Commission Implementing Regulation (EU) 2024/251

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition^note, and in particular Article 9(2) thereof,Whereas:

(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation.

(2)The preparations of Lactiplantibacillus plantarum (previously taxonomically identified as Lactobacillus plantarum) CNCM I-3235 and of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736 (previously taxonomically identified as Lactobacillus plantarum CNCM MA 18/5U) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1065/2012^note.

(3)The preparation of Pediococcus acidilactici CNCM I-3237 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 304/2014^note.

(4)The preparations of Pediococcus acidilactici DSM 11673/CNCM I-4622 (previously taxonomically identified as Pediococcus acidilactici CNCM MA 18/5M – DSM 11673) and of Pediococcus pentosaceus NCIMB 12455 were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1119/2012^note.

(5)The preparation of Acidipropionibacterium acidipropionici CNCM I-4661 (previously taxonomically identified as Propionibacterium acidipropionici CNCM MA 26/4U) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 990/2012^note.

(6)The preparation of Lentilactobacillus buchneri (previously taxonomically identified as Lactobacillus buchneri) NCIMB 40788/CNCM I-4323 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 1113/2013^note.

(7)The preparation of Lentilactobacillus hilgardii (previously taxonomically identified as Lactobacillus hilgardii) CNCM I-4785 and Lentilactobacillus buchneri (previously taxonomically identified as Lactobacillus buchneri) CNCM I-4323/NCIMB 40788 was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) 2019/764^note.

(8)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives for all animal species, requesting the additives to be classified in the additive category ‘technological additives’ and in the functional group ‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

(9)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 31 January 2023^note that the abovementioned preparations remain safe for all animal species, the consumers and the environment under the existing conditions of authorisation. It also concluded that the additives should be considered as respiratory sensitisers. In the absence of data, no conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additives, with the exception for Pediococcus acidilactici DSM 11673/CNCM I-4622 that is considered non-irritant to skin and eyes. It also indicated that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation.

(10)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessments carried out regarding the method of analysis of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives in the context of the previous authorisations are valid and applicable for the current application. In accordance with Article 5(4), point (c) of Commission Regulation (EC) No 378/2005^note, an evaluation report of the Reference Laboratory is therefore not required.

(11)In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(12)As a consequence of the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici CNCM I-3237, Pediococcus acidilactici DSM 11673/CNCM I-4622, Pediococcus pentosaceus NCIMB 12455, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 as feed additives, Implementing Regulations (EU) No 1065/2012, (EU) No 1119/2012, (EU) No 1113/2013 and (EU) No 304/2014 should be amended and Implementing Regulations (EU) No 990/2012 and (EU) 2019/764 should be repealed.

(13)Since safety reasons do not require the immediate application of the modifications to the conditions of the authorisation of the preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici DSM 11673/CNCM I-4622, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788, in relation to the taxonomical change of the microorganisms contained therein, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisations.

(14)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1Renewal of authorisation#

The authorisation of the preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are renewed subject to the conditions laid down in that Annex.

Article 2Amendment to Implementing Regulation (EU) No 1065/2012#

In the Annex to Implementing Regulation (EU) No 1065/2012, entry 1k20717 on Lactobacillus plantarum (CNCM I-3235) and entry 1k20722 on Lactobacillus plantarum (CNCM MA 18/5U) are deleted.

Article 3Amendment to Implementing Regulation (EU) No 1119/2012#

In the Annex to Implementing Regulation (EU) No 1119/2012, entry 1k2104 on Pediococcus acidilactici CNCM MA 18/5M DSM 11673 and entry 1k2106 on Pediococcus pentosaceus NCIMB 12455 are deleted.

Article 4Amendment to Implementing Regulation (EU) No 1113/2013#

In the Annex to Implementing Regulation (EU) No 1113/2013, entry 1k20739 on Lactobacillus buchneri NCIMB 40788/CNCM I-4323 is deleted.

Article 5Amendment to Implementing Regulation (EU) No 304/2014#

In the Annex to Implementing Regulation (EU) No 304/2014, entry 1k21009 on Pediococcus acidilactici CNCM I-3237 is deleted.

Article 6Repeal of Implementing Regulations (EU) No 990/2012 and (EU) 2019/764#

Implementing Regulations (EU) No 990/2012 and (EU) 2019/764 are repealed.

Article 7Transitional measures#

The preparations of Lactiplantibacillus plantarum CNCM I-3235, Lactiplantibacillus plantarum DSM 11672/CNCM I-3736, Pediococcus acidilactici DSM 11673/CNCM I-4622, Acidipropionibacterium acidipropionici CNCM I-4661, Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 and Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 specified in the Annex, and feed containing them which are produced and labelled before 6 February 2025 in accordance with the rules applicable before 6 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 8Entry 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.

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k20717	Lactiplantibacillus plantarum CNCM I-3235	Additive compositionPreparation of Lactiplantibacillus plantarum CNCM I-3235 containing a minimum of 5 × 10¹⁰ CFU/g additiveCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum CNCM I-3235Analytical method^noteEnumeration: Spread plate method: EN 15787Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other microorganisms as silage additives: 2 × 107 CFU/kg fresh material.3. 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 skin, eye and breathing protective equipment.	6 February 2034

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k20722	Lactiplantibacillus plantarum DSM 11672/CNCM I-3736	Additive compositionPreparation of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736 containing a minimum of 2 × 10 ¹⁰ CFU/g additiveCharacterisation of the active substanceViable cells of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736Analytical method^noteEnumeration: Spread plate method: EN 15787Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other microorganisms as silage additives: 1 × 108 CFU/kg fresh material.3. 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 skin, eye and breathing protective equipment.	6 February 2034

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k21009	Pediococcus acidilactici CNCM I-3237	Additive compositionPreparation of Pediococcus acidilactici CNCM I-3237 containing a minimum of 1 × 10¹⁰ CFU/g additiveCharacterisation of the active substanceViable cells of Pediococcus acidilactici CNCM I-3237Analytical method^noteEnumeration: Spread plate method: EN 15786Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other microorganisms as silage additives: 5 × 107 CFU/kg fresh material.3. 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 skin, eye and breathing protective equipment	6 February 2034
1k2104	Pediococcus acidilactici DSM 11673/CNCM I-4622	Additive compositionPreparation of Pediococcus acidilactici DSM 11673/CNCM I-4622 containing a minimum of 3 × 10⁹ CFU/g additive.Characterisation of the active substanceViable cells of Pediococcus. acidilactici DSM 11673/CNCM I-4622Analytical method^noteEnumeration: Spread plate method: EN 15786Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other microorganisms as silage additives: 3 × 107 CFU/kg fresh material.3. 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 skin and breathing protective equipment.	6 February 2034

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k2106	Pediococcus pentosaceus NCIMB 12455	Additive compositionPreparation of Pediococcus pentosaceus NCIMB 12455 containing a minimum of 3 × 10⁹ CFU/g additiveCharacterisation of the active substanceViable cells of Pediococcus pentosaceus NCIMB 12455Analytical method^noteEnumeration: Spread plate method: EN 15786Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other microorganisms as silage additives: 3 × 107 CFU/kg fresh material.3. 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 skin, eye and breathing protective equipment.	6 February 2034

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k2111	Acidipropionibacterium acidipropionici CNCM I-4661	Additive compositionPreparation of Acidipropionibacterium acidipropionici CNCM I-4661 containing a minimum of 1 × 10⁸ CFU/g additiveCharacterisation of the active substanceViable cells of Acidipropionibacterium acidipropionici CNCM I-4661Analytical method^noteEnumeration: Spread plate method: EN 15787Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other microorganisms as silage additives: 1 × 108 CFU/kg fresh material.3. 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 skin, eye and breathing protective equipment.	6 February 2034

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k20739	Lentilactobacillus. buchneri NCIMB 40788/CNCM I-4323	Additive compositionPreparation of Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 containing a minimum of 3 × 10⁹ CFU/g additiveCharacterisation of the active substanceViable cells of Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323Analytical method^noteEnumeration: Spread plate method: EN 15787Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.3. 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 skin, eye and breathing protective equipment.	6 February 2034

Identification number of the additive	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
CFU/kg of fresh material
Category of technological additives. Functional group: silage additives
1k20757	Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus. buchneri CNCM I-4323/NCIMB 40788	Additive compositionPreparation of Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788 containing a minimum of 1,5 × 10¹¹ CFU/g additive (ratio of 1:1)Characterisation of the active substanceViable cells of Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788Analytical method^noteEnumeration: Spread plate method: EN 15787Identification: Pulsed- Field Gel Electrophoresis (PFGE) – CEN/TS 17697 or DNA sequencing methods	All animal species	—	—	—	1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated.2. Minimum content of the additive when used without combination with other micro-organisms as silage additives: 3 × 108 CFU/kg (L. hilgardii CNCM I-4785 and L. buchneri CNCM I-4323/NCIMB 40788 in ratio of 1:1) of easy and moderately difficult to ensile fresh material.3. 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 skin, eye and breathing protective equipment.	6 February 2034