L-valine from Escherichia coli CGMCC 22721 (3c374): at least 98 % DM, determination by IEC-VIS, moisture stated on the label instead of a limit, losses in premixture up to 15 % after 6 months, endotoxins — 100 EU per working day against a threshold of 900 EU
Commission Implementing Regulation (EU) 2025/756, published on 22 April 2025, authorises until 12 May 2035 L-valine produced with genetically modified E. coli CGMCC 22721 (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), which EFSA temporarily removed on 11 October 2024 and republished with corrections on 26 October 2024.
- Specification in the act: solid form, at least 98 % L-valine on a dry matter basis (C5H11NO2, CAS 72-18-4); there is no moisture limit — moisture is stated on the label of the additive (according to EFSA the applicant specified at most 1.5 %). Methods: identification according to the Food Chemical Codex L-valine monograph; in the additive 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; in water IEC-VIS or IEC-VIS/FLD.
- EFSA data: five batches averaged 100 % valine in DM (99.3–102.3 %), moisture on average 0.04 % (0–0.1 %), specific optical rotation +27.9 to +28.5° (Ph. Eur.: +26.5 to +29.0°). Cadmium, lead, mercury and arsenic below the LOQ; mycotoxins below the limits of detection except aflatoxins at 0.3–0.9 μg/kg; upper bound 0.14 ng WHO-TEQ/kg for PCDD/Fs, 0.27 ng WHO-TEQ/kg together with dl-PCBs, sum of ndl-PCBs 3 μg/kg. No viable cells or DNA of the strain were detected.
- Stability: no losses in the additive after 6 months; in a vitamin–mineral premixture for chickens for fattening losses of 4–15 % after 6 months; pelleting at 75–77 °C without losses, after 6 months losses of 2–4 % in mash and 3–5 % in pelleted feed; in water 0–2.5 % after 48 h at 20 °C. The coefficient of variation of valine in 10 subsamples of pelleted feed (after subtracting the background) was 7 %.
- Users: dusting potential 400–600 mg/m³ (Stauber-Heubach), endotoxins in three batches below the LOQ of 300 EU/g (limit test, Ph. Eur. method A); taking 299 EU/g as the worst case, exposure is 100 EU per working day against a threshold of 900 EU; the act sets no endotoxin exposure limit (the authorisation of tryptophan CGMCC 7.460 has one). EFSA did not conclude on skin and eye irritation or skin and respiratory sensitisation for lack of data; the act requires rumen protection, a warning on essential amino acids and personal protective equipment.