title: Commission Directive 2006/129/EC of 8 December 2006 amending and correcting Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners   (Text with EEA relevance)

text:
               9.12.2006

               EN

               Official Journal of the European Union

               L 346/15

      COMMISSION DIRECTIVE 2006/129/EC
   of 8 December 2006
   amending and correcting Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners
   (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 authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   After consulting the Scientific Committee on Food and the European Food Safety Authority,
   Whereas:

               (1)

               Commission Directive 96/77/EC (2) of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners sets out the purity criteria for the additives mentioned in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (3).

               (2)

               It is appropriate to withdraw the purity criteria for E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate which are no longer permitted for use as food additives.

               (3)

               A number of language versions of Directive 96/77/EC contain errors regarding the following substances: E 307 alpha-tocopherol, E 315 erythorbic acid, E 415 xanthan gum. Those errors need to be corrected. In addition it is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In particular where appropriate, the specific purity criteria have been adapted to reflect the limits for individual heavy metals of interest. For reasons of clarity the whole text concerning those substances should be replaced.

               (4)

               The level of sulphated ash in the purity criteria for E 472c citric acid esters of mono- and diglycerides of fatty acids should be amended in order to cover partially or wholly neutralised products.

               (5)

               It is necessary to ensure that E 559 aluminium silicate is produced from raw kaolinitic clay which is free from unacceptable dioxin contamination. The presence of dioxin in the raw kaolinitic clay should therefore be restricted to the lowest possible level.

               (6)

               It is necessary to adopt specifications for the new food additives authorised through Directive 2006/52/EC of the European Parliament and of the Council of 5 July 2006 amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs: E 319 tertiary-butylhydroquinone (TBHQ), E 426 soybean hemicellulose, E 462 ethyl cellulose, E 586 4-hexylresorcinol, E 1204 pullulan and E 1452 starch aluminium octenyl succinate.

               (7)

               Directive 96/77/EC should therefore be amended and corrected accordingly.

               (8)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The Annex to Directive 96/77/EC is amended and corrected in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   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, 8 December 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 339, 30.12.1996, p. 1. Directive as last amended by Directive 2004/45/EC (OJ L 113, 20.4.2004, p. 19).

      (3)  OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, p. 10).

      ANNEX
      The Annex to Directive 96/77/EC is amended and corrected as follows:

                  1.

                  The texts concerning E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-hydroxybenzoate are deleted.

                  2.

                  The text concerning E 307 alpha-tocopherol is replaced by the following:

                              ‘E 307 ALPHA-TOCOPHEROL

                                 Synonyms

                              DL-α-Tocopherol

                              Definition

                              Chemical name

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

                              Einecs

                              233-466-0

                              Chemical formula

                              C29H50O2

                              Molecular weight

                              430,71

                              Assay

                              Content not less than 96 %

                                 Description

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

                              Identification

                                          A.

                                          Solubility tests

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

                                          B.

                                          Spectrophotometry

                              In absolute ethanol the maximum absorption is about 292 nm

                              Purity

                              Refractive index

                              nD
                                 20 1,503 to 1,507

                              Specific absorption E1 %
                                 1 cm in ethanol

                              E1 %
                                 1 cm (292 nm) 72 to 76
                              (0,01 g in 200 ml of absolute ethanol)

                              Sulphated ash

                              Not more than 0,1 %

                              Specific rotation

                              [α]25
                                 D0° ± 0,05° (1 in 10 solution in chloroform)

                              Lead

                              Not more than 2 mg/kg’

                  3.

                  The text concerning E 315 erythorbic acid is replaced by the following:

                              ‘E 315 ERYTHORBIC ACID

                                 Synonyms

                              Isoascorbic acid
                              D-Araboascorbic acid

                              Definition

                              Chemical name

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

                              Einecs

                              201-928-0

                              Chemical formula

                              C6H8O6

                              Molecular weight

                              176,13

                              Assay

                              Content not less than 98 % on the anhydrous basis

                                 Description

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

                              Identification

                                          A.

                                          Melting range

                              About 164 °C to 172 °C with decomposition

                                          B.

                                          Positive test for ascorbic acid/colour reaction

                              Purity

                              Loss on drying

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

                              Sulphated ash

                              Not more than 0,3 %

                              Specific rotation

                              [α]25
                                 D10 % (w/v) aqueous solution between – 16,5° to – 18,0°

                              Oxalate

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

                              Lead

                              Not more than 2 mg/kg’

                  4.

                  The following text concerning E 319 tertiary-butylhydroquinone (TBHQ) is inserted after E 316 sodium erythorbate:

                              ‘E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)

                                 Synonyms

                              TBHQ

                              Definition

                              Chemical names

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

                              Einecs

                              217-752-2

                              Chemical formula

                              C10H14O2

                              Molecular weight

                              166,22

                              Assay

                              Content not less than 99 % of C10H14O2

                                 Description

                              White crystalline solid having a characteristic odour

                              Identification

                                          A.

                                          Solubility

                              Practically insoluble in water; soluble in ethanol

                                          B.

                                          Melting point

                              Not less than 126,5 °C

                                          C.

                                          Phenolics

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

                              Purity

                                 Tertiary-Butyl-p-benzoquinone

                              Not more than 0,2 %

                              2,5-Di-tertiary-butyl hydroquinone

                              Not more than 0,2 %

                              Hydroxyquinone

                              Not more than 0,1 %

                              Toluene

                              Not more than 25 mg/kg

                              Lead

                              Not more than 2 mg/kg’

                  5.

                  The text concerning E 415 xanthan gum is replaced by the following:

                              ‘E 415 XANTHAN GUM

                                 Definition

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

                              Molecular weight

                              Approximately 1 000 000

                              Einecs

                              234-394-2

                              Assay

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

                                 Description

                              Cream-coloured powder

                              Identification

                                          A.

                                          Solubility

                              Soluble in water. Insoluble in ethanol

                              Purity

                              Loss on drying

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

                              Total ash

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

                              Pyruvic acid

                              Not less than 1,5 %

                              Nitrogen

                              Not more than 1,5 %

                              Ethanol and propan-2-ol

                              Not more than 500 mg/kg singly or in combination

                              Lead

                              Not more than 2 mg/kg

                              Total plate count

                              Not more than 5 000 colonies per gram

                              Yeast and mould

                              Not more than 300 colonies per gram

                                 E. coli

                              Absent in 5 g

                                 Salmonella spp.

                              Absent in 10 g

                                 Xanthomonas campestris

                              Viable cells absent in 1 g’

                  6.

                  The following text concerning E 426 soybean hemicellulose is inserted after E 425(ii) konjac glucomannan:

                              ‘E 426 SOYBEAN HEMICELLULOSE

                                 Synonyms

                                 Definition

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

                              Chemical names

                              Water soluble soybean polysaccharides
                              Water soluble soybean fibre

                              Assay

                              Not less than 74 % carbohydrate

                                 Description

                              Free flowing spray-dried white powder

                              Identification

                                          A.

                                          Solubility

                              Soluble in hot and cold water without gel formation

                              pH of 1 % solution

                              5,5 ± 1,5

                                          B.

                                          Viscosity of 10 % solution

                              Not more than 200 mPa.s

                              Purity

                              Loss on drying

                              Not more than 7 % (105 °C, 4 h)

                              Protein

                              Not more than 14 %

                              Total ash

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

                              Arsenic

                              Not more than 2 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg

                              Standard plate count

                              Not more than 3 000 colonies per gram

                              Yeast and mould

                              Not more than 100 colonies per gram

                                 E. Coli

                              Negative in 10 g’

                  7.

                  The following text concerning E 462 ethyl cellulose is inserted after E 461 methyl cellulose:

                              ‘E 462 ETHYL CELLULOSE

                                 Synonyms

                              Cellulose ethyl ether

                                 Definition

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

                              Chemical names

                              Ethyl ether of cellulose

                              Chemical formula

                              The polymers contain substituted anhydroglucose units with the following general formula:
                              C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:

                                          —

                                          H

                                          —

                                          CH2CH3

                              Assay

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

                                 Description

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

                              Identification

                                          A.

                                          Solubility

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

                                          B.

                                          Film forming test

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

                              Purity

                              Loss on drying

                              Not more than 3 % (105 °C, 2 h)

                              Sulphated ash

                              Not more than 0,4 %

                              pH of a 1 % colloidal solution

                              Neutral to litmus

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Mercury

                              Not more than 1 mg/kg

                              Cadmium

                              Not more than 1 mg/kg’

                  8.

                  The text concerning E 472c citric acid esters of mono- and diglycerides of fatty acids is replaced by the following:

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

                                 Synonyms

                              Citrem
                              Citric acid esters of mono- and diglycerides
                              Citroglycerides
                              Mono- and diglycerides of fatty acids esterified with citric acid

                                 Definition

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

                                 Description

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

                              Identification

                                          A.

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

                                          B.

                                          Solubility

                              Insoluble in cold water
                              Dispersible in hot water
                              Soluble in oils and fats
                              In soluble in cold ethanol

                              Purity

                              Acids other than citric and fatty acids

                              Not detectable

                              Free glycerol

                              Not more than 2 %

                              Total glycerol

                              Not less than 8 % and not more than 33 %

                              Total citric acid

                              Not less than 13 % and not more than 50 %

                              Sulphated ash (determined at 800 ± 25 °C)

                              Non-neutralised products: not more than 0,5 %
                              Partially or wholly neutralised products: not more than 10 %

                              Lead

                              Not more than 2 mg/kg

                              Free fatty acids

                              Not more than 3 % estimated as oleic acid

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

                  9.

                  The text concerning E 559 aluminium silicate (kaolin) is replaced by the following:

                              ‘E 559 ALUMINIUM SILICATE (KAOLIN)

                                 Synonyms

                              Kaolin, light or heavy

                                 Definition

                              Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption

                              Einecs

                              215-286-4 (kaolinite)

                              Chemical formula

                              Al2Si2O5(OH)4 (kaolinite)

                              Molecular weight

                              264

                              Assay

                              Content not less than 90 % (sum of silica and alumina, after ignition)
                              Silica (SiO2) Between 45 % and 55 %
                              Alumina (A12O3) Between 30 % and 39 %

                                 Description

                              Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes.

                              Identification

                                          A.

                                          Positive test for alumina and for silicate

                                          B.

                                          X-ray diffraction

                              Characteristic peaks at 7,18/3,58/2,38/1,78 Å

                                          C.

                                          IR absorption

                              Peaks at 3 700 and 3 620 cm–1

                              Purity

                              Loss on ignition

                              Between 10 and 14 % (1 000 °C, constant weight)

                              Water soluble matter

                              Not more than 0,3 %

                              Acid soluble matter

                              Not more than 2 %

                              Iron

                              Not more than 5 %

                              Potassium oxide (K2O)

                              Not more than 5 %

                              Carbon

                              Not more than 0,5 %

                              Arsenic

                              Not more than 3 mg/kg

                              Lead

                              Not more than 5 mg/kg

                              Mercury

                              Not more than 1 mg/kg’

                  10.

                  The following text concerning E 586 4-hexylresorcinol is inserted after E 578 calcium gluconate:

                              ‘E 586 4-HEXYLRESORCINOL

                                 Synonyms

                              4-Hexyl-1,3-benzenediol
                              Hexylresorcinol

                              Definition

                              Chemical names

                              4-Hexylresorcinol

                              Einecs

                              205-257-4

                              Chemical formula

                              C12H18O2

                              Molecular weight

                              197,24

                              Assay

                              Not less than 98,0 % on the dried basis

                                 Description

                              White powder

                              Identification

                                          A.

                                          Solubility

                              Freely soluble in ether and acetone; very slightly soluble in water

                                          B.

                                          Nitric acid test

                              To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears

                                          C.

                                          Bromine test

                              To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution

                                          D.

                                          Melting range

                              62 to 67 °C

                              Purity

                              Acidity

                              Not more than 0,05 %

                              Sulphated ash

                              Not more than 0,1 %

                              Resorcinol and other phenols

                              Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced

                              Nickel

                              Not more than 2 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Mercury

                              Not more than 3 mg/kg’

                  11.

                  The following text concerning E 1204 pullulan is inserted after E 1200 polydextrose:

                              ‘E 1204 PULLULAN

                                 Definition

                              Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food grade hydrolysed starch using a non-toxin producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography

                              Einecs

                              232-945-1

                              Chemical formula

                              (C6H10O5)x

                              Assay

                              Not less than 90 % of glucan on the dried basis

                                 Description

                              White to off-white odourless powder

                              Identification

                                          A.

                                          Solubility

                              Soluble in water, practically insoluble in ethanol.

                                          B.

                                          pH of 10 % solution

                              5,0 to 7,0

                                          C.

                                          Precipitation with polyethylene glycol 600

                              Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed

                                          D.

                                          Depolymerisation with pullulanase

                              Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 °C for 20 min, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution

                              Purity

                              Loss on drying

                              Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 h)

                              Mono-, di- and oligosaccharides

                              Not more than 10 % expressed as glucose

                              Viscosity

                              100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C)

                              Lead

                              Not more than 1 mg/kg

                              Yeast and moulds

                              Not more than 100 colonies per gram

                              Coliforms

                              Absent in 25 g

                              Salmonella

                              Absent in 25 g’

                  12.

                  The following text concerning E 1452 starch aluminium octenyl succinate is inserted after E 1451 acetylated oxidised starch:

                              ‘E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE

                                 Synonyms

                              SAOS

                                 Definition

                              Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate

                                 Description

                              White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

                              Identification

                                          A.

                                          If not pregelatinised: by miscroscopic observation

                                          B.

                                          Iodine staining positive (dark blue to light red colour)

                              Purity

                              (all values expressed on an anhydrous basis except for loss on drying)

                              Loss on drying

                              Not more than 21 %

                              Octenylsuccinyl groups

                              Not more than 3 %

                              Octenylsuccinic acid residue

                              Not more than 0,3 %

                              Sulphur dioxide

                              Not more than 50 mg/kg for modified cereal starches
                              Not more than 10 mg/kg for the other modified starches unless otherwise specified

                              Arsenic

                              Not more than 1 mg/kg

                              Lead

                              Not more than 2 mg/kg

                              Mercury

                              Not more than 0,1 mg/kg

                              Aluminium

                              Not more than 0,3 %’


Avis juridique important

|

31973L0264

First Commission Directive 73/264/EEC of 27 July 1973 modifying the Annexes to the Council Directive of 23 November 1970 on additives in feedingstuffs

Official Journal L 253 , 10/09/1973 P. 0012 - 0014 Greek special edition: Chapter 03 Volume 10 P. 0010

+++++( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 124 , 10 . 5 . 1973 , P . 17 .  FIRST COMMISSION DIRECTIVE OF 27 JULY 1973 MODIFYING THE ANNEXES TO THE COUNCIL DIRECTIVE OF 23 NOVEMBER 1970 ON ADDITIVES IN FEEDINGSTUFFS ( 73/264/EEC )  THE COMMISSION OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ;  HAVING REGARD TO THE COUNCIL DIRECTIVE OF 23 NOVEMBER 1970 ( 1 ) ON ADDITIVES IN FEEDINGSTUFFS , AS LAST AMENDED BY THE DIRECTIVE OF 28 APRIL 1973 ( 2 ) , AND IN PARTICULAR ARTICLE 6 PARAGRAPH 1 ( A ) ;  WHEREAS THE PROVISIONS OF THE ABOVEMENTIONED DIRECTIVE PROVIDE THAT THE CONTENT OF THE ANNEXES MUST BE CONSTANTLY AMENDED DUE TO THE DEVELOPMENT OF SCIENTIFIC AND TECHNICAL KNOWLEDGE ;  WHEREAS IT IS APPARENT THAT TETRACYCLINE , CHLORTETRACYCLINE AND OXYTETRACYCLINE LISTED IN ANNEX I DO NOT CORRESPOND AT THE PRESENT TIME TO CERTAIN ASPECTS OF THE REQUIREMENTS OF ANIMAL NUTRITION ; WHEREAS IT IS NOW CONVENIENT TO PLACE THEM IN ANNEX II , UNDER CERTAIN CONDITIONS OF USE ;  WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ;  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  THE ANNEXES TO THE COUNCIL DIRECTIVE OF 23 NOVEMBER 1970 , ON ADDITIVES IN FEEDINGSTUFFS , SHALL BE AMENDED AS STIPULATED IN THE FOLLOWING ARTICLES .  ARTICLE 2  IN ANNEX I PART A " ANTIBIOTICS " , THE ADDITIVES NUMBERED EEC E 701 , E 702 AND E 703 AND ALL RELEVANT REFERENCES SHALL BE DELETED .  ARTICLE 3  ANNEX II SHALL BE AMENDED AS FOLLOWS :  1 . FOUR COLUMNS SHALL BE ADDED TO THE EXISTING TABLE ; THE COLUMNS SHALL BE HEADED AS FOLLOWS : ( SEE OJ NO L 253 OF 10 . 9 . 1973 ) .  2 . THE FOLLOWING PROVISIONS SHALL BE ADDED TO PART A " ANTIBIOTICS " : ( SEE OJ )  ARTICLE 4  THE MEMBER STATES SHALL , NOT LATER THAN 1 JANUARY 1974 , BRING INTO FORCE THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE . THEY SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  ARTICLE 5  THIS DIRECTIVE IS ADDRESSED TO ALL MEMBER STATES .  DONE AT BRUSSELS , 27 JULY 1973 .  FOR THE COMMISSION  THE PRESIDENT  FRANCOIS-XAVIER ORTOLI


title: Commission Directive 2006/128/EC of 8 December 2006 amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs   (Text with EEA relevance)

text:
               9.12.2006

               EN

               Official Journal of the European Union

               L 346/6

      COMMISSION DIRECTIVE 2006/128/EC
   of 8 December 2006
   amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs
   (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 authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   After consulting the Scientific Committee on Food and the European Food Safety Authority (EFSA),
   Whereas:

               (1)

               Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (2), lists those substances which may be used as sweeteners in foodstuffs.

               (2)

               Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (3), sets out the purity criteria for the sweeteners listed in Directive 94/35/EC.

               (3)

               It is necessary to adopt specific criteria for E 968 erythritol, a new food additive authorised by Directive 2006/52/EC of the European Parliament and of the Council of 5 July 2006 amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs.

               (4)

               A number of language versions of Directive 95/31/EC contain some errors regarding the following substances: E 954 saccharin and its Na, K and Ca salts, E 955 sucralose, E 962 salt of aspartame-acesulfame, E 965 (i) maltitol, E 966 lactitol. Those errors need to be corrected. In addition it is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In particular where appropriate, the specific purity criteria have been adapted to reflect the limits for individual heavy metals of interest. For reasons of clarity the whole text concerning those substances should be replaced.

               (5)

               EFSA in its scientific opinion of 19 April 2006 concluded that the composition of maltitol syrup based on a new production method will be similar to that of the existing product and will be in accordance with the existing specification. It is therefore necessary to amend the definition of E 965 (ii) maltitol syrup set out in Directive 95/31/EC for E 965 by including that new production method.

               (6)

               Directive 95/31/EC should therefore be amended and corrected accordingly.

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The Annex to Directive 95/31/EC is amended and corrected in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 8 December 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, p. 10).

      (3)  OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2004/46/EC (OJ L 114, 21.4.2004, p. 15).

      ANNEX
      The Annex to Directive 95/31/EC is amended and corrected as follows:

                  1.

                  The following text concerning E 968 erythritol is inserted after E 967 xylitol:

                              ‘E 968 ERYTHRITOL

                                 Synonyms

                              Meso-erythritol, tetrahydroxybutane, erythrite

                                 Definition

                              Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachilensis, followed by purification and drying

                              Chemical name

                              1,2,3,4-Butanetetrol

                              Einecs

                              205-737-3

                              Chemical formula

                              C4H10O4

                              Molecular weight

                              122,12

                              Assay

                              Not less than 99 % after drying

                                 Description

                              White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.

                              Identification

                                          A.

                                          Solubility

                              Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.

                                          B.

                                          Melting range

                              119-123 °C

                              Purity

                              Loss on drying

                              Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)

                              Sulphated ash

                              Not more than 0,1 %

                              Reducing substances

                              Not more than 0,3 % expressed as D-glucose

                              Ribitol and glycerol

                              Not more than 0,1 %

                              Lead

                              Not more than 0,5 mg/kg’

                  2.

                  The text concerning E 954 saccharin and its Na, K and Ca salts is replaced by the following:

                              ‘E 954 SACCHARIN AND ITS Na, K AND Ca SALTS

                        (I)   SACCHARIN

                              Definition

                              Chemical name

                              3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide

                              Einecs

                              201-321-0

                              Chemical formula

                              C7H5NO3S

                              Relative molecular mass

                              183,18

                              Assay

                              Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis

                                 Description

                              White crystals or a white crystalline powder, odourless or with a faint, aromatic odour, having a sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose

                              Identification

                              Solubility

                              Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol

                              Purity

                              Loss on drying

                              Not more than 1 % (105 °C, two hours)

                              Melting range

                              226-230 °C

                              Sulphated ash

                              Not more than 0,2 % expressed on dry weight basis

                              Benzoic and salicylic acid

                              To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                              o-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              p-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              Benzoic acid p-sulfonamide

                              Not more than 25 mg/kg expressed on dry weight basis

                              Readily carbonisable substances

                              Absent

                              Arsenic

                              Not more than 3 mg/kg expressed on dry weight basis

                              Selenium

                              Not more than 30 mg/kg expressed on dry weight basis

                              Lead

                              Not more than 1 mg/kg expressed on dry weight basis.

                        (II)   SODIUM SACCHARIN

                                 Synonyms

                              Saccharin, sodium salt of saccharin

                              Definition

                              Chemical name

                              Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide sodium salt dihydrate

                              Einecs

                              204-886-1

                              Chemical formula

                              C7H4NNaO3S·2H2O

                              Relative molecular mass

                              241,19

                              Assay

                              Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis

                                 Description

                              White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions

                              Identification

                              Solubility

                              Freely soluble in water, sparingly soluble in ethanol

                              Purity

                              Loss on drying

                              Not more than 15 % (120 °C, four hours)

                              Benzoic and salicylic acid

                              To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                              o-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              p-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              Benzoic acid p-sulphonamide

                              Not more than 25 mg/kg expressed on dry weight basis

                              Readily carbonisable substances

                              Absent

                              Arsenic

                              Not more than 3 mg/kg expressed on dry weight basis

                              Selenium

                              Not more than 30 mg/kg expressed on dry weight basis

                              Lead

                              Not more than 1 mg/kg expressed on dry weight basis

                        (III)   CALCIUM SACCHARIN

                                 Synonyms

                              Saccharin, calcium salt of saccharin

                              Definition

                              Chemical name

                              Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulfonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)

                              Einecs

                              229-349-9

                              Chemical formula

                              C14H8CaN2O6S2·31/2H2O

                              Relative molecular mass

                              467,48

                              Assay

                              Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis

                                 Description

                              White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions

                              Identification

                              Solubility

                              Freely soluble in water, soluble in ethanol

                              Purity

                              Loss on drying

                              Not more than 13,5 % (120 °C, four hours)

                              Benzoic and salicylic acid

                              To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                              o-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              p-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              Benzoic acid p-sulphonamide

                              Not more than 25 mg/kg expressed on dry weight basis

                              Readily carbonisable substances

                              Absent

                              Arsenic

                              Not more than 3 mg/kg expressed on dry weight basis

                              Selenium

                              Not more than 30 mg/kg expressed on dry weight basis

                              Lead

                              Not more than 1 mg/kg expressed on dry weight basis

                        (IV)   POTASSIUM SACCHARIN

                                 Synonyms

                              Saccharin, potassium salt of saccharin

                              Definition

                              Chemical name

                              Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate

                              Einecs

                              Chemical formula

                              C7H4KNO3S·H2O

                              Relative molecular mass

                              239,77

                              Assay

                              Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis

                                 Description

                              White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose

                              Identification

                              Solubility

                              Freely soluble in water, sparingly soluble in ethanol

                              Purity

                              Loss on drying

                              Not more than 8 % (120 °C, four hours)

                              Benzoic and salicylic acid

                              To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

                              o-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              p-Toluenesulphonamide

                              Not more than 10 mg/kg expressed on dry weight basis

                              Benzoic acid p-sulphonamide

                              Not more than 25 mg/kg expressed on dry weight basis

                              Readily carbonisable substances

                              Absent

                              Arsenic

                              Not more than 3 mg/kg expressed on dry weight basis

                              Selenium

                              Not more than 30 mg/kg expressed on dry weight basis

                              Lead

                              Not more than 1 mg/kg expressed on dry weight basis’

                  3.

                  The text concerning E 955 sucralose is replaced by the following:

                              ‘E 955 SUCRALOSE

                                 Synonyms

                              4,1′,6′-Trichlorogalactosucrose

                              Definition

                              Chemical name

                              1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside

                              Einecs

                              259-952-2

                              Chemical formula

                              C12H19Cl3O8

                              Molecular weight

                              397,64

                              Assay

                              Content not less than 98 % and not more than 102 % of C12H19Cl3O8 calculated on an anhydrous basis.

                                 Description

                              White to off-white, practically odourless crystalline powder.

                              Identification

                                          A.

                                          Solubility

                              Freely soluble in water, methanol and ethanol
                              Slightly soluble in ethyl acetate

                                          B.

                                          Infrared absorption

                              The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard

                                          C.

                                          Thin layer chromatography

                              The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0 g of sucralose reference standard in 10 ml of methanol

                                          D.

                                          Specific rotation

                              [α]D20
                                  = + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution)

                              Purity

                              Water

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

                              Sulphated ash

                              Not more than 0,7 %

                              Other chlorinated disaccharides

                              Not more than 0,5 %

                              Chlorinated monosaccharides

                              Not more than 0,1 %

                              Triphenylphosphine oxide

                              Not more than 150 mg/kg

                              Methanol

                              Not more than 0,1 %

                              Lead

                              Not more than 1 mg/kg’

                  4.

                  The text concerning E 962 salt of aspartame-acesulfame is replaced by the following:

                              ‘E 962 SALT OF ASPARTAME-ACESULFAME

                                 Synonyms

                              Aspartame-acesulfame, aspartame-acesulfame salt

                                 Definition

                              The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone

                              Chemical name

                              6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid

                              Chemical formula

                              C18H23O9N3S

                              Molecular weight

                              457,46

                              Assay

                              63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37 % acesulfame (acid form on a dry basis)

                                 Description

                              A white, odourless, crystalline powder

                              Identification

                                          A.

                                          Solubility

                              Sparingly soluble in water, slightly soluble in ethanol

                                          B.

                                          Transmittance

                              The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022

                                          C.

                                          Specific rotation

                              [α]D20
                                  = + 14,5° to + 16,5°
                              Determine at concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame

                              Purity

                              Loss on drying

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

                              5-Benzyl-3,6-dioxo-2-piperazineacetic acid

                              Not more than 0,5 %

                              Lead

                              Not more than 1 mg/kg’

                  5.

                  The text concerning E 965 (i) maltitol is replaced by the following:

                              ‘E 965 (i) MALTITOL

                                 Synonyms

                              D-Maltitol, hydrogenated maltose

                              Definition

                              Chemical name

                              (α)-D-Glucopyranosyl-1,4-D-glucitol

                              Einecs

                              209-567-0

                              Chemical formula

                              C12H24O11

                              Relative molecular mass

                              344,31

                              Assay

                              Content not less than 98 % of D-maltitol
                              C12H24O11 on the anhydrous basis

                                 Description

                              Sweet tasting, white crystalline powder

                              Identification

                                          A.

                                          Solubility

                              Very soluble in water, slightly soluble in ethanol

                                          B.

                                          Melting range

                              148 to 151 °C

                                          C.

                                          Specific rotation

                              [α]D20
                                  = + 105,5° to + 108,5° (5 % w/v solution)

                              Purity

                              Water

                              Not more than 1 % (Karl Fischer method)

                              Sulphated ash

                              Not more than 0,1 % expressed on dry weight basis

                              Reducing sugars

                              Not more than 0,1 % expressed as glucose on dry weight basis

                              Chlorides

                              Not more than 50 mg/kg expressed on dry weight basis

                              Sulphates

                              Not more than 100 mg/kg expressed on dry weight basis

                              Nickel

                              Not more than 2 mg/kg expressed on dry weight basis

                              Arsenic

                              Not more than 3 mg/kg expressed on dry weight basis

                              Lead

                              Not more than 1 mg/kg expressed on dry weight basis’

                  6.

                  The text concerning E 965 (ii) maltitol syrup is replaced by the following:

                              ‘E 965 (ii) MALTITOL SYRUP

                                 Synonyms

                              Hydrogenated high-maltose glucose syrup, hydrogenated glucose syrup

                                 Definition

                              A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product

                              Assay

                              Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis

                                 Description

                              Colourless and odourless, clear viscous liquids or white crystalline masses

                              Identification

                                          A.

                                          Solubility

                              Very soluble in water, slightly soluble in ethanol

                                          B.

                                          Thin layer chromatography

                              Passes test

                              Purity

                              Water

                              Not more than 31 % (Karl Fischer)

                              Reducing sugars

                              Not more than 0,3 % (as glucose)

                              Sulphated ash

                              Not more than 0,1 %

                              Chlorides

                              Not more than 50 mg/kg

                              Sulphate

                              Not more than 100 mg/kg

                              Nickel

                              Not more than 2 mg/kg

                              Lead

                              Not more than 1 mg/kg’

                  7.

                  The text concerning E 966 lactitol is replaced by the following:

                              ‘E 966 LACTITOL

                                 Synonyms

                              Lactit, lactositol, lactobiosit

                              Definition

                              Chemical name

                              4-O-β-D-Galactopyranosyl-D-glucitol

                              Einecs

                              209-566-5

                              Chemical formula

                              C12H24O11

                              Relative molecular mass

                              344,32

                              Assay

                              Not less than 95 % on the dry weight basis

                                 Description

                              Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms

                              Identification

                                          A.

                                          Solubility

                              Very soluble in water

                                          B.

                                          Specific rotation

                              [α]D20
                                  = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution)

                              Purity

                              Water

                              Crystalline products; not more than 10,5 % (Karl Fischer method)

                              Other polyols

                              Not more than 2,5 % on the anhydrous basis

                              Reducing sugars

                              Not more than 0,2 % expressed as glucose on dry weight basis

                              Chlorides

                              Not more than 100 mg/kg expressed on dry weight basis

                              Sulphates

                              Not more than 200 mg/kg expressed on dry weight basis

                              Sulphated ash

                              Not more than 0,1 % expressed on dry weight basis

                              Nickel

                              Not more than 2 mg/kg expressed on dry weight basis

                              Arsenic

                              Not more than 3 mg/kg expressed on dry weight basis

                              Lead

                              Not more than 1 mg/kg expressed on dry weight basis’