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)
EU Decision 2005/581 · Adopted 25 July 2005 · Extends to United Kingdom
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)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 ingredientsf1, and in particular Article 7 thereof,
Whereas:
(1)
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.
(2)
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 meeting of 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.
(5)
As regards the nutrition information included in the labelling and advertising of foods containing isomaltulose, Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffsf2 applies.
(6)
On the basis of the initial assessment report, it is established that isomaltulose complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
(7)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Annotations to the whole text
Footnotes
- f1
-
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).
- f2
-
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).
Contents
- 1Article 1
- 2Article 2
- 3Article 3
- Signature
- Annex SPECIFICATIONS OF ISOMALTULOSE
- Definition
- Chemical name
- CAS number
- Chemical formula
- Structural formula
- Formula weight
- Assay
- Description
- Loss on drying
- Lead
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.
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.
3
This Decision is addressed to Südzucker AG Mannheim/Ochsenfurt, Maximilianstraβe 10, D-68165 Mannheim.
Signature
Done at Brussels, 25 July 2005.
For the Commission
Markos Kyprianou
Member of the Commission
SPECIFICATIONS OF ISOMALTULOSE
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 5f1, ‘Instrumental methods’.
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
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