L-arginine from Corynebacterium glutamicum KCCM 80393 (3c366) authorised for all species, also in water for drinking despite EFSA concerns; ≥ 98.5 % on dry matter, determination by IEC-VIS/FLD, authorisation until 4 February 2036
Commission Implementing Regulation (EU) 2026/90, published on 15 January 2026, authorises L-arginine produced with the genetically modified strain Corynebacterium glutamicum KCCM 80393 as a nutritional additive (amino acids) in feed and water for drinking for all animal species. It is based on EFSA opinion e9453.
- Specification and methods (annex): L-arginine ≥ 98.5 % on a dry matter basis, solid form; identification according to the Food Chemical Codex L-arginine monograph; determination in the additive — ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD or IEC-VIS), in premixtures — IEC-VIS according to Regulation (EC) No 152/2009 or IEC-VIS/FLD, in compound feed and in water for drinking — IEC-VIS. No content limits in feed; the authorisation is valid until 4 February 2036.
- Conditions: the additive may be used in water for drinking; for ruminants L-arginine must be protected against degradation in the rumen; moisture is stated on the label; a warning to take into account the dietary supply of all essential and conditionally essential amino acids, in particular when administered via water; personal protective equipment for skin, eyes and respiratory tract where procedures do not eliminate the risks. EFSA raised concerns about use in water for drinking (risk of nutritional imbalance and hygiene) — the Commission considered the hygiene issue to fall under Regulation (EC) No 183/2005.
- Data from the EFSA opinion (e9453): strain modified to increase L-arginine production, no DNA of the strain detected in the product; in five batches on average 99.5 % L-arginine on dry matter (98.9–100.1 %), by another method on average 98.9 %; water on average 0.3 % against the applicant’s specification of max. 0.5 % (the act only requires moisture to be stated on the label); specific optical rotation in eight batches from +27.12° to +27.72° against the Ph. Eur. range +25.5…+28.5°; deoxynivalenol 157–330 μg/kg; dioxins and DL-PCBs combined (upper bound) 0.27 ng WHO-TEQ/kg. Stability in water: 2 % L-arginine for 48 h at 20 °C without losses.
- User safety: in the absence of data EFSA could not conclude whether the additive is irritant to skin or eyes or a sensitiser — hence the requirement for protective equipment. No dusting data for this additive were submitted, and the Panel considered data for L-arginine from another strain not relevant. The act gives the date of the EFSA opinion as 18 March 2025, whereas the published opinion states “Adopted: 1 May 2025” (published on 28 May 2025) — both facts side by side.