Commission Implementing Regulation (EU) 2024/1161 of 22 April 2024 concerning 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
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  • Corrigendum to Commission Implementing Regulation (EU) 2024/1161 of 22 April 2024 concerning 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, 32024R1161R(01), May 17, 2024
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)
Article 1Renewal of authorisationThe authorisation of the "micro-encapsulated form" and the "micro-encapsulated form with shellac" of the preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers", for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, as well as of the "micro-encapsulated form", the "micro-encapsulated form with shellac" and the "non-coated granulated form" of that preparation for use in feed for calves for rearing and for fattening, kids for rearing and for fattening, sows, suckling piglets, weaned piglets and pigs for fattening, is renewed subject to the conditions laid down in that Annex.
Article 2AuthorisationThe "non-coated granulated form" of the 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 for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, subject to the conditions laid down in that Annex. The "micro-encapsulated form", the "micro-encapsulated form with shellac" and the "non-coated granulated form" of that preparation are authorised as an additive in animal nutrition for use in feed for chickens reared for breeding, turkeys for fattening and reared for breeding, minor poultry species reared for breeding, ornamental birds, lambs for rearing and for fattening, minor ruminant species for rearing and for fattening, and all categories of minor porcine species, subject to the conditions laid down in that Annex. The "micro-encapsulated form" and the "non-coated granulated form" of that preparation are authorised as an additive in animal nutrition for use in water for drinking for all poultry species for fattening, reared for laying and reared for breeding, ornamental birds, sows of all Suidae species, suckling and weaned piglets of all Suidae species, pigs for fattening of all Suidae species, calves for rearing and for fattening, kids for rearing and for fattening, lambs for rearing and for fattening, and minor ruminant species for rearing and for fattening, subject to the conditions laid down in that Annex.
Article 3Amendment to Implementing Regulation (EU) No 1061/2013In the Annex to Implementing Regulation (EU) No 1061/2013, the first entry 4b1705 relating to calves and kids is deleted.
Article 4RepealsImplementing Regulations (EU) No 361/2011, (EU) 2015/518 and (EU) 2019/11 are repealed.
Article 5Transitional measures1.The "micro-encapsulated form" and the "micro-encapsulated form with shellac" of the preparation specified in the Annex and premixtures containing those forms of that preparation, which are intended for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, as well as the "micro-encapsulated form", the "micro-encapsulated form with shellac" and the "non-coated granulated form" of that preparation and premixtures containing those forms of that preparation, which are intended for use in feed for calves for rearing and for fattening, kids for rearing and for fattening, sows, suckling piglets, weaned piglets and pigs for fattening, and which are produced and labelled before 13 November 2024 in accordance with the rules applicable before 13 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.2.Compound feed and feed materials containing the "micro-encapsulated form" or the "micro-encapsulated form with shellac" of the preparation specified in the Annex and premixtures containing those forms of that preparation, which are intended for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, as well as containing the "micro-encapsulated form", the "micro-encapsulated form with shellac" or the "non-coated granulated form" of that preparation, which are intended for use in feed for calves for rearing and for fattening, kids for rearing and for fattening, sows, suckling piglets, weaned piglets and pigs for fattening, and which are produced and labelled before 13 May 2025 in accordance with the rules applicable before 13 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 6Entry 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.ANNEXPART I
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Identification number of the feed additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1705DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.Enterococcus lactis NCIMB 10415Additive compositionPreparation of Enterococcus lactis NCIMB 10415 containing a minimum of:micro-encapsulated form: 1 × 1010 CFU/g additive, ornon-coated granulated form: 3,5 × 1010 CFU/g additive.Solid formsCharacterisation of the active substanceViable cells of Enterococcus lactis NCIMB 10415Analytical methodIdentification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697.Enumeration in the feed additive, premixtures, compound feed and water: spread plate method using bile esculin azide agar (EN 15788)All poultry species for fatteningAll poultry species reared for layingAll poultry species reared for breedingOrnamental birds—3 × 108—1,5 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.The additive may be used via water for drinking.3.The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, semduramicin, lasalocid A sodium, maduramicin ammonium, narasin, a combination of narasin with nicarbazin, salinomycin sodium.4.The additive shall be administered to lactating sows and simultaneously to the suckling piglets.5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment, and also eye protective equipment for the granulated non-coated form.13 May 2034
Sows of all Suidae species7 × 1083,5 × 108
Suckling piglets of all Suidae speciesCalves, kids, lambs and minor ruminant species for rearingCalves, kids, lambs and minor ruminant species for fattening1 × 1090,5 × 109
Weaned piglets of all Suidae speciesPigs for fattening of all Suidae species3,5 × 1082 × 108
PART II
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Identification number of the feed 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 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1705iDSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.Enterococcus lactis NCIMB 10415Additive compositionPreparation of Enterococcus lactis NCIMB 10415 containing a minimum of:micro-encapsulated form with shellac: 2 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Enterococcus lactis NCIMB 10415Analytical methodIdentification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697.Enumeration in the feed additive, premixtures, compound feed and water: spread plate method using bile esculin azide agar (EN 15788)All poultry species for fatteningAll poultry species reared for layingAll poultry species reared for breedingOrnamental birds—3 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, semduramicin, lasalocid A sodium, maduramicin ammonium, narasin, a combination of narasin with nicarbazin, salinomycin sodium.3.The additive shall be administered to lactating sows and simultaneously to the suckling piglets.4.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.13 May 2034
Sows of all Suidae species7 × 108
Suckling piglets of all Suidae speciesCalves, kids, lambs and minor ruminant species for rearingCalves, kids, lambs and minor ruminant species for fattening1 × 109
Weaned piglets of all Suidae speciesPigs for fattening of all Suidae species3,5 × 108
Article 1Renewal of authorisationThe authorisation of the "micro-encapsulated form" and the "micro-encapsulated form with shellac" of the preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "gut flora stabilisers", for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, as well as of the "micro-encapsulated form", the "micro-encapsulated form with shellac" and the "non-coated granulated form" of that preparation for use in feed for calves for rearing and for fattening, kids for rearing and for fattening, sows, suckling piglets, weaned piglets and pigs for fattening, is renewed subject to the conditions laid down in that Annex.
Article 2AuthorisationThe "non-coated granulated form" of the 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 for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, subject to the conditions laid down in that Annex. The "micro-encapsulated form", the "micro-encapsulated form with shellac" and the "non-coated granulated form" of that preparation are authorised as an additive in animal nutrition for use in feed for chickens reared for breeding, turkeys for fattening and reared for breeding, minor poultry species reared for breeding, ornamental birds, lambs for rearing and for fattening, minor ruminant species for rearing and for fattening, and all categories of minor porcine species, subject to the conditions laid down in that Annex. The "micro-encapsulated form" and the "non-coated granulated form" of that preparation are authorised as an additive in animal nutrition for use in water for drinking for all poultry species for fattening, reared for laying and reared for breeding, ornamental birds, sows of all Suidae species, suckling and weaned piglets of all Suidae species, pigs for fattening of all Suidae species, calves for rearing and for fattening, kids for rearing and for fattening, lambs for rearing and for fattening, and minor ruminant species for rearing and for fattening, subject to the conditions laid down in that Annex.
Article 3Amendment to Implementing Regulation (EU) No 1061/2013In the Annex to Implementing Regulation (EU) No 1061/2013, the first entry 4b1705 relating to calves and kids is deleted.
Article 4RepealsImplementing Regulations (EU) No 361/2011, (EU) 2015/518 and (EU) 2019/11 are repealed.
Article 5Transitional measures1.The "micro-encapsulated form" and the "micro-encapsulated form with shellac" of the preparation specified in the Annex and premixtures containing those forms of that preparation, which are intended for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, as well as the "micro-encapsulated form", the "micro-encapsulated form with shellac" and the "non-coated granulated form" of that preparation and premixtures containing those forms of that preparation, which are intended for use in feed for calves for rearing and for fattening, kids for rearing and for fattening, sows, suckling piglets, weaned piglets and pigs for fattening, and which are produced and labelled before 13 November 2024 in accordance with the rules applicable before 13 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.2.Compound feed and feed materials containing the "micro-encapsulated form" or the "micro-encapsulated form with shellac" of the preparation specified in the Annex and premixtures containing those forms of that preparation, which are intended for use in feed for chickens for fattening and reared for laying and minor poultry species for fattening and reared for laying, as well as containing the "micro-encapsulated form", the "micro-encapsulated form with shellac" or the "non-coated granulated form" of that preparation, which are intended for use in feed for calves for rearing and for fattening, kids for rearing and for fattening, sows, suckling piglets, weaned piglets and pigs for fattening, and which are produced and labelled before 13 May 2025 in accordance with the rules applicable before 13 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 6Entry 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.ANNEXPART I
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Identification number of the feed additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %CFU/l of water for drinking
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1705DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.Enterococcus lactis NCIMB 10415Additive compositionPreparation of Enterococcus lactis NCIMB 10415 containing a minimum of:micro-encapsulated form: 1 × 1010 CFU/g additive, ornon-coated granulated form: 3,5 × 1010 CFU/g additive.Solid formsCharacterisation of the active substanceViable cells of Enterococcus lactis NCIMB 10415Analytical methodIdentification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697.Enumeration in the feed additive, premixtures, compound feed and water: spread plate method using bile esculin azide agar (EN 15788)All poultry species for fatteningAll poultry species reared for layingAll poultry species reared for breedingOrnamental birds—3 × 108—1,5 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.The additive may be used via water for drinking.3.The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, semduramicin, lasalocid A sodium, maduramicin ammonium, narasin, a combination of narasin with nicarbazin, salinomycin sodium.4.The additive shall be administered to lactating sows and simultaneously to the suckling piglets.5.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment, and also eye protective equipment for the granulated non-coated form.13 May 2034
Sows of all Suidae species7 × 1083,5 × 108
Suckling piglets of all Suidae speciesCalves, kids, lambs and minor ruminant species for rearingCalves, kids, lambs and minor ruminant species for fattening1 × 1090,5 × 109
Weaned piglets of all Suidae speciesPigs for fattening of all Suidae species3,5 × 1082 × 108
PART II
Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Identification number of the feed 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 %
Category: zootechnical additives. Functional group: gut flora stabilisers
4b1705iDSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.Enterococcus lactis NCIMB 10415Additive compositionPreparation of Enterococcus lactis NCIMB 10415 containing a minimum of:micro-encapsulated form with shellac: 2 × 1010 CFU/g additiveSolid formCharacterisation of the active substanceViable cells of Enterococcus lactis NCIMB 10415Analytical methodIdentification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697.Enumeration in the feed additive, premixtures, compound feed and water: spread plate method using bile esculin azide agar (EN 15788)All poultry species for fatteningAll poultry species reared for layingAll poultry species reared for breedingOrnamental birds—3 × 108—1.In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2.The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, semduramicin, lasalocid A sodium, maduramicin ammonium, narasin, a combination of narasin with nicarbazin, salinomycin sodium.3.The additive shall be administered to lactating sows and simultaneously to the suckling piglets.4.For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.13 May 2034
Sows of all Suidae species7 × 108
Suckling piglets of all Suidae speciesCalves, kids, lambs and minor ruminant species for rearingCalves, kids, lambs and minor ruminant species for fattening1 × 109
Weaned piglets of all Suidae speciesPigs for fattening of all Suidae species3,5 × 108