Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (Codified version) (Text with EEA relevance)
Date: 2008-06-17
Institutions: European Commission
Subjects: codification of EU law, food safety, foodstuff, health control, human nutrition, product quality, sweetener

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DIRECTIVES

COMMISSION DIRECTIVE 2008/60/EC

of 17 June 2008

laying down specific purity criteria concerning sweeteners for use in foodstuffs

(Text with EEA relevance)

(Codified version)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

to

regard

Council Directive

Having
of
21 December 1988 on the approximation of the laws of the
Member States concerning food additives authorized for use in
intended for human consumption (1),
and in
foodstuffs
particular Article 3(3)(a) thereof,

89/107/EEC

(5)

(6)

Whereas:

significantly different

Food additives prepared by production methods or
starting materials
from those
evaluated by the Scientific Committee for Food or
different from those mentioned in this Directive should
be submitted for safety evaluation by the European Food
Safety Authority with emphasis on the purity criteria.

The measures provided for in this Directive are in line
with the opinion of the Standing Committee on the Food
Chain and Animal Health.

This Directive should be without prejudice to the obli-
gations of the Member States relating to the time-limits
for transposition into national law of the Directives set
out in Annex II, Part B,

(1)

(2)

(3)

Commission Directive 95/31/EC of 5 July 1995 laying
down specific criteria of purity concerning sweeteners for
use in foodstuffs (2) has been substantially amended
several times (3). In the interest of clarity and rationality
the said Directive should be codified.

HAS ADOPTED THIS DIRECTIVE:

all
is necessary to establish purity criteria
It
sweeteners mentioned in European Parliament
and
Council Directive 94/35/EC of 30 June 1994 on
sweeteners for use in foodstuffs (4).

for

Article 1

The purity criteria referred to in Article 3(3)(a) of Directive
89/107/EEC for sweeteners mentioned in Directive 94/35/EC
are set out in Annex I to this Directive.

It is necessary to take into account the specifications and
analytical techniques for sweeteners as set out in the
Codex Alimentarius as drafted by the Joint FAO/WHO
Expert Committee on Food Additives (JECFA).

Article 2

Directive 95/31/EC, as amended by the Directives listed in
is repealed, without prejudice to the obli-
Annex II, Part A,
gations of the Member States relating to the time-limits for
transposition into national
in
law of
Annex II, Part B.

the Directives set out

(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive

2006/128/EC (OJ L 346, 9.12.2006, p. 6).

(3) See Annex II, Part A.
(4) OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive

2006/52/EC (OJ L 204, 26.7.2006, p. 10).

References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance
with the correlation table in Annex III.

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This Directive shall enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 17 June 2008.

For the Commission
The President

José Manuel BARROSO

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ANNEX I

D-glucitol, D-sorbitol

D-glucitol

200-061-5

C6H14O6

182,17

Content not less than 97 % of total glycitols and not less than 91 %
of D-sorbitol on dry weight basis.

Glycitols are compounds with the structural
(CHOH)n-CH2OH, where ‘n’ is an integer

formula CH2OH-

White hygroscopic powder, crystalline powder,
having a sweet taste

flakes or granules

E 420 (i) — SORBITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Relative molecular mass

Assay

Description

Identification

A. Solubility

Very soluble in water, slightly soluble in ethanol

B. Melting range

88 to 102 °C

C. Sorbitol monobenzylidene derivative

To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde
and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker
until crystals appear. Filter with the aid of suction, dissolve the
crystals in 20 ml of boiling water containing 1 g of sodium bicar-
bonate, 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

Sulphated ash

Not more than 1 % (Karl Fischer method)

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

Sulphates

Nickel

Arsenic

Lead

Not more than 50 mg/kg expressed on dry weight basis

Not more than 100 mg/kg expressed on dry weight basis

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

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

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E 420 (ii) — SORBITOL SYRUP

Synonyms

Definition

Chemical name

Einecs

Assay

Description

Identification

A. Solubility

B. Melting range

Purity

Water content

Sulphated ash

D-glucitol syrup

Sorbitol
syrup formed by hydrogenation of glucose syrup is
composed of D-sorbitol, D-mannitol and hydrogenated saccharides.

The part of the product which is not D-sorbitol is composed mainly
of hydrogenated oligosaccharides formed by the hydrogenation of
glucose syrup used as raw material
(in which case the syrup is
non-crystallising) or mannitol. Minor quantities of glycitols where
n ≤ 4 may be present. Glycitols are compounds with the structural
formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer

270-337-8

Content not less than 69 % total solids and not less than 50 % of
D-sorbitol on the anhydrous basis

Clear colourless and sweet-tasting aqueous solution

Miscible with water, with glycerol, and with propane-1,2-diol

To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde
and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker
until crystals appear. Filter with the aid of suction, dissolve the
crystals in 20 ml of boiling water containing 1 g of sodium bicar-
bonate, 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

Not more than 31 % (Karl Fischer method)

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

Sulphates

Nickel

Arsenic

Lead

Not more than 50 mg/kg expressed on dry weight basis

Not more than 100 mg/kg expressed on dry weight basis

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

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

(I) MANNITOL

Synonyms

D-mannitol

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Definition

Manufactured by catalytic hydrogenation of carbohydrate solutions
containing glucose and/or fructose

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

D-mannitol

200-711-8

C6H14O6

182,2

Content not less than 96,0 % D-mannitol and not more than 102 %
on the dried basis

White, odourless, crystalline powder

Soluble in water, very slightly soluble in ethanol, practically insoluble
in ether

B. Melting range

Between 164 and 169 °C

C. Thin layer chromatography

Passes test

D. Specific rotation

[α] 20

D: + 23 ° to + 25 ° (borate solution)

E. pH

Between 5 and 8

Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of
a 10 % w/v solution of the sample, then measure the pH

Purity

Loss on drying

Reducing sugars

Total sugars

Sulphated ash

Chlorides

Sulphate

Nickel

Lead

(II) MANNITOL MANUFACTURED

BY FERMENTATION

Synonyms

Definition

Not more than 0,3 % (105 °C, four hours)

Not more than 0,3 % (as glucose)

Not more than 1 % (as glucose)

Not more than 0,1 %

Not more than 70 mg/kg

Not more than 100 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

D-mannitol

by

Manufactured
aerobic
conditions using a conventional strain of the yeast Zygosaccharomyces
rouxii

discontinuous

fermentation

under

Chemical name

D-mannitol

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Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

200-711-8

C6H14O6

182,2

Not less than 99 % on the dried basis

White, odourless crystalline powder

Soluble in water, very slightly soluble in ethanol, practically insoluble
in ether

B. Melting range

Between 164 and 169 °C

C. Thin layer chromatography

Passes test

D. Specific rotation

[α] 20

D: + 23 ° to + 25 ° (borate solution)

E. pH

Between 5 and 8

Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of
a 10 % w/v solution of the sample, then measure the pH

Purity

Arabitol

Loss on drying

Reducing sugars

Total sugars

Sulphated ash

Chlorides

Sulphate

Lead

Not more than 0,3 %

Not more than 0,3 % (105 °C, four hours)

Not more than 0,3 % (as glucose)

Not more than 1 % (as glucose)

Not more than 0,1 %

Not more than 70 mg/kg

Not more than 100 mg/kg

Not more than 1 mg/kg

Aerobic mesophilic bacteria

Not more than 103/g

Coliforms

Salmonella

E. Coli

Staphylococcus aureus

Pseudomonas aeruginosa

Moulds

Yeasts

Absent in 10 g

Absent in 10 g

Absent in 10 g

Absent in 10 g

Absent in 10 g

Not more than 100/g

Not more than 100/g

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E 950 — ACESULFAME K

Synonyms

Definition

Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-
oxathiazin-4-one,2,2-dioxide

Chemical name

6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

259-715-3

C4H4KNO4S

201,24

Content not less than 99 % of C4H4KNO4S on the anhydrous basis

Odourless, white, crystalline powder. Approximately 200 times as
sweet as sucrose

A. Solubility

Very soluble in water, very slightly soluble in ethanol

B. Ultraviolet absorption

Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water

C. Positive test for potassium

Passes test (test the residue obtained by igniting 2 g of the sample)

D. Precipitation test

Purity

Add a few drops of a 10 % solution of sodium cobalt nitrite to a
solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of
water. A yellow precipitate is produced

Loss on drying

Not more than 1 % (105 °C, two hours)

Organic impurities

Passes test for 20 mg/kg of UV active components

Fluoride

Lead

Not more than 3 mg/kg

Not more than 1 mg/kg

E 951 — ASPARTAME

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Aspartyl phenylalanine methyl ester

N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbo-
methoxy-phenethyl)-succinamic acid-N-methyl ester

245-261-3

C14H18N2O5

Relative molecular mass

294,31

Assay

Not less than 98 % and not more than 102 % of C14H18N2O5 on the
anhydrous basis

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Description

Identification

Solubility

Purity

Loss on drying

Sulphated ash

pH

Transmittance

White, odourless, crystalline powder having a sweet taste. Approxi-
mately 200 times as sweet as sucrose

Slightly soluble in water and in ethanol

Not more than 4,5 % (105 °C, four hours)

Not more than 0,2 % expressed on dry weight basis

Between 4,5 and 6,0 (1 in 125 solution)

The transmittance of a 1 % solution in 2N hydrochloric acid,
determined in a 1-cm cell at 430 nm with a suitable spectrophot-
ometer, using 2N hydrochloric acid as a reference, is not less than
0,95, equivalent to an absorbance of not more than approximately
0,022

Specific rotation

[α]D

20: + 14,5 to + 16,5 °

Determine in a 4 in 100/15 N formic acid solution within 30
minutes after preparation of the sample solution

Arsenic

Lead

Not more than 3 mg/kg expressed on dry weight basis

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 acid

Not more than 1,5 % expressed on dry weight basis

E 952 — CYCLAMIC ACID AND ITS Na AND Ca SALTS

(I) CYCLAMIC ACID

Synonyms

Definition

Cyclohexylsulphamic acid, cyclamate

Chemical name

Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid

Einecs

Chemical formula

Relative molecular mass

Assay

Description

Identification

202-898-1

C6H13NO3S

179,24

Cyclohexylsulphamic acid contains not less than 98 % and not more
than the equivalent of 102 % of C6H13NO3S, calculated on the
anhydrous basis

A practically colourless, white crystalline powder with a sweet-sour
taste. Approximately 40 times as sweet as sucrose

A. Solubility

Soluble in water and in ethanol

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B. Precipitation test

Purity

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.

Loss on drying

Not more than 1 % (105 °C, one hour)

Selenium

Lead

Heavy metals

Arsenic

Not more than 30 mg/kg expressed as selenium on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

Not more than 10 mg/kg expressed as Pb on dry weight basis

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

Definition

Cyclamate, sodium salt of cyclamic acid

Chemical name

Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate

Einecs

Chemical formula

205-348-9

C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O

Relative molecular mass

201,22 calculated on the anhydrous form

237,22 calculated on the hydrated form

Assay

Not less than 98 % and not more than 102 % on the dried basis

Description

Identification

Solubility

Purity

Dihydrate form: not less than 84 % on the dried basis

White, odourless crystals or crystalline powder. Approximately 30
times as sweet as sucrose

Soluble in water, practically insoluble in ethanol

Loss on drying

Not more than 1 % (105 °C, one hour)

Selenium

Arsenic

Lead

Not more than 15,2 % (105 °C, two hours) for the dihydrate form

Not more than 30 mg/kg expressed as selenium on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

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

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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

Definition

Cyclamate, calcium salt of cyclamic acid

Chemical name

Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate

Einecs

205-349-4

Chemical formula

C12H24CaN2O6S2

·2H2O

Relative molecular mass

432,57

Assay

Description

Identification

Solubility

Purity

Not less than 98 % and not more than 101 % on the dried basis

White, colourless crystals or crystalline powder. Approximately 30
times as sweet as sucrose

Soluble in water, sparingly soluble in ethanol

Loss on drying

Not more than 1 % (105 °C, one hour)

Selenium

Arsenic

Lead

Not more than 8,5 % (140 °C, four hours) for the dihydrate form

Not more than 30 mg/kg expressed as selenium on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

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 953 — ISOMALT

Synonyms

Hydrogenated isomaltulose, hydrogenated palatinose.

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Definition

Chemical name

Chemical formula

Relative molecular mass

Assay

Description

Identification

Isomalt is a mixture of hydrogenated mono- and disaccharides whose
principal components are the disaccharides:
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)

6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O

6-O-α-D-Glucopyranosyl-D-sorbitol: 344,32
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32

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
dihydrate
determined on the anhydrous basis.

1-O-α-D-Glucopyranosyl-D-mannitol

and

Odourless, white, slightly hygroscopic, crystalline mass.

A. Solubility

Soluble in water, very slightly soluble in ethanol.

B. Thin layer chromatography

Examine by thin layer chromatography using a plate coated with an
approximately 0,2 mm layer of chromatographic silica gel. The
principal spots in the chromatogram are those of 1,1-GPM and
1,6-GPS.

Purity

Water content

Sulphated ash

D-Mannitol

D-Sorbitol

Not more than 7 % (Karl Fischer Method)

Not more than 0,05 % expressed on dry weight basis

Not more than 3 %

Not more than 6 %

Reducing sugars

Not more than 0,3 % expressed as glucose on dry weight basis

Nickel

Arsenic

Lead

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

Heavy metals (as Pb)

Not more than 10 mg/kg expressed on dry weight basis.

E 954 — SACCHARIN AND ITS Na, K AND Ca SALTS

(I) SACCHARIN

Definition

Chemical name

3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide

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Einecs

Chemical formula

Relative molecular mass

201-321-0

C7H5NO3S

183,18

Assay

Description

Identification

Solubility

Purity

Not less than 99 % and not more than 101 % of C7H5NO3S on the
anhydrous basis

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

Slightly soluble in water, soluble in basic solutions, sparingly soluble
in ethanol

Loss on drying

Melting range

Sulphated ash

Benzoic and salicylic acid

Not more than 1 % (105 °C, two hours)

226 to 230 °C

Not more than 0,2 % expressed on dry weight basis

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-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

(II) SODIUM SACCHARIN

Synonyms

Definition

Chemical name

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

Saccharin, sodium salt of saccharin

Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzi-
sosulphonazole,
1,2-benzisothiazolin-3-
one-1, 1-dioxide sodium salt dihydrate

oxobenzisosulphonazole,

Einecs

204-886-1

Chemical formula

C7H4NNaO3S·2H2O

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Relative molecular mass

241,19

Assay

Description

Identification

Solubility

Purity

Not less than 99 % and not more than 101 % of C7H4NNaO3S on
the anhydrous basis

White crystals or a white crystalline efflorescent powder, odourless or
with a faint odour, having an intensely sweet taste, even in very
dilute solutions. Approximately between 300 and 500 times as
sweet as sucrose in dilute solutions

Freely soluble in water, sparingly soluble in ethanol

Loss on drying

Not more than 15 % (120 °C, four hours)

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-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

(III) CALCIUM SACCHARIN

Synonyms

Definition

Chemical name

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

Saccharin, calcium salt of saccharin

Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzi-
sosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt
hydrate (2:7)

Einecs

229-349-9

Chemical formula

C14H8CaN2O6S2

·3½H2O

Relative molecular mass

467,48

Assay

Description

Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis

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

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Identification

Solubility

Purity

Freely soluble in water, soluble in ethanol

Loss on drying

Not more than 13,5 % (120 °C, four hours)

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-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

(IV) POTASSIUM SACCHARIN

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Saccharin, potassium salt of saccharin

Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-
oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-
one-1,1-dioxide monohydrate

C7H4KNO3S·H2O

Relative molecular mass

239,77

Assay

Description

Identification

Solubility

Purity

Not less than 99 % and not more than 101 % of C7H4KNO3S on the
anhydrous basis

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

Freely soluble in water, sparingly soluble in ethanol

Loss on drying

Not more than 8 % (120 °C, four hours)

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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-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

E 955 — SUCRALOSE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

4,1′,6′-Trichlorogalactosucrose

1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-
galactopyranoside

259-952-2

C12H19Cl3O8

397,64

Content not less than 98 % and not more than 102 % C12H19Cl3O8
calculated on an anhydrous basis.

White to off-white, practically odourless, crystalline powder.

A. Solubility

Freely soluble in water, methanol and ethanol

Slightly soluble in ethyl acetate

B. Infrared absorption

C. Thin layer chromatography

The infrared spectrum of a potassium bromide dispersion of the
sample exhibits relative maxima at similar wave numbers as those
shown in the reference spectrum obtained using a sucralose reference
standard.

The main spot in the test solution has the same Rf value as that of
the main spot of standard solution A referred to in the test for other
chlorinated disaccharides. This standard solution is obtained by
dissolving 1,0g of sucralose reference standard in 10 ml of methanol.

D. Specific rotation

[α] 20

D + 84,0 ° to + 87,5 ° calculated on the anhydrous basis

(10 % w/v solution)

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Purity

Water

Not more than 2,0 % (Karl Fischer method)

Sulphated ash

Not more than 0,7 %

Other chlorinated disaccharides

Not more than 0,5 %

Chlorinated monosaccharides

Not more than 0,1 %

Triphenylphosphine oxide

Not more than 150 mg/kg

Methanol

Lead

Not more than 0,1 %

Not more than 1 mg/kg

E 957 — THAUMATIN

Synonyms

Definition

Chemical name

the fruit of

Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the
the natural strain of Thaumatococcus daniellii
arils of
(Benth) and consists essentially of
the proteins thaumatin I and
together with minor amounts of plant constituents
thaumatin II
derived from the source material

Einecs

258-822-2

Chemical formula

Polypeptide of 207 amino acids

Relative molecular mass

Thaumatin I 22209

Thaumatin II 22293

Assay

Description

Identification

Solubility

Purity

Loss on drying

Carbohydrates

Sulphated ash

Not less than 16 % nitrogen on the dried basis equivalent to not less
than 94 % proteins (N × 5,8)

Odourless, cream-coloured powder with an intensely sweet
Approximately 2 000 to 3 000 times as sweet as sucrose

taste.

Very soluble in water, insoluble in acetone

Not more than 9 % (105 °C to constant weight)

Not more than 3 % expressed on dry weight basis

Not more than 2 % expressed on dry weight basis

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Aluminium

Not more than 100 mg/kg expressed on dry weight basis

Arsenic

Lead

Not more than 3 mg/kg expressed on dry weight basis

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

Definition

Chemical name

Einecs

Chemical formula

Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-
4′-β-neohesperidoside, neohesperidin DC

2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydro-
chalcone; obtained by catalytic hydrogenation of neohesperidin

243-978-6

C28H36O15

Relative molecular mass

612,6

Assay

Description

Identification

A. Solubility

Content not less than 96 % on the dried basis

Off-white, odourless, crystalline powder having a characteristic,
taste. Approximately between 1 000 and 1 800
intensive sweet
times as sweet as sucrose

Freely soluble in hot water, very slightly soluble in cold water, prac-
tically 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

Purity

Loss on drying

Sulphated ash

Arsenic

Lead

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

Not more than 11 % (105 °C, three hours)

Not more than 0,2 % expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

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

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18.6.2008

E 962 — SALT OF ASPARTAME-ACESULFAME

Synonyms

Definition

Aspartame-acesulfame, Aspartame-acesulfame salt

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-pheny-
lalanyl-2-methyl-L-α-aspartic acid

Chemical formula

C18H23O9N3S

Molecular weight

457,46

Assay

Description

Identification

63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 %
acesulfame (acid form on a dry basis)

A white, odourless, crystalline powder.

A. Solubility

Sparingly soluble water; slightly soluble in ethanol

B. Transmittance

The transmittance of a 1 % solution in water determined in a 1 cm
cell at 430 nm with a suitable spectrophotometer using water as a
reference, is not less than 0,95, equivalent to an absorbance of not
more than approximately 0,022.

C. Specific rotation

[α] 20

D + 14,5 ° to + 16,5 °

Determine at a concentration of 6,2 g in 100 ml formic acid (15N)
within 30 min of preparation of the solution. Divide the calculated
specific rotation by 0,646 to correct for the aspartame content of the
salt of aspartame-acesulfame

Purity

Loss on drying

Not more than 0,5 % (105 °C, four hours)

5-Benzyl-3,6-dioxo-2-piper-azineacetic acid

Not more than 0,5 %

Lead

Not more than 1 mg/kg

E 965 (i) — MALTITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

D-Maltitol, hydrogenated maltose

(α)-D-Glucopyranosyl-1,4-D-glucitol

209-567-0

C12H24O11

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Relative molecular mass

344,31

Assay

Description

Identification

Content not less than 98 % D-maltitol C12H24O11 on the anhydrous
basis

Sweet tasting, white crystalline powder

A. Solubility

Very soluble in water, slightly soluble in ethanol

B. Melting range

148 to 151 °C

C. Specific rotation

[α]D

20 = + 105,5 ° to + 108,5 ° (5 % w/v solution)

Purity

Water content

Sulphated ash

Not more than 1 % (Karl Fischer method)

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

Sulphates

Nickel

Arsenic

Lead

Not more than 50 mg/kg expressed on dry weight basis

Not more than 100 mg/kg expressed on dry weight basis

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

E 965 (ii) — MALTITOL SYRUP

Synonyms

Definition

Assay

Description

Identification

Hydrogenated high-maltose-glucose
syrup

syrup, hydrogenated glucose

A mixture consisting of mainly maltitol with sorbitol and hydro-
genated oligo- and polysaccharides.
is manufactured by the
catalytic hydrogenation of high maltose-content glucose syrup or
by the hydrogenation of
its individual components followed by
blending. The article of commerce is supplied both as a syrup and
as a solid product.

It

Content not less than 99 % of total hydrogenated saccharides on the
anhydrous basis and not less than 50 % of maltitol on the anhydrous
basis

Colourless and odourless, clear viscous liquids or white crystalline
masses

A. Solubility

Very soluble in water, slightly soluble in ethanol

B. Thin layer chromatography

Passes test

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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

Sulphate

Nickel

Lead

E 966 — LACTITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Not more than 50 mg/kg

Not more than 100 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Lactit, lactositol, lactobiosit

4-O-β-D-Galactopyranosyl-D-glucitol

209-566-5

C12H24O11

Relative molecular mass

344,32

Assay

Description

Identification

Not less than 95 % on the dry weight basis

Sweet-tasting crystalline powders or colourless solutions. Crystalline
products occur in anhydrous, monohydrate and dihydrate forms

A. Solubility

Very soluble in water

B. Specific rotation

20 = + 13 ° to + 16 ° calculated on the anhydrous basis (10 %

[α]D
w/v aqueous solution)

Purity

Water content

Other polyols

Crystalline products; not more than 10,5 % (Karl Fischer method)

Not more than 2,5 % on the anhydrous basis

Reducing sugars

Not more than 0,2 % expressed as glucose on dry weight basis

Chlorides

Sulphates

Not more than 100 mg/kg expressed on dry weight basis

Not more than 200 mg/kg expressed on dry weight basis

Sulphated ash

Not more than 0,1 % expressed on dry weight basis

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Nickel

Arsenic

Lead

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

E 967 — XYLITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Relative molecular mass

Assay

Description

Identification

Xylitol

D-xylitol

201-788-0

C5H12O5

152,15

Not less than 98,5 % as xylitol on the anhydrous basis

White, crystalline powder, practically odourless with a very sweet
taste

A. Solubility

Very soluble in water, sparingly soluble in ethanol

B. Melting range

92 to 96 °C

C. pH

Purity

Loss on drying

5 to 7 (10 % w/v aqueous solution)

Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phos-
phorus 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

Arsenic

Lead

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

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

Sulphates

Not more than 100 mg/kg expressed on dry weight basis

Not more than 200 mg/kg expressed on dry weight basis

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E 968 — ERYTHRITOL

Synonyms

Definition

Meso-erythritol, tetrahydroxybutane, erythrite

Obtained by fermentation of carbohydrate source by safe and suitable
food grade osmophilic yeasts such as Moniliella pollinis or Trichospor-
onoides megachilensis, followed by purification and drying

Chemical name

1,2,3,4-Butanetetrol

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

205-737-3

C4H10O4

122,12

Not less than 99 % after drying

White, odourless, non-hygroscopic, heat-stable
sweetness of approximately 60-80 % that of sucrose.

crystals with a

Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl
ether.

B. Melting range

119-123 °C

Purity

Loss on drying

Sulphated ash

Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)

Not more than 0,1 %

Reducing substances

Not more than 0,3 % expressed as D-glucose

Ribitol and glycerol

Not more than 0,1 %

Lead

Not more than 0,5 mg/kg

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ANNEX II

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 2)

Commission Directive 95/31/EC

(OJ L 178, 28.7.1995, p. 1)

Commission Directive 98/66/EC

(OJ L 257, 19.9.1998, p. 35)

Commission Directive 2000/51/EC

(OJ L 198, 4.8.2000, p. 41)

Commission Directive 2001/52/EC

(OJ L 190, 12.7.2001, p. 18)

Commission Directive 2004/46/EC

(OJ L 114, 21.4.2004, p. 15)

Commission Directive 2006/128/EC

(OJ L 346, 9.12.2006, p. 6)

PART B

List of time-limits for transposition into national law

(referred to in Article 2)

Directive

Time-limit for transposition

95/31/EC

98/66/EC

2000/51/EC

2001/52/EC

2004/46/EC

2006/128/EC

1 July 1996 (1)

1 July 1999

30 June 2001

30 June 2002

1 April 2005

15 February 2008

(1) According to Article 2(2) of Directive 95/31/EC, products put on the market or labelled before 1 July 1996 which do not comply with

this Directive may be marketed until stocks are exhausted.

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ANNEX III

Correlation table

Directive 95/31/EC

This Directive

Article 1(1)

Article 1(2)

Article 2

—

Article 3

Article 4

Annex

—

—

Article 1

—

—

Article 2

Article 3

Article 4

Annex I

Annex II

Annex III