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
Date: 2013-10-24
Institutions: European Commission
Subjects: animal feedingstuffs, food safety, food supplement, market approval, swine




L_2013283EN.01004601.xml










25.10.2013   


EN


Official Journal of the European Union


L 283/46








            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)


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 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 1091/2009 (2), for weaned piglets by Commission Implementing Regulation (EU) No 1088/2011 (3) and for laying hens and minor poultry species for fattening and laying by Commission Implementing Regulation (EU) No 989/2012 (4).












(5)


The European Food Safety Authority (‘the Authority’) in its opinions of 12 March 2013 (5) 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 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, 24 October 2013.


For the Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  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) (OJ L 299, 14.11.2009, p. 6).

(3)  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) (OJ L 281, 28.10.2011, p. 14).

(4)  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)
(OJ L 297, 26.10.2012, p. 11).

(5)  
            EFSA Journal 2013; 11(4):3171 and EFSA Journal 2013; 11(4):3172.




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






4a9


Aveve NV


Endo-1,4-beta-xylanase
EC 3.2.1.8
Endo-1,3(4)-beta-glucanase
EC 3.2.1.6








 



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: 40 000  XU (1) and 9 000  BGU (2)/g Solid and liquid forms










 



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
 (3)

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-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 fattening
Minor porcine species for fattening other than Sus scrofa domesticus

Turkeys for fattening


—


4 000  XU
900 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






(1)  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.

(2)  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.

(3)  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