8.6.2017   

EN

Official Journal of the European Union

L 145/7

(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 such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The preparation of Enterococcus faecium CECT 4515 was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for weaned piglets by Commission Regulation (EC) No 2036/2005 (3). That preparation was subsequently entered in the Register of Feed Additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. That preparation has been authorised for chickens for fattening by Commission Implementing Regulation (EU) No 887/2011 (4).

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, applications were submitted for the re-evaluation of the preparation of Enterococcus faecium CECT 4515 as a feed additive in feed for weaned piglets and for a new use in water for drinking for weaned piglets and chickens for fattening. The applicant requested the additive to be classified in the additive category ‘zootechnical additives’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 9 April 2014 (5), 29 April 2015 (6) and 8 September 2015 (7) that, under the proposed conditions of use, the preparation of Enterococcus faecium CECT 4515 does not have an adverse effect on animal health, human health or the environment. In its opinion of 29 April 2015, the Authority also concluded that the additive has the potential to improve the zootechnical performance of weaned piglets when used in feed. In its opinion of 8 September 2015, the Authority further concluded that the use of the preparation of Enterococcus faecium CECT 4515 in water for drinking for weaned piglets and chickens for fattening has the same efficacy as when it is used in feed. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It 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 the preparation of Enterococcus faecium CECT 4515 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annexes to this Regulation.

(6)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 2036/2005 should be amended accordingly. Furthermore, the existing authorisation of the preparation of Enterococcus faecium CECT 4515 for chickens for fattening in Implementing Regulation (EU) No 887/2011 should be supplemented by a new use in water for drinking by way of an amendment to that Implementing Regulation.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from 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,