1995L0031 — EN — 11.05.2004 — 004.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►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 4.8.2000
►M3 Commission Directive 2001/52/EC of 3 July 2001 L 190 18 12.7.2001
►M4 Commission Directive 2004/46/EC of 16 April 2004 L 114 15 21.4.2004
▼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)
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 concerningfood additives authorized for use in foodstuffs intended for humanconsumption (
1), as amended by Directive 94/34/EC (2), and in parti-
cular 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 of30 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 Alimen-
tarius 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 theScientific Committee for Food with a view to full evaluation withemphasis 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 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 bring into force the laws, regulations 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
reference to this Directive or shall be accompanied by such referenceat the time of their official publication. The procedure for such refer-ence 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 stocksare exhausted.1995L0031 — EN — 11.05.2004 — 004.001 — 2
(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.
▼B
Article 3
This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
Article 4
This Directive is addressed to the Member States.1995L0031 — EN — 11.05.2004 — 004.001 — 3
▼B
ANNEX
E 420 (i) — SORBITOLSynonyms D-glucitol, D-sorbitol
Definition
Chemical name D-glucitol
Einecs 200-061-5
E number E 420 (i)Chemical formula C
6H14O6
Relative molecular mass 182,17Assay 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-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 ºC
C. Sorbitol monobenzylidene deriva-
tiveTo 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 ºC
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 basisArsenic 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 hydro-
genated 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-crystal-
lizing) or mannitol. Minor quantities of glycitols where1995L0031 — EN — 11.05.2004 — 004.001 — 4
▼B
n≤ 4 may be present. Glycitols are compounds with
the structural formula CH2OH-(CHOH)n-CH2OH, where
‘n’ is an integer
Einecs 270-337-8
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 monobenzylidene deriva-
tiveTo 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 ºC
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 basisSulphates 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 basisLead 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 Manufactured by catalytic hydrogenation of carbohy-
drate solutions containing glucose and/or fructose
Chemical name D-mannitol
Einecs 200-711-8Chemical formula C
6H14O6
Molecular weight 182,2Assay 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, practi-
cally insoluble in ether
B. Melting range Between 164 and 169 ºC
C. Thin layer chromatography Passes test
D. Specific rotation [ α]
20
D: + 23º to + 25º (borate solution)1995L0031 — EN — 11.05.2004 — 004.001 — 5
▼M3
▼M3
E. pH Between 5 and 8
Add 0,5 ml of a saturated solution of potassium chloride
to 10 ml of a 10 % w/v solution of the sample, then
measure the pH
Purity
Loss on drying Not more than 0,3 % (105 ºC, four hours)Reducing sugars Not more than 0,3 % (as glucose)Total sugars Not more than 1 % (as glucose)Sulphated ash Not more than 0,1 %Chlorides Not more than 70 mg/kg
Sulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kgLead Not more than 1 mg/kg
2. Mannitol manufactured by fermen-
tation
Synonyms D-mannitol
Definition Manufactured by discontinous fermentation under
aerobic conditions using a conventional strain of the
yeast Zygosaccharomyces rouxii
Chemical name D-mannitolEinecs 200-711-8Chemical formula C
6H14O6
Molecular weight 182,2Assay Not less than 99 % on the dried basis
Description White, odourless crystalline powder
Identification
A. Solubility Soluble in water, very slightly soluble in ethanol, practi-
cally insoluble in ether
B. Melting range Between 164 and 169 ºCC. Thin layer chromatography passes testD. Specific rotation [ α]
20
D: + 23º to + 25º (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 ºC, four hours)Reducing sugars Not more than 0,3 % (as glucose)
Total sugars Not more than 1 % (as glucose)
Sulphated ash Not more than 0,1 %Chlorides Not more than 70 mg/kgSulphate Not more than 100 mg/kgLead Not more than 1 mg/kgAerobic mesophilic bacteria Not more than 10
3/g
Coliforms Absent in 10 g
Salmonella Absent in 10 g
E. coli Absent in 10 g1995L0031 — EN — 11.05.2004 — 004.001 — 6
▼M3
Staphylococcus aureus Absent in 10 g
Pseudomonas aeruginosa Absent in 10 g
Moulds Not more than 100/gYeasts Not more than 100/g
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
disaccharides:
6-O- α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-
α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
Chemical formula 6-O- α-D-Glucopyranosyl-D-sorbitol: C
12H24O11
1-O- α-D-Glucopyranosyl-D-mannitol dihydrate:-
C12H24O11.2H2O
Relative molecular mass 6-O- α-D-Glucopyranosyl-D-sorbitol: 344,32
1-O- α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32
Assay Content not less than 98 % of hydrogenated mono- and
disaccharides and not less than 86 % of the mixture of
6-O- α-D-Glucopyranosyl-D-sorbitol and 1-O- α-D-
Glucopyranosyl-D-mannitol dihydrate determined on
the anhydrous basis.
Description Odourless, white, slightly hygroscopic, crystalline mass.
Identification
A.Solubility Soluble in water, very slightly soluble in ethanol.
B.Thin layer chromatography Examine by thin layer chromatography using a plate
coated with an approximately 0,2 mm layer of chroma-
tographic silica gel. The principal spots in the
chromatogram are those of 1,1-GPM and 1,6-GPS.
Purity
Water content Not more than 7 % (Karl Fischer Method)
Sulphated ash Not more than 0,05 % expressed on 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.1995L0031 — EN — 11.05.2004 — 004.001 — 7
▼M1
▼B
E 965 (i) — MALTITOL
Synonyms D-maltitol, hydrogenated maltose
Definition
Chemical name ( α)-D-glucopyranosyl-1,4-D-glucitol
Einecs 209-567-0
E number E 965 (i)Chemical formula C
12H24O11
Relative molecular mass 344,31Assay 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 ºCC. Specific rotation ðαÞ
20
D= + 105,5 to + 105,5º (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 basisNickel 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 basisHeavy 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
Identification
A. Solubility Very soluble in water, slightly soluble in ethanol
B. Thin layer chromatography Passes test
Purity
Water Not more than 31 % (Karl Fischer)
Reducing sugars Not more than 0,3 % (as glucose)
Sulphated ash Not more than 0,1 %1995L0031 — EN — 11.05.2004 — 004.001 — 8
▼M2
▼M2
Chlorides Not more than 50 mg/kg
Sulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg
E 966 — LACTITOL
Synonyms Lactit, lactositol, lactobiosit
Definition
Chemical name 4-O- β-D-galactopyranosyl-D-glucitol
Einecs 209-566-5
E number E 966Chemical formula C
12H24O11
Relative molecular mass 344,32Assay Not less than 95 % on the dry weight basis
Description Sweet-tasting crystalline powders or colourless solu-
tions. Crystalline products occur in anhydrous,
monohydrate and dihydrate forms
Identification
A. Solubility Very soluble in water
B. Specific rotation ðαÞ
20
D= + 13 to + 16º 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 basisReducing sugars Not more than 0,2 % expressed as glucose on dry
weight basis
Chlorides Not more than 100 mg/kg expressed on dry weight basisSulphates 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 basisArsenic 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 201-788-0E number E 967
Chemical formula C
5H12O5
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 taste1995L0031 — EN — 11.05.2004 — 004.001 — 9
▼B
▼B
Identification
A. Solubility Very soluble in water, sparingly soluble in ethanol
B. Melting range 92 to 96 ºCC. 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 ºC for four hours
Sulphated ash Not more than 0,1 % expressed on dry weight basisReducing sugars Not more than 0,2 % expressed as glucose on dry
weight basis
Other polyhydric alcohols Not more than 1 % expressed on dry weight basisNickel 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 basisHeavy 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, 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
Chemical formula C
4H4KNO4S
Molecular weight 201,24
Assay Content not less than 99 % of C4H4KNO4S on the anhy-
drous basis
Description Odourless, white, crystalline powder. Approximately
200 times as sweet as sucrose
Identification
A. Solubility Very soluble in water, very slightly soluble in ethanol
B. Ultra violet absorption Maximum 227 ± 2 nm for a solution of 10 mg in
1 000 ml of water
C. Positive test for potassium Passes test (test the residue obtained by igniting 2 g of
the sample)
D. Precipitation test Add a few drops of a 10 % solution of sodium cobaltni-
trite to a solution of 0,2 g of the sample in 2 ml of
acetic acid and 2 ml of water. A yellow precipitate is
produced
Purity
Loss on drying Not more than 1 % (105 ºC, two hours)Organic impurities Passes test for 20 mg/kg of UV active components
Fluoride Not more than 3 mg/kg
Lead Not more than 1 mg/kg1995L0031 — EN — 11.05.2004 — 004.001 — 10
▼M3
▼B
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 951Chemical formula C
14H18N2O5
Relative molecular mass 294,31Assay 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 ºC, 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 ðαÞ
20
D: + 14,5 to + 16,5º
Determine in a 4 in 100/15 N formic acid solution
within 30 minutes after preparation of the sample solu-
tion
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight
basis
5-Benzyl-3,6-dioxo-2-piperazineacetic
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
Description A practically colourless, white crystalline powder with a
sweet-sour taste. Approximately 40 times as sweet as
sucrose1995L0031 — EN — 11.05.2004 — 004.001 — 11
▼B
Identification
A. Solubility Soluble in water and in ethanolB. 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 ºC, 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 basisHeavy 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 basisDicyclohexylamine Not more than 1 mg/kg expressed on dry weight basisAniline 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 205-348-9E number E 952Chemical formula C
6H12NNaO3S and the dihydrate form
C6H12NNaO3S·2H2O
Relative molecular mass 201,22 calculated on the anhydrous form
237,22 calculated on the hydrated form
Assay Not 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 ºC, one hour)
Not more than 15,2 % (105 ºC, two hours) for the dihy-
drate 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 basisLead Not more than 1 mg/kg expressed on dry weight basisHeavy 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 basisDicyclohexylamine Not more than 1 mg/kg expressed on dry weight basisAniline Not more than 1 mg/kg expressed on dry weight basis1995L0031 — EN — 11.05.2004 — 004.001 — 12
▼B
(III) CALCIUM CYCLAMATE
Synonyms Cyclamate, calcium salt of cyclamic acid
Definition
Chemical name Calcium cyclohexanesulphamate, calcium cyclohexylsul-
phamate
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 ºC, one hour)
Not more than 8,5 % (140 ºC, four hours) for the dihy-
drate 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 basisLead 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 basisAniline 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-dioxideEinecs 201-321-0
E number E 954
Chemical formula C
7H5NO3S
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 having a sweet taste
even in very dilute solutions. Approximately between
300 and 500 times as sweet as sucrose
Identification
Solubility Slightly soluble in water, soluble in basic solutions,
sparingly soluble in ethanol
Purity
Loss on drying Not more than 1 % (105 ºC, two hours)
Melting range 226 to 230 ºC1995L0031 — EN — 11.05.2004 — 004.001 — 13
▼B
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Selenium Not more than 30 mg/kg expressed on dry weight basisLead Not more than 1 mg/kg expressed on dry weight basisHeavy 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 basisBenzoic 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 approxi-
mately 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 basisBenzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basisReadily carbonizable substances Absent
(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 C
7H4NNaO3S·2H2O
Relative molecular mass 241,19Assay Not less than 99 % and not more than 101 % of
C
7H4NNaO3S 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 ºC, four hours)
Arsenic Not more than 3 mg/kg expressed on dry weight basisSelenium Not more than 30 mg/kg expressed on dry weight basisLead Not more than 1 mg/kg expressed on dry weight basisHeavy metals 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 approxi-
mately 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 basisp-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basisBenzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis
Readily carbonizable substances Absent
(III) CALCIUM SACCHARIN
Synonyms Saccharin, calcium salt of saccharin1995L0031 — EN — 11.05.2004 — 004.001 — 14
▼B
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
Chemical formula C14H8CaN2O6S2·3½H2O
Relative molecular mass 467,48Assay Not less than 95 % of C
14H8CaN2O6S2on the anhydrous
basis
Description White crystals or a white crystalline powder, odourless
or with a faint odour, having an intensely sweet taste,
even in very dilute solutions. Approximately between
300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility Freely soluble in water, soluble in ethanol
Purity
Loss on drying Not more than 13,5 % (120 ºC, four hours)Arsenic Not more than 3 mg/kg expressed on dry weight basisSelenium Not more than 30 mg/kg expressed on dry weight basisLead 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 acid To 10 ml of a 1 in 20 solution, previously acidified with
five drops of acetic acid, add three drops of an approxi-
mately 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 basisp-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basisBenzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basisReadily carbonizable substances Absent
(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
7H4KNO3S·H2O
Relative molecular mass 239,77Assay Not less than 99 % and not more than 101 % of
C
7H4KNO3S 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 ethanol1995L0031 — EN — 11.05.2004 — 004.001 — 15
▼B
Purity
Loss on drying Not more than 8 % (120 ºC, four hours)
Arsenic Not more than 3 mg/kg expressed on dry weight basisSelenium 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 acid To 10 ml of a 1 in 20 solution, previously acidified with
five drops of acetic acid, add three drops of an approxi-
mately 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 basisBenzoic acid p-sulfonamide Not more than 25 mg/kg expressed on dry weight basis
Readily carbonizable substances Absent
E 955 — SUCRALOSE
Synonyms 4,1',6'-trichlorogalactosucrose
Definition
Chemical name 1,6-Dichloro-1,6-dideoxy-b-D-fructofuranosyl-4-chloro-
4-deoxy-a-D-galactopyranoside
Einecs 259-952-2
Chemical formula C
12H19Cl3O8
Molecular weight 397,64
Assay Content not less than 98 % and not more than 102 %
C12H19Cl3O8calculated on an anhydrous basis.
Description White to off-white, practically odourless crystalline
powder.
Identification
A. pH of a 10 % solution Not less than 5,0 and not more than 7,0
B. Solubility Freely soluble in water, methanol and ethanol
Slightly soluble in ethyl acetate
C. Infrared absorption The infrared spectrum of a potassium bromide disper-
sion of the sample exhibits relative maxima at similar
wave numbers as those shown in the reference spectrum
obtained using a sucralose reference standard.
D. Thin-layer chromatography The main spot in the test solution has the same Rf value
as that of the main spot of standard solution A referred
to in the test for other chlorinated disaccharides. This
standard solution is obtained by dissolving 1,0 g of
sucralose reference standard in 10 ml of methanol.
E. Specific rotation [ α]20D: + 84,0º to + 87,5º calculated on the anhydrous
basis
(10 % w/v solution)
Purity
Water Not more than 2,0 % (Karl Fischer method)
Sulphated ash Not more than 0,7 %
Lead Not more than 1 mg/kgOther chlorinated disaccharides Not more than 0,5 %
Chlorinated monosaccharides Not more than 0,1 %
Triphenylphosphine oxide Not more than 150 mg/kg1995L0031 — EN — 11.05.2004 — 004.001 — 16
▼M4
▼M4
Methanol Not more than 0,1 %
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 Thau-
matococcus 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 aminoacidsRelative molecular mass Thaumatin I 22209
Thaumatin II 22293
Assay Not less than 16 % nitrogen on the dried basis equiva-
lent 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 ºC 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 basisArsenic Not more than 3 mg/kg expressed on dry weight basis
Lead 3 mg/kg expressed on dry weight basis
Microbiological criteria Total aerobic microbial count: Max 1 000/g E. Coli:
absent in 1 g
E 959 — NEOHESPERIDINE DIHYDROCHALCONE
Synonyms Neohesperidin dihydrochalcone, NHDC, hesperetin
dihydrochalcone-4 ′-β-neohesperidoside, neohesperidin
DC
Definition
Chemical name 2-O- α-L-rhamnopyranosyl-4 ′-β-D-glucopyranosyl
hesperetin dihydrochalcone; obtained by catalytic hydro-
genation of neohesperidin
Einecs 243-978-6
E number E 959Chemical formula C
28H36O15
Relative molecular mass 612,6Assay Content not less than 96 % on the dried basis
Description Off white, odourless, crystalline powder having a char-
acteristic, 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 cold1995L0031 — EN — 11.05.2004 — 004.001 — 17
▼B
▼B
water, practically insoluble in ether and benzene
B. Ultraviolet absorption maximum 282 to 283 nm for a solution of 2 mg in 100 ml
methanol
C. Neu's test Dissolve about 10 mg of neohesperidine DC in 1 ml
methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl
borate methanolic solution. A bright yellow colour is
produced
Purity
Loss on drying Not more than 11 % (105 ºC, three huors)
Sulphated ash Not more than 0,2 % expressed on dry weight basisArsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 2 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight
basis
E 962 — SALT OF ASPARTAME-ACESULFAME
Synonyms Aspartame-acesulfame
Aspartame-acesulfame salt
Definition The salt is prepared by heating an approximately 2:1
ratio (w/w) of aspartame and acesulfame K in solution
at acidic pH and allowing crystallisation to occur. The
potassium and moisture are eliminated. The product is
more stable than aspartame alone.
Chemical name 6-methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of
L-phenylalanyl-2-methyl-L-a-aspartic acid
Chemical formula C
18H23O9N3S
Molecular weight 457,46
Assay 63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to
37,0 % acesulfame (acid form on a dry basis)
Description A white, odourless, crystalline powder.
Identification
A. Solubility Sparingly soluble in water; slightly soluble in ethanol.
B. Transmittance The transmittance of a 1 % solution in water determined
in a 1 cm cell at 430 nm with a suitable spectrophot-
ometer using water as a reference, is not less than 0,95,
equivalent to an absorbance of not more than approxi-
mately 0,022.
C. Specific rotation [ α]20D: +14,5º to +16,5º
Determine at a concentration of 6,2 g in 100 ml formic
acid (15N) within 30 min of preparation of the solution.
Divide the calculated specific rotation by 0,646 to
correct for the aspartame content of the salt of aspar-
tame-acesulfame.
Purity
Loss on drying Not more than 0,5 % (105 ºC, 4 h)
5-Benzyl-3,6-dioxo-2-piperazineacetic
acidNot more than 0,5 %
Lead Not more than 1 mg/kg1995L0031 — EN — 11.05.2004 — 004.001 — 18
▼M4