Commission Regulation (EC) No 1292/2008 of 18 December 2008 concerning the authorisation of Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) as a feed additive (Text with EEA relevance)
Modified by
  • Commission Regulation (EU) No 336/2011of 7 April 2011amending Regulation (EC) No 1292/2008 as regards the use of the feed additive Bacillus amyloliquefaciens CECT 5940 in feed containing diclazuril, monensin sodium and nicarbazin(Text with EEA relevance), 32011R0336, April 8, 2011
Commission Regulation (EC) No 1292/2008of 18 December 2008concerning the authorisation of Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) as a feed additive(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. (3)The application concerns the authorisation of a preparation of Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus), as a feed additive for chickens for fattening, to be classified in the additive category "zootechnical additives". (4)From the Opinion of the European Food Safety Authority (the Authority) of 16 July 2008Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the safety and efficacy of Ecobiol® (Bacillus amyloliquefaciens) as feed additives for chickens for fattening. The EFSA Journal (2008) 773, pp. 1-13. it results that, on the basis of the data provided by the manufacturer, Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) does not have an adverse effect on animal health, human health or the environment and that it is efficacious in stabilising the gut flora. The Authority further concluded that Bacillus amyloliquefaciens CECT 5940 (Ecobiol and Ecobiol plus) does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of the preparation does not have an adverse effect on chicken 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 Community Reference Laboratory set up by Regulation (EC) No 1831/2003. (5)The assessment of that preparation shows that the conditions for authorisation, 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 European Union 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 %
4b1822 Norel SA Bacillus amyloliquefaciens CECT 5940 Additive compositionPreparation of Bacillus amyloliquefaciens CECT 5940 containing a minimum of 1 × 109 CFU/g additive Characterisation of active substanceSpores of Bacillus amyloliquefaciens CECT 5940 Analytical methodsEnumeration: spread plate method using tryptone soya agar following a heat treatment.Identification: pulsed-field gel electrophoresis (PFGE) method. Chickens for fattening — 1 × 109 — 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, monensin sodium, or nicarbazin.3.For safety reasons: breathing protection; glasses and gloves shall be used during handling 8.1.2019