Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office) (Text with EEA relevance)
Modified by
  • Commission Implementing Regulation (EU) 2016/897of 8 June 2016concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation(Text with EEA relevance), 32016R0897, June 9, 2016
Commission Regulation (EU) No 333/2010of 22 April 2010concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office)(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 under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets, to be classified in the additive category "zootechnical additives".(4)The use of that micro-organism preparation has been authorised for chickens for fattening by Commission Regulation (EC) No 1444/2006OJ L 271, 30.9.2006, p. 19..(5)New data were submitted in support of the application for authorisation for weaned piglets. The European Food Safety Authority (the Authority) concluded in its opinion of 9 December 2009The EFSA Journal 2010; 8(1):1426. that Bacillus subtilis C-3102 (DSM 15544) 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.(6)The assessment of Bacillus subtilis C-3102 (DSM 15544) 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 1The 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 2This 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.ec.europa.eu/crl-feed-additivesCategory of zootechnical additives. Functional group: gut flora stabilisers
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
4b1820Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative OfficeBacillus subtilis C-3102 (DSM 15544)Additive composition:Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/gCharacterisation of the active substance:Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)Analytical method:Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15874:2009)Identification: pulsed-field gel electrophoresis (PFGE).Piglets (weaned)—3 × 108—1.In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting2.For use in weaned piglets up to approximately 35 kg.3.For safety: breathing protection, glasses and gloves shall be used during handling.13 May 2020