Neohesperidine DC in feed renewed until 2036: 35 mg/kg for seven animal groups, determination by HPLC-UV according to Ph. Eur. 1547 and HPLC-DAD, EFSA data on batches from bitter orange, pomelo and grapefruit
Commission Implementing Regulation (EU) 2026/1150, published on 29 May 2026, renews until 18 June 2036 the authorisation of neohesperidine DC (neohesperidine dihydrochalcone) as a flavouring for piglets, pigs for fattening, calves, sheep, food-producing fish, ornamental fish and dogs, with a maximum content of 35 mg/kg complete feed for each of these groups; it repeals Regulation 2015/264. It is based on two applications and two EFSA opinions of 19 March and 16 September 2025.
- Specification: purity at least 96 % on a dry matter basis, ethanol ≤ 5000 mg/kg. Two synthesis routes: catalytic hydrogenation of neohesperidin extracted from unripe bitter orange fruit (Citrus aurantium), or conversion of naringin from grapefruit (Citrus paradisi) or pomelo (Citrus maxima) followed by condensation with isovanillin. Methods: in the additive HPLC with UV detection according to European Pharmacopoeia monograph 1547, in premixtures and compound feed HPLC with diode array detection (HPLC-DAD).
- The September 2025 EFSA opinion (e9681) compares three products: from bitter orange on average 98.4 % (96.3–100.2 %; 17 batches), from pomelo 97.1 % (96.2–98.9 %; 10 batches) and from grapefruit 96.8 % (96.6–96.9 %; 5 batches) on a dry matter basis; residual ethanol in 3 batches of the first product was 90.1–100.7 mg/kg.
- The March 2025 opinion (e9358): 5 batches contained 97.8–98.2 % of the substance, loss on drying 9.5–9.9 % (limit ≤ 11 %), sulphated ash 0.04–0.08 %; impurities as defined in Ph. Eur.: neodiosmin (impurity B) 0.8–1.0 %, impurity D 1.2 %. Stauber-Heubach dusting potential 1066–1375 mg/m³, and 78–79 % of particles by volume were below 10 µm — EFSA considered inhalation exposure likely.
- The substance is not a skin or eye irritant and not a skin sensitiser; the label requires respiratory protection and information on storage conditions and stability to heat treatment. Efficacy was not reassessed because the applications did not change the conditions of authorisation. Additive and premixtures made under the old rules before 18 December 2026, feed for food-producing animals before 18 June 2027 and other feed before 18 June 2028 may be used until stocks are exhausted.