(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om godkjenning av et preparat av Bacillus subtilis DSM 33862 og Lentilactobacillus buchneri DSM 12856 som tilsetningsstoff i fôr for alle dyrearter
Godkjenning av Bacillus subtilis DSM 33862 og Lentilactobacillus buchneri DSM 12856 som tilsetningsstoff i fôr til alle dyrearter
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 17.8.2026
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 Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856. 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 Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘acidity regulators’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 December 2025 that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 is safe for all animal species, as well as for the consumers and the environment. The Authority also concluded that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 is considered as a skin and respiratory sensitiser. Exposure of users via dermal and respiratory routes is considered a risk. This conclusion applies, in principle, to any preparations containing the active agents. The Authority further concluded that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 has the potential to reduce the pH of feed materials of plant origin at the minimum recommended level of 1.0×108 CFU/kg feed material. 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 Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all animal species. 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,