(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 faecium NCIMB 11181 was authorised for 10 years as a feed additive for calves for rearing and for fattening and weaned piglets by Commission Implementing Regulation (EU) No 797/2013. 

(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 11181 as a feed additive, for calves for rearing and for fattening and weaned piglets, requesting the additive to be classified in the category of zootechnical additives and in the functional group of gut flora stabilisers. 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 14 November 2023 that the preparation of Enterococcus lactis NCIMB 11181 (strain originally taxonomically identified as Enterococcus faecium and reclassified as Enterococcus lactis) remains safe for calves for rearing and for fattening (up to 6 months) and weaned piglets (up to 35 kg), the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of Enterococcus lactis NCIMB 11181 in the solid water-soluble formulation of the additive is considered not irritant to skin or eyes. Due to the proteinaceous nature of the active agent, both solid and solid water-soluble formulations of the additive are considered respiratory sensitisers. The Authority could not conclude on the potential of the solid formulation of the additive to be irritant for skin and eyes or on the potential of both formulations of the additive to cause skin sensitisation. The opinion also indicated that it is not necessary to assess the efficacy of the preparation of Enterococcus lactis NCIMB 11181 in the context of the renewal of the authorisation as the application for renewal of the authorisation does not include a proposal to amend or supplement the conditions of the original authorisation that would have an impact on the efficacy of the additive. According to the conclusions of the Authority in its opinion of 1 February 2012, the preparation of Enterococcus lactis NCIMB 11181 is efficacious in improving zootechnical performance of piglets and calves, with the minimum effective dose for piglets being in the order of 1×1010 CFU/kg feed and for calves in the region of 2×109 CFU/kg milk replacer, independently of route of delivery provided that the same dose is given. The Authority did not consider that there is the 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 NCIMB 11181 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, 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 11181 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 the minimum contents specified in the Annex need to be adjusted to the effective dose of the additive, and 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 11181 as a feed additive, Implementing Regulation (EU) No 797/2013 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 11181, 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,