Kommisjonens gjennomføringsforordning (EU) 2026/1806 av 24. juli 2026 om endring av forordning (EU) nr. 37/2010 med hensyn til klassifisering av stoffet rekombinant equint koriongonadotropin med hensyn til øvre grenseverdi for restmengden i næringsmidler av animalsk opprinnelse
Restkonsentrasjoner av veterinærlegemidler i matvarer: endringsbestemmelser for rekombinant equint koriongonadotropin
Commission Implementing Regulation (EU) 2026/1806 of 24 July 2026 amending Regulation (EU) No 37/2010 as regards the classification of the substance recombinant equine chorionic gonadotropin with respect to its maximum residue limit in foodstuffs of animal origin
Kommisjonsforordning publisert i EU-tidende 27.7.2026
Bakgrunn
(fra kommisjonsforordningen)
(1) In accordance with Regulation (EC) No 470/2009, the Commission is to establish, by way of a Regulation, maximum residue limits (‘MRLs’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry.
(2) Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
(3) Commission Regulation (EU) 2018/782 (3) lays down the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009.
(4) Section I.6 of Annex I to Regulation (EU) 2018/782 provides that biological substances, other than those identified in Article 1(2), point (a), of Regulation (EC) No 470/2009, are subject to either an evaluation of all elements set out in Article 6 of Regulation (EC) No 470/2009 (‘full MRL evaluation’) if chemical-like, or a case-by-case evaluation if chemical-unlike.
(5) Section I.7 of Annex I to Regulation (EU) 2018/782 further provides that the European Medicines Agency (‘the Agency’) is to assess chemical-unlike biological substances in order to determine whether a full MRL evaluation is required and whether a ‘no MRL required’ classification according to Article 14(2), point (c), of Regulation (EC) No 470/2009 is appropriate.
(6) On 19 December 2025, Syn Vet-Pharma Ireland Limited submitted an application to the Agency for the evaluation of the chemical-unlike biological substance recombinant equine chorionic gonadotropin (reCG).
(7) On 16 April 2026, the Committee for Veterinary Medicinal Products (‘CVMP’) concluded that no further MRL assessment is necessary and that the substance can be included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 with a ‘No MRL required’ classification (4).
(8) On the basis of the assessment of the CVMP, the Commission considers it appropriate that the chemical-unlike biological substance recombinant equine chorionic gonadotropin (reCG) is included in Table 1 of the Annex to Regulation (EU) No 37/2010.
(9) Regulation (EU) No 37/2010 should therefore be amended accordingly.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,