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
Commission Implementing Regulation (EU) No 1040/2013of 24 October 2013concerning 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) 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 nutritionOJ L 268, 18.10.2003, p. 29., 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 a new use 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). 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 a new use 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, to be classified in the additive category "zootechnical additives".(4)The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1091/2009Commission 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) (OJ L 299, 14.11.2009, p. 6)., for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011Commission 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) (OJ L 281, 28.10.2011, p. 14). and for laying hens and minor poultry species for fattening and laying by Commission Implementing Regulation (EU) No 989/2012Commission 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)(OJ L 297, 26.10.2012, p. 11)..(5)The European Food Safety Authority ("the Authority") in its opinions of 12 March 2013EFSA Journal 2013; 11(4):3171 and EFSA Journal 2013; 11(4):3172. confirmed its previous conclusions that, under the proposed conditions of use, the 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. The Authority concluded that the additive has the potential to improve the zootechnical performance in pigs for fattening and that this conclusion can be extrapolated to minor porcine species for fattening other than Sus scrofa domesticus. The Authority also concluded that the additive has the potential to improve the final body weight and feed to gain ratio in turkeys for fattening. 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 produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754) 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:
Article 1The 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 2This 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, 24 October 2013.For the CommissionThe PresidentJosé Manuel BarrosoANNEX
XU is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) per minute from xylan of oat spelt at pH 4,8 and 50 °C.BGU is the amount of enzyme which liberates 1 micromole of reducing sugars (cellobiose equivalents) per minute from ß-glucan of barley at pH 5,0 and 50 °C.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.aspxCategory of zootechnical additives. Functional group: digestibility enhancers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
4a9Aveve NVEndo-1,4-beta-xylanaseEC 3.2.1.8Endo-1,3(4)-beta-glucanaseEC 3.2.1.6Additive compositionPreparation 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 and 9000 BGU/g Solid and liquid formsCharacterisation of the active substanceendo-1,4-beta-xylanase produced by Trichoderma reesei (MUCL 49755) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei (MUCL 49754)Analytical methodCharacterisation 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-beta-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)-beta-glucanase on a beta-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.Pigs for fatteningMinor porcine species for fattening other than Sus scrofa domesticusTurkeys for fattening—4000 XU900 BGU—1.In the directions for use of the additive and premixture, indicate the storage conditions, and stability to pelleting.2.For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans)3.For safety: breathing protection, glasses and gloves shall be used during handling.14 November 2023