L-lysine sulphate from Corynebacterium glutamicum CGMCC 23982 (3c330) until 5 February 2036: IEC-VIS/FLD to EN ISO 17180, sulphate to Ph. Eur. 20301, max. 10 000 mg/kg feed; in the batches ochratoxin A 11.4–16.5 µg/kg, DON up to 351 µg/kg, cadaverine 939–955 mg/kg
Commission Implementing Regulation (EU) 2026/93, published on 16 January 2026, authorises until 5 February 2036 L-lysine sulphate produced by a non-genetically modified strain of Corynebacterium glutamicum CGMCC 23982 (obtained by conventional mutagenesis) as a nutritional additive for all animal species, in feed and in water for drinking. In its opinion of 18 March 2025 EFSA found it safe in feed but had concerns about water for drinking; the Commission considered water hygiene a matter for Regulation (EC) No 183/2005 and required a warning on the label. The additive is irritant to skin, eyes and the respiratory tract. In recitals 3 and 5 of the Polish text the strain is named “KCCM 23982”; the English text uses CGMCC throughout.
- Methods in the annex: sulphate in the additive — qualitatively according to European Pharmacopoeia monograph 20301; lysine in the additive — ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS/FLD) to EN ISO 17180; in premixtures — EN ISO 17180 or IEC-VIS according to Regulation (EC) No 152/2009; in compound feed — IEC-VIS (152/2009); in water for drinking — IEC-VIS. Specification: at least 55 % L-lysine and at most 21 % sulphate; moisture on the label.
- Five batches (EFSA): lysine 55.4 % DM (55.0–56.2), sulphate 19.9 % (19.3–20.3), water 1.9 %; the theoretical lysine content of lysine sulphate is 75 %. The applicant declared ≥ 10 % “other amino acids”; free amino acids other than lysine were 0.7 % and protein calculated from nitrogen 9.6–10 %. Cadaverine 939–955 mg/kg, tyramine 43–45 mg/kg, ammonia 1.12–1.13 %; on average 96.4 % of DM identified. No viable cells of the strain were detected in the product.
- Impurities (three batches): ochratoxin A 11.4–16.5 µg/kg, deoxynivalenol 221–351 µg/kg, citrinin 21.7–25.7 µg/kg, aflatoxins up to 1.12 µg/kg; arsenic 0.16, lead 0.039–0.042, mercury 0.003–0.004 mg/kg; dioxins with DL-PCBs up to 0.276 ng WHO2005-TEQ/kg — of no concern according to EFSA. Stauber-Heubach dusting potential 100 mg/m³, solubility 360 g/l at 30 °C; stability and homogeneity data were carried over from a lysine sulphate of the same producer made with strain CGMCC 7.266 (assessed in 2020).
- The Commission set the maximum of 10 000 mg/kg complete feed because of the sulphate — following a 2015 EFSA opinion on another lysine sulphate. EFSA recalls the total sulphur limits of the NRC (2005): 3 g S/kg DM in concentrate-rich ruminant diets, 5 g in roughage-rich diets, 4 g for non-ruminants — including sulphate from water for drinking. In ruminants lysine must be protected against degradation in the rumen. Skin, eye and respiratory protection.