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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

Type Implementing Regulation

Publication 2024-04-23

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 6

Reform history JSON API

Article 1

Renewal of authorisation

The 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 2

Authorisation

The ‘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 3

Amendment to Implementing Regulation (EU) No 1061/2013

In the Annex to Implementing Regulation (EU) No 1061/2013, the first entry 4b1705 relating to calves and kids is deleted.

Article 4

Repeals

Implementing Regulations (EU) No 361/2011, (EU) 2015/518 and (EU) 2019/11 are repealed.

Article 5

Transitional measures

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.

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 6

Entry into force

This 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

PART I

Identification number of the feed additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Minimum content	Maximum content	Minimum content	Maximum content	Other provisions	End of period of authorisation
Identification number of the feed additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	CFU/kg of complete feedingstuff with a moisture content of 12 %	CFU/kg of complete feedingstuff with a moisture content of 12 %	CFU/l of water for drinking	CFU/l of water for drinking	Other provisions	End of period of authorisation
Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers
4b1705	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.	Enterococcus lactis NCIMB 10415	*Additive composition* Preparation of Enterococcus lactis NCIMB 10415 containing a minimum of: — micro-encapsulated form: 1 × 10¹⁰ CFU/g additive, or — non-coated granulated form: 3,5 × 10¹⁰ CFU/g additive. Solid forms *Characterisation of the active substance* Viable cells of Enterococcus lactis NCIMB 10415 *Analytical method* [^E0001] Identification: 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 fattening All poultry species reared for laying All poultry species reared for breeding Ornamental birds	Other provisions	End of period of authorisation	—	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
4b1705	Sows of all Suidae species	7 × 10⁸	3,5 × 10⁸
4b1705	Suckling piglets of all Suidae species Calves, kids, lambs and minor ruminant species for rearing Calves, kids, lambs and minor ruminant species for fattening	1 × 10⁹	0,5 × 10⁹
4b1705	Weaned piglets of all Suidae species Pigs for fattening of all Suidae species	3,5 × 10⁸	2 × 10⁸

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

PART II

Identification number of the feed additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
Identification number of the feed additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	CFU/kg of complete feedingstuff with a moisture content of 12 %	CFU/kg of complete feedingstuff with a moisture content of 12 %	Other provisions	End of period of authorisation
Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers	Category: zootechnical additives. Functional group: gut flora stabilisers
4b1705i	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.	Enterococcus lactis NCIMB 10415	Other provisions	End of period of authorisation	*Additive composition* Preparation of Enterococcus lactis NCIMB 10415 containing a minimum of: — micro-encapsulated form with shellac: 2 × 10¹⁰ CFU/g additive Solid form *Characterisation of the active substance* Viable cells of Enterococcus lactis NCIMB 10415 *Analytical method* [^E0002] Identification: 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 fattening All poultry species reared for laying All poultry species reared for breeding Ornamental 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
4b1705i	Sows of all Suidae species	7 × 10⁸
4b1705i	Suckling piglets of all Suidae species Calves, kids, lambs and minor ruminant species for rearing Calves, kids, lambs and minor ruminant species for fattening	1 × 10⁹
4b1705i	Weaned piglets of all Suidae species Pigs for fattening of all Suidae species	3,5 × 10⁸

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