L-arginine from Escherichia coli CGMCC 7.401 (3c366): determination by IEC-VIS, losses of 17–33 % in premixture after 6 months, pelleting at 76 °C takes 10–16 %, distribution in feed after subtracting the background — CV 56 %, citrinin in the additive 27–419 μg/kg
Commission Implementing Regulation (EU) 2025/634, published on 2 April 2025, authorises until 22 April 2035 L-arginine produced with genetically modified E. coli CGMCC 7.401 (a K-12 derivative) as a nutritional additive for all animal species, in feed and in water for drinking. It is based on the EFSA opinion of 18 September 2024 (applicant: Eppen Europe SAS). In recitals 2–5 of the Polish version the substance appears 9 times spelt “L-arganina”, in the title and annex as L-arginina; the English version has L-arginine throughout.
- Specification in the act: solid form, L-arginine at least 98.5 % on a dry matter basis (C6H14N4O2, CAS 74-79-3); moisture is stated on the label (according to EFSA the applicant specified at most 1 % water). Methods: identification according to the Food Chemical Codex L-arginine monograph; in the additive and in water ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS); in premixtures and compound feed IEC-VIS according to Regulation (EC) No 152/2009.
- EFSA data: five batches averaged 100 % arginine in DM (99.8–100.4 %), water 0.3–0.5 %, specific optical rotation +26.7 to +27.2° (Ph. Eur.: +25.5 to +28.5°). Cadmium, lead, mercury and arsenic below the LOQ; upper bound 0.14 ng WHO-TEQ/kg for PCDD/Fs and 0.27 ng WHO-TEQ/kg with dl-PCBs. Zearalenone, ochratoxin A and fumonisins below the LOD, but aflatoxins 4–5.7 μg/kg, deoxynivalenol 272–308 μg/kg and citrinin 27–419 μg/kg — the Panel considered them of no concern. No viable cells or DNA of the strain were detected.
- Stability: the additive itself lost 4–10 % within 6 months, 17–33 % in a premixture for chickens for fattening; pelleting of pig feed at 76 °C reduced arginine by 10–16 %, then over 3 months losses of 0–3 % in mash and no further losses in pelleted feed; 5 % in water after 48 h. In 10 subsamples of pelleted feed (protein-bound arginine 1.3 %) the CV of total arginine was 6 %, and after subtracting the background — 56 %.
- Users: dusting potential 0.4–0.9 g/m³ (Stauber-Heubach). Endotoxins in three batches below the LOQ of 0.03 IU/mg (Ph. Eur. method A); in the target species section the opinion states “< 0.30 EU/mg”, in the user section “< 30 IU/g”; taking 29 IU/g, EFSA calculated 15 IU per working day against a threshold of 900 IU. No conclusions on irritation and sensitisation (skin, respiratory) for lack of data; the act requires rumen protection, a warning on essential amino acids and personal protective equipment.