Commission Implementing Regulation (EU) No 1021/2012

of 6 November 2012

concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for minor poultry species other than ducks (holder of authorisation Danisco Animal Nutrition)

(Text with EEA relevance)

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 nutrition1, and in particular Article 9(2) and Article 13(3) 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)
The use of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) was authorised for 10 years for chickens for fattening, laying hens, ducks and turkeys for fattening by Commission Regulation (EU) No 9/20102 and for weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) No 528/20113.
(3)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) for minor poultry species other than ducks requesting that the additive be classified in the additive category ‘zootechnical additives’.

(4)

The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support its requests.

(5)
The European Food Safety Authority (‘the Authority’) focused its assessment on safety and efficacy for the new target species. The Authority concluded in its opinion of 22 May 20124 that, under the proposed conditions of use, since safety of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588) has been established in the major poultry species with a wide margin of safety, this conclusion can be extended to all poultry species requested. They stated that a similar conclusion on efficacy can be extrapolated from major poultry species to all minor poultry species. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003.
(6)

The assessment of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588) 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 the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION: