Commission Regulation (EC) No 1091/2009 of 13 November 2009 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for chickens for fattening (holder of authorisation Aveve NV) (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2009/1091@2009-11-13/en
Contents
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 the preparation set out in the Annex to this Regulation. 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 the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for chickens for fattening, to be classified in the additive category zootechnical additives.
(4) The Authority concluded in its opinion of 13 May 2009 that the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation increases body weight gain significantly. The Authority did 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.
(5) The assessment of that preparation shows that the conditions for authorisation, 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 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, 13 November 2009. For the Commission Androulla Vassiliou Member of the Commission
ANNEX
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. 4a9 Aveve NV Endo-1,4-beta-xylanase EC 3.2.1.8 Endo-1,3(4)-beta-glucanase EC 3.2.1.6 Chickens for fattening — 4000 XU 900 BGU In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e.g. containing more than 30 % wheat, barley, rye and/or triticale. For safety reasons: breathing protection, glasses and gloves shall be used during handling. 4 December 2019
Additive composition: Preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) having a minimum activity of 40000 XU/g and 9000 BGU/g
Characterisation of the active substance: endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754)
Analytical method Characterisation of the active substance in the additive:
colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,4-β-xylanase on a xylan containing substrate,
colorimetric method based on reaction of dinitrosalicylic acid on reducing sugar produced by action of endo-1,3(4)-β-glucanase on a β-glucan containing substrate,
Characterisation of the active substances in the feedingstuffs:
colorimetric method measuring water soluble dye released by action of endo-1,4-beta-xylanase from dye cross-linked wheat arabinoxylan substrate,
colorimetric method measuring water soluble dye released by action of endo-1,3(4)-beta-glucanase from dye cross-linked barley betaglucan substrate,
Versions
Cited by
- Commission Implementing Regulation (EU) 2021/329 of 24 February 2021 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase for chickens for fattening (holder of the authorisation: AVEVE NV), and repealing Regulation (EC) No 1091/2009 (Text with EEA relevance) Regulation · Grade B
A preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1091/2009.
- Commission Implementing Regulation (EU) 2021/329 of 24 February 2021 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase for chickens for fattening (holder of the authorisation: AVEVE NV), and repealing Regulation (EC) No 1091/2009 (Text with EEA relevance) Regulation · Grade B
As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (formerly identified as Trichoderma reesei) MUCL 49755 and endo-1,3(4)-beta-glucanase produced by Trichoderma longibrachiatum (formerly identified as Trichoderma reesei) MUCL 49754 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1091/2009 should be repealed.
- Commission Implementing Regulation (EU) 2021/329 of 24 February 2021 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase for chickens for fattening (holder of the authorisation: AVEVE NV), and repealing Regulation (EC) No 1091/2009 (Text with EEA relevance) Regulation · Grade B
Regulation (EC) No 1091/2009 is repealed.
- Commission Implementing Regulation (EU) No 1088/2011 of 27 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for weaned piglets (holder of authorisation Aveve NV) (Text with EEA relevance) Regulation · Grade B
The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009.
- Commission Implementing Regulation (EU) No 989/2012 of 25 October 2012 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MULC 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MULC 49754) as a feed additive for laying hens and minor poultry species for fattening and laying (holder of authorisation Aveve NV) (Text with EEA relevance) Regulation · Grade B
The use of those enzymes was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009 and for 10 years for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011.
- Commission Implementing Regulation (EU) No 1040/2013 of 24 October 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for pigs for fattening and minor porcine species for fattening other than Sus scrofa domesticus and turkeys for fattening (holder of authorisation Aveve NV) (Text with EEA relevance) Regulation · Grade B
The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009, for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011 and for laying hens and minor poultry species for fattening and laying by Commission Implementing Regulation (EU) No 989/2012.
- Commission Regulation (EU) No 335/2011 of 7 April 2011 amending Regulation (EC) No 1091/2009 as regards the minimum content of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive in feed for chickens for fattening (Text with EEA relevance) Regulation · Grade B
The use of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009 of 13 November 2009 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive for chickens for fattening (holder of authorisation Aveve NV).
- Commission Regulation (EU) No 335/2011 of 7 April 2011 amending Regulation (EC) No 1091/2009 as regards the minimum content of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive in feed for chickens for fattening (Text with EEA relevance) Regulation · Grade B
Regulation (EC) No 1091/2009 should therefore be amended accordingly.
- Commission Regulation (EU) No 335/2011 of 7 April 2011 amending Regulation (EC) No 1091/2009 as regards the minimum content of the enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) as a feed additive in feed for chickens for fattening (Text with EEA relevance) Regulation · Grade B
The Annex to Regulation (EC) No 1091/2009 is replaced by the text in the Annex to this Regulation.