Commission Implementing Regulation (EU) No 373/2011 of 15 April 2011 concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 903/2009 (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) No 357/2013of 18 April 2013amending Regulation (EC) No 903/2009 and Implementing Regulation (EU) No 373/2011 as regards the minimum content of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens for fattening and minor avian species (excluding laying birds) (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.)(Text with EEA relevance), 32013R0357, April 19, 2013
  • 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) No 373/2011of 15 April 2011concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 903/2009 (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 2In Regulation (EC) No 903/2009 the words "Clostridium butyricum MIYAIRI 588 (FERM-P 1467)" and the words "Mitsui & Co. Deutschland GmbH" are replaced respectively by the words "Clostridium butyricum FERM-BP 2789" and by the words "Miyarisan Pharmaceutical Europe S.L.U".In point 2 of the "Other provisions" column of the Annex to Regulation (EC) No 903/2009 the words "monensin sodium or lasalocid" are added.
Article 3Feed containing Clostridium butyricum MIYAIRI 588 (FERM-P 1467) labelled in accordance with Regulation (EC) No 903/2009 may continue to be placed on the market and used until stocks are exhausted.
Article 4This 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 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 butyricumFERM BP-2789Additive compositionPreparation of Clostridium butyricum FERM BP-2789 containing a minimum of solid form 5 × 108 CFU/g additive.Characterisation of the active substanceClostridium butyricum FERM BP-2789.Analytical methodQuantification: pour plate method based on ISO 15213 standard.Identification: pulsed-field gel electrophoresis (PFGE) method.Minor avian species (excluding laying birds).—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, maduramycin ammonium, robenidine, narasin, narasin/nicarbazin, semduramicin, decoquinate, salinomycin sodium or lasalocid sodium.3.For safety: breathing protection shall be used during the handling.6 May 2021
Piglets (weaned) and minor porcine species (weaned).2,5 × 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 2In Regulation (EC) No 903/2009 the words "Clostridium butyricum MIYAIRI 588 (FERM-P 1467)" and the words "Mitsui & Co. Deutschland GmbH" are replaced respectively by the words "Clostridium butyricum FERM-BP 2789" and by the words "Miyarisan Pharmaceutical Europe S.L.U".In point 2 of the "Other provisions" column of the Annex to Regulation (EC) No 903/2009 the words "monensin sodium or lasalocid" are added.
Article 3Feed containing Clostridium butyricum MIYAIRI 588 (FERM-P 1467) labelled in accordance with Regulation (EC) No 903/2009 may continue to be placed on the market and used until stocks are exhausted.
Article 4This 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 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 butyricumFERM BP-2789Additive compositionPreparation of Clostridium butyricum FERM BP-2789 containing a minimum of solid form 5 × 108 CFU/g additive.Characterisation of the active substanceClostridium butyricum FERM BP-2789.Analytical methodQuantification: pour plate method based on ISO 15213 standard.Identification: pulsed-field gel electrophoresis (PFGE) method.Minor avian species (excluding laying birds).—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, maduramycin ammonium, robenidine, narasin, narasin/nicarbazin, semduramicin, decoquinate, salinomycin sodium or lasalocid sodium.3.For safety: breathing protection shall be used during the handling.6 May 2021
Piglets (weaned) and minor porcine species (weaned).2,5 × 108