Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the Union 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) 2019/893of 28 May 2019concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (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 authorisation of the additive specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers", is renewed subject to the conditions laid down in that Annex.
Article 2Regulation (EC) No 1444/2006 is repealed.
Article 3This 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
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory 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 × 1010 CFU/gCharacterisation of the active substance:Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)Analytical methodEnumeration: spread plate method using tryptone soya agar (EN 15784:2009)Identification: pulsed-field gel electrophoresis (PFGE).Chickens for fattening—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.The use is permitted in feed containing one of the following authorised coccidiostats: monensin sodium, salinomycin sodium, seduramycin sodium, lasalocid sodium, maduramycin ammonium, narasin/nicarbazin, diclazuril.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 eye and breathing protection.18 June 2029
Article 1The authorisation of the additive specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers", is renewed subject to the conditions laid down in that Annex.
Article 2Regulation (EC) No 1444/2006 is repealed.
Article 3This 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
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reportsCategory 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 × 1010 CFU/gCharacterisation of the active substance:Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)Analytical methodEnumeration: spread plate method using tryptone soya agar (EN 15784:2009)Identification: pulsed-field gel electrophoresis (PFGE).Chickens for fattening—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.The use is permitted in feed containing one of the following authorised coccidiostats: monensin sodium, salinomycin sodium, seduramycin sodium, lasalocid sodium, maduramycin ammonium, narasin/nicarbazin, diclazuril.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 eye and breathing protection.18 June 2029