Commission Regulation (EC) No 905/2009

of 28 September 2009

amending Regulation (EC) No 537/2007 as regards the name of the holder of the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1] and in particular Article 13(3) thereof,

Whereas:

(1) Trouw Nutrition BV has submitted an application under Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Regulation (EC) No 537/2007 of 15 May 2007 concerning the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm) [2] as a feed additive for dairy cows. The authorisation is linked to the holder of the authorisation. The holder is Trouw Nutrition BV.

(2) The applicant claims that it transferred its marketing authorisation for that additive to Biozyme Incorporated which now owns the marketing rights for that additive. The applicant has submitted appropriate documents supporting its allegations.

(3) The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The European Food Safety Authority was informed of the application.

(4) To allow Biozyme Incorporated to exploit its marketing rights it is necessary to change the terms of the authorisations.

(5) Regulation (EC) No 537/2007 should therefore be amended accordingly.

(6) It is appropriate to provide for a transitional period during which existing stocks may be used up.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

In the Annex to Regulation (EC) No 537/2007, in column 2, the words "Trouw Nutrition BV" are replaced by the words "Biozyme Incorporated".

Article 2

Existing stocks which are in conformity with the provisions applying before the date of entry into force of this Regulation may continue to be placed on the market and used until 1 April 2010.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 28 September 2009.

For the Commission

Androulla Vassiliou

Member of the Commission

[1] OJ L 268, 18.10.2003, p. 29.

[2] OJ L 128, 16.5.2007, p. 13.

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