Recombinant equine chorionic gonadotropin (reCG) needs no maximum residue limit in any food-producing animal — Regulation (EU) 2026/1806
Commission Implementing Regulation (EU) 2026/1806 of 24 July 2026, published on 27 July, adds reCG to Table 1 of Regulation (EU) No 37/2010 with a “No MRL required” classification for all food-producing species. The substance was assessed under the procedure for “chemical-unlike” biological substances in Regulation (EU) 2018/782: on 16 April 2026 EMA’s Committee for Veterinary Medicinal Products found that a full MRL evaluation is not needed.
- The application was submitted on 19 December 2025 by Syn Vet-Pharma Ireland. reCG is a single-chain construct containing the same amino acid sequences as the α- and β-subunits of natural eCG, but covalently linked and with additional O-glycosylation sites. It is a macromolecular protein with imprecisely defined glycosylation whose biological activity is determined by biological testing — so the committee classed it as a “chemical-unlike” biological substance.
- No residue data were provided for reCG, there are no residue depletion studies for natural eCG either, and no NO(A)EL from which an ADI could be derived. The committee accepted that, like eCG, reCG loses its tertiary structure in the digestive tract and is rapidly digested by enzymes, while the size of the molecule hinders absorption — so oral bioavailability is negligible.
- The application covered cattle, sheep and pigs, but the committee extended the conclusion to all food-producing species, because the Table 1 entry for pregnant mare serum gonadotrophin (PMSG) also covers all species and, from a consumer safety perspective, reCG is not expected to differ from eCG.
- The entry reads: marker residue “not applicable”, target tissues “not applicable”, no other provisions and no therapeutic classification. Table 1 thus contains no numerical limit for reCG against which an analytical result would be assessed. The regulation entered into force on the twentieth day after publication.