Commission Implementing Regulation (EU) No 544/2013 of 14 June 2013 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH) Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2015/1105of 8 July 2015concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation Biomin GmbH)(Text with EEA relevance), 32015R1105, July 9, 2015
Commission Implementing Regulation (EU) No 544/2013of 14 June 2013concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH)(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
As total content of the mixture.Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxCategory 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 %
4b1890Biomin GmbHBifidobacterium animalis ssp. animalisDSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913Additive compositionPreparation in form of a mixture of:Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additiveLactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additiveEnterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additiveSolid preparation (ratio 3:1:6)Characterisation of active substanceViable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913Analytical methodsFor the enumeration of:Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787Enterococcus faecium DSM 21913 spread plate method EN 15788For the identification:Pulsed Field Gel Electrophoresis (PFGE)Chickens for fattening—1 × 1081 × 1091.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.3.For safety: breathing protection, glasses and gloves shall be used during handling.5 July 2023
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
As total content of the mixture.Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxCategory 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 %
4b1890Biomin GmbHBifidobacterium animalis ssp. animalisDSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913Additive compositionPreparation in form of a mixture of:Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additiveLactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additiveEnterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additiveSolid preparation (ratio 3:1:6)Characterisation of active substanceViable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913Analytical methodsFor the enumeration of:Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787Enterococcus faecium DSM 21913 spread plate method EN 15788For the identification:Pulsed Field Gel Electrophoresis (PFGE)Chickens for fattening—1 × 1081 × 1091.In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.2.The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.3.For safety: breathing protection, glasses and gloves shall be used during handling.5 July 2023