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 ammonium chloride was authorised for 10 years as a feed additive for ruminants, cats and dogs by Commission Implementing Regulation (EU) No 725/2013 (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 ammonium chloride as a feed additive for ruminants, cats and dogs in the additive category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives (reduction of urinary pH)’. The 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 23 March 2022 (3) that the preparation of ammonium chloride remains safe for ruminants, cats and dogs, the consumers and the environment under the conditions of use currently authorised. The Authority concluded that ammonium chloride is considered an eye and skin irritant and a potential respiratory sensitiser, but that it is not a dermal sensitiser. It further concluded 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. 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 ammonium chloride 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 ammonium chloride 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 ammonium chloride as a feed additive, Implementing Regulation (EU) No 725/2013 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,