Commission Regulation (EU) No 107/2010 of 8 February 2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV) (Text with EEA relevance)
Modified by
  • Commission Regulation (EU) No 168/2011of 23 February 2011amending 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), 32011R0168, February 24, 2011
Commission Regulation (EU) No 107/2010of 8 February 2010concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa 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 the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required pursuant to Article 7(3) of Regulation (EC) No 1831/2003. (3)The application concerns the authorisation of the micro-organism Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens for fattening, to be classified in the additive category "zootechnical additives". (4)The European Food Safety Authority (the Authority) concluded in its opinion of 15 September 2009The EFSA Journal 2009; 7(9): 1314. that the Bacillus subtilis (ATCC PTA-6737) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can improve the performance of the animals. 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. (5)The assessment of that preparation 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. (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 "gut flora stabilisers", 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. ANNEX
Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additivesCategory of zootechnical additives. Functional group: gut flora stabilisers
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 %
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: 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