carotene: C40H56

                  Molecular weight

                  Beta-carotene: 536,88

                  Assay

                  Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats.
                  E1 cm
                     1 %2 500 at approximately 440 nm to 457 nm in cyclohexane

                  Identification

                  Spectrometry

                  Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm

                  Purity

                  Solvent residues

                  Acetone
                  Methyl ethyl ketone
                  Methanol
                  Propan-2-ol
                  Hexane
                  Ethanol

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: Not more than 10 mg/kg

                  Lead

                  Not more than 5 mg/kg

            2.   Algal carotenes

                     Synonyms

                  CI Food Orange 5

                     Definition

                  Mixed carotenes may also be produced from natural strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.
                  The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.

                  Class

                  Carotenoid

                  Colour Index No

                  75130

                  Chemical formula

                  Beta-Carotene: C40H56

                  Molecular weight

                  Beta-Carotene: 536,88

                  Assay

                  Content of carotenes (calculated as beta-carotene) is not less than 20 %
                  E1 cm
                     1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane

                  Identification

                  Spectrometry

                  Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm

                  Purity

                  Natural tocopherols in edible oil

                  Not more than 0,3 %

                  Lead

                  Not more than 5 mg/kg

                  E 160a (ii) BETA-CAROTENE

            1.   Beta-carotene

                     Synonyms

                  CI Food Orange 5

                     Definition

                  These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.

                  Class

                  Carotenoid

                  Colour Index No

                  40800

                  Einecs

                  230-636-6

                  Chemical names

                  Beta-carotene, beta, beta-carotene

                  Chemical formula

                  C40H56

                  Molecular weight

                  536,88

                  Assay

                  Not less than 96 % total colouring matters (expressed as beta-carotene)
                  E1 cm
                     1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane

                     Description

                  Red to brownish-red crystals or crystalline powder

                  Identification

                  Spectrometry

                  Maximum in cyclohexane at 453 nm to 456 nm

                  Purity

                  Sulfated ash

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

                  Lead

                  Not more than 2 mg/kg

            2.   Beta-carotene from Blakeslea trispora

                     Synonyms

                  CI Food Orange 5

                     Definition

                  Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of natural strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.

                  Class

                  Carotenoid

                  Colour Index No

                  40800

                  Einecs

                  230-636-6

                  Chemical names

                  Beta-carotene, beta,beta-carotene

                  Chemical formula

                  C40H56

                  Molecular weight

                  536,88

                  Assay

                  Not less than 96 % total colouring matters (expressed as beta-carotene)
                  E1 cm
                     1 %2 500 at approximately 440 nm to 457 nm in cyclohexane

                     Description

                  Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)

                  Identification

                  Spectrometry

                  Maximum in cyclohexane at 453 nm to 456 nm

                  Purity

                  Solvent residues

                  Ethyl acetate
                  Ethanol

                  Not more than 0,8 %, singly or in combination

                  Isobutyl acetate: Not more than 1,0 %

                  Isopropyl alcohol: Not more than 0,1 %

                  Sulfated ash

                  Not more than 0,2 %

                  Subsidiary colouring matters

                  Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

                  Lead

                  Not more than 2 mg/kg

                  Mycotoxins:

                  Aflatoxin B1

                  Absent

                  Trichothecene (T2)

                  Absent

                  Ochratoxin

                  Absent

                  Zearalenone

                  Absent

                  Microbiology:

                  Moulds

                  Not more than 100/g

                  Yeasts

                  Not more than 100/g

                     Salmonella

                  Absent in 25 g

                     Escherichia coli

                  Absent in 5 g

                  E 160b ANNATTO, BIXIN, NORBIXIN

                     Synonyms

                  CI Natural Orange 4

                  Definition

                  Class

                  Carotenoid

                  Colour Index No

                  75120

                  Einecs

                  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7

                  Chemical names

                              Bixin

                              :

                              6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate
                              6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

                              Norbixin

                              :

                              9′Cis-6,6′-diapocarotene-6,6′-dioic acid
                              9′-Trans-6,6′-diapocarotene-6,6′-dioic acid

                  Chemical formula

                              Bixin

                              :

                              C25H30O4

                              Norbixin

                              :

                              C24H28O4

                  Molecular weight

                              Bixin

                              :

                              394,51

                              Norbixin

                              :

                              380,48

                     Description

                  Reddish-brown powder, suspension or solution

                  Identification

                  Spectrometry

                              Bixin

                              :

                              maximum in chloroform at ca 502 nm

                              Norbixin

                              :

                              maximum in dilute KOH solution at ca 482 nm

            (i)   Solvent extracted bixin and norbixin

                     Definition

                  Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.
                  Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.
                  Bixin and norbixin may contain other materials extracted from the annatto seed.
                  The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.
                  The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.

                  Assay

                  Content of bixin powders not less than 75 % total carotenoids calculated as bixin.
                  Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin

                              Bixin

                              :

                              E1 cm
                                 1 %2 870 at ca 502 nm in chloroform

                              Norbixin

                              :

                              E1 cm
                                 1 %2 870 at ca 482 nm in KOH solution

                  Purity

                  Solvent residues

                  Acetone
                  Methanol
                  Hexane

                  not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

            (ii)   Alkali extracted annatto

                     Definition

                  Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.)
                  Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.

                  Assay

                  Contains not less than 0,1 % of total carotenoids expressed as norbixin

                              Norbixin

                              :

                              E1 cm
                                 1 %2 870 at ca 482 nm in KOH solution

                  Purity

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

            (iii)   Oil extracted annatto

                     Definition

                  Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present.

                  Assay

                  Contains not less than 0,1 % of total carotenoids expressed as bixin

                              Bixin

                              :

                              E1 cm
                                 1 %2 870 at ca 502 nm in chloroform

                  Purity

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN

                     Synonyms

                  Paprika Oleoresin

                     Definition

                  Paprika extract is obtained by solvent extraction of the natural strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.
                  Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate and carbon dioxide.

                  Class

                  Carotenoid

                  Einecs

                  Capsanthin: 207-364-1, capsorubin: 207-425-2

                  Chemical names

                  Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-one
                  Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-carotene-6,6′-dione

                  Chemical formula

                  Capsanthin: C40H56O3

                  Capsorubin: C40H56O4

                  Molecular weight

                  Capsanthin: 584,85
                  Capsorubin: 600,85

                  Assay

                  Paprika extract: content not less than 7,0 % carotenoids
                  Capsanthin/capsorubin: not less than 30 % of total carotenoids
                  E1 cm
                     1 %2 100 at ca 462 nm in acetone

                     Description

                  Dark-red viscous liquid

                  Identification

                              A.

                              Spectrometry

                  Maximum in acetone at ca 462 nm

                              B.

                              Colour reaction

                  A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform

                  Purity

                  Solvent residues

                  Ethyl acetate
                  Methanol
                  Ethanol
                  Acetone
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Capsaicin

                  Not more than 250 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 160d LYCOPENE

                     Synonyms

                  Natural Yellow 27

                     Definition

                  Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes.

                  Class

                  Carotenoid

                  Colour Index No

                  75125

                  Chemical names

                  Lycopene, ψ,ψ-carotene

                  Chemical formula

                  C40H56

                  Molecular weight

                  536,85

                  Assay

                  Content not less than 5 % total colouring matters
                  E1 cm
                     1 %3 450 at ca 472 nm in hexane

                     Description

                  Dark red viscous liquid

                  Identification

                  Spectrometry

                  Maximum in hexane at ca 472 nm

                  Purity

                  Solvent residues

                  Ethyl acetate
                  Methanol
                  Ethanol
                  Acetone
                  Hexane
                  Propan-2-ol

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Sulfated ash

                  Not more than 0,1 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 160e BETA-APO-8′-CAROTENAL (C30)

                     Synonyms

                  CI Food Orange 6

                     Definition

                  These specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

                  Class

                  Carotinoid

                  Colour Index No

                  40820

                  Einecs

                  214-171-6

                  Chemical names

                  β-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehyde

                  Chemical formula

                  C30H40O

                  Molecular weight

                  416,65

                  Assay

                  Not less than 96 % of total colouring matters
                  E1 cm
                     1 %2 640 at ca 460-462 nm in cyclohexane

                     Description

                  Dark violet crystals with metallic lustre or crystalline powder

                  Identification

                  Spectrometry

                  Maximum in cyclohexane at 460-462 nm

                  Purity

                  Sulfated ash

                  Not more than 0,1 %

                  Subsidiary colouring matters

                  Carotenoids other than β-apo-8′-carotenal:
                  not more than 3,0 % of total colouring matters

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30)

                     Synonyms

                  CI Food Orange 7, β-apo-8′-carotenoic ester

                     Definition

                  These specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

                  Class

                  Carotenoid

                  Colour Index No

                  40825

                  Einecs

                  214-173-7

                  Chemical names

                  β-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate

                  Chemical formula

                  C32H44O2

                  Molecular weight

                  460,70

                  Assay

                  Not less than 96 % of total colouring matters
                  E1 cm
                     1 %2 550 at ca 449 nm in cyclohexane

                     Description

                  Red to violet-red crystals or crystalline powder

                  Identification

                  Spectrometry

                  Maximum in cyclohexane at ca 449 nm

                  Purity

                  Sulfated ash

                  Not more than 0,1 %

                  Subsidiary colouring matters

                  Carotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring matters

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 161b LUTEIN

                     Synonyms

                  Mixed Carotenoids, Xanthophylls

                     Definition

                  Lutein is obtained by solvent extraction of the natural strains of edible fruits and plants, grass, lucerne (alfalfa) and tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material.
                  Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone, dichloromethane and carbon dioxide

                  Class

                  Carotenoid

                  Einecs

                  204-840-0

                  Chemical names

                  3,3′-dihydroxy-d-carotene

                  Chemical formula

                  C40H56O2

                  Molecular weight

                  568,88

                  Assay

                  Content of total colouring matter not less than 4 % calculated as lutein
                  E1 cm
                     1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)

                     Description

                  Dark, yellowish brown liquid

                  Identification

                  Spectrometry

                  Maximum in chloroform/ethanol (10 + 90) at ca 445 nm

                  Purity

                  Solvent residues

                  Acetone
                  Methyl ethyl ketone
                  Methanol
                  Ethanol
                  Propan-2-ol
                  Hexane

                  Not more than 50 mg/kg, singly or in combination

                  Dichloromethane: not more than 10 mg/kg

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 161g CANTHAXANTHIN

                     Synonyms

                  CI Food Orange 8

                     Definition

                  These specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

                  Class

                  Carotinoid

                  Colour Index No

                  40850

                  Einecs

                  208-187-2

                  Chemical names

                  β-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-carotene

                  Chemical formula

                  C40H52O2

                  Molecular weight

                  564,86

                  Assay

                  Not less than 96 % of total colouring matters (expressed as canthaxanthin)

                              E1 cm
                                 1 %2 200

                              at ca 485 nm in chloroform
                              at 468-472 nm in cyclohexane
                              at 464-467 nm in petroleum ether

                     Description

                  Deep violet crystals or crystalline powder

                  Identification

                  Spectrometry

                  Maximum in chloroform at ca 485 nm
                  Maximum in cyclohexane at 468-472 nm
                  Maximum in petroleum ether at 464-467 nm

                  Purity

                  Sulfated ash

                  Not more than 0,1 %

                  Subsidiary colouring matters

                  Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 162 BEETROOT RED, BETANIN

                     Synonyms

                  Beet Red

                     Definition

                  Beet red is obtained from the roots of natural strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.
                  Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.

                  Class

                  Betalaine

                  Einecs

                  231-628-5

                  Chemical names

                  (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate

                  Chemical formula

                  Betanin: C24H26N2O13

                  Molecular weight

                  550,48

                  Assay

                  Content of red colour (expressed as betanine) is not less than 0,4 %
                  E1 cm
                     1 %1 120 at ca 535 nm in aqueous solution at pH 5

                     Description

                  Red or dark red liquid, paste, powder or solid

                  Identification

                  Spectrometry

                  Maximum in water of pH 5 at ca 535 nm

                  Purity

                  Nitrate

                  Not more than 2 g nitrate anion/g of red colour (as calculated from assay).

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 163 ANTHOCYANINS

                     Definition

                  Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material.

                  Class

                  Anthocyanin

                  Einecs

                  208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)

                  Chemical names

                  3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)
                  3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)
                  3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)
                  3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin)
                  3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)
                  3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)

                  Chemical formula

                  Cyanidin: C15H11O6Cl
                  Peonidin: C16H13O6Cl
                  Malvidin: C17H15O7Cl
                  Delphinidin: C15H11O7Cl
                  Petunidin: C16H13O7Cl
                  Pelargonidin: C15H11O5Cl

                  Molecular weight

                  Cyanidin: 322,6
                  Peonidin: 336,7
                  Malvidin: 366,7
                  Delphinidin: 340,6
                  Petunidin: 352,7
                  Pelargonidin: 306,7

                  Assay

                  E1 cm
                     1 % 300 for the pure pigment at 515-535 nm at pH 3,0

                     Description

                  Purplish-red liquid, powder or paste, having a slight characteristic odour

                  Identification

                  Spectrometry

                  Maximum in methanol with 0,01 % conc. HCl
                  Cyanidin: 535 nm
                  Peonidin: 532 nm
                  Malvidin: 542 nm
                  Delphinidin: 546 nm
                  Petunidin: 543 nm
                  Pelargonidin: 530 nm

                  Purity

                  Solvent residues

                  Methanol
                  Ethanol

                  Not more than 50 mg/kg, singly or in combination

                  Sulfur dioxide

                  Not more than 1 000 mg/kg per percent pigment

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 170 CALCIUM CARBONATE

                     Synonyms

                  CI Pigment White 18, Chalk

                     Definition

                  Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.

                  Class

                  Inorganic

                  Colour Index No

                  77220

                  Einecs

                  Calcium carbonate: 207-439-9
                  Limestone: 215-279-6

                  Chemical names

                  Calcium carbonate

                  Chemical formula

                  CaCO3

                  Molecular weight

                  100,1

                  Assay

                  Content not less than 98 % on the anhydrous basis

                     Description

                  White crystalline or amorphous, odourless and tasteless powder

                  Identification

                  Solubility

                  Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.

                  Purity

                  Loss on drying

                  Not more than 2,0 % (200 °C, 4 hours)

                  Acid-insoluble substances

                  Not more than 0,2 %

                  Magnesium and alkali salts

                  Not more than 1,5 %

                  Fluoride

                  Not more than 50 mg/kg

                  Antimony (as Sb)
                  Copper (as Cu)
                  Chromium (as Cr)
                  Zinc (as Zn)
                  Barium (as Ba)

                  Not more than 100 mg/kg, singly or in combination

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  E 171 TITANIUM DIOXIDE

                     Synonyms

                  CI Pigment White 6

                     Definition

                  Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.

                  Class

                  Inorganic

                  Colour Index No

                  77891

                  Einecs

                  236-675-5

                  Chemical names

                  Titanium dioxide

                  Chemical formula

                  TiO2

                  Molecular weight

                  79,88

                  Assay

                  Content not less than 99 % on an alumina and silica-free basis

                     Description

                  White to slightly coloured powder

                  Identification

                  Solubility

                  Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.

                  Purity

                  Loss on drying

                  Not more than 0,5 % (105 °C, 3 hours)

                  Loss on ignition

                  Not more than 1,0 % on a volatile matter free basis (800 °C)

                  Aluminium oxide and/or silicon dioxide

                  Total not more than 2,0 %

                  Matter soluble in 0,5 N HCl

                  Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.

                  Water soluble matter

                  Not more than 0,5 %

                  Cadmium

                  Not more than 1 mg/kg

                  Antimony

                  Not more than 50 mg/kg by total dissolution

                  Arsenic

                  Not more than 3 mg/kg by total dissolution

                  Lead

                  Not more than 10 mg/kg by total dissolution

                  Mercury

                  Not more than 1 mg/kg by total dissolution

                  Zink

                  Not more than 50 mg/kg by total dissolution

                  E 172 IRON OXIDES AND IRON HYDROXIDES

                     Synonyms

                              Iron Oxide Yellow

                              :

                              CI Pigment Yellow 42 and 43

                              Iron Oxide Red

                              :

                              CI Pigment Red 101 and 102

                              Iron Oxide Black

                              :

                              CI Pigment Black 11

                     Definition

                  Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.

                  Class

                  Inorganic

                  Colour Index No

                              Iron Oxide Yellow

                              :

                              77492

                              Iron Oxide Red

                              :

                              77491

                              Iron Oxide Black

                              :

                              77499

                  Einecs

                              Iron Oxide Yellow

                              :

                              257-098-5

                              Iron Oxide Red

                              :

                              215-168-2

                              Iron Oxide Black

                              :

                              235-442-5

                  Chemical names

                              Iron Oxide Yellow

                              :

                              hydrated ferric oxide, hydrated iron (III) oxide

                              Iron Oxide Red

                              :

                              anhydrous ferric oxide, anhydrous iron (III) oxide

                              Iron Oxide Black

                              :

                              ferroso ferric oxide, iron (II, III) oxide

                  Chemical formula

                              Iron Oxide Yellow

                              :

                              FeO(OH)·H2O

                              Iron Oxide Red

                              :

                              Fe2O3

                              Iron Oxide Black

                              :

                              FeO·Fe2O3

                  Molecular weight

                              88,85

                              :

                              FeO(OH)

                              159,70

                              :

                              Fe2O3

                              231,55

                              :

                              FeO·Fe2O3

                  Assay

                  Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron

                     Description

                  Powder; yellow, red, brown or black in hue

                  Identification

                  Solubility

                  Insoluble in water and in organic solvents
                  Soluble in concentrated mineral acids

                  Purity

                  Water soluble matter

                  Not more than 1,0 %

                  By total dissolution

                  Arsenic

                  Not more than 5 mg/kg

                  Barium

                  Not more than 50 mg/kg

                  Cadmium

                  Not more than 5 mg/kg

                  Chromium

                  Not more than 100 mg/kg

                  Copper

                  Not more than 50 mg/kg

                  Lead

                  Not more than 20 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Nickel

                  Not more than 200 mg/kg

                  Zinc

                  Not more than 100 mg/kg

                  E 173 ALUMINIUM

                     Synonyms

                  CI Pigment Metal, Al

                     Definition

                  Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.

                  Colour Index No

                  77000

                  Einecs

                  231-072-3

                  Chemical names

                  Aluminium

                  Chemical formula

                  Al

                  Atomic weight

                  26,98

                  Assay

                  Not less than 99 % calculated as Al on an oil-free basis

                     Description

                  A silvery-grey powder or tiny sheets

                  Identification

                  Solubility

                  Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium.

                  Purity

                  Loss on drying

                  Not more than 0,5 % (105 °C, to constant weight)

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

                  E 174 SILVER

                     Synonyms

                  Argentum, Ag

                  Class

                  Inorganic

                  Colour Index No

                  77820

                  Einecs

                  231-131-3

                  Chemical names

                  Silver

                  Chemical formula

                  Ag

                  Atomic weight

                  107,87

                  Assay

                  Content not less than 99,5 % Ag

                     Description

                  Silver-coloured powder or tiny sheets

                  E 175 GOLD

                     Synonyms

                  Pigment Metal 3, Aurum, Au

                  Class

                  Inorganic

                  Colour Index No

                  77480

                  Einecs

                  231-165-9

                  Chemical names

                  Gold

                  Chemical formula

                  Au

                  Atomic weight

                  197,0

                  Assay

                  Content not less than 90 % Au

                     Description

                  Gold-coloured powder or tiny sheets

                  Purity

                  Silver

                  Not more than 7,0 %

                  After complete dissolution

                  Copper

                  Not more than 4,0 %

                  E 180 LITHOLRUBINE BK

                     Synonyms

                  CI Pigment Red 57, Rubinpigment, Carmine 6B

                     Definition

                  Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulfate as the principal uncoloured components.

                  Class

                  Monoazo

                  Colour Index No

                  15850:1

                  Einecs

                  226-109-5

                  Chemical names

                  Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate

                  Chemical formula

                  C18H12CaN2O6S

                  Molecular weight

                  424,45

                  Assay

                  Content not less than 90 % total colouring matters
                  E1 cm
                     1 % 200 at ca 442 nm in dimethylformamide

                     Description

                  Red powder

                  Identification

                  Spectrometry

                  Maximum in dimethylformamide at ca 442 nm

                  Purity

                  Subsidiary colouring matters

                  Not more than 0,5 %

                  Organic compounds other than colouring matters:

                  2-Amino-5-methylbenzenesulfonic acid, calcium salt

                  Not more than 0,2 %

                  3-hydroxy-2-naphthalenecarboxylic acid, calcium salt

                  Not more than 0,4 %

                  Unsulfonated primary aromatic amines

                  Not more than 0,01 % (expressed as aniline)

                  Ether extractable matter

                  From a solution of pH 7, not more than 0,2 %

                  Arsenic

                  Not more than 3 mg/kg

                  Lead

                  Not more than 10 mg/kg

                  Mercury

                  Not more than 1 mg/kg

                  Cadmium

                  Not more than 1 mg/kg

                  Heavy metals (as Pb)

                  Not more than 40 mg/kg

         (1)  Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

         (2)  Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

         (3)  Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).

         (4)  Benzene not more than 0,05 % v/v.

      ANNEX II
      PART A
      Repealed Directive with list of its successive amendments
      (referred to in Article 2)

                  Commission Directive 95/45/EC

                  (OJ L 226, 22.9.1995, p. 1)

                  Commission Directive 1999/75/EC

                  (OJ L 206, 5.8.1999, p. 19)

                  Commission Directive 2001/50/EC

                  (OJ L 190, 12.7.2001, p. 14)

                  Commission Directive 2004/47/EC

                  (OJ L 113, 20.4.2004, p. 24)

                  Commission Directive 2006/33/EC

                  (OJ L 82, 21.3.2006, p. 10)

            PART B
      List of time-limits for transposition into national law
      (referred to in Article 2)

                  Directive

                  Time-limit for transposition

                  95/45/EC

                  1 July 1996 (1)

                  1999/75/EC

                  1 July 2000

                  2001/50/EC

                  29 June 2002

                  2004/47/EC

                  1 April 2005 (2)

                  2006/33/EC

                  10 April 2007

         (1)  According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted.

         (2)  According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted.

      ANNEX III
      Correlation table

                  Directive 95/45/EC

                  This Directive

                  Article 1, first paragraph

                  Article 1

                  Article 1, second paragraph

                  —

                  Article 2

                  —

                  —

                  Article 2

                  Article 3

                  Article 3

                  Article 4

                  Article 4

                  Annex

                  Annex I

                  —

                  Annex II

                  —

                  Annex III