Commission Directive 2000/51/EC of 26 July 2000 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)
Date: 2000-07-26
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, marketing, product quality, sweetener

4.8.2000

EN

Official Journal of the European Communities

L 198/41

COMMISSION DIRECTIVE 2000/51/EC

of 26 July 2000

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
European Parliament and Council Directive 94/34/EC (2), and in
particular Article 3(3)(a) thereof,

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

European Parliament and Council Directive 94/35/EC of
30 June 1994 on sweeteners for use in foodstuffs (3), as
amended
those
substances which may be used as sweeteners in food-
stuffs.

by Directive

96/83/EC (4),

lists

Commission Directive 95/31/EC of 5 July 1995 laying
down specific criteria of purity concerning sweeteners
for use in foodstuffs (5), as amended by Directive 98/
66/EC (6), sets out the purity criteria for the sweeteners
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 maltitol syrup (E 965(ii)). It is
consequently necessary to adapt that Directive.

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

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 965 (ii)) maltitol syrup 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 2001 at the latest. They shall forthwith
inform the Commission thereof.

those provisions,

they shall
When Member States adopt
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 twentieth day
the European
following its publication in Official
Communities.

Journal of

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 26 July 2000.

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 257, 19.9.1998, p. 35.

L 198/42

EN

Official Journal of the European Communities

4.8.2000

ANNEX

‘E 421 MANNITOL

1. Mannitol

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

D-mannitol

Mannitol is manufactured by catalytic hydrogenation of a mixture of glucose
and fructose made from invert sugar

D-mannitol

200-711-8

H
C
6

O
6

14

182,2

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

B. Melting range

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

Between 164 and 169 °C.

C. Thin layer chromatography

Passes test

D. Specific rotation

[α] 20

D: + 23° to + 25° (borate solution)

E. pH

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

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

Not more than 0,3 % (105 °C, 4 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

Mannitol can also be manufactured by discontinous fermentation under
aerobic conditions a conventional strain of the yeast Zygosaccharomyces rouxii

D-mannitol

200-711-8

H
C
6

O
6

14

182,2

Not less than 99 % on the dried basis

White, odourles crystalline powder

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Official Journal of the European Communities

L 198/43

Identification

A. Solubility

B. Melting range

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

Between 164 and 169 °C.

C. Thin layer chromatography

Passes test

D. Specific rotation

[α] 20

D: + 23° to + 25° (borate solution)

E. pH

Purity

Arabitol

Loss on drying

Reducing sugars

Total sugars

Sulphated ash

Chlorides

Sulphate

Lead

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

Not more than 0,3 %

Not more than 0,3 % (105 °C, 4 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’

‘E 965(ii) SYRUP MALTITOL

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Hydrogenated high-maltose-glucose syrup, hydrogenated glucose syrup

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.

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

Colourless and odourless, clear viscous liquids or white crystalline masses

Very soluble in water, slightly soluble in ethanol

B. Thin layer chromatography

Passes test

Purity

Water

Reducing sugars

Sulphated ash

Chlorides

Sulphate

Nickel

Lead

Not more than 31 % (Karl Fischer)

Not more than 0,3 % (as glucose)

Not more than 0,1 %

Not more than 50 mg/kg

Not more than 100 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg’