L-valine from Corynebacterium glutamicum KCCM 80365 for all species: IEC-VIS in the additive and feed, IEC-VIS or IEC-VIS/FLD in water — five batches at 98.5–99.7 %, no losses in water (1 g/L, 48 h)
Commission Implementing Regulation (EU) 2025/2590, published on 19 December 2025, authorises until 8 January 2036 L-valine (3c374i, ≥ 98 % on a dry matter basis) produced by fermentation with the genetically modified strain C. glutamicum KCCM 80365 (applicant: CJ Europe GmbH) as a nutritional additive for all animal species, also in water for drinking — despite EFSA’s concerns, with a mandatory label warning on amino acid balance.
- Methods: identification — the Food Chemicals Codex L-valine monograph; valine in the additive — ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS); in premixtures and compound feed — IEC-VIS under Regulation (EC) No 152/2009; in water for drinking — IEC-VIS or IEC-VIS/FLD.
- Five batches (EFSA opinion of 18 March 2025): on average 99.0 % L-valine on a dry matter basis (98.5–99.7 %), moisture < 0.2 %, ash < 0.4 %; rotation +27.07 to +28.15° (Ph. Eur. range +26.6 to +29.0°). Metals, mycotoxins and dioxins below the LOQ (upper bound 0.05683 ng WHO-TEQ/kg for PCDD/F and 0.1161 ng with dioxin-like PCBs); yeasts and moulds < 10 CFU/g, Enterobacteriaceae and E. coli not detected in 10 g, Salmonella in 25 g.
- Stability: losses after 6 months < 0.25 % (25 °C) and < 0.35 % (40 °C); premixture with 10 % valine < 0.10 %; feed with 0.3 % valine — pelleting without losses, < 0.91 % in mash after 3 months; no losses in water (1 g/L, 48 h). Homogeneity: CV 1.89 % in the premixture, 1.59 % and 1.11 % in mash and pelleted feed.
- Users: dusting potential 55–195 mg/m³ — much lower than for the L-tryptophan of Regulation 2025/1915 (1045–1490 mg/m³); the additive is not irritant to skin or eyes and not a skin sensitiser. In ruminants L-valine must be protected from ruminal degradation. The Commission considered hygiene issues of use in water to be covered by Regulation (EC) No 183/2005.