BAKGRUNN (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) Preparations of Lactiplantibacillus plantarum DSM 3676 (previously taxonomically identified as Lactobacillus plantarum DSM 3676), Lactiplantibacillus plantarum DSM 3677 (previously taxonomically identified as Lactobacillus plantarum DSM 3677) and Lentilactobacillus buchneri DSM 13573 (previously taxonomically identified as Lactobacillus buchneri DSM 13573) were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 1119/2012 (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 preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 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 Regulation (EC) No 1831/2003.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023 (3) that the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 remain safe for all animal species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the additives are not irritant to skin or eyes and that they should be considered respiratory sensitisers. No conclusions could be drawn on their skin sensitisation potential. The Authority indicated that there is no need for assessing the efficacy of the additives as the application for renewal of the three authorisations does not include a proposal for amending or supplementing the conditions of the original authorisations that would have an impact on the efficacy of the additives.

(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 preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 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 (4), an evaluation report of the Reference Laboratory is therefore not required.

(6) In view of the above, the Commission considers that the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 satisfy the conditions, as 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.

(7) As a consequence of the renewal of the authorisation of the preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573 as feed additives, Implementing Regulation (EU) No 1119/2012 should be repealed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of preparations of Lactiplantibacillus plantarum DSM 3676, Lactiplantibacillus plantarum DSM 3677 and Lentilactobacillus buchneri DSM 13573, 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,