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"B COMMISSION DIRECTIVE 95/31/EC
of 5 July 1995
laying down specific criteria of purity concerning sweeteners for use in foodstuffs
(Text with EEA relevance)
(OJ L 178, 28.7.1995, p. 1)
Amended by:
Official Journal
No page date
"M1 Commission Directive 98/66/EC of 4 September 1998 L 257 35 19.9.1998
"M2 Commission Directive 2000/51/EC of 26 July 2000 L 198 41 4.8.20001995L0031 — EN — 24.08.2000 — 002.001 — 1
COMMISSION DIRECTIVE 95/31/EC
of 5 July 1995
laying 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 additivesauthorized for use in foodstuffs intended for human consumption (
1), as
amended by Directive 94/34/EC (2), 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 foodstuffs (
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 1
1. 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 substancesmentioned in the Annex to Council Directive 78/663/EEC (
4).
Article 2
1. 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 3
This Directive shall enter into force on the 20th day following its publication
in the Official Journal of the European Communities .!B
(1) OJ No L 40, 11. 2. 1989, p. 27.
(2) OJ No L 237, 10. 9. 1994, p. 1.
(3) OJ No L 237, 10. 9. 1994, p. 3.
(4) OJ No L 223, 14. 8. 1978, p. 7.1995L0031 — EN — 24.08.2000 — 002.001 — 2
Article 4
This Directive is addressed to the Member States.!B1995L0031 — EN — 24.08.2000 — 002.001 — 3
ANNEX
E 420 (i) — SORBITOL
Synonyms D-glucitol, D-sorbitol
Definition
Chemical name D-glucitol
Einecs 200-061-5
E number E 420 (i)
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 the
dry weight basis.
Glycitols are compounds with the structural formula CH 2OH-(CHOH) n-CH 2OH, 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 monobenzyli-
dene 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. Filterwith the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g ofsodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 mlof methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between173 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-clucitol 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 (inwhich case the syrup is non-crystallizing) or mannitol. Minor quantities of glycitolswhere n44 may be present. Glycitols are compounds with the structural formula
CH
2OH-(CHOH) n-CH 2OH, where ‘ n’ is an integer
Einecs 270-337-8!B1995L0031 — EN — 24.08.2000 — 002.001 — 4
E number E 420 (ii)
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.Sorbitol monobenzyli-
dene 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. Filterwith the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g ofsodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 mlof 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
1.Mannitol
Synonyms D-mannitol
Definition Mannitol is manufactured by catalytic hydrogenation of a mixture of glucose and
fructose made from invert sugar
Chemical name D-mannitol
Einecs 200-711-8
Chemical formula C
6H14O6
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 chromato-
graphyPasses test
D. Specific rotation α½/C13820
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!B
!M21995L0031 — EN — 24.08.2000 — 002.001 — 5
Purity
Loss on drying Not more than 0,3 % (105 °C, 4 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/kgNickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg
2.Mannitol manufactured by
fermentation
Synonyms D-mannitol
Definition Mannitol can also be manufactured by discontinous fermentation under aerobic
conditions a conventional strain of the yeast Zygosaccharomyces rouxii
Chemical name D-mannitol
Einecs 200-711-8
Chemical formula C
6H14O6
Molecular weight 182,2
Assay Not less than 99 % on the dried basis
Description White, odourles 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 chromato-
graphyPasses test
D. Specific rotation α½/C13820
D: + 23° to + 25° (borate solution)
E. pH Between 5 and 8
Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution
of the sample, then measure the pH
Purity
Arabitol Not more than 0,3 %
Loss on drying Not more than 0,3 % (105 °C, 4 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/kgSulphate Not more than 100 mg/kg
Lead Not more than 1 mg/kg
Aerobic mesophilic bac-
teriaNot more than 10
3/g
Coliforms Absent in 10 g
Salmonella Absent in 10 g
E. coli Absent in 10 g!M21995L0031 — EN — 24.08.2000 — 002.001 — 6
Staphylococcus aureus Absent in 10 g
Pseudomonas aerugino-
saAbsent in 10 g
Moulds Not more than 100/g
Y easts Not more than 100/g
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-man-
nitol dihydrate (1,1-GPM)
Chemical formula 6-O- α-D-Glucopyranosyl-D-sorbitol: C 12H24O11
1-O- α-D-Glucopyranosyl-D-mannitol dihydrate: C 12H24O11.2H 2O
Relative molecular mass 6-O- α-D-Glucopyranosyl-D-sorbitol: 344,32
1-O- α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32
Assay Content not less than 98 % of hydrogenated mono- and disaccharides and not less than
86 % of the mixture of 6-O- α-D-Glucopyranosyl-D-sorbitol and 1-O- α-D-Glucopyr-
anosyl-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 chromatogra-
phyExamine 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 arethose 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 the 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 the dry weight basis
Nickel Not more than 2 mg/kg expressed on the dry weight basis
Arsenic Not more than 3 mg/kg expressed on the dry weight basis
Lead Not 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) — MALTITOL
Synonyms D-maltitol, hydrogenated maltose
Definition
Chemical name (α)-D-glucopyranosyl-1,4-D-glucitol
Einecs 209-567-0!
M2
!M1
!B1995L0031 — EN — 24.08.2000 — 002.001 — 7
E number E 965 (i)
Chemical formula C12H24O11
Relative molecular mass 344,31
Assay Content not less than 98 % D-mannitol C 12H24O11on 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 ðαÞ20
D= + 105,5 to + 105,5° (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
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
E 965 (ii) SYRUP MALTITOL
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. 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
IdentificationA. Solubility Very soluble in water, slightly soluble in ethanolB. 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/kgSulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg!
B
!M2
!B1995L0031 — EN — 24.08.2000 — 002.001 — 8
E 966 — LACTITOL
Synonyms Lactit, lactositol, lactobiosit
Definition
Chemical name 4-O- /betatwo-D-galactopyranosyl-D-glucitol
Einecs 209-566-5
E number E 966
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 ðαÞ20
D= + 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
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
E 967 — XYLITOL
Synonyms Xylitol
Definition
Chemical name D-xylitol
Einecs 201-788-0
E number E 967
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!B1995L0031 — EN — 24.08.2000 — 002.001 — 9
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 950 — ACESULFAME K
Synonyms Acesulfame potassium, acesulfam, 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
E number E 950
Chemical formula C4H4NO 4SK
Relative molecular mass 201,24
Assay Not less than 99 % of C 4H4NO 4SK on the anhydrous basis
Description Odourless, white, crystalline powder having an intensively sweet taste. Aproximately
200 times as sweet as sucrose
Identification
A.Solubility Very soluble in water, very slightly soluble in ethanol
B.Ultra-violet absorption Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water
Purity
Loss on drying Not more than 1 % (105 °C, two hours)
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Selenium Not more than 30 mg/kg expressed on dry weight basis
Fluoride 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 951 — ASP ARTAME
Synonyms Aspartyl phenylalanine methyl ester!B1995L0031 — EN — 24.08.2000 — 002.001 — 10
Definition
Chemical name N-L- α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-( α-carbomethoxy-phe-
nethyl)-succinamic acid-N-methyl ester
Einecs 245-261-3
E number E 951
Chemical formula C14H18N2O5
Relative molecular mass 294,31
Assay Not less than 98 % and not more than 102 % of C 14H18N2O5on 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 ðαÞ20
D: + 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-piper-
azineacetic acidNot 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
E number E 952
Chemical formula C6H13NO 3S
Relative molecular mass 179,24
Assay Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent
of 102 % of C 6H13NO 3S, calculated on the anhydrous basis
Description A practically colourless, white crystalline powder with a sweet-sour taste. Approxi-
mately 40 times as sweet as sucrose
Identification
A.Solubility Soluble in water and in ethanol!B1995L0031 — EN — 24.08.2000 — 002.001 — 11
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 theclear 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 CYCLAMA TE
Synonyms Cyclamate, sodium salt of cyclamic acid
Definition
Chemical name Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate
Einecs 205-348-9
E number E 952
Chemical formula C
6H12NNaO 3S and the dihydrate form C 6H12NNaO 3S.2H2O
Relative molecular mass 201,22 calculated on the anhydrous form
237,22 calculated on the hydrated form
Assay Not les sthan 98 % and not more than 102 % on the dried basis
Dihydrate form: not less than 84 % on the dried basis
Description White, odourless crystals or crystalline powder. Approximately 30 times as sweet as
sucrose
Identification
Solubility Soluble in water, practically insoluble in ethanol
Purity
Loss on drying Not more than 1 % (105 °C, one hour)
Not more than 15,2 % (105 °C, two hours) for the dihydrate form
Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis
Aniline Not more than 1 mg/kg expressed on dry weight basis
(III) CALCIUM CYCLAMATE
Synonyms Cyclamate, calcium salt of cyclamic acid
Definition
Chemical name Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate
Einecs 205-349-4
E number E 952!B1995L0031 — EN — 24.08.2000 — 002.001 — 12
Chemical formula C12H24CaN 2O6S2.2H2O
Relative molecular mass 432,57
Assay Not less than 98 % and not more than 10 % on the dried basis
Description White, colourless crystals or crystaline 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 954 — SACCHARIN AND ITS Na. K AND Ca SALTS
(I) SACCHARIN
Definition
Chemical name 3-oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide
Einecs 201-321-0
E number E 954
Chemical formula C7H5NO 3S
Relative molecular mass 183,18
Assay Not less than 99 % and not more than 101,0 % of C 7H5NO 3S 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 500times 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
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
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
Sulphated ash Not more than 0,2 % expressed on dry weight basis!
B1995L0031 — EN — 24.08.2000 — 002.001 — 13
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 precipitateor 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-sulfona-
mideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonizable
substancesAbsent
(II) SODIUM SACCHARIN
Synonyms Saccharin, sodium salt of saccharin
Definition
Chemical name Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulfonazole,
oxobenzisosulfonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
Einecs 204-886-1
E number E 954
Chemical formula C
7H4NNaO 3S.2H2O
Relative molecular mass 241,19
Assay Not less than 99 % and not more than 101 % of C 7H4NNaO 3S on the anhydrous basis
Description White crystals or a white crystalline efflorescent powder, odourless or with a faint,
odour, hvaing 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)
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
Heavy metals Not more than 10 mg/kg expressed as Pb 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-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-sulfona-
mideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonizable
substancesAbsent
(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 229-349-0
E number E 954!B1995L0031 — EN — 24.08.2000 — 002.001 — 14
Chemical formula C14H8CaN 2O6S2.31⁄2H2O
Relative molecular mass 467,48
Assay Not less than 95 % of C 14H8CaN 2O6S2on 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 500times 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)
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
Heavy metals Not more than 10 mg/kg expressed as Pb 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-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-sulfona-
mideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonizable
substancesAbsent
(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
EinecsE number E 954
Chemical formula C
7H4KNO 3S.H2O
Relative molecular mass 239,77
Assay Not less than 99 % and not more than 101 % of C 7H4KNO 3S 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)
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
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis!B1995L0031 — EN — 24.08.2000 — 002.001 — 15
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 precipitateor 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-sulfona-
mideNot more than 25 mg/kg expressed on dry weight basis
Readily carbonizable
substancesAbsent
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 constituentsderived from the source material
Einecs 258-822-2
E number E 957
Chemical formula Polypeptide of 207 aminoacids
Relative molecular mass Thaumatin I 22209
Thaumatin II 22293
Assay Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins
(N × 5,8)
Description Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000
to 3 000 times as sweet as sucrose
Identification
Solubility Very soluble in water, insoluble in acetone
Purity
Loss on drying Not more than 9 % (105 °C to constant weight)
Carbohydrates Not more than 3 % expressed on dry weight basis
Sulphated ash Not more than 2 % expressed on dry weight basis
Aluminium Not more than 100 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead 3 mg/kg expressed on dry weight basis
Microbiological criteria Total aerobic microbial count: Max 1 000/g E. Coli: absent in 1 g
E 959 — NEOHESPERIDINE DIHYDROCHALCONE
Synonyms Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4 ’-/betatwo-neohesper-
idoside, neohesperidin DC
Definition
Chemical name 2-O- α-L-rhamnopyranosyl-4 ’-/betatwo-D-glucopyranosyl hesperetin dihydrochalcone; ob-
tained by catalytic hydrogenation of neohesperidin
Einecs 243-978-6
E number E 959!
B1995L0031 — EN — 24.08.2000 — 002.001 — 16
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
maximum282 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 huors)
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!B1995L0031 — EN — 24.08.2000 — 002.001 — 17