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 Implementing Regulation (EU) 2020/146of 3 February 2020amending Regulation (EU) No 333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No 184/2011 concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive(Text with EEA relevance), 32020R0146, February 4, 2020
  • Commission Implementing Regulation (EU) 2022/703of 5 May 2022concerning the renewal of the authorisation of a preparation of Bacillus velezensis DSM 15544 as a feed additive for weaned piglets, the authorisation for all avian species and categories, amending Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2017/2312 and Implementing Regulation (EU) 2018/1081 and repealing Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 (holder of the authorisation: Asahi Biocycle Co. Ltd., represented in the Union by Pen & Tec Consulting S.L.U.)(Text with EEA relevance), 32022R0703, May 6, 2022
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 Pen & Tec Consulting S.L.U.)(Text with EEA relevance)
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 Pen & Tec Consulting S.L.U.Bacillus 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
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