2005/581/EC: Commission Decision of 25 July 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) 2776)
Date: 2005-07-25
Institutions: European Commission
Subjects: food additive, foodstuffs legislation, labelling, market approval

L 199/90

EN

Official Journal of the European Union

29.7.2005

COMMISSION DECISION

of 25 July 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) 2776)

(Only the German text is authentic)

(2005/581/EC)

(6)

(7)

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 Regulation (EC) No 258/97.

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

in this Decision are in
Standing
the

opinion

the

of

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

Article 2

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

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.

Article 3

This Decision is addressed to Südzucker AG Mannheim/Och-
senfurt, Maximilianstraβe 10, D-68165 Mannheim.

Done at Brussels, 25 July 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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)

On 4 March 2004 Südzucker AG made a request to the
competent authorities of Germany to place isomaltulose
on the market as a novel food or novel food ingredient.

On 1 October 2004 the competent
food assessment
body of Germany issued its initial assessment report. In
that report it came to the conclusion that the proposed
uses for isomaltulose are safe for human consumption.

(3)

The Commission forwarded the initial assessment report
to all Member States on 30 November 2004.

(4) Within the 60-day period laid down in Article 6(4) of
Regulation (EC) No 258/97 reasoned objections to the
marketing of the product were raised in accordance with
that provision. The objections/comments were discussed
with Member States at
the Standing
Committee on 14 February 2005 in connection with
the first request
for the placing on the Community
market of isomaltulose submitted by Cargill.

the meeting of

(5)

As regards the nutrition information included in the
labelling and advertising of
foods containing isomal-
tulose, Council Directive 90/496/EEC of 24 September
1990 on nutrition labelling for foodstuffs (2) applies.

(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).

29.7.2005

EN

Official Journal of the European Union

L 199/91

ANNEX

SPECIFICATIONS OF ISOMALTULOSE

Definition

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

Chemical name
6-O-α-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

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

Description

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 pp., English, ISBN 92-5-102991-1.