(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 authorisation.

(2)

Article 10(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(3)

The preparation of Saccharomyces cerevisiae CNCM I-4407 (former Saccharomyces cerevisiae NCYC Sc 47) was authorised, without a time limit, in accordance with Directive 70/524/EEC as a feed additive for weaned piglets by Commission Regulation (EC) No 2148/2004 (3), for sows by Commission Regulation (EC) No 1288/2004 (4) and for dairy cows by Commission Regulation (EC) No 1811/2005 (5). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(4)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003, an application was submitted for the re-evaluation of the preparation of Saccharomyces cerevisiae CNCM I-4407 (former Saccharomyces cerevisiae NCYC Sc 47) as a feed additive for weaned piglets, sows and dairy cows. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 22 January 2019 (6) that, under the proposed conditions of use, the preparation Saccharomyces cerevisiae CNCM I-4407 does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to improve performance parameters in weaned piglets and sows in order to have a benefit in sucking piglets. It also concluded that the additive showed a positive effect on performance in dairy cows in two studies. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

Since the additive has already demonstrated the capacity to improve the performance parameters in other dairy ruminants, namely dairy goats, dairy sheep and dairy buffalos, it was considered that the conditions for the demonstration of the efficacy for dairy cows are met by the results of the provided two in vivo studies.

(7)

The assessment of the preparation of Saccharomyces cerevisiae CNCM I-4407 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

(8)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 2148/2004, (EC) No 1288/2004 and (EC) No 1811/2005 should be amended accordingly.

(9)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(10)

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