Address https://gelex.eu/eli/EU/regulation/2019/929@2019-06-05/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX 1.2.3.
5. ANNEX Additive composition

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 a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755). That 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 a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for chickens for fattening and weaned piglets to be classified in the additive category zootechnical additives.

(4) The European Food Safety Authority (the Authority) concluded in its opinions of 25 January 2017 and 2 October 2018 that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) does not have an adverse effect on animal health, consumer safety or the environment. It was also concluded that the additive may have a skin and respiratory sensitisation potential. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that the additive is considered efficacious in improving final body weight and feed to gain ratio in chickens for fattening and weaned piglets. 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) The assessment of the preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) 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.

(6) 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:

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 twentieth day following that of 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, 5 June 2019. For the Commission The President Jean-Claude Juncker

ANNEX

Grp. composition. Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) with a minimum activity of 15000 EPU/g Solid form Grp_of_active. substance. endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) (1) colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates. Grp. method. For quantification of endo-1,4-beta-xylanase activity in the feed additive, premixtures and feedingstuffs: Anx. 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. 4a26 Berg and Schmidt GmbH Co. KG Endo-1,4-beta-xylanase (EC 3.2.1.8) Chickens for fattening Weaned piglets — 1500 EPU In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. For use in weaned piglets up to approximately 35 kg body weight. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. 26.6.2029

ANNEX 1.2.3.

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. 4a26 Berg and Schmidt GmbH Co. KG Endo-1,4-beta-xylanase (EC 3.2.1.8) Chickens for fattening Weaned piglets — 1500 EPU In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. For use in weaned piglets up to approximately 35 kg body weight. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection. 26.6.2029 Grp. composition. Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) with a minimum activity of 15000 EPU/g Solid form Grp_of_active. substance. endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) (1) colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates. Grp. method. For quantification of endo-1,4-beta-xylanase activity in the feed additive, premixtures and feedingstuffs:

ANNEX Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) with a minimum activity of 15000 EPU/g Solid form

Characterisation of active substance

endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755)

Analytical method

For quantification of endo-1,4-beta-xylanase activity in the feed additive, premixtures and feedingstuffs: (1) colorimetric method measuring water soluble dye released by action of endo-1,4-β-xylanase from azurine cross-linked wheat arabinoxylan substrates.

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

Versions

1. 2019-06-05

Cited by

• Commission Implementing Regulation (EU) 2020/993 of 9 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) as a feed additive for all avian species for fattening other than chickens for fattening, ornamental birds, all weaned porcine species other than weaned piglets and all porcine species for fattening other than pigs for fattening (holder of authorisation Berg und Schmidt GmbH Co. KG) (Text with EEA relevance) Regulation · Grade B

  The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Trichoderma reesei (BCCM/MUCL 49755) was authorised for 10 years by Commission Implementing Regulation (EU) 2018/130 for pigs for fattening and by Commission Implementing Regulation (EU) 2019/929 for chickens for fattening and weaned piglets.