2024/251

17.1.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/251

of 16 January 2024

concerning 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, amending Implementing Regulations (EU) No 1065/2012, (EU) No 1119/2012, (EU) No 1113/2013 and (EU) No 304/2014 and repealing Implementing Regulations (EU) No 990/2012 and (EU) 2019/764

(Text with EEA relevance)

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 (1), 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 (2).

(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 (3).

(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 (4).

(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 (5).

(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 (6).

(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 (7).

(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 (8) 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 (9), 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 1

Renewal 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 2

Amendment 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 3

Amendment 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 4

Amendment 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 5

Amendment 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 6

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

Implementing Regulations (EU) No 990/2012 and (EU) 2019/764 are repealed.

Article 7

Transitional 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 8

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.

Done at Brussels, 16 January 2024.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 268, 18.10.2003, p. 29

(2) Commission Implementing Regulation (EU) No 1065/2012 of 13 November 2012 concerning the authorisation of preparations of

Lactobacillus plantarum

(DSM 23375, CNCM I-3235, DSM 19457, DSM 16565, DSM 16568, LMG 21295, CNCM MA 18/5U, NCIMB 30094, VTT E-78076, ATCC PTSA-6139, DSM 18112, DSM 18113, DSM 18114, ATCC 55943 and ATCC 55944) as feed additives for all animal species (

OJ L 314, 14.11.2012, p. 15

(3) Commission Implementing Regulation (EU) No 304/2014 of 25 March 2014 concerning the authorisation of the preparations of

Enterococcus faecium

NCIMB 10415,

Enterococcus faecium

DSM 22502 and

Pediococcus acidilactici

CNCM I-3237 as feed additives for all animal species (

OJ L 90, 26.3.2014, p. 8

(4) Commission Implementing Regulation (EU) No 1119/2012 of 29 November 2012 concerning the authorisation of preparations of

Pediococcus acidilactici

CNCM MA 18/5M DSM 11673,

Pediococcus pentosaceus

DSM 23376

NCIMB 12455 and NCIMB 30168,

Lactobacillus plantarum

DSM 3676 and DSM 3677 and

Lactobacillus buchneri

DSM 13573 as feed additives for all animal species (

OJ L 330, 30.11.2012, p. 14

(5) Commission Implementing Regulation (EU) No 990/2012 of 25 October 2012 concerning the authorisation of a preparation of

Propionibacterium acidipropionici

(CNCM MA 26/4U) as a feed additive for all animal species (

OJ L 297, 26.10.2012, p. 15

(6) Commission Implementing Regulation (EU) No 1113/2013 of 7 November 2013 concerning the authorisation of preparations of

Lactobacillus plantarum

NCIMB 40027,

Lactobacillus buchneri

DSM 22501,

Lactobacillus buchneri

NCIMB 40788/CNCM I-4323,

Lactobacillus buchneri

LN 40177/ATCC PTA-6138, and

Lactobacillus buchneri

LN 4637/ATCC PTA-2494 as feed additives for all animal species (

OJ L 298, 8.11.2013, p. 29

(7) Commission Implementing Regulation (EU) 2019/764 of 14 May 2019 concerning the authorisation of a preparation of

Lactobacillus hilgardii

CNCM I-4785 and

Lactobacillus buchneri

CNCM I-4323/NCIMB 40788 as a feed additive for all animal species (

OJ L 126, 15.5.2019, p. 1

(8)

EFSA Journal

2023;21(2):7865.

(9) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (

OJ L 59, 5.3.2005, p. 8

ANNEX

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 composition

Preparation of Lactiplantibacillus plantarum CNCM I-3235 containing a minimum of 5 × 1010 CFU/g additive

Characterisation of the active substance

Viable cells of Lactiplantibacillus plantarum CNCM I-3235

Analytical method (1)

—	Enumeration: Spread plate method: EN 15787

—	Identification: 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.

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 composition

Preparation of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736 containing a minimum of 2 × 10 10 CFU/g additive

Characterisation of the active substance

Viable cells of Lactiplantibacillus plantarum DSM 11672/CNCM I-3736

Analytical method (2)

—	Enumeration: Spread plate method: EN 15787

—	Identification: 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.

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 composition

Preparation of Pediococcus acidilactici CNCM I-3237 containing a minimum of 1 × 1010 CFU/g additive

Characterisation of the active substance

Viable cells of Pediococcus acidilactici CNCM I-3237

Analytical method (3)

—	Enumeration: Spread plate method: EN 15786

—	Identification: 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.

6 February 2034

1k2104

Pediococcus acidilactici DSM 11673/CNCM I-4622

Additive composition

Preparation of Pediococcus acidilactici DSM 11673/CNCM I-4622 containing a minimum of 3 × 109 CFU/g additive.

Characterisation of the active substance

Viable cells of Pediococcus. acidilactici DSM 11673/CNCM I-4622

Analytical method (3)

—	Enumeration: Spread plate method: EN 15786

—	Identification: 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.

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 composition

Preparation of Pediococcus pentosaceus NCIMB 12455 containing a minimum of 3 × 109 CFU/g additive

Characterisation of the active substance

Viable cells of Pediococcus pentosaceus NCIMB 12455

Analytical method (4)

—	Enumeration: Spread plate method: EN 15786

—	Identification: 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.

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 composition

Preparation of Acidipropionibacterium acidipropionici CNCM I-4661 containing a minimum of 1 × 108 CFU/g additive

Characterisation of the active substance

Viable cells of Acidipropionibacterium acidipropionici CNCM I-4661

Analytical method (5)

—	Enumeration: Spread plate method: EN 15787

—	Identification: 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.

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 composition

Preparation of Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323 containing a minimum of 3 × 109 CFU/g additive

Characterisation of the active substance

Viable cells of Lentilactobacillus buchneri NCIMB 40788/CNCM I-4323

Analytical method (6)

—	Enumeration: Spread plate method: EN 15787

—	Identification: 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.

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 composition

Preparation 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 substance

Viable cells of Lentilactobacillus hilgardii CNCM I-4785 and Lentilactobacillus buchneri CNCM I-4323/NCIMB 40788

Analytical method (7)

—	Enumeration: Spread plate method: EN 15787

—	Identification: 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(8).

6 February 2034

(1) 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

(2) 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

(3) 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

(4) 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

(5) 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

(6) 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

(7) 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

(8) Easy to ensile forage: > 3 % soluble carbohydrates in fresh material. Moderately difficult to ensile forage: 1,5–3,0 % soluble carbohydrates in the fresh material. Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (

OJ L 133, 22.5.2008, p. 1

ELI: http://data.europa.eu/eli/reg_impl/2024/251/oj

ISSN 1977-0677 (electronic edition)