(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 endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1259/2004 (3), for weaned piglets by Commission Regulation (EC) No 1206/2005 (4), for pigs for fattening and turkeys for fattening by Commission Regulation (EC) No 516/2007 (5) and for laying hens by Commission Regulation (EC) No 322/2009 (6). 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. In accordance with Regulation (EC) No 1831/2003, that preparation was also authorised for 10 years for ducks by Commission Regulation (EC) No 242/2007 (7).

(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 endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) as a feed additive for poultry, weaned piglets and pigs for fattening. 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 13 July 2016 (8) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the use of that preparation has the potential to be efficacious in chickens for fattening, laying hens, weaned piglets and pigs for fattening. This conclusion can be extended to chickens reared for laying and breeding hens. The Authority further considered that the conclusions on the efficacy can be extrapolated to minor poultry species for fattening, for breeding and for laying. It 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 Authority also concluded on turkeys for fattening that in two studies there was evidence of a positive effect on final body weight and on feed to gain ratio. A third one with a significant greater feed to gain ratio, as already evaluated and accepted in the previous evaluation for the authorisation, was not considered significant by the Authority. Since these evidences were judged a substantial indication of the improvement of zootechnical parameters, in addition to the long history of use, it was considered that the provided data meet the conditions for the demonstration of the efficacy of the additive for turkeys for fattening.

(6)

The assessment of the preparation endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Bacillus subtilis (LMG-S 15136) 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)

Regulations (EC) No 1259/2004, (EC) No 1206/2005, and (EC) No 322/2009 should be amended accordingly. Regulation (EC) No 516/2007 should be repealed.

(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,