THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
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, and in particular Article 9(2) thereof,
Whereas:
(1)
Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation.
(2)
Selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 900/2009.
(3)
In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 as feed additive for all animal species in the additive category ‘nutritional additives’. The application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
(4)
It results from the opinion of the European Food Safety Authority (‘the Authority’) of 7 May 2020 that, under the proposed conditions of use, selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 does not have an adverse effect on animal health, consumer safety or the environment. The Authority also concluded that the additive is a potential dermal and respiratory sensitizer. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The proof of the efficacy of the additive, on which the initial authorisation was based, withstands in a renewal procedure. Finally, the Authority recommended changing the denomination of the additive. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)
The assessment of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of this additive should be renewed.
(6)
As a consequence of the renewal of the authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399 as feed additive, Regulation (EC) No 900/2009 should be repealed.
(7)
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for selenomethionine produced by Saccharomyces cerevisiae CNCM I-3399, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(8)
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: