Vitamin B1 in feed for another 10 years: thiamine hydrochloride and mononitrate with four chromatographic methods — from HPLC-UV per the US Pharmacopeia to HPLC-FLD with post-column derivatisation for drinking water; the mononitrate preparation withdrawn
Commission Implementing Regulation (EU) 2026/460 of 26 February 2026, published on 27 February, renews until 19 March 2036 the authorisation of thiamine hydrochloride (3a820, purity at least 98.5% on an anhydrous basis) and thiamine mononitrate (3a821, at least 98%) as nutritional additives for all animal species, also in water for drinking. The authorisation of a thiamine mononitrate preparation was not renewed because the applicant withdrew its application.
- Methods in the annex: for characterising the additive — HPLC with UV detection according to the US Pharmacopeia monograph; in premixtures — ion-exchange HPLC-UV (VDLUFA, Volume III, 13.9.1) or reversed-phase HPLC with fluorescence detection (HPLC-FLD) according to the Italian decree of 20 February 2006; in compound feed — the same HPLC-FLD; in water for drinking — reversed-phase HPLC-FLD with post-column derivatisation.
- The reference laboratory considered the conclusions of the method evaluation from the previous authorisation still valid. For use in water for drinking, the directions for use must state the stability in water, alongside storage conditions and stability to heat treatment. No minimum or maximum contents in feed were set.
- EFSA issued two opinions (18 March and 4 April 2025): vitamin B1 remains safe for animals, consumers and the environment. The assessments of irritancy differed — in one opinion the hydrochloride was not a skin irritant but was an eye irritant, and the mononitrate was not an eye irritant; in the other both salts were considered skin and eye irritants. The regulation takes both to be skin and eye irritants and skin and respiratory sensitisers, and requires respiratory, eye and skin protection.
- In one applicant’s data the purity of thiamine hydrochloride in eight batches averaged 99.86% (99.70–100%) of dry matter, and residual methanol in five batches was 35–139 mg/kg. Thiamine mononitrate preparations and premixtures containing them labelled before 19 September 2026 may be used up; compound feed if labelled before 19 March 2027 (food-producing animals) or 19 March 2028 (others).