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

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 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). , 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 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). 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 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). . (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

Annex

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-TOCOPHEROLSynonymsDL-α-TocopherolDefinitionChemical name DL-5,7,8-Trimethyltocol DL-2,5,7,8-Tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol Einecs233-466-0Chemical formulaC29H50O2Molecular weight430,71AssayContent not less than 96 %DescriptionSlightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or lightIdentification A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether B. Spectrophotometry In absolute ethanol the maximum absorption is about 292 nmPurityRefractive indexnD20 1,503 to 1,507Specific absorption E1 %1 cm in ethanol E1 %1 cm (292 nm) 72 to 76 (0,01 g in 200 ml of absolute ethanol) Sulphated ashNot more than 0,1 %Specific rotation[α]25D0° ± 0,05° (1 in 10 solution in chloroform)LeadNot more than 2 mg/kg
3. The text concerning E 315 erythorbic acid is replaced by the following: E 315 ERYTHORBIC ACIDSynonyms Isoascorbic acid D-Araboascorbic acid DefinitionChemical name D-Erythro-hex-2-enoic acid γ-lactone Isoascorbic acid D-Isoascorbic acid Einecs201-928-0Chemical formulaC6H8O6Molecular weight176,13AssayContent not less than 98 % on the anhydrous basisDescriptionWhite to slightly yellow crystalline solid which darkens gradually on exposure to lightIdentification A. Melting range About 164 °C to 172 °C with decomposition

B. Positive test for ascorbic acid/colour reaction PurityLoss on dryingNot more than 0,4 % after drying under reduced pressure on silica gel for 3 hoursSulphated ashNot more than 0,3 %Specific rotation[α]25D10 % (w/v) aqueous solution between – 16,5° to – 18,0°OxalateTo 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 clearLeadNot 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)SynonymsTBHQDefinitionChemical names Tert-butyl-1,4-benzenediol 2-(1,1-Dimethylethyl)-1,4-benzenediol Einecs217-752-2Chemical formulaC10H14O2Molecular weight166,22AssayContent not less than 99 % of C10H14O2DescriptionWhite crystalline solid having a characteristic odourIdentification 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 PurityTertiary-Butyl-p-benzoquinoneNot more than 0,2 %2,5-Di-tertiary-butyl hydroquinoneNot more than 0,2 %HydroxyquinoneNot more than 0,1 %TolueneNot more than 25 mg/kgLeadNot more than 2 mg/kg 5. The text concerning E 415 xanthan gum is replaced by the following: E 415 XANTHAN GUMDefinitionXanthan 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 neutralMolecular weightApproximately 1000000Einecs234-394-2AssayYields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gumDescriptionCream-coloured powderIdentification A. Solubility Soluble in water. Insoluble in ethanolPurityLoss on dryingNot more than 15 % (105 °C, 21/2hours)Total ashNot more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hoursPyruvic acidNot less than 1,5 %NitrogenNot more than 1,5 %Ethanol and propan-2-olNot more than 500 mg/kg singly or in combinationLeadNot more than 2 mg/kgTotal plate countNot more than 5000 colonies per gramYeast and mouldNot more than 300 colonies per gramE. coliAbsent in 5 gSalmonella spp.Absent in 10 gXanthomonas campestrisViable 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 HEMICELLULOSESynonymsDefinitionSoybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extractionChemical names Water soluble soybean polysaccharides

Water soluble soybean fibre AssayNot less than 74 % carbohydrateDescriptionFree flowing spray-dried white powderIdentification A. Solubility Soluble in hot and cold water without gel formationpH of 1 % solution5,5 ± 1,5 B. Viscosity of 10 % solution Not more than 200 mPa.sPurityLoss on dryingNot more than 7 % (105 °C, 4 h)ProteinNot more than 14 %Total ashNot more than 9,5 % (600 °C, 4 h)ArsenicNot more than 2 mg/kgLeadNot more than 5 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgStandard plate countNot more than 3000 colonies per gramYeast and mouldNot more than 100 colonies per gramE. ColiNegative in 10 g 7. The following text concerning E 462 ethyl cellulose is inserted after E 461 methyl cellulose: E 462 ETHYL CELLULOSESynonymsCellulose ethyl etherDefinitionEthyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groupsChemical namesEthyl ether of celluloseChemical 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 AssayContent 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)DescriptionSlightly hygroscopic, white to off white, odourless and tasteless powderIdentification 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 flammablePurityLoss on dryingNot more than 3 % (105 °C, 2 h)Sulphated ashNot more than 0,4 %pH of a 1 % colloidal solutionNeutral to litmusArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot 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 ACIDSSynonyms Citrem Citric acid esters of mono- and diglycerides Citroglycerides Mono- and diglycerides of fatty acids esterified with citric acid DefinitionEsters 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 hydroxideDescriptionYellowish or light brown liquids to waxy solids or semi-solidsIdentification

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 PurityAcids other than citric and fatty acidsNot detectableFree glycerolNot more than 2 %Total glycerolNot less than 8 % and not more than 33 %Total citric acidNot 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 % LeadNot more than 2 mg/kgFree fatty acidsNot more than 3 % estimated as oleic acidPurity 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)SynonymsKaolin, light or heavyDefinitionAluminium 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 consumptionEinecs215-286-4 (kaolinite)Chemical formulaAl2Si2O5(OH)4 (kaolinite)Molecular weight264Assay Content not less than 90 % (sum of silica and alumina, after ignition) Silica (SiO2) Between 45 % and 55 % Alumina (A12O3) Between 30 % and 39 % DescriptionFine, 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 3700 and 3620 cm–1PurityLoss on ignitionBetween 10 and 14 % (1000 °C, constant weight)Water soluble matterNot more than 0,3 %Acid soluble matterNot more than 2 %IronNot more than 5 %Potassium oxide (K2O)Not more than 5 %CarbonNot more than 0,5 %ArsenicNot more than 3 mg/kg LeadNot more than 5 mg/kgMercuryNot more than 1 mg/kg 10. The following text concerning E 586 4-hexylresorcinol is inserted after E 578 calcium gluconate: E 586 4-HEXYLRESORCINOLSynonyms 4-Hexyl-1,3-benzenediol Hexylresorcinol DefinitionChemical names4-HexylresorcinolEinecs205-257-4Chemical formulaC12H18O2Molecular weight197,24AssayNot less than 98,0 % on the dried basisDescriptionWhite powderIdentification 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 °CPurityAcidityNot more than 0,05 %Sulphated ashNot more than 0,1 %Resorcinol and other phenolsShake 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 producedNickelNot more than 2 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 3 mg/kg

1. The following text concerning E 1204 pullulan is inserted after E 1200 polydextrose: E 1204 PULLULANDefinitionLinear, 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 Einecs232-945-1Chemical formula(C6H10O5)xAssayNot less than 90 % of glucan on the dried basisDescriptionWhite to off-white odourless powderIdentification 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 solutionPurityLoss on dryingNot more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 h)Mono-, di- and oligosaccharidesNot more than 10 % expressed as glucoseViscosity100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C)LeadNot more than 1 mg/kgYeast and mouldsNot more than 100 colonies per gramColiformsAbsent in 25 gSalmonellaAbsent in 25 g
2. The following text concerning E 1452 starch aluminium octenyl succinate is inserted after E 1451 acetylated oxidised starch: E 1452 STARCH ALUMINIUM OCTENYL SUCCINATESynonymsSAOSDefinitionStarch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphateDescriptionWhite or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particlesIdentification 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 dryingNot more than 21 %Octenylsuccinyl groupsNot more than 3 %Octenylsuccinic acid residueNot 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 ArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 0,1 mg/kgAluminiumNot more than 0,3 %