Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs
Modified by
  • Commission Directive 98/66/ECof 4 September 1998amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(Text with EEA relevance), 31998L0066, September 19, 1998
  • Commission Directive 2000/51/ECof 26 July 2000amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(Text with EEA relevance), 32000L0051, August 4, 2000
  • Commission Directive 2001/52/ECof 3 July 2001amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(Text with EEA relevance), 32001L0052, July 12, 2001
  • Commission Directive 2004/46/ECof 16 April 2004amending Directive 95/31/EC as regards E 955 sucralose and E 962 salt of aspartame-acesulfame(Text with EEA relevance), 32004L0046, April 21, 2004
  • Commission Directive 2006/128/ECof 8 December 2006amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(Text with EEA relevance), 32006L0128, December 9, 2006
  • Commission Directive 2008/60/ECof 17 June 2008laying down specific purity criteria concerning sweeteners for use in foodstuffs(Text with EEA relevance)(Codified version), 32008L0060, June 18, 2008
Commission Directive 95/31/ECof 5 July 1995laying down specific criteria of purity concerning sweeteners for use in foodstuffs(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumptionOJ No L 40, 11. 2. 1989, p. 27., as amended by Directive 94/34/ECOJ No L 237, 10. 9. 1994, p. 1., and in particular Article 3 (3) (a) thereof,After consultation of the Scientific Committee on Food,Whereas 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 foodstuffsOJ No L 237, 10. 9. 1994, p. 3.;Whereas it is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius and the Joint FAO/WHO Expert Committee on Food Additives (Jecfa);Whereas food additives, prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or different from those mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food with a view to full evaluation with emphasis on the purity criteria;Whereas the measures provided for in this Directive are in line with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:
Article 11.Purity criteria mentioned under Article 3 (3) (a) of Directive 89/107/EEC for sweeteners mentioned in Directive 94/35/EC are set out in the Annex.2.The purity criteria for E 420 (i), E 420 (ii) and E 421 mentioned in the Annex to this Directive supersede the purity criteria for the said substances mentioned in the Annex to Council Directive 78/663/EECOJ No L 223, 14. 8. 1978, p. 7..
Article 21.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1996. They shall forthwith inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2.Products put on the market or labelled before that date which do not comply with this Directive may, however, be marketed until stocks are exhausted.
Article 3This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4This Directive is addressed to the Member States.
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E 420 (i) — SORBITOLDefinitionIdentificationPurity
SynonymsD-glucitol, D-sorbitol
Chemical nameD-glucitol
Einecs200-061-5
E numberE 420 (i)
Chemical formulaC6H14O6
Relative molecular mass182,17
AssayContent not less than 97% of total glycitols and not less than 91% of D-sorbitol on the 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
A. SolubilityVery soluble in water, slightly soluble in ethanol
B. Melting range88 to 102°C
C. Sorbitol monobenzylidene derivativeTo 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
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 SYRUPDefinitionIdentificationPurity
SynonymsD-clucitol syrup
Chemical nameSorbitol 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-crystallizing) 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
E numberE 420 (ii)
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
A. SolubilityMiscible with water, with glycerol, and with propane-1,2-diol
B. Sorbitol monobenzylidene derivativeTo 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
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 MANNITOL1.MannitolIdentificationPurity2Mannitol manufactured by fermentationIdentificationPurity
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
A. SolubilitySoluble in water, very slightly soluble in ethanol, practically insoluble in ether
B. Melting rangeBetween 164 and 169 °C
C. Thin layer chromatographyPasses test
D. Specific rotation[α] 20D: + 23° to + 25° (borate solution)
E. pHBetween 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
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
SynonymsD-mannitol
DefinitionManufactured by discontinous 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
A. SolubilitySoluble in water, very slightly soluble in ethanol, practically insoluble in ether
B. Melting rangeBetween 164 and 169 °C
C. Thin layer chromatographypasses test
D. Specific rotation[α] 20D: + 23° to + 25° (borate solution)
E. pHBetween 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
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 953 — ISOMALTDefinitionIdentificationPurity
SynonymsHydrogenated isomaltulose, hydrogenated palatinose.
Chemical nameIsomalt 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 formula6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O111-O-α-D-Glucopyranosyl-D-mannitol dihydrate:C12H24O11.2H2O
Relative molecular mass6-O-α-D-Glucopyranosyl-D-sorbitol: 344,321-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.
A. SolubilitySoluble in water, very slightly soluble in ethanol.
B. Thin layer chromatographyExamine 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.
Water contentNot more than 7 % (Karl Fischer Method)
Sulphated ashNot more than 0,05 % expressed on the dry weight basis
D-MannitolNot more than 3 %
D-SorbitolNot more than 6 %
Reducing sugarsNot more than 0,3 % expressed as glucose on the dry weight basis
NickelNot more than 2 mg/kg expressed on the dry weight basis
ArsenicNot more than 3 mg/kg expressed on the dry weight basis
LeadNot more than 1 mg/kg expressed on the dry weight basis
Heavy metals (as Pb)Not more than 10 mg/kg expressed on the dry weight basis.
E 965 (i) MALTITOLDefinitionIdentificationPurity
SynonymsD-Maltitol, hydrogenated maltose
Chemical name(α)-D-Glucopyranosyl-1,4-D-glucitol
Einecs209-567-0
Chemical formulaC12H24O11
Relative molecular mass344,31
AssayContent not less than 98 % of D-maltitolC12H24O11 on the anhydrous basis
DescriptionSweet tasting, white crystalline powder
A.SolubilityVery soluble in water, slightly soluble in ethanol
B.Melting range148 to 151 °C
C.Specific rotation[α]D20 = + 105,5° to + 108,5° (5 % w/v solution)
WaterNot 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 SYRUPIdentificationPurity
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
A.SolubilityVery soluble in water, slightly soluble in ethanol
B.Thin layer chromatographyPasses test
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 LACTITOLDefinitionIdentificationPurity
SynonymsLactit, lactositol, lactobiosit
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
A.SolubilityVery soluble in water
B.Specific rotation[α]D20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution)
WaterCrystalline 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 — XYLITOLDefinitionIdentificationPurity
SynonymsXylitol
Chemical nameD-xylitol
Einecs201-788-0
E numberE 967
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
A. SolubilityVery soluble in water, sparingly soluble in ethanol
B. Melting range92 to 96°C
C. pH5 to 7 (10% w/v aqueous solution)
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 ERYTHRITOLIdentificationPurity
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.
A.SolubilityFreely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.
B.Melting range119-123 °C
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
E 950 — ACESULFAME KDefinitionIdentificationPurity
SynonymsAcesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one, 2,2-dioxide
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
A. SolubilityVery soluble in water, very slightly soluble in ethanol
B. Ultra violet absorptionMaximum 227 ± 2 nm for a solution of 10 mg in 1000 ml of water
C. Positive test for potassiumPasses test (test the residue obtained by igniting 2 g of the sample)
D. Precipitation testAdd a few drops of a 10 % solution of sodium cobaltnitrite 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
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 — ASPARTAMEDefinitionIdentificationPurity
SynonymsAspartyl phenylalanine methyl ester
Chemical nameN-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester
Einecs245-261-3
E numberE 951
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
SolubilitySlightly soluble in water and in ethanol
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 rotationDetermine 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 ACIDDefinitionIdentificationPurity(II)SODIUM CYCLAMATEDefinitionIdentificationPurity(III)CALCIUM CYCLAMATEDefinitionIdentificationPurity
SynonymsCyclohexylsulphamic acid, cyclamate
Chemical nameCyclohexanesulphamic acid, cyclohexylaminosulphonic acid
Einecs202-898-1
E numberE 952
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
A. SolubilitySoluble in water and in ethanol
B. Precipitation testAcidify 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.
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
SynonymsCyclamate, sodium salt of cyclamic acid
Chemical nameSodium cyclohexanesulphamate, sodium cyclohexylsulphamate
Einecs205-348-9
E numberE 952
Chemical formulaC6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O
Relative molecular mass201,22 calculated on the anhydrous form237,22 calculated on the hydrated form
AssayNot les sthan 98% and not more than 102% on the dried basisDihydrate form: not less than 84% on the dried basis
DescriptionWhite, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
SolubilitySoluble in water, practically insoluble in ethanol
Loss on dryingNot 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
SynonymsCyclamate, calcium salt of cyclamic acid
Chemical nameCalcium cyclohexanesulphamate, calcium cyclohexylsulphamate
Einecs205-349-4
E numberE 952
Chemical formulaC12H24CaN2O6S2·2H2O
Relative molecular mass432,57
AssayNot less than 98% and not more than 10% on the dried basis
DescriptionWhite, colourless crystals or crystaline powder. Approximately 30 times as sweet as sucrose
SolubilitySoluble in water, sparingly soluble in ethanol
Loss on dryingNot 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 954 SACCHARIN AND ITS Na, K AND Ca SALTS(I)SACCHARINDefinitionIdentificationPurity(II)SODIUM SACCHARINDefinitionIdentificationPurity(III)CALCIUM SACCHARINDefinitionIdentificationPurity(IV)POTASSIUM SACCHARINDefinitionIdentificationPurity
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
SolubilitySlightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
Loss on dryingNot more than 1 % (105 °C, two hours)
Melting range226-230 °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-sulfonamideNot 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.
SynonymsSaccharin, sodium salt of saccharin
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
SolubilityFreely soluble in water, sparingly soluble in ethanol
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
SynonymsSaccharin, calcium salt of saccharin
Chemical nameCalcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulfonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
Einecs229-349-9
Chemical formulaC14H8CaN2O6S2·31/2H2O
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
SolubilityFreely soluble in water, soluble in ethanol
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
SynonymsSaccharin, potassium salt of saccharin
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
SolubilityFreely soluble in water, sparingly soluble in ethanol
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 SUCRALOSEDefinitionIdentificationPurity
Synonyms4,1′,6′-Trichlorogalactosucrose
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 % of C12H19Cl3O8 calculated on an anhydrous basis.
DescriptionWhite to off-white, practically odourless crystalline powder.
A.SolubilityFreely soluble in water, methanol and ethanolSlightly soluble in ethyl acetate
B.Infrared absorptionThe 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 chromatographyThe 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 1,0 g of sucralose reference standard in 10 ml of methanol
D.Specific rotation[α]D20 = + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution)
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 — THAUMATINDefinitionIdentificationPurity
Synonyms
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
E numberE 957
Chemical formulaPolypeptide of 207 aminoacids
Relative molecular massThaumatin I 22209Thaumatin II 22293
AssayNot less than 16% nitrogen on the dried basis equivalent to not less than 94% proteins (N × 5,8)
DescriptionOdourless, cream-coloured powder with an intensely sweet taste. Approximately 2000 to 3000 times as sweet as sucrose
SolubilityVery soluble in water, insoluble in acetone
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 1000/g E. Coli: absent in 1 g
E 959 — NEOHESPERIDINE DIHYDROCHALCONEDefinitionIdentificationPurity
SynonymsNeohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC
Chemical name2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin
Einecs243-978-6
E numberE 959
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 1000 and 1800 times as sweet as sucrose
A. SolubilityFreely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
B. Ultraviolet absorption maximum282 to 283 nm for a solution of 2 mg in 100 ml methanol
C. Neu's testDissolve 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
Loss on dryingNot more than 11% (105°C, three huors)
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-ACESULFAMEIdentificationPurity
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 % acesulfame (acid form on a dry basis)
DescriptionA white, odourless, crystalline powder
A.SolubilitySparingly soluble in water, slightly soluble in ethanol
B.TransmittanceThe 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]D20 = + 14,5° to + 16,5°Determine at 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
Loss on dryingNot more than 0,5 % (105 °C, four hours)
5-Benzyl-3,6-dioxo-2-piperazineacetic acidNot more than 0,5 %
LeadNot more than 1 mg/kg