Commission Implementing Regulation (EU) 2025/154 of 29 January 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae DSM 34246 as a feed additive for dogs and cats (holder of authorisation: ACEL pharma s.r.l.)

Official Journal EN of the European Union L series 2025/154 30.1.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/154 of 29 January 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae DSM 34246 as a feed additive for dogs and cats (holder of authorisation: ACEL pharma s.r.l.) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on additives for use in animal nutrition(1), and in particular Article 9(2) thereof, Whereas: (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. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Saccharomyces cerevisiae DSM 34246. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of a preparation of Saccharomyces cerevisiae DSM 34246 as a feed additive for dogs and cats, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 April 2024(2)that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae DSM 34246 is safe for dogs and cats. Furthermore, it stated that there is no need to perform an assessment of the safety for the consumer or the environment because the additive is intended to be used only in feed for cats and dogs. It also concluded that the preparation of Saccharomyces cerevisiae DSM 34246 is not a skin or eye irritant but should be considered a skin and respiratory sensitiser. The Authority further concluded that the preparation of Saccharomyces cerevisiae DSM 34246, has the potential to be efficacious as a zootechnical additive for dogs and cats when added to feed at 5 × 109 CFU/kg complete feed. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority 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. (5) In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae DSM 34246 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for dogs and cats. 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) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal. 2024;22:e8802. ELI: http://data.europa.eu/eli/reg_impl/2025/154/oj 1/3EN OJ L, 30.1.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 January 2025. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/154/ojANNEX Minimum Maximum Identifica- content content Name of the Composition, chemical Species or tion number Maximum End of period of holder of Additive formula, description, category of Other provisions of the feed age CFU/kg of complete authorisation authorisation analytical method animal additive feedingstuff with a moisture content of 12 % Category: zootechnical additives. Functional group: gut flora stabilisers 4b1873 ACEL pharma Saccharomyces Additive composition Dogs and — 5 × 109 — 1. In the directions for use of 19 February 2035 S.r.l. cerevisiae DSM Preparation of cats the additive and 34246 Saccharomyces cerevisiae premixtures, the storage DSM 34246 conditions and stability to containing a minimum of 2 heat treatment shall be × 1010 CFU/g indicated. Solid form. 2. For users of the additive Characterisation of the active and premixtures, feed substance business operators shall Viable cells of Saccharomyces establish operational cerevisiae DSM 34246 procedures and Analytical method(1) organisational measures Enumeration in the feed to address potential risks additive and compound resulting from their use. feed: Pour or spread plate Where those risks cannot method (EN 15789) be eliminated by such procedures and measures, Identification: Polymerase the additive and Chain Reaction (PCR) – premixtures shall be used CEN / TS 15790 with personal breathing and skin protective equipment. (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en. ELI: http://data.europa.eu/eli/reg_impl/2025/154/oj 3/3 OJ L, 30.1.2025 EN