Lidocaine in piglets up to 7 days of age may also be injected at castration — Regulation (EU) 2026/892 amends the MRL table entry without setting a residue limit
Commission Implementing Regulation (EU) 2026/892 of 23 April 2026, published on 24 April, amends the lidocaine entry in Table 1 of Regulation (EU) No 37/2010. For pigs the “No MRL required” classification is kept, but injection into the scrotum, testicles and spermatic cord is added to cutaneous and epilesional use — only in piglets up to 7 days of age. It is based on the opinion of EMA’s Committee for Veterinary Medicinal Products of 4 December 2025.
- The applicant, Scanvet Animal Health, applied on 9 February 2024 so that lidocaine could be injected into piglets before castration. On 15 May 2025 the committee recommended a provisional “No MRL required” classification with restrictions on the route of administration and on the time to slaughter, but the Commission asked it to reconsider, because Article 14(2) of Regulation (EC) No 470/2009 does not provide for such a provisional classification.
- In the residue depletion study 16 piglets were slaughtered after 12, 18, 24 and 48 hours. Peak concentrations of 2,6-xylidine — a genotoxic metabolite — were 107, 160, 149 and 906 µg/kg in liver, kidney, muscle and skin with fat, and after 48 hours they were still above the limit of quantification of 0.2 µg/kg.
- Determination: UHPLC with tandem mass spectrometry in two chromatographic set-ups (lidocaine, MEGX, 3-OH lidocaine and lidocaine N-oxide, and separately 2,6-xylidine and GX). EMA pointed out that samples were stored at about -18 °C for up to 321 days, while freezer stability of the tissues had been shown for only 47–50 days; the 2,6-xylidine results were therefore adjusted with a correction factor.
- After a new study measuring the lidocaine left in the removed testicles (on average 4.521 mg of the 20 mg given per piglet), the correction factor was lowered to 3.78. The estimated intake came to 10.42% of the acceptable share of the ADI for lidocaine and 35.9% of the acceptable exposure to 2,6-xylidine, so the committee dropped the 50-day slaughter restriction. Cattle keep numerical MRLs, including 150 µg/kg in muscle and 30 µg/kg in milk.