Kommisjonens gjennomføringsforordning (EU) 2024/754 av 29. februar 2024 om endring av gjennomføringsforordning (EU) 2020/1762 med hensyn til vilkårene for godkjenning av et preparat av Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 og Bacillus amyloliquefaciens DSM 25840 som tilsetningsstoff i fôrvarer til alle fjørfearter ment for slakt og alle fjørfearter som blir foret opp for eggproduksjon eller avl (innehaver av godkjenningen Chr. Hansen A/S)
Vilkårene for godkjenning av av et preparat av B. subtilis mfl. som tilsetningsstoff i fôrvarer til alle fjørfearter for oppfôring, egglegging eller avl
Kommisjonsforordning publisert i EU-tidende 1.3.2024
Nærmere omtale
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 and modifying such authorisation.
(2) Commission Implementing Regulation (EU) 2020/1762 (2) authorised the use of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding for a 10-year period.
(3) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted on 24 April 2022 for the modification of the terms of the authorisation of the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding, requesting to allow the simultaneous use of that preparation with the coccidiostats monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid, which are authorised as feed additives. The request was accompanied by the relevant supporting data.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 July 2023 (3) that the proposed modification in the terms of the authorisation of the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 would not modify the conclusions previously drawn regarding the safety of the additive. It also concluded that the use of that preparation is compatible with the coccidiostats monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid.
(5) In view of the above, the Commission considers that the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 still satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003 when modifying the terms of the authorisation by specifying the compatibility of the use of that preparation with the coccidiostats monensin, salinomycin, narasin, a combination of nicarbazin and narasin, and lasalocid. In addition, considering that those coccidiostats may not be authorised as feed additives for each of the species or categories listed in the Annex, their simultaneous use with the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 should only be possible in accordance with their respective conditions of authorisation as feed additives.
(6) Implementing Regulation (EU) 2020/1762 should therefore be amended accordingly.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,