Commission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o) Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2024/1161of 22 April 2024concerning the renewal of the authorisation of a preparation of Enterococcus lactis NCIMB 10415 as a feed additive for certain animal species, the authorisation of that preparation as a feed additive for certain other animal species (holder of authorisation: DSM Nutritional Products Ltd.), amending Implementing Regulation (EU) No 1061/2013 and repealing Implementing Regulations (EU) No 361/2011, (EU) 2015/518 and (EU) 2019/11(Text with EEA relevance), 32024R1161, April 23, 2024
Commission Implementing Regulation (EU) No 1061/2013of 29 October 2013concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o)(Text with EEA relevance)
Article 1AuthorisationThe preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional groups "gut flora stabilisers" and "other zootechnical additives", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Repeal of Regulation (EC) No 102/2009Regulation (EC) No 102/2009 is repealed.
Article 3Amendment to Regulation (EC) No 1288/2004In Annex I to Regulation (EC) No 1288/2004 the entry on E 1705, Enterococcus faecium NCIMB 10415 is deleted.
Article 4Transitional measuresThe preparation specified in Annex as far as its use for calves is concerned, and feed containing that preparation, which are produced and labelled before 19 May 2014 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.The preparation specified in Annex as far as its use for cats and dogs is concerned, and feed containing that preparation, which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 5Entry into forceThis 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: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxCategory of zootechnical additives. Functional group: gut flora stabilisersCategory of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions)
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 %
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.oEnterococcus faeciumNCIMB 10415Additive compositionPreparation of Enterococcus faeciumNCIMB 10415 containing a minimum of: microencapsulated form with shellac and other microencapsulated forms:1 × 1010 CFU/g additive;non-coated granulated forms:3,5 × 1010 CFU/g additiveCharacterisation of the active substanceViable cells of Enterococcus faeciumNCIMB 10415Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)CalvesKids—1 × 109—In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.oEnterococcus faeciumNCIMB 10415Additive compositionPreparation of Enterococcus faeciumNCIMB 10415 containing a minimum of: 5 × 109 CFU/g of additive;Microencapsulated forms (shellac).Characterisation of the active substanceViable cells of Enterococcus faeciumNCIMB 10415Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)Cats—7 × 109—In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.oEnterococcus faeciumNCIMB 10415Additive compositionPreparation of Enterococcus faeciumNCIMB 10415 containing a minimum of 5 × 109 CFU/g of additive.Microencapsulated forms (shellac).Characterisation of the active substanceViable cells of Enterococcus faeciumNCIMB 10415Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)Dogs—2,5 × 109In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
Article 1AuthorisationThe preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional groups "gut flora stabilisers" and "other zootechnical additives", is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2Repeal of Regulation (EC) No 102/2009Regulation (EC) No 102/2009 is repealed.
Article 3Amendment to Regulation (EC) No 1288/2004In Annex I to Regulation (EC) No 1288/2004 the entry on E 1705, Enterococcus faecium NCIMB 10415 is deleted.
Article 4Transitional measuresThe preparation specified in Annex as far as its use for calves is concerned, and feed containing that preparation, which are produced and labelled before 19 May 2014 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.The preparation specified in Annex as far as its use for cats and dogs is concerned, and feed containing that preparation, which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 5Entry into forceThis 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: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxCategory of zootechnical additives. Functional group: gut flora stabilisersCategory of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions)
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 %
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.oEnterococcus faeciumNCIMB 10415Additive compositionPreparation of Enterococcus faeciumNCIMB 10415 containing a minimum of: microencapsulated form with shellac and other microencapsulated forms:1 × 1010 CFU/g additive;non-coated granulated forms:3,5 × 1010 CFU/g additiveCharacterisation of the active substanceViable cells of Enterococcus faeciumNCIMB 10415Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)CalvesKids—1 × 109—In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.oEnterococcus faeciumNCIMB 10415Additive compositionPreparation of Enterococcus faeciumNCIMB 10415 containing a minimum of: 5 × 109 CFU/g of additive;Microencapsulated forms (shellac).Characterisation of the active substanceViable cells of Enterococcus faeciumNCIMB 10415Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)Cats—7 × 109—In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023
4b1705DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.oEnterococcus faeciumNCIMB 10415Additive compositionPreparation of Enterococcus faeciumNCIMB 10415 containing a minimum of 5 × 109 CFU/g of additive.Microencapsulated forms (shellac).Characterisation of the active substanceViable cells of Enterococcus faeciumNCIMB 10415Analytical methodEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed-Field Gel Electrophoresis (PFGE)Dogs—2,5 × 109In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.19 November 2023