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Commission Directive 2008/60/EC (repealed)Show full title

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down specific purity criteria concerning sweeteners for use in foodstuffs (Text with EEA relevance) (Codified version) (repealed)

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ANNEX I

E 420 (i) — SORBITOL
SynonymsD-glucitol, D-sorbitol
Definition
Chemical nameD-glucitol
Einecs200-061-5
Chemical formulaC6H14O6
Relative molecular mass182,17
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

DescriptionWhite 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 contentNot more than 1 % (Karl Fischer method)
Sulphated ashNot more than 0,1 % expressed on dry weight basis
Reducing sugarsNot more than 0,3 % expressed as glucose on dry weight basis
Total sugarsNot more than 1 % expressed as glucose on dry weight basis
ChloridesNot more than 50 mg/kg expressed on dry weight basis
SulphatesNot more than 100 mg/kg expressed on dry weight basis
NickelNot more than 2 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
E 420 (ii) — SORBITOL SYRUP
SynonymsD-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

Einecs270-337-8
AssayContent not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis
DescriptionClear 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 contentNot more than 31 % (Karl Fischer method)
Sulphated ashNot more than 0,1 % expressed on dry weight basis
Reducing sugarsNot more than 0,3 % expressed as glucose on dry weight basis
ChloridesNot more than 50 mg/kg expressed on dry weight basis
SulphatesNot more than 100 mg/kg expressed on dry weight basis
NickelNot more than 2 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy 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 fructose
Chemical nameD-mannitol
Einecs200-711-8
Chemical formulaC6H14O6
Molecular weight182,2
AssayContent not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
DescriptionWhite, 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 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/kg
SulphateNot more than 100 mg/kg
NickelNot more than 2 mg/kg
LeadNot more than 1 mg/kg
(II) MANNITOL MANUFACTURED BY FERMENTATION
SynonymsD-mannitol
DefinitionManufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii
Chemical nameD-mannitol
Einecs200-711-8
Chemical formulaC6H14O6
Molecular weight182,2
AssayNot less than 99 % on the dried basis
DescriptionWhite, 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
ArabitolNot 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/kg
SulphateNot more than 100 mg/kg
LeadNot more than 1 mg/kg
Aerobic mesophilic bacteriaNot more than 103/g
ColiformsAbsent in 10 g
SalmonellaAbsent in 10 g
E. ColiAbsent in 10 g
Staphylococcus aureusAbsent in 10 g
Pseudomonas aeruginosaAbsent in 10 g
MouldsNot more than 100/g
YeastsNot 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-dioxide
Definition
Chemical name6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt
Einecs259-715-3
Chemical formulaC4H4KNO4S
Molecular weight201,24
AssayContent not less than 99 % of C4H4KNO4S on the anhydrous basis
DescriptionOdourless, 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 dryingNot more than 1 % (105 °C, two hours)
Organic impuritiesPasses test for 20 mg/kg of UV active components
FluorideNot more than 3 mg/kg
LeadNot more than 1 mg/kg
E 951 — ASPARTAME
SynonymsAspartyl phenylalanine methyl ester
Definition
Chemical nameN-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester
Einecs245-261-3
Chemical formulaC14H18N2O5
Relative molecular mass294,31
AssayNot 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 sucrose
Identification
SolubilitySlightly soluble in water and in ethanol
Purity
Loss on dryingNot more than 4,5 % (105 °C, four hours)
Sulphated ashNot more than 0,2 % expressed on dry weight basis
pHBetween 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 0,022
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

ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
5-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, cyclamate
Definition
Chemical nameCyclohexanesulphamic acid, cyclohexylaminosulphonic acid
Einecs202-898-1
Chemical formulaC6H13NO3S
Relative molecular mass179,24
AssayCyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis
DescriptionA 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 dryingNot more than 1 % (105 °C, one hour)
SeleniumNot more than 30 mg/kg expressed as selenium on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
CyclohexylamineNot more than 10 mg/kg expressed on dry weight basis
DicyclohexylamineNot more than 1 mg/kg expressed on dry weight basis
AnilineNot more than 1 mg/kg expressed on dry weight basis
(II) SODIUM CYCLAMATE
SynonymsCyclamate, sodium salt of cyclamic acid
Definition
Chemical nameSodium cyclohexanesulphamate, sodium cyclohexylsulphamate
Einecs205-348-9
Chemical formulaC6H12NNaO3S 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

DescriptionWhite, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
SolubilitySoluble 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

SeleniumNot more than 30 mg/kg expressed as selenium on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
CyclohexylamineNot more than 10 mg/kg expressed on dry weight basis
DicyclohexylamineNot more than 1 mg/kg expressed on dry weight basis
AnilineNot more than 1 mg/kg expressed on dry weight basis
(III) CALCIUM CYCLAMATE
SynonymsCyclamate, calcium salt of cyclamic acid
Definition
Chemical nameCalcium cyclohexanesulphamate, calcium cyclohexylsulphamate
Einecs205-349-4
Chemical formulaC12H24CaN2O6S2·2H2O
Relative molecular mass432,57
AssayNot less than 98 % and not more than 101 % on the dried basis
DescriptionWhite, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
SolubilitySoluble 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

SeleniumNot more than 30 mg/kg expressed as selenium on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
CyclohexylamineNot more than 10 mg/kg expressed on dry weight basis
DicyclohexylamineNot more than 1 mg/kg expressed on dry weight basis
AnilineNot more than 1 mg/kg expressed on dry weight basis
E 953 — ISOMALT
SynonymsHydrogenated 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

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.
Purity
Water contentNot more than 7 % (Karl Fischer Method)
Sulphated ashNot more than 0,05 % expressed on dry weight basis
D-MannitolNot more than 3 %
D-SorbitolNot more than 6 %
Reducing sugarsNot more than 0,3 % expressed as glucose on dry weight basis
NickelNot more than 2 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot 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 name3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide
Einecs201-321-0
Chemical formulaC7H5NO3S
Relative molecular mass183,18
AssayNot less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis
DescriptionWhite 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
SolubilitySlightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
Purity
Loss on dryingNot more than 1 % (105 °C, two hours)
Melting range226 to 230 °C
Sulphated ashNot more than 0,2 % expressed on dry weight basis
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 appears
o-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
p-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substancesAbsent
ArsenicNot more than 3 mg/kg expressed on dry weight basis
SeleniumNot more than 30 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
(II) SODIUM SACCHARIN
SynonymsSaccharin, sodium salt of saccharin
Definition
Chemical nameSodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
Einecs204-886-1
Chemical formulaC7H4NNaO3S·2H2O
Relative molecular mass241,19
AssayNot less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis
DescriptionWhite 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
SolubilityFreely soluble in water, sparingly soluble in ethanol
Purity
Loss 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 appears
o-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
p-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substancesAbsent
ArsenicNot more than 3 mg/kg expressed on dry weight basis
SeleniumNot more than 30 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
(III) CALCIUM SACCHARIN
SynonymsSaccharin, calcium salt of saccharin
Definition
Chemical nameCalcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
Einecs229-349-9
Chemical formulaC14H8CaN2O6S2·3 H2O
Relative molecular mass467,48
AssayNot less than 95 % of C14H8CaN2O6S2 on the anhydrous basis
DescriptionWhite 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
SolubilityFreely soluble in water, soluble in ethanol
Purity
Loss 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 appears
o-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
p-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substancesAbsent
ArsenicNot more than 3 mg/kg expressed on dry weight basis
SeleniumNot more than 30 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
(IV) POTASSIUM SACCHARIN
SynonymsSaccharin, potassium salt of saccharin
Definition
Chemical namePotassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate
Einecs
Chemical formulaC7H4KNO3S·H2O
Relative molecular mass239,77
AssayNot less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis
DescriptionWhite 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
SolubilityFreely soluble in water, sparingly soluble in ethanol
Purity
Loss 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 appears
o-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
p-ToluenesulphonamideNot more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substancesAbsent
ArsenicNot more than 3 mg/kg expressed on dry weight basis
SeleniumNot more than 30 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
E 955 — SUCRALOSE
Synonyms4,1′,6′-Trichlorogalactosucrose
Definition
Chemical name1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside
Einecs259-952-2
Chemical formulaC12H19Cl3O8
Molecular weight397,64
AssayContent 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] 20 D + 84,0 ° to + 87,5 ° calculated on the anhydrous basis

(10 % w/v solution)

Purity
WaterNot 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/kg
MethanolNot more than 0,1 %
LeadNot more than 1 mg/kg
E 957 — THAUMATIN
Synonyms
Definition
Chemical 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 material
Einecs258-822-2
Chemical formulaPolypeptide of 207 amino acids
Relative 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 2 000 to 3 000 times as sweet as sucrose
Identification
SolubilityVery soluble in water, insoluble in acetone
Purity
Loss on dryingNot more than 9 % (105 °C to constant weight)
CarbohydratesNot more than 3 % expressed on dry weight basis
Sulphated ashNot more than 2 % expressed on dry weight basis
AluminiumNot more than 100 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
Lead3 mg/kg expressed on dry weight basis
Microbiological criteriaTotal aerobic microbial count: Max 1 000/g E. Coli: absent in 1 g
E 959 — NEOHESPERIDINE DIHYDROCHALCONE
SynonymsNeohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC
Definition
Chemical name2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin
Einecs243-978-6
Chemical formulaC28H36O15
Relative molecular mass612,6
AssayContent not less than 96 % on the dried basis
DescriptionOff-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 dryingNot more than 11 % (105 °C, three hours)
Sulphated ashNot more than 0,2 % expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 2 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
E 962 — SALT OF ASPARTAME-ACESULFAME
SynonymsAspartame-acesulfame, Aspartame-acesulfame salt
DefinitionThe 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 acid
Chemical formulaC18H23O9N3S
Molecular weight457,46
Assay63,0 % 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] 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 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 maltose
Definition
Chemical name(α)-D-Glucopyranosyl-1,4-D-glucitol
Einecs209-567-0
Chemical formulaC12H24O11
Relative molecular mass344,31
AssayContent not less than 98 % D-maltitol C12H24O11 on the anhydrous basis
DescriptionSweet 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 contentNot more than 1 % (Karl Fischer method)
Sulphated ashNot more than 0,1 % expressed on dry weight basis
Reducing sugarsNot more than 0,1 % expressed as glucose on dry weight basis
ChloridesNot more than 50 mg/kg expressed on dry weight basis
SulphatesNot more than 100 mg/kg expressed on dry weight basis
NickelNot more than 2 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
E 965 (ii) — MALTITOL SYRUP
SynonymsHydrogenated high-maltose-glucose syrup, hydrogenated glucose syrup
DefinitionA 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 basis
DescriptionColourless 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
WaterNot more than 31 % (Karl Fischer)
Reducing sugarsNot more than 0,3 % (as glucose)
Sulphated ashNot more than 0,1 %
ChloridesNot more than 50 mg/kg
SulphateNot more than 100 mg/kg
NickelNot more than 2 mg/kg
LeadNot more than 1 mg/kg
E 966 — LACTITOL
SynonymsLactit, lactositol, lactobiosit
Definition
Chemical name4-O-β-D-Galactopyranosyl-D-glucitol
Einecs209-566-5
Chemical formulaC12H24O11
Relative molecular mass344,32
AssayNot less than 95 % on the dry weight basis
DescriptionSweet-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 contentCrystalline products; not more than 10,5 % (Karl Fischer method)
Other polyolsNot more than 2,5 % on the anhydrous basis
Reducing sugarsNot more than 0,2 % expressed as glucose on dry weight basis
ChloridesNot more than 100 mg/kg expressed on dry weight basis
SulphatesNot more than 200 mg/kg expressed on dry weight basis
Sulphated ashNot more than 0,1 % expressed on dry weight basis
NickelNot more than 2 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
E 967 — XYLITOL
SynonymsXylitol
Definition
Chemical nameD-xylitol
Einecs201-788-0
Chemical formulaC5H12O5
Relative molecular mass152,15
AssayNot less than 98,5 % as xylitol on the anhydrous basis
DescriptionWhite, 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 dryingNot more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours
Sulphated ashNot more than 0,1 % expressed on dry weight basis
Reducing sugarsNot more than 0,2 % expressed as glucose on dry weight basis
Other polyhydric alcoholsNot more than 1 % expressed on dry weight basis
NickelNot more than 2 mg/kg expressed on dry weight basis
ArsenicNot more than 3 mg/kg expressed on dry weight basis
LeadNot more than 1 mg/kg expressed on dry weight basis
Heavy metalsNot more than 10 mg/kg expressed as Pb on dry weight basis
ChloridesNot more than 100 mg/kg expressed on dry weight basis
SulphatesNot more than 200 mg/kg expressed on dry weight basis
E 968 — ERYTHRITOL
SynonymsMeso-erythritol, tetrahydroxybutane, erythrite
DefinitionObtained 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 name1,2,3,4-Butanetetrol
Einecs205-737-3
Chemical formulaC4H10O4
Molecular weight122,12
AssayNot less than 99 % after drying
DescriptionWhite, 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 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-glucose
Ribitol and glycerolNot more than 0,1 %
LeadNot more than 0,5 mg/kg

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