Commission Implementing Regulation (EU) 2024/252 of 16 January 2024 concerning the renewal of the authorisation of a preparation of Lactiplantibacillus plantarum DSM 23375 as a feed additive for all animal species and amending Implementing Regulation (EU) No 1065/2012

Official Journal EN of the European Union L series 2024/252 17.1.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/252 of 16 January 2024 concerning the renewal of the authorisation of a preparation of Lactiplantibacillus plantarum DSM 23375 as a feed additive for all animal species and amending Implementing Regulation (EU) No 1065/2012 (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 2003on 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 preparation of Lactiplantibacillus plantarum DSM 23375 (previously taxonomically identified as Lactobacillus plantarum DSM 23375) was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 1065/2012(2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Lactiplantibacillus plantarum DSM 23375 as a feed additive for all animal species, requesting the additive 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.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 May 2023(3) that the preparation of Lactiplantibacillus plantarum DSM 23375 remains safe for all animal species, the consumers and the environment under the conditions of use currently authorised, including the proposed use of a new carrier in the formulation of the preparation. It also concluded that the additive is not irritant to skin or eyes but that, owing to its proteinaceous nature, it should be considered a respiratory sensitiser. The Authority could not conclude on the skin sensitisation potential of the additive. It also indicated that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

(5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation of Lactiplantibacillus plantarum DSM 23375 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required.

(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) EFSA Journal 2023;21(6):8054.

(4) 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).

ELI: http://data.europa.eu/eli/reg_impl/2024/252/oj 1/4EN OJ L, 17.1.2024

(6) In view of the above, the Commission considers that the preparation of Lactiplantibacillus plantarum DSM 23375 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive 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.

(7) As a consequence of the renewal of the authorisation of the preparation of Lactiplantibacillus plantarum DSM 23375 as a feed additive, Implementing Regulation (EU) No 1065/2012 should be amended accordingly.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of Lactiplantibacillus plantarum DSM 23375, 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 authorisation.

(9) 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 the authorisation The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is 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 1k20716 on ‘Lactobacillus plantarum (DSM 23375)’ is deleted.

Article 3 Transitional measures The preparation specified in the Annex and feed containing it, which are produced and labelled before 6 February 2025in accordance with the rules applicable before 6 February 2024may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 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.

2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/252/ojEN OJ L, 17.1.2024 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

ELI: http://data.europa.eu/eli/reg_impl/2024/252/oj 3/44/4

ELI:

http://data.europa.eu/eli/reg_impl/2024/252/oj ANNEX Minimum Maximum Identification Species or Composition, chemical formula, Maximum content content End of period of number of the Additive category of Other provisions description, analytical method age authorisation additive animal CFU/kg of fresh material

Category: technological additives. Functional group: silage additives 1k20716 Lactiplantiba- Additive composition All animal — — 1. In the directions for use of the additive and pre­ 6 February 2034 cillus species mixtures, the storage conditions shall be indi­ Preparation of Lactiplantibacillus plantarum cated.

plantarum DSM 23375 containing a DSM 23375 minimum of 2 × 1010 CFU/g additive

2. Minimum dose of the additive when used with­ Solid form out combination with other micro-organisms

Characterisation of the active substance as silage additives: 1×108 CFU/kg fresh material.

Viable cells of Lactiplantibacillus 3. For users of the additive and premixtures, feed plantarum DSM 23375 business operators shall establish operational procedures and organisational measures to ad­ Analytical method(1) dress potential risks resulting from their use.

Enumeration in the feed additive of Where those risks cannot be eliminated by such Lactiplantibacillus plantarum DSM procedures and measures, the additive and pre­ 23375: mixtures shall be used with personal skin and — Spread plate method using MRS breathing protective equipment.

Agar (EN 15787) Identification of Lactiplantibacillus plantarum DSM 23375: — Pulsed Field Gel Electrophoresis

(PFGE) – CEN/TS 17697 or DNA sequencing methods

(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 EN OJ L,

17.1.2024