(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) The substance clinoptilolite of sedimentary origin was authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation (EU) No 651/2013. 

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of clinoptilolite of sedimentary origin as a feed additive for all animal species, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional groups ‘binders’ and ‘anticaking agents’. 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 19 March 2025 that the additive clinoptilolite of sedimentary origin remains safe for all animal species, consumers and the environment under the conditions of use currently authorised. It also concluded that the additive is not a skin nor an eye irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The Authority also indicated that there is no need for assessing the efficacy of the additive, as the application for renewal of its authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation which would have an impact on the efficacy of the additive.

(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 clinoptilolite of sedimentary origin 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 clinoptilolite of sedimentary origin 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 clinoptilolite of sedimentary origin as a feed additive, Implementing Regulation (EU) No 651/2013 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,