(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)

Urea was authorised for a period of 10 years as a feed additive for ruminants with a functional rumen by Commission Implementing Regulation (EU) No 839/2012 (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 urea as a feed additive for ruminants with a functional rumen, requesting the additive to be classified in the additive category ‘nutritional additives’ and in the functional group ‘urea and its derivatives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 January 2023 (3) that the applicant provided evidence that the additive remains safe for the target species, the consumers and the environment under the existing conditions of authorisation. In the absence of new information providing evidence for the safety of the additive for the user, the Authority could not conclude on the users’ safety. The Authority also indicated that the conclusion made previously on the efficacy remains valid. 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 assessment carried out regarding the method of analysis of urea 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 conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. 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.

(7)

As a consequence of the renewal of the authorisation of urea as a feed additive, Implementing Regulation (EU) No 839/2012 should be repealed.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,