Commission Decision

of 25 July 2005

refusing the placing on the market of betaine 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) 2770)

(Only the Finnish and Swedish texts are authentic)

(2005/580/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 ingredients [1], and in particular Article 7 thereof,

Whereas:

(1) On 24 January 2003 Finnfeeds Finland Ltd made a request to the competent authorities of Finland to place betaine on the market as a novel food or novel food ingredient.

(2) On 3 July 2003 the competent authorities of Finland issued their initial assessment report.

(3) In their initial assessment report, Finland’s competent authorities came to the conclusion that betaine may be placed on the market.

(4) The Commission forwarded the initial assessment report to all Member States on 18 August 2003.

(5) Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97, reasoned objections to the marketing of betaine were raised in accordance with that provision.

(6) The European Food Safety Authority, in its opinion on an application concerning the use of betaine as a novel food in the European Union of 22 February 2005 [2], came to the conclusion that the safety of betaine for the intended use as proposed by the applicant has not been established.

(7) As it has not been demonstrated that the product complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97, it should not be placed on the market in the Community.

(8) 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:

Article 1

Betaine may not be placed on the Community market as food or food ingredient.

Article 2

This Decision is addressed to Finnfeeds Finland Ltd, Sokeritehtaantie 20, FI-02460 Kantvik.

Done at Brussels, 25 July 2005.

For the Commission

Markos Kyprianou

Member of the Commission

[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] The opinion can be found on the website of the European Food Safety Authority, Scientific Panel on Dietetic Products, Nutrition and Allergies.

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