2005/457/EC: Commission Decision of 4 April 2005 authorising the placing on the market of isomaltulose as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2005) 1001)
Date: 2005-04-04
Institutions: European Commission
Subjects: food additive, foodstuffs legislation, market approval

L 160/28

EN

Official Journal of the European Union

23.6.2005

COMMISSION

COMMISSION DECISION

of 4 April 2005

authorising the placing on the market of isomaltulose as a novel food or novel food ingredient
under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2005) 1001)

(Only the Dutch text is authentic)

(2005/457/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(7)

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning
novel foods and novel food ingredients (1), and in particular
Article 7 thereof,

Whereas:

(1)

(2)

(3)

acting
On 30 October 2003 Cargill
through Cerestar, made a request
to the competent
authorities of the United Kingdom to place isomaltulose
as a novel food or novel food ingredient on the market.

Incorporated,

On 19 March 2004 the competent authorities of the
United Kingdom issued their initial assessment report.

In their initial assessment report the United Kingdom’s
competent food assessment body came to the conclusion
the proposed uses for isomaltulose are safe for
that
human consumption.

As regards the nutrition information included in the
labelling and advertising of
foods containing isomal-
tulose,
the rules of Council Directive 90/496/EC of
24 September 1990 on nutrition labelling for food-
stuffs (2) apply.

On the basis of the initial assessment report, it is estab-
lished that isomaltulose complies with the criteria laid
down in Article 3(1) of the Regulation.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

(8)

(9)

HAS ADOPTED THIS DECISION:

Article 1

Isomaltulose as specified in the Annex, may be placed on the
market
food
ingredient for use in foodstuffs.

in the Community as a novel

food or novel

(4)

The Commission forwarded the initial assessment report
to all Member States on 15 April 2004.

Article 2

(5) Within the 60-day period laid down in Article 6(4) of the
Regulation, reasoned objections to the marketing of the
product were raised in accordance with that provision.

The designation ‘isomaltulose’ shall be displayed on the labelling
of the product as such or in the list of ingredients of foodstuffs
containing it.

(6)

At a meeting on 10 December 2004 Member States
experts considered the initial assessment report as far
as risk assessment was concerned and there was no
need for
the European Food
Safety Authority.

further consultation of

In a prominently displayed footnote related to the designation
isomaltulose by means of an asterisk (*) the words ‘isomaltulose
is a source of glucose and fructose’ shall be displayed. The
words shall have a typeface of at least the same size as the
list of ingredients itself.

(1) OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 276, 6.10.1990, p. 40. Directive as

last amended by
Commission Directive 2003/120/EC (OJ L 333, 20.12.2003, p. 51).

23.6.2005

EN

Official Journal of the European Union

L 160/29

This Decision is addressed to Cargill Incorporated, c/o Cerestar, Havenstraat 84, B-1800 Vilvoorde.

Article 3

Done at Brussels, 4 April 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 160/30

EN

Official Journal of the European Union

23.6.2005

ANNEX

SPECIFICATIONS OF ISOMALTULOSE

Definition:

A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glucosidic bond. It is
obtained from sucrose by an enzymatic process. The commercial product is the monohydrate.

Chemical name

6-O-a-D-glucopyranosyl-D-fructofuranose, monohydrate

CAS number

13718-94-0

Chemical formula

C12H22O11

· H2O

Structural formula

Formula weight

360,3 (monohydrate)

Assay

Not less than 98 % on the dry basis

Description

Virtually odourless, white or almost white crystals with a sweet taste

Loss on drying

Not more than 6,5 % (60 °C, 5 hours)

Lead

Not more than 0,1 mg/kg

Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and
‘Instrumental
method of sample preparation may be based on the principles of the method described in FNP 5 (1),
methods’.

(1) Food and Nutrition Paper 5 Rev.2 — Guide to specifications for general notices, general analytical techniques, identification tests, test

solutions and other reference materials. (JECFA) 1991, 322 p. English — ISBN 92-5-102991-1.