Commission Regulation (EU) No 168/2011 of 23 February 2011 amending Regulation (EU) No 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride  Text with EEA relevance
Date: 2011-02-23
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, health risk, microorganism, zootechnics




L_2011049EN.01000401.xml










24.2.2011   


EN


Official Journal of the European Union


L 49/4








            COMMISSION REGULATION (EU) No 168/2011
of 23 February 2011
         
amending Regulation (EU) No 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride
(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 13(3) 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)


Regulation (EC) No 1831/2003 provides for the possibility to modify the authorisation of a feed additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority).












(3)


The use of the micro-organism preparation of Bacillus subtilis ATCC PTA-6737 was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 107/2010 (2).












(4)


The holder of the authorisation applied for a modification of the authorisation of Bacillus subtilis ATCC PTA-6737 to allow its use in feed containing the coccidiostats maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride for chickens for fattening. The holder of the authorisation submitted the relevant data to support this request.












(5)


The Authority concluded in its opinion of 7 October 2010 that the additive Bacillus subtilis ATCC PTA-6737 is compatible with maduramycin ammonium, monensin sodium, narasin, or robenidine hydrochloride (3).












(6)


The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.












(7)


Regulation (EU) No 107/2010 should therefore be amended accordingly.












(8)


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 Annex to Regulation (EU) No 107/2010 is replaced by the text in the Annex to this Regulation.


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, 23 February 2011.


For the Commission


The President

José Manuel BARROSO
            





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

(2)  
            OJ L 36, 9.2.2010, p. 1.

(3)  EFSA Journal 2010; 8(10):1863.




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




CFU/kg of complete feedingstuff with a moisture content of 12 %





Category of zootechnical additives. Functional group: gut flora stabilisers






4b1823


Kemin Europa NV



Bacillus subtilis ATCC PTA-6737








 



Additive composition:

Preparation of Bacillus subtilis ATCC PTA-6737 containing a minimum of 1 × 1010 CFU/g additive










 



Characterisation of active substance:

Spores of Bacillus subtilis ATCC PTA-6737










 



Analytical methods
 (1)







 


Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples










 


Identification: pulsed-field gel electrophoresis (PFGE) method










Chickens for fattening


—


1 × 107



—








1.


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










2.


May be used in feed containing the permitted coccidiostats: diclazuril, decoquinate, salinomycin sodium, narasin/nicarbazin, lasalocid A sodium, maduramycin ammonium, monensin sodium, narasin or robenidine hydrochloride.






1.3.2020






(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives