L-histidine from Corynebacterium glutamicum KCCM 80389 authorised in feed as an amino acid and a flavouring — with a histamine limit of 100 ppm and ion-exchange chromatography with post-column derivatisation
Commission Implementing Regulation (EU) 2026/353 of 18 February 2026, published on 19 February, authorises until 11 March 2036 L-histidine (3c353, at least 90% on a dry matter basis) and L-histidine monohydrochloride monohydrate (3c354, at least 98%, with at least 72% histidine) produced with Corynebacterium glutamicum KCCM 80389 — as nutritional (amino acids) and sensory (flavouring) additives for all animal species. In both, histamine may not exceed 100 ppm.
- Methods: histidine in the additive is determined by ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS or IEC-VIS/FLD) or by HPLC-UV; in premixtures and compound feed by IEC-VIS according to Regulation (EC) No 152/2009, in water for drinking by IEC-VIS. Histamine in the additive is determined by HPLC with spectrophotometric detection (HPLC-UV).
- In the data submitted to EFSA (opinion of 24 June 2025), histamine in five batches of L-histidine ranged from 3.2 to 6.3 mg/kg, and in five batches of the monohydrochloride monohydrate it was below the limit of quantification (< 5 mg/kg); the L-histidine content averaged 93.14% (91.7–93.7%) of dry matter. No viable cells or DNA of the production strain were detected in the final products, and the genetic modifications of the strain raise no concern.
- As an amino acid the additive may be given in water for drinking — EFSA had concerns about nutritional imbalance and hygiene, and the Commission referred hygiene matters to Regulation (EC) No 183/2005 and required a label warning to take into account the supply of all essential amino acids. In ruminants L-histidine must be protected against degradation in the rumen; the label states the moisture content.
- As a flavouring the additive is incorporated into feed only via premixtures, with a recommended maximum content of 25 mg/kg complete feed; Regulation (EC) No 1831/2003 does not provide for flavourings in water for drinking, so the applicant withdrew that part of the application. According to EFSA the products are not skin or eye irritants or skin sensitisers.