L-arginine from Escherichia coli CCTCC M 20231961: IEC-VIS/FLD, deoxynivalenol above 500 µg/kg in two of three batches, losses in premixture up to 31.9 % after 6 months
Commission Implementing Regulation (EU) 2026/352, published on 19 February 2026, authorises until 11 March 2036 L-arginine (at least 98.5 % DM) from genetically modified E. coli CCTCC M 20231961 for all animal species, in feed and water for drinking. EFSA recommended attention to deoxynivalenol during production.
- Methods: identification according to the Food Chemicals Codex monograph; determination in the additive — IEC-VIS/FLD or IEC-VIS, in premixtures IEC-VIS/FLD or IEC-VIS according to Regulation (EC) No 152/2009, in compound feed and water for drinking IEC-VIS. The act sets no endotoxin exposure limit; personal protective equipment covers skin and eyes.
- EFSA data (5 batches): arginine 99.6–100.4 % DM, loss on drying 0.1–0.7 %, specific optical rotation +27.1 to +27.2° (specification +25.5 to +28.5°). Mycotoxins (3 batches): deoxynivalenol 279.6–555.4 µg/kg, ochratoxin A 3.8–4.0 µg/kg, citrinin < 15.0–42.7 µg/kg; EFSA noted DON above 500 µg/kg in two of three batches and recommended monitoring in production, although it did not consider the impurities a safety concern.
- Stability: losses in a vitamin–mineral premixture 28.2–31.9 % after 6 months, in mash feed for chickens 0–25.4 %, in pelleted feed 15.8–30.7 % after 3 months, in water 0 % after 48 h at 8–10 °C; coefficient of variation of arginine in feed 7.6 % for total and 39.8 % for free.
- Users: dusting potential 200–300 mg/m³, endotoxins < 0.9 IU/mg; assuming 900 IU/g EFSA calculated an exposure of 150 IU per working day against a recommended threshold of 900 IU — no risk of exceedance. EFSA drew no conclusions on skin and eye irritation or skin sensitisation; recital 4 of the act also mentions respiratory sensitisation at this point. Concerns about water for drinking, rumen protection for ruminants.