(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om godkjenning av et preparat av Saccharomyces cerevisiae DSM 34246 som tilsettningsstoff i fôr til hunder og katter
Godkjenning av et preparat produsert av Saccharomyces cerevisiae DSM 34246 som tilsetningsstoff i fôr til hunder og katter
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 17.1.2025
Bakgrunn
(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.
(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 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,