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►B COMMISSION DIRECTIVE 95/31/EC
of 5July 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
►M1Commission Directive 98/66/EC of 4 September 1998 L 257 35 19.9.19981995L0031 — EN — 09.10.1998 — 001.001 — 1
1995L0031 — EN — 09.10.1998 — 001.001 — 2
▼B
COMMISSION DIRECTIVE 95/31/EC
of 5July 1995
laying down specific criteria of purity concerning sweeteners for
use in foodstuffs
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Havingreg ard to the Treaty establishingthe European Community,Havingreg ard to Council Directive 89/107/EEC of 21 December 1988
on the approximation of the laws of the Member States concerningfood
additives authorized for use in foodstuffs intended for human consump-
tion(
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 ana-
lytical 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 inthis Directive, should be submitted for evaluation by the ScientificCommittee for Food with a view to full evaluation with emphasis on thepurity criteria;
Whereas the measures provided for in this Directive are in line with the
opinion of the StandingCommittee 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 inthe 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/EEC(
4).
Article 2
1. Member States shall bringinto force the laws, reg ulations and
administrative provisions necessary to comply with this Directive notlater than 1 July 1996. They shall forthwith inform the Commission
thereof.
When Member States adopt these provisions, these shall contain a refer-
ence to this Directive or shall be accompanied by such reference at thetime of their official publication. The procedure for such reference shallbe 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 stocksare exhausted.
(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 — 09.10.1998 — 001.001 — 3
▼B
Article 3
This Directive shall enter into force on the 20th day followingits publi-
cation in the Official Journal of the European Communities .
Article 4
This Directive is addressed to the Member States.
1995L0031 — EN — 09.10.1998 — 001.001 — 4
▼B
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 CH2OH-
(CHOH)n-CH2OH, where ‘ n’ is an integer
Description White hygroscopic powder, crystalline powder, flakes or
granules having a sweet taste
Identification
A.Solubility Very soluble in water, slightly soluble in ethanol
B.Melting range 88 to 102°C
C.Sorbitol monobenzylidene derivative To 5 gof the sample add 7 ml of methanol, 1 ml of ben-
zaldehyde 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 boil-
ingwater containing1 gof sodium bicarbonate, filter
while hot, cool the filtrate, filter with suction, wash with
5 ml of methanol-water mixture (1 in 2) and dry in air.
The crystals so obtained melt between 173 and 179°C
Purity
Water content Not more than 1% (Karl Fischer method)
Sulphated ash Not more than 0,1% expressed on dry weight basis
Reducing sugars Not more than 0,3% expressed as glucose on dry weight
basis
Total sugars Not more than 1% expressed as glucose on dry weight
basis
Chlorides Not more than 50 mg/kg expressed on dry weight basis
Sulphates Not more than 100 mg/kg expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavymetals 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-sorbi-
tol is composed mainly of hydrogenated oligosaccharides
formed by the hydrogenation of glucose syrup used as
raw material (in which case the syrup is non-crystalliz-
ing) 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
1995L0031 — EN — 09.10.1998 — 001.001 — 5
▼B
Einecs 270-337-8
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 tastingaqueous solution
Identification
A. Solubility Miscible with water, with glycerol, and with propane-
1,2-diol
B. Sorbitol monobenzylidene
derivativeTo 5 gof the sample add 7 ml of methanol, 1 ml of ben-
zaldehyde 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 boil-
ingwater containing1 gof sodium bicarbonate, filter
while hot. Cool the filtrate filter with suction, wash with
5 ml of methanol-water mixture (1 in 2) and dry in air.
The crystals so obtained melt between 173 and 179°C
Purity
Water content Not more than 31% (Karl Fischer method)
Sulphated ash Not more than 0,1% expressed on dry weight basis
Reducing sugars Not more than 0,3% expressed as glucose on dry weight
basis
Chlorides Not more than 50 mg/kg expressed on dry weight basis
Sulphates Not more than 100 mg/kg expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
E 421 — MANNITOL
Synonyms D-mannitol
Definition
Chemical name D-mannitol
Einecs 200-711-8
E number E 421
Chemical formula C6H14O6
Relative molecular mass 182,2
Assay Content not less than 96% D-mannitol on the dried basis
Description Sweet tasting, white, odourless, crystalline powder
Identification
A. Solubility Soluble
Purity
Loss on drying Not more than 0,3% (105°C, four hours)
pH Between 5 and 8Add 0,5 ml of a saturated solution of
potassium chloride to 10 ml of a 10% w/v solution of the
sample then measure the pH
Specific rotation (α)D20
Specific rotation in a borated solution calculated with
reference to the anhydrous substance is between +23 and
+25°
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
1995L0031 — EN — 09.10.1998 — 001.001 — 6
▼B
Total sugars Not more than 1% expressed as glucose on dry weight
basis
Chlorides Not more than 70 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
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
E 953 — ISOMALT
Synonyms Hydrogenated isomaltulose, hydrogenated palatinose.
Definition
Chemical name Isomalt is a mixture of hydrogenated mono- and disac-
charides whose principal components are the disacchar-
ides:
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-
α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
Chemical formula 6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O111-O-α-D-Glucopyranosyl-D-mannitol
dihydrate: C12H24O11.2H2O
Relative molecular mass 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,32
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-Gluco-
pyranosyl-D-mannitol dihydrate determined on the anhy-
drous basis.
Description Odourless, white, slightly hygroscopic, crystalline mass.
Identification
A.Solubility Soluble in water, very slightly soluble in ethanol.
B.Thin layer chromatography Examine by thin layer chromatography using a plate
coated with an approximately 0,2 mm layer of chromato-
graphic silica gel. The principal spots in the chromato-
gram are those of 1,1-GPM and 1,6-GPS.
Purity
Water content Not more than 7 % (Karl Fischer Method)
Sulphated ash Not more than 0,05 % expressed on 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
Heavymetals (as Pb) Not more than 10 mg/kg expressed on the dry weight
basis.
E 965(i) — MALTITOL
Synonyms D-maltitol, hydrogenated maltose▼M1
▼B
1995L0031 — EN — 09.10.1998 — 001.001 — 7
▼B
Definition
Chemical name (α)-D-glucopyranosyl-1,4-D-glucitol
Einecs 209-567-0
E number E 965 (i)
Chemical formula C12H24O11
Relative molecular mass 344,31
Assay Content not less than 98% D-mannitol C12H24O11on the
anhydrous basis
Description Sweet tasting, white crystalline powder
Identification
A.Solubility Very soluble in water, slightly soluble in ethanol
B.Melting range 148 to 151°C
C.Specific rotation (α)D20= +105,5 to +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
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
E 965(ii) — MALTITOL SYRUP
Synonyms Hydrogenated high maltose-glucose syrup, hydrogenated
glucose syrup
Definition
Chemical name A mixture consistingof mainly maltitol with sorbitol and
hydrogenated oligo- and polysaccharides. It is manufac-
tured by the catalytic hydrogenation of high maltose-con-
tent glucose syrup. The article of commerce is supplied
both as a syrup and as a solid product
Einecs 270-337-8
E number E 965 (ii)
Assay The followingrang es apply on the anhydrous basis:
Maltitol not less than 50%
Sorbitol not more than 8%
Maltotriitol not more than 25%
Hydrogenated polysaccharides
containingmore than three g lucose
or glucitol units not not more than 30%
Description Sweet-tasting, colourless and odourless, clear viscous
liquids or sweet-tastingwhite crystalline masses
Identification
A.Solubility Very soluble in water, slightly soluble in ethanol
B.Thin layer chromatography Examine by the thin layer chromatography using a plate
coated with a 0,25 mm layer of chromatographic silica
gel
1995L0031 — EN — 09.10.1998 — 001.001 — 8
▼B
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
eavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
E 966 — LACTITOL
Synonyms Lactit, lactositol, lactobiosit
Definition
Chemical name 4-O-β-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-tastingcrystalline powders or colourless solutions.
Crystalline products occur in anhydrous, monohydrate
and dihydrate forms
Identification
A.Solubility Very soluble in water
B.Specific rotation (α)D20= +13 to +16° calculated on the anhydrous basis
(10% w/v aqueous solution)
Purity
Water content Crystalline products; not more than 10,5% (Karl Fischer
method)
Other polyols Not more than 2,5% on the anhydrous basis
Reducing sugars Not more than 0,2% expressed as glucose on dry weight
basis
Chlorides Not more than 100 mg/kg expressed on dry weight basis
Sulphates Not more than 200 mg/kg expressed on dry weight basis
Sulphated ash Not more than 0,1% expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavymetals 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
1995L0031 — EN — 09.10.1998 — 001.001 — 9
▼B
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
C.pH 5 to 7 (10% w/v aqueous solution)
Purity
Loss on drying Not more than 0,5%. Dry 0,5 gof 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
Heavymetals 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 potas-
sium salt
Einecs 259-715-3
E number E 950
Chemical formula C4H4NO4SK
Relative molecular mass 201,24
Assay Not less than 99% of C4H4NO4SK on the anhydrous basis
Description Odourless, white, crystalline powder havingan inten-
sively 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 mgin
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
1995L0031 — EN — 09.10.1998 — 001.001 — 10
▼B
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
E 951 — ASPARTAME
Synonyms Aspartyl phenylalanine methyl ester
Definition
Chemical name N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-
amino-N-( α-carbomethoxy-phenethyl)-succinamic acid-
N-methyl ester
Einecs 245-261-3
E number E 951
Chemical formula C14H18N2O5
Relative molecular mass 294,31
Assay Not less than 98% and not more than 102% of
C14H18N2O5on the anhydrous basis
Description White, odourless, crystalline powder havinga 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, using2N hydrochloric acid as a
reference, is not less than 0,95, equivalent to an absor-
bance of not more than approximately 0,022
Specific rotation (α)D20: +14,5 to +16,5°Determine in a 4 in 100/15 N for-
mic 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
Heavymetals Not 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
Synonyms Cyclohexylsulphamic acid, cyclamate
Definition
Chemical name Cyclohexanesulphamic acid, cyclohexylaminosulphonic
acid
Einecs 202-898-1
E number E 952
Chemical formula C6H13NO3S
Relative molecular mass 179,24
Assay Cyclohexylsulphamic acid contains not less than 98%
and not more than the equivalent of 102% of
C6H13NO3S, calculated on the anhydrous basis
1995L0031 — EN — 09.10.1998 — 001.001 — 11
▼B
Description A practically colourless, white crystalline powder with
a sweet-sour taste. Approximately 40 times as sweet as
sucrose
Identification
A.Solubility Soluble in water and in ethanol
B.Precipitation test Acidify a 2% solution with hydrochloric acid, add 1 ml
of an approximately molar solution of barium chloride
in water and filter if any haze or precipitate forms. To
the clear solution add 1 ml of a 10% solution of sodium
nitrite. A white precipitate forms.
Purity
Loss on drying Not more than 1% (105°C, one hour)
Selenium Not more than 30 mg/kg expressed as selenium on dry
weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis
Aniline Not more than 1 mg/kg expressed on dry weight basis
(II)SODIUM CYCLAMATE
Synonyms Cyclamate, sodium salt of cyclamic acid
Definition
Chemical name Sodium cyclohexanesulphamate, sodium cyclohexylsul-
phamate
Einecs 205-348-9
E number E 952
Chemical formula C6H12NNaO3S and the dihydrate form
C6H12NNaO3S·2H2O
Relative molecular mass 201,22 calculated on the anhydrous form237,22 calcu-
lated on the hydrated form
Assay Not les sthan 98% and not more than 102% on the dried
basisDihydrate form: not less than 84% on the dried
basis
Description White, odourless crystals or crystalline powder.
Approximately 30 times as sweet as sucrose
Identification
Solubility Soluble in water, practically insoluble in ethanol
Purity
Loss on drying Not more than 1% (105°C, one hour)Not more than
15,2% (105°C, two hours) for the dihydrate form
Selenium Not more than 30 mg/kg expressed as selenium on dry
weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavymetals 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
1995L0031 — EN — 09.10.1998 — 001.001 — 12
▼B
Definition
Chemical name Calcium cyclohexanesulphamate, calcium cyclohexyl-
sulphamate
Einecs 205-349-4
E number E 952
Chemical formula C12H24CaN2O6S2·2H2O
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
Heavymetals 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 C7H5NO3S
Relative molecular mass 183,18
Assay Not less than 99% and not more than 101,0% of
C7H5NO3S on the anhydrous basis
Description White crystals or a white crystalline powder, odourless
or with a faint, aromatic odour havinga sweet taste
even in very dilute solutions. Approximately between
300 and 500 times as sweet as sucrose
Identification
Solubility Slightly soluble in water, soluble in basic solutions,
sparingly soluble in ethanol
Purity
Loss on drying Not more than 1% (105°C, two hours)
Melting range 226 to 230°C
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
1995L0031 — EN — 09.10.1998 — 001.001 — 13
▼B
Heavymetals 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
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified
with five drops of acetic acid, add three drops of an
approximately molar solution of ferric chloride in
water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis
Readilycarbonizable
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 dihy-
drate
Einecs 204-886-1
E number E 954
Chemical formula C7H4NNaO3S·2H2O
Relative molecular mass 241,19
Assay Not less than 99% and not more than 101% of
C7H4NNaO3S on the anhydrous basis
Description White crystals or a white crystalline efflorescent pow-
der, odourless or with a faint, odour, hvaingan inten-
sely sweet taste, even in very dilute solutions. Approxi-
mately 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
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified
with five drops of acetic acid, add three drops of an
approximately molar solution of ferric chloride in
water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis
Readilycarbonizable substances Absent
(III)CALCIUM SACCHARIN
Synonyms Saccharin, calcium salt of saccharin
Definition
Chemical name Calcium o-benzosulphimide, calcium salt of 2,3-dihy-
dro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-
one-1,1-dioxide calcium salt hydrate (2:7)
Einecs 229-349-0
1995L0031 — EN — 09.10.1998 — 001.001 — 14
▼B
E number E 954
Chemical formula C14H8CaN2O6S2·3½H2O
Relative molecular mass 467,48
Assay Not less than 95% of C14H8CaN2O6S2on the anhydrous
basis
Description White crystals or a white crystalline powder, odourless
or with a faint odour, havingan intensely sweet taste,
even in very dilute solutions. Approximately between
300 and 500 times as sweet as sucrose in dilute solu-
tions
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
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified
with five drops of acetic acid, add three drops of an
approximately molar solution of ferric chloride in
water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis
Readilycarbonizable
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
Einecs
E number E 954
Chemical formula C7H4KNO3S·H2O
Relative molecular mass 239,77
Assay Not less than 99% and not more than 101% of
C7H4KNO3S on the anhydrous basis
Description White crystals or a white crystalline powder, odourless
or with a faint odour, havingan 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
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis
1995L0031 — EN — 09.10.1998 — 001.001 — 15
▼B
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified
with five drops of acetic acid, add three drops of an
approximately molar solution of ferric chloride in
water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis
Readilycarbonizable
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 Thauma-
tococcus daniellii (Benth) and consists essentially of the
proteins thaumatin I and thaumatin II together with
minor amounts of plant constituents derived from the
source material
Einecs 258-822-2
E number E 957
Chemical formula Polypeptide of 207 aminoacids
Relative molecular mass Thaumatin I 22209Thaumatin II 22293
Assay Not less than 16% nitrogen on the dried basis equivalent
to not less than 94% proteins (N×5,8)
Description Odourless, cream-coloured powder with an intensely
sweet taste. Approximately 2000 to 3000 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 dihy-
drochalcone-4 /prime1-β-neohesperidoside, neohesperidin DC
Definition
Chemical name 2-O-α-L-rhamnopyranosyl-4 /prime1-β-D-glucopyranosyl
hesperetin dihydrochalcone; obtained by catalytic hydro-
genation of neohesperidin
Einecs 243-978-6
E number E 959
Chemical formula C28H36O15
Relative molecular mass 612,6
Assay Content not less than 96% on the dried basis
1995L0031 — EN — 09.10.1998 — 001.001 — 16
▼B
Description Off white, odourless, crystalline powder havinga charac-
teristic, 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 mgin 100 ml methanol
C.Neu's test Dissolve about 10 mgof 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
Heavymetals Not more than 10 mg/kg expressed as Pb on dry weight
basis