Commission Implementing Regulation (EU) 2025/1103 of 3 June 2025 amending Implementing Regulation (EU) 2017/12 as regards the requirements for applications and requests for the establishment of a no MRL required classification for chemical-unlike biological substances
Date: 2025-06-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, animal product, classification, drug residue, food inspection, food safety, foodstuff, health control, health risk, veterinary medicinal product




L_202501103EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1103


4.6.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1103
of 3 June 2025
         
amending Implementing Regulation (EU) 2017/12 as regards the requirements for applications and requests for the establishment of a ‘no MRL required’ classification for chemical-unlike biological substances
(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 13(1) thereof,

Whereas:







(1)


Pharmacologically active substances are classified on the basis of opinions on maximum residue limits (MRLs) issued by the European Medicines Agency (EMA).












(2)


Commission Implementing Regulation (EU) 2017/12 (2) sets out the form and content of the applications and requests submitted to EMA requesting the opinion to establish MRLs.












(3)


Commission Regulation (EU) 2018/782 (3) establishes the methodological principles for the risk assessment and risk management recommendations to be applied by EMA when preparing opinions on the MRLs. Section I.7 of Annex I to Regulation (EU) 2018/782 was amended by Commission Regulation (EU) 2025/1101 (4) to introduce a requirement for EMA to determine whether for a given chemical-unlike biological substance a classification ‘no MRL required’ is appropriate.












(4)


The content of particulars and documents accompanying an application or a request for a ‘no MRL required’ classification for chemical-unlike biological substances should thus be clearly specified.












(5)


Implementing Regulation (EU) 2017/12 should therefore be amended accordingly.












(6)


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
In Article 1(2) of Implementing Regulation (EU) 2017/12, the following subparagraph is added:


                  ‘However, with regard to requests for a ‘
                  ‘no MRL required’
                  ’ classification for chemical-unlike biological substances, the particulars and documents shall be those specified in section I.7, first paragraph, points (a) to (e), of Annex I to Commission Regulation (EU) 2018/782 (*1).



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, 3 June 2025.


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 Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 4, 7.1.2017, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2017/12/oj).

(3)  Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (OJ L 132, 30.5.2018, p. 5, ELI: http://data.europa.eu/eli/reg/2018/782/oj).

(4)  Commission Regulation (EU) 2025/1101 of 3 June 2025 amending Regulation (EU) 2018/782 concerning the assessment by the European Medicines Agency of maximum residue limits for chemical-unlike biological substances (OJ L 2025/1101, 4.6.2025, ELI: http://data.europa.eu/eli/reg/2025/1101/oj).


ELI: http://data.europa.eu/eli/reg_impl/2025/1103/oj
ISSN 1977-0677 (electronic edition)