Diario Oficial de la Unión Europea del 4/9/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
L 217/2
EN
Official Journal of the European Union
4.9.2023
5
The Annex to Implementing Regulation EU No 371/2011 erroneously provides for the description of the functional group zootechnical additives improvement of zootechnical parameters. The opinion of the European Food Safety Authority the Authority of 7 December 2010 4 stated that the additive has the potential to increase performance in chickens for fattening. The term zootechnical is too generic and may encompass different functions, while not expressing the specific effects of the additive. Therefore, in order to be in line with the opinion of the Authority, the functional group of the feed additive should refer to the improvement of performance parameters. In addition, the Authority concluded in its opinion of 7 December 2020 5 that the additive is efficacious at a level of 1 000 mg/kg, consequently, a minimum level should be established.
6
In accordance with Article 54, point c, of Commission Regulation EC No 378/2005 6, the Reference Laboratory set up by Regulation EC No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment are applicable for the current application.
7
The assessment of dimethylglycine sodium salt shows that the conditions for authorisation, as provided for in Article 5 of Regulation EC No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
8
As a consequence of the renewal of the authorisation of dimethylglycine sodium salt as a feed additive, Implementing Regulation EU No 371/2011 should be repealed.
9
Considering that the functional group should appear on the label of the feed additive, of the premixtures and compound feed containing it, it is necessary to provide for a transitional period allowing feed business operators to make the necessary adaptations to the labels.
10
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Renewal of the authorisation The authorisation of the substance specified in the Annex, belonging to the additive category zootechnical additives and in the functional group other zootechnical additives: improvement of performance parameters, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal of Implementing Regulation EU No 371/2011
Implementing Regulation EU No 371/2011 is repealed.
4 EFSA Journal 2011; 91:1950
5 EFSA Journal 2021;195:6621
6 Commission Regulation EC No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation EC
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives OJ L 59, 5.3.2005, p. 8.
