Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof,

18.6.2008 | EN | Official Journal of the European Union | L 158/17 ---|---|---|--- * * * 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 (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 (2) has been substantially amended several times (3). 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 (4). ---|--- (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 * * * (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 178, 28.7.1995, p. 1. Directive as last amended by Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6). (3) See Annex II, Part A. (4) 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). * * * ANNEX I E 420 (i) — SORBITOL --- Synonyms | D-glucitol, D-sorbitol Definition Chemical name | D-glucitol Einecs | 200-061-5 Chemical formula | C6H14O6 Relative molecular mass | 182,17 Assay | 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 Description | White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste Identification | 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 °C Purity Water content | Not more than 1 % (Karl Fischer method) Sulphated ash | Not more than 0,1 % expressed on dry weight basis Reducing sugars | Not more than 0,3 % expressed as glucose on dry weight basis Total sugars | Not more than 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 Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis E 420 (ii) — SORBITOL SYRUP Synonyms | D-glucitol syrup Definition Chemical 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 Einecs | 270-337-8 Assay | Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis Description | Clear colourless and sweet-tasting aqueous solution Identification | 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 °C Purity Water content | Not more than 31 % (Karl Fischer method) Sulphated ash | Not more than 0,1 % expressed on dry weight basis Reducing sugars | Not more than 0,3 % 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 Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis E 421 — MANNITOL (I) MANNITOL Synonyms | D-mannitol Definition | Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose Chemical name | D-mannitol Einecs | 200-711-8 Chemical formula | C6H14O6 Molecular weight | 182,2 Assay | Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis Description | White, odourless, crystalline powder Identification | 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] 20 D: + 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 Purity Loss on drying | Not more than 0,3 % (105 °C, four hours) Reducing sugars | Not more than 0,3 % (as glucose) Total sugars | Not more than 1 % (as glucose) Sulphated ash | Not more than 0,1 % Chlorides | Not more than 70 mg/kg Sulphate | Not more than 100 mg/kg Nickel | Not more than 2 mg/kg Lead | Not more than 1 mg/kg (II) MANNITOL MANUFACTURED BY FERMENTATION Synonyms | D-mannitol Definition | Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii Chemical name | D-mannitol Einecs | 200-711-8 Chemical formula | C6H14O6 Molecular weight | 182,2 Assay | Not less than 99 % on the dried basis Description | White, odourless crystalline powder Identification | 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] 20 D: + 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 Purity Arabitol | Not more than 0,3 % Loss on drying | Not more than 0,3 % (105 °C, four hours) Reducing sugars | Not more than 0,3 % (as glucose) Total sugars | Not more than 1 % (as glucose) Sulphated ash | Not more than 0,1 % Chlorides | Not more than 70 mg/kg Sulphate | Not more than 100 mg/kg Lead | Not more than 1 mg/kg Aerobic mesophilic bacteria | Not more than 103/g Coliforms | Absent in 10 g Salmonella | Absent in 10 g E. Coli | Absent in 10 g Staphylococcus aureus | Absent in 10 g Pseudomonas aeruginosa | Absent in 10 g Moulds | Not more than 100/g Yeasts | Not more than 100/g E 950 — ACESULFAME K Synonyms | Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxide Definition Chemical name | 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt Einecs | 259-715-3 Chemical formula | C4H4KNO4S Molecular weight | 201,24 Assay | Content not less than 99 % of C4H4KNO4S on the anhydrous basis Description | Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose Identification | 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 1 000 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 produced Purity Loss on drying | Not more than 1 % (105 °C, two hours) Organic impurities | Passes test for 20 mg/kg of UV active components Fluoride | Not more than 3 mg/kg Lead | Not more than 1 mg/kg E 951 — ASPARTAME Synonyms | Aspartyl phenylalanine methyl ester Definition Chemical name | N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester Einecs | 245-261-3 Chemical formula | C14H18N2O5 Relative molecular mass | 294,31 Assay | Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis Description | White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose Identification Solubility | Slightly soluble in water and in ethanol Purity Loss on drying | Not more than 4,5 % (105 °C, four hours) Sulphated ash | Not more than 0,2 % expressed on dry weight basis pH | Between 4,5 and 6,0 (1 in 125 solution) Transmittance | The 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 0,022 Specific rotation | [α]D 20: + 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 Arsenic | Not more than 3 mg/kg expressed on dry weight basis Lead | Not more than 1 mg/kg expressed on dry weight basis Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis 5-Benzyl-3,6-dioxo-2-piperazineacetic acid | Not more than 1,5 % expressed on dry weight basis E 952 — CYCLAMIC ACID AND ITS Na AND Ca SALTS (I) CYCLAMIC ACID Synonyms | Cyclohexylsulphamic acid, cyclamate Definition Chemical name | Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid Einecs | 202-898-1 Chemical formula | C6H13NO3S Relative molecular mass | 179,24 Assay | Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis Description | A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose Identification | 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. Purity Loss on drying | Not more than 1 % (105 °C, one hour) Selenium | Not more than 30 mg/kg expressed as selenium on dry weight basis Lead | Not more than 1 mg/kg expressed on dry weight basis Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis Arsenic | Not more than 3 mg/kg expressed on dry weight basis Cyclohexylamine | Not more than 10 mg/kg expressed on dry weight basis Dicyclohexylamine | Not more than 1 mg/kg expressed on dry weight basis Aniline | Not more than 1 mg/kg expressed on dry weight basis (II) SODIUM CYCLAMATE Synonyms | Cyclamate, sodium salt of cyclamic acid Definition Chemical name | Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate Einecs | 205-348-9 Chemical formula | C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O Relative 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 Description | White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose Identification Solubility | Soluble in water, practically insoluble in ethanol Purity Loss on drying | Not more than 1 % (105 °C, one hour) Not more than 15,2 % (105 °C, two hours) for the dihydrate form Selenium | Not more than 30 mg/kg expressed as selenium 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 Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis Cyclohexylamine | Not more than 10 mg/kg expressed on dry weight basis Dicyclohexylamine | Not more than 1 mg/kg expressed on dry weight basis Aniline | Not more than 1 mg/kg expressed on dry weight basis (III) CALCIUM CYCLAMATE Synonyms | Cyclamate, calcium salt of cyclamic acid Definition Chemical name | Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate Einecs | 205-349-4 Chemical formula | C12H24CaN2O6S2·2H2O Relative molecular mass | 432,57 Assay | Not less than 98 % and not more than 101 % on the dried basis Description | White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose Identification Solubility | Soluble in water, sparingly soluble in ethanol Purity Loss on drying | Not more than 1 % (105 °C, one hour) Not more than 8,5 % (140 °C, four hours) for the dihydrate form Selenium | Not more than 30 mg/kg expressed as selenium 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 Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis Cyclohexylamine | Not more than 10 mg/kg expressed on dry weight basis Dicyclohexylamine | Not more than 1 mg/kg expressed on dry weight basis Aniline | Not more than 1 mg/kg expressed on dry weight basis E 953 — ISOMALT Synonyms | Hydrogenated isomaltulose, hydrogenated palatinose. Definition Chemical 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 Assay | Content 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. Description | Odourless, 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. Purity Water content | Not more than 7 % (Karl Fischer Method) Sulphated ash | Not more than 0,05 % expressed on dry weight basis D-Mannitol | Not more than 3 % D-Sorbitol | Not more than 6 % Reducing sugars | Not more than 0,3 % expressed as glucose 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 Heavy 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 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 to 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-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 (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-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7) Einecs | 229-349-9 Chemical formula | C14H8CaN2O6S2·3 H2O 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 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 % 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 1,0g of sucralose reference standard in 10 ml of methanol. | D. | Specific rotation ---|--- [α] 20 D \+ 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 E 957 — THAUMATIN Synonyms | Definition Chemical name | Thaumatin 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 material Einecs | 258-822-2 Chemical formula | Polypeptide of 207 amino acids Relative molecular mass | Thaumatin I 22209 Thaumatin II 22293 Assay | Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8) Description | Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose Identification Solubility | Very soluble in water, insoluble in acetone Purity Loss on drying | Not more than 9 % (105 °C to constant weight) Carbohydrates | Not more than 3 % expressed on dry weight basis Sulphated ash | Not more than 2 % expressed on dry weight basis Aluminium | Not more than 100 mg/kg expressed on dry weight basis Arsenic | Not more than 3 mg/kg expressed on dry weight basis Lead | 3 mg/kg expressed on dry weight basis Microbiological criteria | Total aerobic microbial count: Max 1 000 /g E. Coli: absent in 1 g E 959 — NEOHESPERIDINE DIHYDROCHALCONE Synonyms | Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC Definition Chemical name | 2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin Einecs | 243-978-6 Chemical formula | C28H36O15 Relative molecular mass | 612,6 Assay | Content not less than 96 % on the dried basis Description | Off-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose Identification | 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 produced Purity Loss on drying | Not more than 11 % (105 °C, three hours) Sulphated ash | Not more than 0,2 % expressed on dry weight basis Arsenic | Not more than 3 mg/kg expressed on dry weight basis Lead | Not more than 2 mg/kg expressed on dry weight basis Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis 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 37,0 % acesulfame (acid form on a dry basis) Description | A 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] 20 D \+ 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 Purity Loss on drying | Not more than 0,5 % (105 °C, four hours) 5-Benzyl-3,6-dioxo-2-piper-azineacetic acid | Not more than 0,5 % Lead | Not more than 1 mg/kg 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 % 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]D 20 = + 105,5 ° to + 108,5 ° (5 % w/v solution) Purity Water content | 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 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 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]D 20 = + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution) Purity Water content | 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 E 967 — XYLITOL Synonyms | Xylitol Definition Chemical name | D-xylitol Einecs | 201-788-0 Chemical formula | C5H12O5 Relative molecular mass | 152,15 Assay | Not less than 98,5 % as xylitol on the anhydrous basis Description | White, crystalline powder, practically odourless with a very sweet taste Identification | 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) Purity Loss on drying | Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours Sulphated ash | Not more than 0,1 % expressed on dry weight basis Reducing sugars | Not more than 0,2 % expressed as glucose on dry weight basis Other polyhydric alcohols | Not more than 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 Heavy metals | Not more than 10 mg/kg expressed as Pb 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 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 * * * 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) Directive | Time-limit for transposition ---|--- 95/31/EC | 1 July 1996 (1) 98/66/EC | 1 July 1999 2000/51/EC | 30 June 2001 2001/52/EC | 30 June 2002 2004/46/EC | 1 April 2005 2006/128/EC | 15 February 2008 * * * (1) 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. * * * ANNEX III Correlation table Directive 95/31/EC | This Directive ---|--- Article 1(1) | Article 1 Article 1(2) | — Article 2 | — — | Article 2 Article 3 | Article 3 Article 4 | Article 4 Annex | Annex I — | Annex II — | Annex III * * *