15.3.2017   

EN

Official Journal of the European Union

L 69/18

(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 Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for sows by Commission Regulation (EC) No 1453/2004 (3), for pigs for fattening and piglets by Commission Regulation (EC) No 2148/2004 (4), for turkeys for fattening and calves by Commission Regulation (EC) No 600/2005 (5). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, piglets, pigs for fattening, calves for rearing and turkeys for fattening. The application in accordance with Article 7 of that Regulation was also for the assessment of this preparation for a new use in water for drinking. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was 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 opinion of 12 July 2016 (6) that, under the proposed conditions of use, the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve performance in piglets, pigs for fattening, sows and calves for rearing in feed and in water for drinking. Concerning the use of the additive on turkeys for fattening, it was concluded that in two studies there was some evidence of a positive effect on growth and feed to gain ratio and in a third one a significant greater weight gain was found in females, but no significant difference in weight gain in males was detected. 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)

However these evidences have been judged a substantial indication of the improvement of zootechnical parameters of weight gain in addition to the long history of use. Therefore it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for turkeys for fattening to be used in feed and water for drinking.

(6)

The assessment of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) 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 Annex to this Regulation.

(7)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 should be amended accordingly.

(8)

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.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,