(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 such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC. 

(2) The preparation of Saccharomyces cerevisiae CNCM I-4407 (previously taxonomically identified as Saccharomyces cerevisiae NCYC Sc 47) was authorised without a time limit pursuant to Directive 70/524/EEC as a feed additive for cattle for fattening by Commission Regulation (EC) No 316/2003. That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003. 

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening. The applicant requested the additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 22 January 2019 and 13 March 2024 that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-4407 is considered safe for cattle for fattening, consumers and the environment. Regarding the safety for the user, in the absence of data, the Authority could not conclude on the potential of the preparation of Saccharomyces cerevisiae CNCM I-4407 to be irritant to eyes or its dermal sensitisation potential due to the lack of data but concluded that that additive is not a skin irritant and that inhalation exposure is unlikely. The Authority concluded that the preparation of Saccharomyces cerevisiae CNCM I-4407 is efficacious as a zootechnical additive in cattle for fattening at the concentration of 4 × 109 CFU/kg complete feed. It did not consider that there is a need for specific requirements of postmarket monitoring. The Authority also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 

(5) In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae CNCM I-4407 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 for use in cattle for fattening. Accordingly, the use of that preparation should be authorised for cattle for fattening. 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. 

(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation. 

(7) As a consequence of the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for cattle for fattening, Regulation (EC) No 316/2003 should be amended accordingly. 

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