COMMISSION IMPLEMENTING REGULATION (EU) No 528/2011

of 30 May 2011

concerning the authorisation of endo-1,4-β-xylanase produced by Trichoderma reesei (ATCC PTA 5588) as a feed additive for weaned piglets and pigs for fattening (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 nutrition(1), 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-β-xylanase (EC 3.2.1.8) produced by

Trichoderma reesei

(ATCC PTA 5588). The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of endo-1,4-β-xylanase (EC 3.2.1.8) produced by

Trichoderma reesei

(ATCC PTA 5588) as a feed additive for weaned piglets and pigs for fattening, to be classified in the additive category ‘zootechnical additives’.

(4) The use of that preparation was authorised for 10 years for chickens for fattening, laying hens, ducks and turkeys for fattening by Commission Regulation (EC) No 9/2010(2).

(5) New data were submitted in support of the application for the authorisation of endo-1,4-β-xylanase (EC 3.2.1.8) produced by

Trichoderma reesei

(ATCC PTA 5588) for weaned piglets and pigs for fattening. The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 February 2011(3) that, under the proposed conditions of use, endo-1,4-β-xylanase (EC 3.2.1.8) produced by

Trichoderma reesei

(ATCC PTA 5588) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the zootechnical performance. 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 for Feed Additives set up by Regulation (EC) No 1831/2003.

(6) The assessment of endo-1,4-β-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 this 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:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 May 2011.

For the Commission

The President

José Manuel BARROSO

(1)

OJ L 268, 18.10.2003, p. 29

(2)

OJ L 3, 7.1.2010, p. 10

(3)

The EFSA Journal

2011;9(2):2008.

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a11

Danisco Animal Nutrition

Endo-1,4-β-xylanase

EC 3.2.1.8

Additive composition

Preparation of endo-1,4-β-xylanase (EC 3.2.1.8)

produced by Trichoderma reesei (ATCC PTA 5588) having a minimum activity of endo-1,4-β-xylanase: 40 000 U(1)/g

Characterisation of the active substance

Endo-1,4-β-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (ATCC PTA 5588)

Method of analysis (2)

Colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substances

Piglets (weaned) and pigs for fattening

2 000 U

—

1.	In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

2.	For use in feed rich in starch and non-starch polysaccharides.

3.	For piglets (weaned) up to 35 kg.

20 June 2021

(1) 1 U is the amount of enzyme which liberates 0,5 μmol of reducing sugar (expressed as xylose equivalents) from a cross-linked oat spelt arabinoxylan substrate at pH 5,3 and 50 °C in 1 minute.

(2) Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx