L-arginine from Corynebacterium glutamicum KCCM 80387 authorised also in water for drinking despite EFSA’s concerns — IEC-VIS in the additive, water and feed, as a flavouring recommended at most 25 mg/kg
Commission Implementing Regulation (EU) 2025/1787, published on 9 September 2025, authorises until 29 September 2035 L-arginine (≥ 98 % on dry matter) from fermentation with the genetically modified strain C. glutamicum KCCM 80387 for all animal species — as an amino acid (3c367, also in water for drinking) and as a flavouring (only in feed, via premixtures). The applicant withdrew the request for use of the flavouring in water, as Regulation (EC) No 1831/2003 does not provide for it.
- Methods in the annex: identification — Food Chemicals Codex L-arginine monograph; determination of arginine in the additive and in water as well as in premixtures and compound feed — ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS), for premixtures and compound feed with reference to Regulation (EC) No 152/2009.
- Five batches: 99.4–100.0 % L-arginine on dry matter, water 0.2–0.3 %, ash < 0.4 %; specific optical rotation +27.4…+27.6° (Ph. Eur. range +25.5…+28.5°) confirms the L-enantiomer. Heavy metals, dioxins and mycotoxins below the LOQ; no viable cells or DNA of the strain in three batches. Pelleting at 70–75 °C caused a 15 % loss of L-arginine in one of three batches.
- EFSA “has concerns” about use in water for drinking: risk of amino acid imbalance and hygiene reasons when given simultaneously in feed and water; with a balanced diet, use in water also increases urinary nitrogen excretion. The Commission authorised water use while making a label warning mandatory to take into account the dietary supply of all essential and conditionally essential amino acids. The Polish version of recital 5 contains the typo “L-arganiną”.
- Users: L-arginine is not a skin irritant or sensitiser (LLNA, OECD TG 429) but irritates the eyes (OECD TG 437, UN GHS category 1) and the respiratory tract; dusting potential 25–90 mg/m³. In ruminants it must be protected from degradation in the rumen. As a flavouring: recommended maximum content 25 mg/kg complete feed — if exceeded, the substance details must be given on the premixture label.