Commission Implementing Regulation (EU) No 1404/2013 of 20 December 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for pigs for fattening (holder of authorisation BASF SE)  Text with EEA relevance
Date: 2013-12-20
Institutions: European Commission
Subjects: animal feedingstuffs, food safety, food supplement, market approval, swine




L_2013349EN.01008801.xml










21.12.2013   


EN


Official Journal of the European Union


L 349/88








            COMMISSION IMPLEMENTING REGULATION (EU) No 1404/2013
of 20 December 2013
         
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for pigs for fattening (holder of authorisation BASF SE)
(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 Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404). 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 Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for pigs for fattening, to be classified in the additive category ‘zootechnical additives’.












(4)


The use of that preparation was authorised for 10 years for weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening by Commission Regulation (EC) No 271/2009 (2) and for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds by Commission Implementing Regulation (EU) No 1068/2011 (3).












(5)


The European Food Safety Authority (‘the Authority’) in its opinion of 18 June 2013 (4) confirmed its previous conclusions that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) does not have an adverse effect on animal health, human health or the environment. The Authority concluded that it has the potential to be efficacious in pigs 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 Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) 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, 20 December 2013.


For the Commission


The President

José Manuel BARROSO
            





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

(2)  Commission Regulation (EC) No 271/2009 of 2 April 2009 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase as a feed additive for weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening (holder of the authorisation BASF SE) (OJ L 91, 3.4.2009, p. 5).

(3)  Commission Implementing Regulation (EU) No 1068/2011 of 21 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE) (OJ L 277, 22.10.2011, p. 11).

(4)  
            EFSA Journal 2013; 11(7):3285.




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






4a7


BASF SE


Endo-1,4-beta-xylanase
EC 3.2.1.8
Endo-1,4-beta-glucanase
EC 3.2.1.4



Additive composition

Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) having a minimum activity of:
5 600  TXU (1) and 2 500  TGU (2)/g.
Solid and liquid form.

Characterisation of the active substance

endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404).

Analytical method
 (3)

For quantification of endo-1,4-beta-xylanase activity:
viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-xylanase on the xylan containing substrate (wheat arabinoxylan) at pH 3,5 and 55 °C.
For quantification of endo-1,4-beta-glucanase activity:
viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-glucanase on the glucan containing substrate (barley betaglucan) at pH 3,5 and 40 °C.


Pigs for fattening


—


560 TXU
250 TGU


—








1.


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










2.


Recommended doses per kilogram of complete feedingstuffs: 560-840 TXU/250 - 375 TGU.










3.


For safety: breathing protection, glasses and gloves shall be used during handling.






12 January 2024






(1)  TXU is the amount of enzyme which liberates 5 micromole of reducing sugars (xylose equivalents) from wheat arabinoxylan per minute at pH 3,5 and 55 °C.

(2)  TGU is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 3,5 and 40 °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