Commission Directive 98/66/EC of 4 September 1998 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)
Date: 1998-09-04
Institutions: European Commission
Subjects: food additive, food inspection, foodstuffs legislation, human nutrition, sweetener

19. 9. 98

EN

Official Journal of the European Communities

L 257/35

COMMISSION DIRECTIVE 98/66/EC

of 4 September 1998

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,

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

Whereas Commission Directive 95/31/EC of 5 July 1995
laying down specific criteria of purity concerning sweet-
eners for use in foodstuffs (5) sets out the purity criteria for
the sweeteners mentioned in Directive 94/35/EC;

Whereas it is necessary, in the light of technical progress,
to amend the purity criteria set out in Directive 95/31/EC
for isomalt (E 953); whereas it is consequently necessary
to adapt that Directive;

Whereas it is necessary to take into account the specifica-
tions and analytical techniques for sweeteners as set out
in the Codex Alimentarius by 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,
shall be submitted for evaluation by the Scientific
Committee on Food with a view to full evaluation with
emphasis on the purity criteria;

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

In the Annex to Directive 95/31/EC, the text concerning
E 953 (cid:190) isomalt is 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
the Directive before 1 July 1999. They shall immediately
inform the Commission thereof.

When Member States adopt these provisions, these shall
contain a reference to this Directive or shall be accom-
panied by such reference at the time of their official
publication. The procedure for such reference shall be
adopted by Member States.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 4 September 1998.

For the Commission

Martin BANGEMANN

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.

L 257/36

EN

Official Journal of the European Communities

19. 9. 98

‘E 953 (cid:190) ISOMALT

Synonyms

Definition

Chemical name

Chemical formula

Relative molecular mass

Assay

Description

Identification

A. Solubility

B. Thin layer chromatography

Purity

Water content

Sulphated ash

D-Mannitol

D-Sorbitol

Reducing sugars

Nickel

Arsenic

Lead

ANNEX

Hydrogenated isomaltulose, hydrogenated palatinose.

Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal com-
ponents are the disaccharides:

6-O-a-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
1-O-a-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)

6-O-a-D-Glucopyranosyl-D-sorbitol:
1-O-a-D-Glucopyranosyl-D-mannitol dihydrate: C

12

H

C12
O

O
H
24
.2H

11
O
2

24

11

6-O-a-D-Glucopyranosyl-D-sorbitol:
1-O-a-D-Glucopyranosyl-D-mannitol dihydrate:

344,32
380,32

Content not less than 98 % of hydrogenated mono- and disaccharides and not less than
86 % of
the mixture of 6-O-a-D-Glucopyranosyl-D-sorbitol and 1-O-a-D-Gluco-
pyranosyl-D-mannitol dihydrate determined on the anhydrous basis.

Odourless, white, slightly hygroscopic, crystalline mass.

Soluble in water, very slightly soluble in ethanol.

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.

Not more than 7 % (Karl Fischer Method)

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

Not more than 3 %

Not more than 6 %

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

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

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

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.'