Commission Directive 2008/60/ECof 17 June 2008laying down specific purity criteria concerning sweeteners for use in foodstuffs(Text with EEA relevance)(Codified version)

Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (Text with EEA relevance) (Codified version) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized 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, Whereas: (1) Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6). has been substantially amended several times See Annex II, Part A. . In the interest of clarity and rationality the said Directive should be codified. (2) It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs 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) It is necessary to take into account the specifications and analytical techniques for sweeteners 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 line 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 sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.

Article 2

Directive 95/31/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 twentieth 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, 17 June 2008. For the Commission The President José Manuel Barroso

Annex

ANNEX I E 420 (i) — SORBITOL SynonymsD-glucitol, D-sorbitolDefinitionChemical nameD-glucitolEinecs200-061-5Chemical formulaC6H14O6Relative molecular mass182,17Assay Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where n is an integer DescriptionWhite hygroscopic powder, crystalline powder, flakes or granules having a sweet tasteIdentification A. Solubility Very soluble in water, slightly soluble in ethanol B. Melting range 88 to 102 °C C. Sorbitol monobenzylidene derivative To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °CPurityWater contentNot more than 1 % (Karl Fischer method)Sulphated ashNot more than 0,1 % expressed on dry weight basisReducing sugarsNot more than 0,3 % expressed as glucose on dry weight basisTotal sugarsNot more than 1 % expressed as glucose on dry weight basisChloridesNot more than 50 mg/kg expressed on dry weight basisSulphatesNot more than 100 mg/kg expressed on dry weight basisNickelNot more than 2 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis E 420 (ii) — SORBITOL SYRUP SynonymsD-glucitol syrupDefinitionChemical name Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides. The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where n is an integer Einecs270-337-8AssayContent not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basisDescriptionClear colourless and sweet-tasting aqueous solutionIdentification A. Solubility Miscible with water, with glycerol, and with propane-1,2-diol B. Melting range To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °CPurityWater contentNot more than 31 % (Karl Fischer method)Sulphated ashNot more than 0,1 % expressed on dry weight basisReducing sugarsNot more than 0,3 % expressed as glucose on dry weight basisChloridesNot more than 50 mg/kg expressed on dry weight basisSulphatesNot more than 100 mg/kg expressed on dry weight basisNickelNot more than 2 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis

E 421 — MANNITOL (I) MANNITOL SynonymsD-mannitol DefinitionManufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructoseChemical nameD-mannitolEinecs200-711-8Chemical formulaC6H14O6Molecular weight182,2AssayContent not less than 96,0 % D-mannitol and not more than 102 % on the dried basisDescriptionWhite, odourless, crystalline powderIdentification A. Solubility Soluble in water, very slightly soluble in ethanol, practically insoluble in ether B. Melting range Between 164 and 169 °C C. Thin layer chromatography Passes test D. Specific rotation [α] 20D: + 23 ° to + 25 ° (borate solution) E. pH Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH PurityLoss on dryingNot more than 0,3 % (105 °C, four hours)Reducing sugarsNot more than 0,3 % (as glucose)Total sugarsNot more than 1 % (as glucose)Sulphated ashNot more than 0,1 %ChloridesNot more than 70 mg/kgSulphateNot more than 100 mg/kgNickelNot more than 2 mg/kgLeadNot more than 1 mg/kg (II) MANNITOL MANUFACTURED BY FERMENTATION SynonymsD-mannitolDefinitionManufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxiiChemical nameD-mannitol Einecs200-711-8Chemical formulaC6H14O6Molecular weight182,2AssayNot less than 99 % on the dried basisDescriptionWhite, odourless crystalline powderIdentification A. Solubility Soluble in water, very slightly soluble in ethanol, practically insoluble in ether B. Melting range Between 164 and 169 °C C. Thin layer chromatography Passes test D. Specific rotation [α] 20D: + 23 ° to + 25 ° (borate solution) E. pH Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH PurityArabitolNot more than 0,3 %Loss on dryingNot more than 0,3 % (105 °C, four hours)Reducing sugarsNot more than 0,3 % (as glucose)Total sugarsNot more than 1 % (as glucose)Sulphated ashNot more than 0,1 %ChloridesNot more than 70 mg/kgSulphateNot more than 100 mg/kgLeadNot more than 1 mg/kgAerobic mesophilic bacteriaNot more than 103/gColiformsAbsent in 10 gSalmonellaAbsent in 10 gE. ColiAbsent in 10 gStaphylococcus aureusAbsent in 10 gPseudomonas aeruginosaAbsent in 10 gMouldsNot more than 100/gYeastsNot more than 100/g E 950 — ACESULFAME K SynonymsAcesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxideDefinitionChemical name6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium saltEinecs259-715-3Chemical formulaC4H4KNO4SMolecular weight201,24AssayContent not less than 99 % of C4H4KNO4S on the anhydrous basisDescriptionOdourless, white, crystalline powder. Approximately 200 times as sweet as sucroseIdentification A. Solubility Very soluble in water, very slightly soluble in ethanol B. Ultraviolet absorption Maximum 227 ± 2 nm for a solution of 10 mg in 1000 ml of water C. Positive test for potassium

Passes test (test the residue obtained by igniting 2 g of the sample) D. Precipitation test Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is producedPurityLoss on dryingNot more than 1 % (105 °C, two hours)Organic impuritiesPasses test for 20 mg/kg of UV active componentsFluorideNot more than 3 mg/kgLeadNot more than 1 mg/kg E 951 — ASPARTAME SynonymsAspartyl phenylalanine methyl esterDefinitionChemical nameN-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl esterEinecs245-261-3Chemical formulaC14H18N2O5Relative molecular mass294,31AssayNot less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis DescriptionWhite, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucroseIdentificationSolubilitySlightly soluble in water and in ethanolPurityLoss on dryingNot more than 4,5 % (105 °C, four hours)Sulphated ashNot more than 0,2 % expressed on dry weight basispHBetween 4,5 and 6,0 (1 in 125 solution)TransmittanceThe transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022Specific rotation [α]D20: + 14,5 to + 16,5 ° Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution ArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis5-Benzyl-3,6-dioxo-2-piperazineacetic acidNot more than 1,5 % expressed on dry weight basis E 952 — CYCLAMIC ACID AND ITS Na AND Ca SALTS (I) CYCLAMIC ACID SynonymsCyclohexylsulphamic acid, cyclamateDefinitionChemical nameCyclohexanesulphamic acid, cyclohexylaminosulphonic acidEinecs202-898-1Chemical formulaC6H13NO3SRelative molecular mass179,24AssayCyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basisDescriptionA practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucroseIdentification A. Solubility Soluble in water and in ethanol B. Precipitation test Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.PurityLoss on dryingNot more than 1 % (105 °C, one hour)SeleniumNot more than 30 mg/kg expressed as selenium on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisCyclohexylamineNot more than 10 mg/kg expressed on dry weight basisDicyclohexylamineNot more than 1 mg/kg expressed on dry weight basisAnilineNot more than 1 mg/kg expressed on dry weight basis

(II) SODIUM CYCLAMATE SynonymsCyclamate, sodium salt of cyclamic acidDefinitionChemical nameSodium cyclohexanesulphamate, sodium cyclohexylsulphamateEinecs205-348-9Chemical formulaC6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2ORelative molecular mass 201,22 calculated on the anhydrous form 237,22 calculated on the hydrated form Assay Not less than 98 % and not more than 102 % on the dried basis Dihydrate form: not less than 84 % on the dried basis DescriptionWhite, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucroseIdentificationSolubilitySoluble in water, practically insoluble in ethanolPurityLoss on drying Not more than 1 % (105 °C, one hour) Not more than 15,2 % (105 °C, two hours) for the dihydrate form SeleniumNot more than 30 mg/kg expressed as selenium on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis CyclohexylamineNot more than 10 mg/kg expressed on dry weight basisDicyclohexylamineNot more than 1 mg/kg expressed on dry weight basisAnilineNot more than 1 mg/kg expressed on dry weight basis (III) CALCIUM CYCLAMATE SynonymsCyclamate, calcium salt of cyclamic acidDefinitionChemical nameCalcium cyclohexanesulphamate, calcium cyclohexylsulphamateEinecs205-349-4Chemical formulaC12H24CaN2O6S2·2H2ORelative molecular mass432,57AssayNot less than 98 % and not more than 101 % on the dried basisDescriptionWhite, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucroseIdentificationSolubilitySoluble in water, sparingly soluble in ethanolPurityLoss on drying Not more than 1 % (105 °C, one hour) Not more than 8,5 % (140 °C, four hours) for the dihydrate form SeleniumNot more than 30 mg/kg expressed as selenium on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basisCyclohexylamineNot more than 10 mg/kg expressed on dry weight basisDicyclohexylamineNot more than 1 mg/kg expressed on dry weight basisAnilineNot more than 1 mg/kg expressed on dry weight basis E 953 — ISOMALT SynonymsHydrogenated isomaltulose, hydrogenated palatinose. DefinitionChemical name Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides: 6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) Chemical formula 6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O Relative molecular mass 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,32 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32 AssayContent not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.DescriptionOdourless, white, slightly hygroscopic, crystalline mass.Identification

A. Solubility Soluble in water, very slightly soluble in ethanol. B. Thin layer chromatography Examine by thin layer chromatography using a plate coated with an approximately 0,2 mm layer of chromatographic silica gel. The principal spots in the chromatogram are those of 1,1-GPM and 1,6-GPS.PurityWater contentNot more than 7 % (Karl Fischer Method)Sulphated ashNot more than 0,05 % expressed on dry weight basisD-MannitolNot more than 3 %D-SorbitolNot more than 6 %Reducing sugarsNot more than 0,3 % expressed as glucose on dry weight basisNickelNot more than 2 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metals (as Pb)Not more than 10 mg/kg expressed on dry weight basis. E 954 — SACCHARIN AND ITS Na, K AND Ca SALTS (I) SACCHARIN DefinitionChemical name3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide Einecs201-321-0Chemical formulaC7H5NO3SRelative molecular mass183,18AssayNot less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basisDescriptionWhite 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 sucroseIdentificationSolubilitySlightly soluble in water, soluble in basic solutions, sparingly soluble in ethanolPurityLoss on dryingNot more than 1 % (105 °C, two hours)Melting range226 to 230 °CSulphated ashNot more than 0,2 % expressed on dry weight basisBenzoic and salicylic acidTo 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 appearso-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisp-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisBenzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basisReadily carbonisable substancesAbsentArsenicNot more than 3 mg/kg expressed on dry weight basisSeleniumNot more than 30 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basis (II) SODIUM SACCHARIN SynonymsSaccharin, sodium salt of saccharinDefinitionChemical nameSodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrateEinecs204-886-1Chemical formulaC7H4NNaO3S·2H2O Relative molecular mass241,19AssayNot less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basisDescriptionWhite 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 solutionsIdentificationSolubilityFreely soluble in water, sparingly soluble in ethanolPurityLoss on dryingNot more than 15 % (120 °C, four hours)Benzoic and salicylic acidTo 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 appearso-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisp-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisBenzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basisReadily carbonisable substancesAbsentArsenicNot more than 3 mg/kg expressed on dry weight basisSeleniumNot more than 30 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basis

(III) CALCIUM SACCHARIN SynonymsSaccharin, calcium salt of saccharinDefinitionChemical nameCalcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)Einecs229-349-9Chemical formulaC14H8CaN2O6S2·312H2ORelative molecular mass467,48AssayNot less than 95 % of C14H8CaN2O6S2 on the anhydrous basisDescriptionWhite 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 IdentificationSolubilityFreely soluble in water, soluble in ethanolPurityLoss on dryingNot more than 13,5 % (120 °C, four hours)Benzoic and salicylic acidTo 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 appearso-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisp-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisBenzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basisReadily carbonisable substancesAbsentArsenicNot more than 3 mg/kg expressed on dry weight basisSeleniumNot more than 30 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basis (IV) POTASSIUM SACCHARIN SynonymsSaccharin, potassium salt of saccharinDefinitionChemical namePotassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrateEinecsChemical formulaC7H4KNO3S·H2ORelative molecular mass239,77AssayNot less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basisDescriptionWhite 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 sucroseIdentificationSolubilityFreely soluble in water, sparingly soluble in ethanolPurityLoss on dryingNot more than 8 % (120 °C, four hours) Benzoic and salicylic acidTo 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 appearso-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisp-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basisBenzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basisReadily carbonisable substancesAbsentArsenicNot more than 3 mg/kg expressed on dry weight basisSeleniumNot more than 30 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basis E 955 — SUCRALOSE Synonyms4,1′,6′-TrichlorogalactosucroseDefinitionChemical name1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranosideEinecs259-952-2Chemical formulaC12H19Cl3O8Molecular weight397,64AssayContent not less than 98 % and not more than 102 % C12H19Cl3O8 calculated on an anhydrous basis.DescriptionWhite 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 1,0g of sucralose reference standard in 10 ml of methanol. D. Specific rotation [α] 20D + 84,0 ° to + 87,5 ° calculated on the anhydrous basis (10 % w/v solution) PurityWaterNot more than 2,0 % (Karl Fischer method)Sulphated ashNot more than 0,7 %Other chlorinated disaccharidesNot more than 0,5 %Chlorinated monosaccharidesNot more than 0,1 %Triphenylphosphine oxideNot more than 150 mg/kgMethanolNot more than 0,1 %LeadNot more than 1 mg/kg E 957 — THAUMATIN SynonymsDefinitionChemical nameThaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source materialEinecs258-822-2Chemical formulaPolypeptide of 207 amino acidsRelative molecular mass Thaumatin I 22209 Thaumatin II 22293 AssayNot less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8)DescriptionOdourless, cream-coloured powder with an intensely sweet taste. Approximately 2000 to 3000 times as sweet as sucroseIdentificationSolubilityVery soluble in water, insoluble in acetonePurityLoss on dryingNot more than 9 % (105 °C to constant weight)CarbohydratesNot more than 3 % expressed on dry weight basisSulphated ashNot more than 2 % expressed on dry weight basis AluminiumNot more than 100 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLead3 mg/kg expressed on dry weight basisMicrobiological criteriaTotal aerobic microbial count: Max 1000/g E. Coli: absent in 1 g E 959 — NEOHESPERIDINE DIHYDROCHALCONE SynonymsNeohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DCDefinitionChemical name2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidinEinecs243-978-6Chemical formulaC28H36O15Relative molecular mass612,6AssayContent not less than 96 % on the dried basisDescriptionOff-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1000 and 1800 times as sweet as sucroseIdentification A. Solubility Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene B. Ultraviolet absorption maximum 282 to 283 nm for a solution of 2 mg in 100 ml methanol

C. Neu's test Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is producedPurityLoss on dryingNot more than 11 % (105 °C, three hours)Sulphated ashNot more than 0,2 % expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 2 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis E 962 — SALT OF ASPARTAME-ACESULFAME SynonymsAspartame-acesulfame, Aspartame-acesulfame saltDefinitionThe 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 name6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acidChemical formulaC18H23O9N3SMolecular weight457,46Assay63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)DescriptionA white, odourless, crystalline powder.Identification A. Solubility Sparingly soluble 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] 20D + 14,5 ° to + 16,5 ° Determine at a 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 PurityLoss on dryingNot more than 0,5 % (105 °C, four hours)5-Benzyl-3,6-dioxo-2-piper-azineacetic acidNot more than 0,5 %LeadNot more than 1 mg/kg E 965 (i) — MALTITOL SynonymsD-Maltitol, hydrogenated maltoseDefinitionChemical name(α)-D-Glucopyranosyl-1,4-D-glucitolEinecs209-567-0Chemical formulaC12H24O11 Relative molecular mass344,31AssayContent not less than 98 % D-maltitol C12H24O11 on the anhydrous basisDescriptionSweet tasting, white crystalline powderIdentification 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)PurityWater contentNot more than 1 % (Karl Fischer method)Sulphated ashNot more than 0,1 % expressed on dry weight basisReducing sugarsNot more than 0,1 % expressed as glucose on dry weight basisChloridesNot more than 50 mg/kg expressed on dry weight basisSulphatesNot more than 100 mg/kg expressed on dry weight basisNickelNot more than 2 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basis E 965 (ii) — MALTITOL SYRUP SynonymsHydrogenated high-maltose-glucose syrup, hydrogenated glucose syrupDefinitionA 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.AssayContent not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basisDescriptionColourless and odourless, clear viscous liquids or white crystalline massesIdentification

A. Solubility Very soluble in water, slightly soluble in ethanol B. Thin layer chromatography Passes test PurityWaterNot more than 31 % (Karl Fischer)Reducing sugarsNot more than 0,3 % (as glucose)Sulphated ashNot more than 0,1 %ChloridesNot more than 50 mg/kgSulphateNot more than 100 mg/kgNickelNot more than 2 mg/kgLeadNot more than 1 mg/kg E 966 — LACTITOL SynonymsLactit, lactositol, lactobiositDefinitionChemical name4-O-β-D-Galactopyranosyl-D-glucitolEinecs209-566-5Chemical formulaC12H24O11Relative molecular mass344,32AssayNot less than 95 % on the dry weight basisDescriptionSweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate formsIdentification A. Solubility Very soluble in water B. Specific rotation [α]D20 = + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution)PurityWater contentCrystalline products; not more than 10,5 % (Karl Fischer method)Other polyolsNot more than 2,5 % on the anhydrous basisReducing sugarsNot more than 0,2 % expressed as glucose on dry weight basisChloridesNot more than 100 mg/kg expressed on dry weight basisSulphatesNot more than 200 mg/kg expressed on dry weight basisSulphated ashNot more than 0,1 % expressed on dry weight basis NickelNot more than 2 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basis E 967 — XYLITOL SynonymsXylitolDefinitionChemical nameD-xylitolEinecs201-788-0Chemical formulaC5H12O5Relative molecular mass152,15AssayNot less than 98,5 % as xylitol on the anhydrous basisDescriptionWhite, crystalline powder, practically odourless with a very sweet tasteIdentification A. Solubility Very soluble in water, sparingly soluble in ethanol B. Melting range 92 to 96 °C C. pH 5 to 7 (10 % w/v aqueous solution)PurityLoss on dryingNot more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hoursSulphated ashNot more than 0,1 % expressed on dry weight basisReducing sugarsNot more than 0,2 % expressed as glucose on dry weight basisOther polyhydric alcoholsNot more than 1 % expressed on dry weight basisNickelNot more than 2 mg/kg expressed on dry weight basisArsenicNot more than 3 mg/kg expressed on dry weight basisLeadNot more than 1 mg/kg expressed on dry weight basisHeavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basisChloridesNot more than 100 mg/kg expressed on dry weight basisSulphatesNot more than 200 mg/kg expressed on dry weight basis E 968 — ERYTHRITOL SynonymsMeso-erythritol, tetrahydroxybutane, erythriteDefinitionObtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Trichosporonoides megachilensis, followed by purification and dryingChemical name1,2,3,4-ButanetetrolEinecs205-737-3Chemical formulaC4H10O4Molecular weight122,12AssayNot less than 99 % after dryingDescriptionWhite, 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 °CPurityLoss on dryingNot more than 0,2 % (70 °C, six hours, in a vacuum desiccator)Sulphated ashNot more than 0,1 %Reducing substancesNot more than 0,3 % expressed as D-glucoseRibitol and glycerolNot more than 0,1 %LeadNot more than 0,5 mg/kg

Annex

ANNEX II PART A Repealed Directive with list of its successive amendments (referred to in Article 2) Commission Directive 95/31/EC(OJ L 178, 28.7.1995, p. 1)Commission Directive 98/66/EC(OJ L 257, 19.9.1998, p. 35)Commission Directive 2000/51/EC(OJ L 198, 4.8.2000, p. 41)Commission Directive 2001/52/EC(OJ L 190, 12.7.2001, p. 18)Commission Directive 2004/46/EC(OJ L 114, 21.4.2004, p. 15)Commission Directive 2006/128/EC(OJ L 346, 9.12.2006, p. 6) PART B List of time-limits for transposition into national law (referred to in Article 2) According to Article 2(2) of Directive 95/31/EC, products put on the market or labelled before 1 July 1996 which do not comply with this Directive may be marketed until stocks are exhausted. DirectiveTime-limit for transposition95/31/EC1 July 199698/66/EC1 July 19992000/51/EC30 June 20012001/52/EC30 June 20022004/46/EC1 April 20052006/128/EC15 February 2008

Annex

ANNEX III Correlation table Directive 95/31/ECThis DirectiveArticle 1(1)Article 1Article 1(2)—Article 2——Article 2Article 3Article 3Article 4Article 4AnnexAnnex I—Annex II—Annex III