Prováděcí nařízení Komise (EU) 2026/892 ze dne 23. dubna 2026, kterým se mění nařízení (EU) č. 37/2010, pokud jde o klasifikaci látky lidokain podle maximálního limitu reziduí v potravinách živočišného původu

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 CouncilOJ L 152, 16.6.2009, p. 11 , ELI: http://data.europa.eu/eli/reg/2009/470/oj. , and in particular Article 14, in conjunction with Article 17, thereof,

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

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

(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 37/2010Commission 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). 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 opinionOpinion of the Committee for Veterinary Medicinal Products of 4 December 2025 on the establishment of maximum residue limits (EMA/CVMP/330013/2025): https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-lidocaine-emea-v-mrl-003649-modf-0004_en.pdf. 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,

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

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).

Article 1 Article 1

Article 2 Article 2

Opinion of the Committee for Veterinary Medicinal Products of 4 December 2025 on the establishment of maximum residue limits (EMA/CVMP/330013/2025): https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-lidocaine-emea-v-mrl-003649-modf-0004_en.pdf.

HAS ADOPTED THIS REGULATION: