Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance. )
Modified by
  • 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) 2017/2312of 13 December 2017concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the 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 twentieth day following that of 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
Category 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 subtilisDSM 15544Additive compositionPreparation of Bacillus subtilis C-3102DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid formCharacterisation of the active substanceViable cells of Bacillus subtilisDSM 15544Analytical methodEnumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)Identification: pulsed-field gel electrophoresis (PFGE).SowsSuckling piglets—3 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.Indicate in the instruction for the use:"The additive shall be fed to lactating sows and suckling piglets simultaneously"3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.3 January 2028
Dogs1 × 109
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 twentieth day following that of 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
Category 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 subtilisDSM 15544Additive compositionPreparation of Bacillus subtilis C-3102DSM 15544 containing a minimum of 1 × 1010 CFU/g additive in solid formCharacterisation of the active substanceViable cells of Bacillus subtilisDSM 15544Analytical methodEnumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)Identification: pulsed-field gel electrophoresis (PFGE).SowsSuckling piglets—3 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.Indicate in the instruction for the use:"The additive shall be fed to lactating sows and suckling piglets simultaneously"3.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.3 January 2028
Dogs1 × 109