(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om endring av gjennomføringsforordning (EU) 2017/12 med hensyn til kravene for søknader om og forespørsler om etablering av en "ingen MRL kreves"-klassifisering for ikke-kjemikalielignende biologiske stoffer
Restkonsentrasjoner av veterinærlegemidler i matvarer: "ingen MRL kreves"-klassifisering for ikke-kjemikalielignende biologiske stoffer
(Draft) Commission Implementing Regulation (EU) .../... 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
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.2.2025
Bakgrunn
(fra kommisjonsforordningen)
(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) 2017/122 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 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 1 to Regulation (EU) 2018/782 was amended by Commission Regulation C(2025) 8504 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,