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)

• CELEX: Regulation (EC) No 258/97
• Articles: 4

Article 1

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

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/Ochsenfurt, Maximilianstraβe 10, D-68165 Mannheim.

Schedules & Appendices

ANNEX

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

C 12 H 22 O 11 · H 2 O

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 method of sample preparation may be based on the principles of the method described in FNP 5  ( 1 ) , ‘Instrumental 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.