Feed: liquid L-lysine (at least 50 %) from a new strain Corynebacterium glutamicum NRRL B-68248 authorised as 3c320ii — not for use in drinking water; correction: the additive is a preparation, and the analytical methods refer to Regulation 152/2009 as a whole
Commission Implementing Regulation (EU) 2025/1395, published on 16 July 2025, corrects and amends Regulation (EU) 2020/997 on liquid L-lysine base, L-lysine sulphate and L-lysine monohydrochloride. It adds the production strain C. glutamicum NRRL B-68248 — under a separate number 3c320ii, because its product is not intended for drinking water — on the basis of the EFSA opinion of 4 July 2024, and corrects the composition of 3c320, which by mistake did not describe the additive as a preparation.
- Entries after the amendment (authorised until 30 July 2030): 3c320 — L-lysine preparation of at least 50 % (aqueous solution) from strains NRRL B-67439 or NRRL B-67535, also allowed in drinking water; 3c320ii — the same composition from strain NRRL B-68248, not for drinking water and without required user protection measures (EFSA: not a skin or eye irritant, not a skin sensitiser); 3c322 — monohydrochloride with at least 78 % L-lysine, moisture at most 1.5 %; 3c325 — sulphate granules with at least 52 % L-lysine and at most 24 % sulphate, up to 10 000 mg/kg complete feed.
- Analytical methods: lysine in the additive and in premixtures with more than 10 % lysine — ion-exchange chromatography with post-column derivatisation and photometric detection (IEC-VIS/FLD) according to EN ISO 17180; in premixtures, compound feed and feed materials — IEC-VIS according to Regulation (EC) No 152/2009, now referred to as a whole because its annex may change; in water — IEC-VIS/FLD (for 3c322 also IEC-VIS). The monohydrochloride is identified according to the Food Chemical Codex monograph, sulphate qualitatively according to European Pharmacopoeia monograph 20301.
- Characterisation according to EFSA: strain NRRL B-68248 shares its parental strain with the authorised NRRL B-67535, ANI 98.3 % with type strain ATCC 13032; no viable cells or DNA of the strain were detected in three batches (limit of detection 1 ng/mL). In eight batches the sum of quantified components averaged 98.5 % (98.2–99.4 %), heavy metals below the LOQ; in three batches dioxins 0.05–0.10 ng WHO-TEQ/kg, fumonisin B1 37–60 μg/kg, other mycotoxins below the LOQ. A liquid with pH 10.1, viscosity 56.0–57.9 cP (25 °C) and density 1150 kg/m³; scanning electron microscopy showed no particles below 500 nm.
- Transitional measures for 3c320 from strains NRRL B-67439 and B-67535: the additive and premixtures produced and labelled before 5 February 2026 under the rules applicable before 5 August 2025 may be sold until stocks are exhausted; compound feed and feed materials — produced before 5 August 2026 for food-producing animals and before 5 August 2027 for other animals. EFSA adds that in ruminants lysine would be equally efficacious only if protected against degradation in the rumen.