Commission Directive 2001/52/EC of 3 July 2001 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)
Date: 2001-07-03
Institutions: European Commission
Subjects: food chemistry, foodstuffs legislation, sweetener

L 190/18

EN

Official Journal of the European Communities

12.7.2001

COMMISSION DIRECTIVE 2001/52/EC

of 3 July 2001

amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use
in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HAS ADOPTED THIS DIRECTIVE:

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/107/EEC of 21
December 1988 on the approximation of the laws of the
Member States concerning food additives authorised for use in
foodstuffs intended for human consumption (1), as amended by
Directive 94/34/EC (2) of the European Parliament and of the
Council, and in particular Article 3(3)(a) thereof,

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

Directive 94/35/EC of the European Parliament and of
the Council of 30 June 1994 on sweeteners for use in
foodtuffs (3), as amended by Directive 96/83/EC (4), lists
those substances which may be used as sweeteners in
foodstuffs.

Commission Directive 95/31/EC of 5 July 1995 laying
down specific criteria of purity concerning sweeteners
for use in foodstuffs (5), as last amended by Directive
2000/51/EC (6), sets out the purity criteria for the sweet-
eners mentioned in Directive 94/35/EC.

It is necessary,
in the light of technical progress, to
amend the purity criteria set out in Directive 95/31/EC
for mannitol (E 421) and acesulfme K (E 950).

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

It is consequently necessary to adapt Directive 95/31/EC.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

Article 1

In the Annex to Directive 95/31/EC, the text concerning E 421
mannitol and E 950 acesulfame K shall be replaced by the text
in the Annex to this Directive.

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 30 June 2002 at the latest. They shall forthwith
inform the Commission thereof.

those provisions,

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

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.

Done at Brussels, 3 July 2001.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 237, 10.9.1994, p. 1.
(3) OJ L 237, 10.9.1994, p. 3.
(4) OJ L 48, 19.2.1997, p. 16.
(5) OJ L 178, 28.7.1995, p. 1.
(6) OJ L 198, 4.8.2000, p. 41.

12.7.2001

EN

Official Journal of the European Communities

L 190/19

‘E 950 ACESULFAME K

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

ANNEX

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

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

259-715-3

C
4

KNO
H
4
4

S

201,24

Content not less than 99 % of C
H
4

KNO
4
4

S on the anhydrous basis

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

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 cobaltnitrite 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

Organic impurities

Fluoride

Lead

E 421 MANNITOL

1. Mannitol

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

Not more than 1 % (105 °C, two hours)

Passes test for 20 mg/kg of UV active components

Not more than 3 mg /kg

Not more than 1 mg/kg

D-mannitol

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

D-mannitol

200-711-8

C
6

H

14

O
6

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

E. pH

[α] 20

D

: + 23° to + 25° (borate solution)

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

L 190/20

EN

Official Journal of the European Communities

12.7.2001

Purity

Loss on drying

Reducing sugars

Total sugars

Sulphated ash

Chlorides

Sulphate

Nickel

Lead

2. Mannitol manufactured by fermentation

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

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

Manufactured by discontinous fermentation under aerobic conditions
using a conventional strain of the yeast Zygosaccharomyces rouxii

D-mannitol

200-711-8

C
6

H

14

O
6

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

E. pH

[α] 20

D

: + 23° to + 25° (borate solution)

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’