Kommisjonens gjennomføringsforordning (EU) 2026/892 av 23. april 2026 om endring av forordning (EU) nr. 37/2010 med hensyn til klassifisering av stoffet lidokain med hensyn til øvre grenseverdi for restmengden i næringsmidler av animalsk opprinnelse
Restkonsentrasjoner av veterinærlegemidler i matvarer: endringsbestemmelser for lidokain
Commission Implementing Regulation (EU) 2026/892 of 23 April 2026 amending Regulation (EU) No 37/2010 as regards the classification of the substance lidocaine with respect to its maximum residue limit in foodstuffs of animal origin
Kommisjonsforordning publisert i EU-tidende 24.4.2026
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) The substance lidocaine is included in that Regulation as an allowed substance for bovine, porcine and Equidae.
(4) On 9 February 2024, Scanvet Animal Health A/S submitted an application to the European Medicines Agency (‘the Agency’) in accordance with Article 3 of Regulation (EC) No 470/2009 for the modification of the existing conditions for the use of the substance lidocaine in porcine set under the MRL Regulation (EC) No 470/2009.
(5) On 15 May 2025, the Agency, through the opinion of the Committee for Veterinary Medicinal Products, recommended to include a ‘provisional ‘‘no MRL required’’ classification’ for the substance lidocaine in porcine with restrictions to the route of administration and the time until slaughter.
(6) On 5 June 2025, the Commission requested the Agency to reconsider its opinion of 15 May 2025, as a ‘provisional ‘‘no MRL required’’ classification’ is not foreseen in Article 14(2) of Regulation (EC) No 470/2009.
(7) On 4 December 2025, based on the opinion (3) of the Committee for Veterinary Medicinal Products, the Agency recommended the modification of the existing conditions for the use of the substance lidocaine in porcine to also allow the injection into the scrotum, testicles and spermatic cord in piglets up to 7 days of age.
(8) In view of the opinion of the Agency, the Commission considers it appropriate to amend the entry for the substance lidocaine in porcine 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,