Commission Implementing Regulation (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.) Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2017/1126of 23 June 2017amending Regulation (EC) No 903/2009 and Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 as regards the name of the EU representative of the holder of the authorisation of a preparation of Clostridium butyricum (FERM-BP 2789)(Text with EEA relevance), 32017R1126, June 24, 2017
  • Commission Implementing Regulation (EU) 2021/1411of 27 August 2021concerning the renewal of the authorisation of Clostridium butyricum FERM BP-2789 as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, its authorisation for chickens for fattening, suckling piglets and suckling minor porcine species, and repealing Implementing Regulations (EU) No 373/2011, (EU) No 374/2013 and (EU) No 1108/2014 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)(Text with EEA relevance), 32021R1411, August 30, 2021
Commission Implementing Regulation (EU) No 374/2013of 23 April 2013concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium)(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
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: 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 %
4b1830Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV BelgiumClostridium butyricum(FERM BP-2789)Additive compositionPreparation of Clostridium butyricum (FERM BP-2789) containing in solid form a minimum of 5 × 108 CFU/g additive.Characterisation of the active substanceViable spores of Clostridium butyricum FERM BP-2789.Analytical methodQuantification: pour plate method based on ISO 15213 standard.Identification: pulsed-field gel electrophoresis (PFGE) method.Chickens reared for laying—2,5 × 108—1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.The use is allowed in feed containing the authorised coccidiostats: monensin sodium, diclazuril, salinomycin sodium or lasalocid sodium.3.For safety: breathing protection and safety glasses shall be used during the handling.14 May 2023
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