Commission Directive 2004/46/EC of 16 April 2004 amending Directive 95/31/EC as regards E 955 sucralose and E 962 salt of aspartame-acesulfame (Text with EEA relevance)
Date: 2004-04-16
Institutions: European Commission
Subjects: food standard, foodstuffs legislation, human nutrition, labelling, marketing standard, sweetener

21.4.2004

EN

Official Journal of the European Union

L 114/15

COMMISSION DIRECTIVE 2004/46/EC

of 16 April 2004

amending Directive 95/31/EC as regards E 955 sucralose and E 962 salt of aspartame-acesulfame

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Article 2

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
Member States concerning food additives authorised for use in
foodstuffs intended for human consumption (1), and in particu-
lar Article 3(3)(a) thereof,

the laws of

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Directive 95/31/EC of 5 July 1995 laying
down specific criteria of purity concerning sweeteners
for use in foodstuffs (2) sets out the purity criteria for the
the
sweeteners mentioned in Directive 94/35/EC of
European Parliament and of the Council of 30 June
1994 on sweeteners for use in foodstuffs (3).

It is necessary to establish purity criteria for E 955 sucra-
lose and E 962 salt of aspartame-acesulfame.

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

techniques for additives as set out

Directive 95/31/EC should therefore be amended accord-
ingly.

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

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 April 2005 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this Direc-
tive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

Article 4

This Directive is addressed to the Member States.

HAS ADOPTED THIS DIRECTIVE:

Done at Brussels, 16 April 2004.

Article 1

The Annex to Directive 95/31/EC is amended in accordance
with the Annex to this Directive.

For the Commission

David BYRNE

Member of the Commission

(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

2001/52/EC (OJ L 190, 12.7.2001, p. 18).

(3) OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive
2003/115/EC of the European Parliament and of the Council (OJ L
24, 29.1.2004, p. 65).

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Official Journal of the European Union

21.4.2004

In the Annex, the following text is inserted:

ANNEX

‘E955 E 955 SUCRALOSE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

4,1',6'-trichlorogalactosucrose

1,6-Dichloro-1,6-dideoxy-b-D-fructofuranosyl-4-chloro-4-deoxy-a-D-galactopyra-
noside

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. 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

D. Thin-layer
graphy

chromato-

E. Specific rotation

Purity

Water

The infrared spectrum of a potassium bromide dispersion of the sample exhibits
relative maxima at similar wave numbers as those shown in the reference spec-
trum 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 disac-
charides. This standard solution is obtained by dissolving 1,0 g of sucralose
reference standard in 10 ml of methanol.
[α ]20D: + 84,0° to + 87,5° calculated on the anhydrous basis
(10 % w/v solution)

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

Sulphated ash

Not more than 0,7 %

Lead

Other chlorinated disac-
charides

Chlorinated monosacchar-
ides

Not more than 1 mg/kg

Not more than 0,5 %

Not more than 0,1 %

Triphenylphosphine oxide

Not more than 150 mg/kg

Methanol

Not more than 0,1 %

E962 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
methyl-L-a-aspartic acid

salt

of

L-phenylalanyl-2-

Chemical formula

C18H23O9N3S

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)

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Official Journal of the European Union

L 114/17

Description

Identification

A. Solubility

B. Transmittance

C. Specific rotation

Purity

A white, odourless, crystalline powder.

Sparingly soluble in water; slightly soluble in ethanol.

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.
[α ]20D: +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.

Loss on drying

Not more than 0,5 % (105 °C, 4 h)

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

Not more than 0,5 %

Lead

Not more than 1 mg/kg’