L-valine from Corynebacterium glutamicum KCCM 80366 as an inactivated fermentation product — the strain’s cells remain in the additive: at least 72 % valine on dry matter, IEC-VIS determination, no viable cells in 3 batches
Commission Implementing Regulation (EU) 2026/1756, published on 21 July 2026, authorises until 10 August 2036 L-valine produced with the non-genetically modified strain Corynebacterium glutamicum KCCM 80366 as a nutritional additive (amino acids) for all animal species. The additive is a fermentation product with inactivated cells of the strain, which are not removed from the final product. In ruminants L-valine must be protected from degradation in the rumen.
- Specification and methods: fermentation product with inactivated cells of C. glutamicum KCCM 80366 containing at least 72 % L-valine on dry matter, solid form. Valine is quantified in the additive by ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS), and in premixtures and compound feed by IEC-VIS according to Regulation (EC) No 152/2009. Moisture must be stated on the additive label.
- Data from the EFSA opinion: free valine 73.3–76.6 % (6 batches), moisture 0.85–1.74 %, crude protein 64.3–64.7 %, ash 10.1–10.6 %, starch 12.2–15.5 % (5 batches); in the amino acid profile after hydrolysis valine 76.20–76.60 %, and the L-enantiomeric purity was confirmed in 3 batches. The presence of viable cells of the strain was tested in 3 batches in triplicate — none detected; no acquired antimicrobial resistance genes were found, so the strain meets the qualified presumption of safety (QPS) conditions.
- Impurities and properties (3 batches): lead < 0.015 mg/kg, cadmium 0.019–0.026 mg/kg, PCDD/Fs + PCBs 0.116 ng WHO-TEQ/kg, mycotoxins below the limits of quantification, Salmonella not detected in 25 g; Stauber-Heubach dusting potential 85–170 mg/m³. Recovery after 3 months in pelleted chicken feed was 89.3–97.7 %, and pelleting at 70–75 °C did not reduce the content; the homogeneity coefficient of variation in mash feed was 8.93 %.
- The additive and premixture labels must carry a warning to take into account the dietary supply of all essential and conditionally essential amino acids when supplementing L-valine. EFSA did not consider the additive a skin irritant but a potential skin and respiratory sensitiser; it could not conclude on eye irritation and considered any exposure a risk. For non-ruminants the additive is an effective source of L-valine.