Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning 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)
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) 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, represented in the European Union by Pen & Tec Consulting S.L.U.) 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)
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 2In the Annex to Regulation (EC) No 1444/2006, in the second column, name of the holder of authorisation, the term "Calpis Co., Ltd represented in the Community by Orffa International Holding BV" is replaced by the term "Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office".
Article 3Regulation (EU) No 333/2010 is amended as follows:(a)in the title, the term "holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office" is replaced by the term "holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office";(b)in the Annex, in the second column, name of the holder of authorisation, the term "Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office, France" is replaced by the term "Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office".
Article 4Regulation (EU) No 184/2011 is amended as follows:(a)in the title, the term "holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office" is replaced by the term "holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office";(b)in the Annex, in the second column, name of the holder of authorisation, the term "Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office, France" is replaced by the term "Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office".
Article 5This 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: 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 compositionBacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/gCharacterisation of the active substanceViable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)Analytical methodEnumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)Identification: pulsed-field gel electrophoresis (PFGE).Laying hens—3 × 108—1.In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting shall be indicated.2.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.29 June 2026
Ornamental fish1 × 1010
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 2In the Annex to Regulation (EC) No 1444/2006, in the second column, name of the holder of authorisation, the term "Calpis Co., Ltd represented in the Community by Orffa International Holding BV" is replaced by the term "Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office".
Article 3Regulation (EU) No 333/2010 is amended as follows:(a)in the title, the term "holder of authorisation Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office" is replaced by the term "holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office";(b)in the Annex, in the second column, name of the holder of authorisation, the term "Calpis Co. Ltd Japan, represented in the European Union by Calpis Co. Ltd Europe Representative Office, France" is replaced by the term "Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office".
Article 4Regulation (EU) No 184/2011 is amended as follows:(a)in the title, the term "holder of authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office" is replaced by the term "holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office";(b)in the Annex, in the second column, name of the holder of authorisation, the term "Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative Office, France" is replaced by the term "Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office".
Article 5This 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: 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 compositionBacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/gCharacterisation of the active substanceViable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)Analytical methodEnumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)Identification: pulsed-field gel electrophoresis (PFGE).Laying hens—3 × 108—1.In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting shall be indicated.2.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.29 June 2026
Ornamental fish1 × 1010