
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Directive 95/31/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex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References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.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 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] 20D: + 23 ° to + 25 ° (borate solution)

E. pH
 Between 5 and 8Add 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] 20D: + 23 ° to + 25 ° (borate solution)

E. pH
 Between 5 and 8Add 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]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
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 form237,22 calculated on the hydrated form
Assay Not less than 98 % and not more than 102 % on the dried basisDihydrate 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: C12H24O111-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O
Relative molecular mass 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,321-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 C14H8CaN2O6S2·312H2O
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 ethanolSlightly 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)
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 22209Thaumatin 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] 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
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]D20 = + 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]D20 = + 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

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

Directive Time-limit for transposition
95/31/EC 1 July 1996
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


ANNEX III
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