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 such authorisation.
(2)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)
That application concerns the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) as a feed additive for lactating sows (including minor porcine species) and minor porcine species for weaning and fattening, to be classified in the additive category ‘zootechnical additives’.
(4)
The additive was already authorised for use in poultry, weaned piglets and pigs for fattening by Commission Regulation (EU) No 337/2011.
(5)
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 3 December 2015 that, under the proposed conditions of use, endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) does not have an adverse effect on animal health, human health or the environment, and that it is efficacious for lactating sows and minor porcine species at the recommended dose. 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.
(6)
The assessment of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)-beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) 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)
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: