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 an authorisation.

(2) A preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 (previously taxonomically identified as Enterococcus faecium DSM 7134 and Lactobacillus rhamnosus DSM 7133 respectively) was authorised for 10 years as a feed additive for calves for rearing by Commission Implementing Regulation (EU) No 1101/2013 (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 Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 as a feed additive. 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 26 September 2023 (3) that the applicant has provided evidence that the preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 remains safe for calves for rearing, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 is non-irritant to skin and eyes but should be considered a respiratory sensitiser. The Authority could not conclude on the skin sensitisation potential of that preparation. It also indicated that there is no need for assessing the efficacy of the preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 as the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. The Authority did not consider that there is a need for specific requirements of post-market monitoring.

(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 Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 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.

(6) In view of the above, the Commission considers that the preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 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. 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 preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 as a feed additive, Implementing Regulation (EU) No 1101/2013 should be repealed.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133, 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,