Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Calpis Co. Ltd Japan, represented 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 Regulation (EU) No 184/2011of 25 February 2011concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (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.be/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 compositionPreparation of Bacillus subtilis C-3102 DSM 15544 containing a minimum of 1 × 1010 CFU/gCharacterisation of active substanceViable spores of Bacillus subtilis C-3102 (DSM 15544)Analytical methodsEnumeration: spread plate method using tryptone soya agar with preheat treatment of feed samplesIdentification: Pulsed Field Gel Electrophoresis (PFGE)Chickens reared for laying5 × 1081.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.For safety: breathing protection, glasses and gloves shall be used during handling.3.May be used in feed containing the following coccidiostats where authorised: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, lasalocid sodium, halofuginone, narasin, salinomycin sodium, maduramycin ammonium, narasin-nicarbazin, semduramycin sodium or nicarbazin.18 March 2021
Turkeys, minor avian species and other ornamental and game birds3 × 108

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.be/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 compositionPreparation of Bacillus subtilis C-3102 DSM 15544 containing a minimum of 1 × 1010 CFU/gCharacterisation of active substanceViable spores of Bacillus subtilis C-3102 (DSM 15544)Analytical methodsEnumeration: spread plate method using tryptone soya agar with preheat treatment of feed samplesIdentification: Pulsed Field Gel Electrophoresis (PFGE)Chickens reared for laying5 × 1081.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.For safety: breathing protection, glasses and gloves shall be used during handling.3.May be used in feed containing the following coccidiostats where authorised: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, lasalocid sodium, halofuginone, narasin, salinomycin sodium, maduramycin ammonium, narasin-nicarbazin, semduramycin sodium or nicarbazin.18 March 2021
Turkeys, minor avian species and other ornamental and game birds3 × 108