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) A preparation of Enterococcus lactis NCIMB 10415 (previously taxonomically identified as Enterococcus faecium NCIMB 10415) was authorised for 10 years as a feed additive for cats and dogs by Commission Implementing Regulation (EU) No 1061/2013. 

(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 NCIMB 10415 for use in feed for cats and dogs, requesting the additive to be classified in the category ‘zootechnical additives’ and in the functional groups ‘gut flora stabilisers’ for cats, and ‘other zootechnical additives’ for dogs. 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 30 January 2024 that the applicant has provided evidence that the preparation of Enterococcus lactis NCIMB 10415 remains safe for cats and dogs under the conditions of use currently authorised. It also concluded that the additive was not shown to be skin and eye irritant, but that it should be considered a respiratory sensitiser, while no conclusions could be drawn on the skin sensitisation. The Authority further indicated that there was no need for assessing the efficacy of the preparation of Enterococcus lactis NCIMB 10415 in the context of the renewal of the authorisation as the application for renewal 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. It 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 previous assessment concerning the same additive as regards the method of analysis are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005, 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 NCIMB 10415 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. It is appropriate, for control reasons, to allocate a specific identification number to that preparation for cats and dogs to allow differentiating from the other forms of that preparation authorised by Implementing Regulation 2024/1161 for other species. 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 NCIMB 10415 as a feed additive for cats and dogs, Implementing Regulation (EU) No 1061/2013 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 NCIMB 10415 as a feed additive for cats and dogs, it is appropriate to provide for a transitional period for the 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,