(fra kommisjonsforordningen)

(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 DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944 (previously taxonomically identified as Lactobacillus plantarum DSM 18112, Lactobacillus plantarum DSM 18113, Lactobacillus plantarum DSM 18114, Lactobacillus plantarum ATCC 55943, Lactobacillus plantarum ATCC 55944) 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 preparations of Lentilactobacillus buchneri ATCC PTA-2494 (previously identified as Lactobacillus buchneri LN 4637/ATCC PTA-2494) and Lentilactobacillus buchneri ATCC PTA-6138 (previously identified as Lactobacillus buchneri LN 40177/ATCC PTA-6138) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1113/2013 (3).

(4) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, seven applications were submitted for the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 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’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 15 April 2024 (4) (5) and 17 April 2024 (6) (7) (8) (9) (10) that the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 remain safe for all animal species, consumers and the environment, under the conditions of use currently authorised. It also concluded that the additives should be considered as skin and respiratory sensitisers, and that any dermal and respiratory exposure is considered a risk. In the absence of data, the Authority could not conclude on their eye irritation potential. The Authority further concluded that there is no need for assessing the efficacy of the additives as the applications for renewal of their authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additives. Due to the absence of data regarding the microbiological contamination and impurities, the Authority could not conclude on the full characterisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138. In the subsequent opinion of 24 June 2025 (11) the Authority reported that the applicant provided new data and concluded that the additives are characterised regarding the microbiological contamination (except for the Enterobacteriaceae) and chemical purity, and no safety concerns were identified.

(6) 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 preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 as feed additives 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 (12), an evaluation report of the Reference Laboratory is therefore not required.

(7) In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 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 additives. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.

(8) As a consequence of the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138 as feed additives, Implementing Regulation (EU) No 1065/2012 should be amended and Implementing Regulation (EU) No 1113/2013 should be repealed.

(9) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparations of Lactiplantibacillus plantarum DSM 18112, Lactiplantibacillus plantarum DSM 18113, Lactiplantibacillus plantarum DSM 18114, Lactiplantibacillus plantarum ATCC 55943, Lactiplantibacillus plantarum ATCC 55944, Lentilactobacillus buchneri ATCC PTA-2494 and Lentilactobacillus buchneri ATCC PTA-6138, 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.

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