(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 a microorganism strain DSM 11798 of the Coriobacteriaceae family was authorised for a period of 10 years as a feed additive for pigs by Commission Implementing Regulation (EU) No 1016/2013 and for all avian species by Commission Implementing Regulation (EU) 2017/930. 

(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 the bacterial strain DSM 11798 of the Eggerthellaceae family (previously taxonomically identified as belonging to the Coriobacteriaceae family) as a feed additive for pigs and all avian species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘substances for the reduction of the contamination of feed by mycotoxins’. 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 20 March 2025 that the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family remains safe for piglets, pigs for fattening and all avian species, consumers and the environment under the approved terms of the authorisation. It also concluded that the preparation of the bacterial strain DSM 11798 of the Eggerthellaceae family is not irritant to skin or eyes but it should be considered a potential skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Authority stated that 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. Therefore, it concluded that there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. 

(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 the bacterial strain DSM 11798 of the Eggerthellaceae family as a feed additive in the context of the previous authorisations 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 the bacterial strain DSM 11798 of the Eggerthellaceae family 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 the bacterial strain DSM 11798 of the Eggerthellaceae family as a feed additive, Implementing Regulations (EU) No 1016/2013 and (EU) 2017/930 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 the bacterial strain DSM 11798 of the Eggerthellaceae family, 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,