(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 Saccharomyces cerevisiae CBS 493.94, was authorised for a period of 10 years as a feed additive for cattle for fattening, minor ruminant species for fattening, dairy cows and minor dairy ruminant species by Commission Implementing Regulation (EU) No 1109/2014 (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 Saccharomyces cerevisiae CBS 493.94 as a feed additive for dairy cows, minor dairy ruminant species, cattle for fattening and minor ruminant species for fattening, requesting the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘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 19 March 2025 (3) that the preparation of Saccharomyces cerevisiae CBS 493.94 remains safe for the target species, the consumers and the environment under the conditions of use currently authorised. It also concluded that the preparation of Saccharomyces cerevisiae CBS 493.94, in larger prills form is non-irritant to the skin or eyes while in prills form is not irritant to the skin but irritant to the eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Authority also 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 additives. Therefore, it concluded that there is no need for assessing the efficacy of the preparation in the context of the renewal of the authorisation. The Authority 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 the preparation of Saccharomyces cerevisiae CBS 493.94 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 (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 Saccharomyces cerevisiae CBS 493.94 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 Saccharomyces cerevisiae CBS 493.94 as a feed additive, Implementing Regulation (EU) No 1109/2014 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,