L-lysine sulphate and L-lysine monohydrochloride from C. glutamicum CGMCC 7.453: IEC-VIS/FLD to EN ISO 17180, sulphate ≤ 21 % — a maximum of 10 000 mg/kg feed for the sulphate because of sulphur
Commission Implementing Regulation (EU) 2025/2566, published on 19 December 2025, authorises until 8 January 2036 L-lysine sulphate (3c330, ≥ 55 % lysine, ≤ 21 % sulphate) and L-lysine monohydrochloride (3c331, ≥ 78 % lysine on a dry matter basis) produced by fermentation with the genetically modified strain C. glutamicum CGMCC 7.453 for all animal species, also in water for drinking. The Commission took the 10 000 mg/kg complete feed limit for the sulphate from a 2015 EFSA opinion on another L-lysine sulphate.
- Methods: identification of the sulphate — Ph. Eur. monograph 20301, of the monohydrochloride — the Food Chemicals Codex L-lysine monohydrochloride monograph; 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 under Regulation (EC) No 152/2009; in compound feed — IEC-VIS (152/2009); in water for drinking — IEC-VIS.
- Sulphate (EFSA opinion of 18 March 2025): five batches — 55.9 % L-lysine on a dry matter basis (55.5–56.3 %), 19.3 % sulphate (18.6–20.0 %), moisture 2.0–3.5 %; 91.2–91.9 % of dry matter identified, in three batches including 1 % ammonia, 0.1 % cadaverine and 40 mg/kg tyramine. Dusting potential 300 mg/m³. EFSA advises that the maximum tolerable total sulphur level be considered when formulating feed, including sulphur and sulphate from water for drinking.
- Monohydrochloride: lysine 79.2–79.7 % on a dry matter basis, chloride 19.2–19.4 %, 98.5–98.9 % identified; optical rotation +20.4 to +20.7° (USP range +20.3 to +21.5°); PCDD/F dioxins < 0.50, with dioxin-like PCBs 0.55–0.62 ng WHO-TEQ/kg (88 % dry matter); dusting potential 3400–3700 mg/m³. Shelf-life and homogeneity data for both additives were taken from products made with strain CGMCC 7.266 (EFSA opinion of 2020).
- EFSA has concerns about water for drinking (amino acid balance, hygiene); the Commission considered hygiene to be covered by Regulation (EC) No 183/2005 and allowed water use with a label warning. Both additives are irritant to skin, eyes and the respiratory tract. In recital 3 of the Polish version the strain is written as “KCCM 7.453” — everywhere else, including the whole English version, it is CGMCC 7.453.