Kommisjonens gjennomføringsforordning (EU) 2024/2040 av 29. juli 2024 om endring av gjennomføringsforordning (EU) 2024/1070 med hensyn til etablering av overgangstiltak for fornyelse av godkjenning av et preparat av 25-hydroksykolekalciferol produsert av Saccharomyces cerevisiae CBS 146008
Godkjenning av 25-hydroksykolekalciferol som tilsetningsstoff i fôr til slaktekylling, slaktekalkun, andre fjørfe og griser: endringsbestemmelser
Kommisjonsforordning publisert i EU-tidende 30.7.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen)
(1) The authorisation of the preparation of 25-hydroxycholecalciferol produced by Saccharomyces cerevisiae CBS 146008 was renewed for a period of 10 years as a feed additive belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ for chickens for fattening, turkeys for fattening, other poultry and pigs by Commission Implementing Regulation (EU) 2024/1070 (2).
(2) The characterisation of the active substance 25-hydroxycholecalciferol set out in the Annex to Implementing Regulation (EU) 2024/1070 specifies that its precursor compound, 5,7,24-cholestatrienol, is produced with Saccharomyces cerevisiae CBS 146008. That specification was not included in the previous authorisation of the preparation of 25-hydroxycholecalciferol, which was granted by Commission Regulation (EC) No 887/2009 (3). Therefore, Implementing Regulation (EU) 2024/1070 provides for stricter terms of authorisation for the feed additive. Implementing Regulation (EU) 2024/1070 did not, however, lay down transitional measures to allow interested parties to adapt to the stricter terms of authorisation.
(3) Since safety reasons do not require the immediate application of the modification of the conditions of authorisation of the additive resulting from the renewal thereof for chickens for fattening, turkeys for fattening, other poultry and pigs by Implementing Regulation (EU) 2024/1070, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from that renewal of the authorisation.
(4) Implementing Regulation (EU) 2024/1070 should therefore be amended accordingly.
(5) To prevent market disturbance and detrimental consequences for the operators concerned caused by a prohibition, on the date of entry into force of Implementing Regulation (EU) 2024/1070, of 25-hydroxycholecalciferol produced by strains other than Saccharomyces cerevisiae CBS 146008, due to the absence of transitional measures granted by that Implementing Regulation, this Regulation should enter into force as a matter of urgency and apply retroactively from the date of entry into force of Implementing Regulation (EU) 2024/1070.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,