L-valine from genetically modified Corynebacterium glutamicum KCCM 80058 (3c370) renewed until 19 November 2035: identification by the FCC monograph, determination by IEC-VIS; no viable cells or DNA of the strain in the product, new requirements — rumen protection and an amino acid balance warning
Commission Implementing Regulation (EU) 2025/2183, published on 30 October 2025, renews until 19 November 2035 the authorisation of L-valine (at least 98 % DM) produced by a genetically modified strain of Corynebacterium glutamicum KCCM 80058 as a nutritional additive for all animal species and repeals Regulation (EU) No 848/2014. In its opinion of 28 January 2025 EFSA found the additive still safe; it does not irritate skin or eyes and is not a skin sensitiser — unlike most additives, the annex contains no provision on personal protective equipment.
- Methods in the annex: identification of L-valine in the additive — the Food Chemicals Codex “L-valine” monograph; determination of valine in the additive — ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS); in premixtures and compound feed — IEC-VIS according to Regulation (EC) No 152/2009. The reference laboratory considered its earlier conclusions still valid. No minimum or maximum content; moisture on the additive label.
- Batches (EFSA): eight batches — 98.7 % DM on average (98.6–98.8), loss on drying 0.07 %, unidentified material up to 1.32 %; three further batches by another method — 98.9–99.1 %. Cadmium, lead, mercury and arsenic below the LOQ; dioxins (upper bound) 0.057 ng WHO2005-TEQ/kg for PCDD/Fs and 0.116 ng with DL-PCBs, NDL-PCBs 0.53 µg/kg. Aflatoxins, fumonisins, ochratoxin A, DON, zearalenone and T-2 and HT-2 below the LOQ; yeasts and moulds < 10 CFU/g.
- Production strain: identified from the whole genome sequence, all MICs at or below the cut-off values for “Corynebacterium and other Gram-positive”, no resistance genes or virulence factors of concern; details of the genetic modification are redacted in the opinion. In three batches of the product neither viable cells nor DNA of the strain were detected, so the product raises no concern regarding the strain.
- Compared with the 2014 conditions (quoted by EFSA: moisture and voluntary declaration), new provisions cover storage conditions and stability to heat treatment, protection of L-valine against degradation in the rumen when fed to ruminants, and the labels of the additive and premixtures must remind users to consider the dietary supply of all essential and conditionally essential amino acids. As early as 2013 EFSA expressed concerns about valine in water for drinking; the act does not provide for use in water. Transitional periods: additive and premixtures — before 19 May 2026, compound feed — before 19 November 2026 or 2027.