Commission Implementing Regulation (EU) 2024/860 of 18 March 2024 amending Regulation (EU) No 37/2010 as regards the substance 17β-oestradiol
Date: 2024-03-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, consumer protection, food safety, foodstuff, health legislation, human nutrition, livestock, veterinary medicinal product








L_202400860EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/860


19.3.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/860
of 18 March 2024
         
amending Regulation (EU) No 37/2010 as regards the substance 17β-oestradiol
(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 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 14 thereof,

Whereas:







(1)


Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding maximum residue limits (‘MRLs’) in foodstuffs of animal origin. It incorporated the pharmacologically active substances classified in the four Annexes to Council Regulation (EEC) No 2377/90 (3) which was repealed and replaced by Regulation (EC) No 470/2009.












(2)


At the time of the adoption of Regulation (EU) No 37/2010, the substance 17β-oestradiol, which was included in Annex II (‘list of substances not subject to maximum residue limits’) to Regulation (EEC) No 2377/90, was included in Table 1 (‘allowed substances’) of the Annex to Regulation (EU) No 37/2010.












(3)


Article 1(3) of Regulation (EC) No 470/2009 provides that Regulation (EC) No 470/2009 shall apply without prejudice to Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal or thyrostatic action and of beta-agonists, as provided for by Council Directive 96/22/EC (4).












(4)


Directive 96/22/EC prohibits the administering of 17β-oestradiol to farm animals.












(5)


Therefore, it is appropriate to remove the substance 17β-oestradiol from Table 1 of Regulation (EU) No 37/2010.












(6)


Regulation (EU) No 37/2010 should therefore be amended accordingly.












(7)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 March 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/oj.

(2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1, ELI: http://data.europa.eu/eli/reg/2010/37(1)/oj).

(3)  Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1, ELI: http://data.europa.eu/eli/reg/1990/2377/oj);

(4)  Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3, ELI: http://data.europa.eu/eli/dir/1996/22/2008-12-18).




ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for ‘17β-oestradiol’ is deleted.



ELI: http://data.europa.eu/eli/reg_impl/2024/860/oj
ISSN 1977-0677 (electronic edition)