Commission Implementing Regulation (EU) 2024/2040 of 29 July 2024 amending Implementing Regulation (EU) 2024/1070 as regards the establishment of transitional measures for the renewal of the authorisation of a preparation of 25-hydroxycholecalciferol produced by Saccharomyces cerevisiae CBS 146008
Date: 2024-07-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, cattle, fattening, food additive, market approval, poultry, swine, vitamin




L_202402040EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2040


30.7.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2040
of 29 July 2024
         
amending Implementing Regulation (EU) 2024/1070 as regards the establishment of transitional measures for the renewal of the authorisation of a preparation of 25-hydroxycholecalciferol produced by Saccharomyces cerevisiae CBS 146008
(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 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:







(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,





HAS ADOPTED THIS REGULATION:



Article 1

Amendment to Implementing Regulation (EU) 2024/1070

In Implementing Regulation (EU) 2024/1070, the following Article 3a is inserted:


“Article 3a
Transitional measures

1.   The feed additive 25-hydroxycholecalciferol, as authorised by Regulation (EC) No 887/2009, and premixtures containing that additive, which are produced and labelled before 5 November 2024 in accordance with the rules applicable before 5 May 2024, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for chickens for fattening, turkeys for fattening, other poultry and pigs.


2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 5 May 2025 in accordance with the rules applicable before 5 May 2024, may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for chickens for fattening, turkeys for fattening, other poultry and pigs.”





Article 2

Entry into force

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 5 May 2024.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 July 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2)  Commission Implementing Regulation (EU) 2024/1070 of 12 April 2024 concerning the renewal of the authorisation of a preparation of 25-hydroxycholecalciferol produced by Saccharomyces cerevisiae CBS 146008 for chickens for fattening, turkeys for fattening, other poultry and pigs and the authorisation of that preparation for ruminants and repealing Commission Regulation (EC) No 887/2009 (OJ L 2024/1070, ELI: http://data.europa.eu/eli/reg_impl/2024/1070/oj).

(3)  Commission Regulation (EC) No 887/2009 of 25 September 2009 concerning the authorisation of a stabilised form of 25-hydroxycholecalciferol as a feed additive for chickens for fattening, turkeys for fattening, other poultry and pigs (OJ L 254, 26.9.2009, p. 68, ELI: http://data.europa.eu/eli/reg/2009/887/oj).


ELI: http://data.europa.eu/eli/reg_impl/2024/2040/oj
ISSN 1977-0677 (electronic edition)