Lacto-N-tetraose from a new E. coli K-12 MG1655 strain: LNT ≥ 85 % determined by UPLC-RI, endotoxins ≤ 10 EU/mg by the LAL test, and aflatoxin M1 ≤ 0.025 µg/kg — in the Polish language version of the annex mistakenly µg/g
Commission Implementing Regulation (EU) 2026/397, published on 24 February 2026, authorises lacto-N-tetraose (LNT) produced by Inbiose N.V. with a genetically modified derivative strain of E. coli K-12 MG1655 (ATCC 700926) in the same food categories and amounts as the LNT authorised in 2020 — among others 0.8 g/L in infant formula. Data protection lasts until 16 March 2031.
- Specification: sum of LNT, D-lactose and lacto-N-triose II ≥ 90 % DM, LNT ≥ 85 %, D-lactose and lacto-N-triose II each ≤ 7 %, LNT fructose isomer ≤ 1 %, other carbohydrates ≤ 5 %, water ≤ 7 %, protein ≤ 0.01 %; lead ≤ 0.02 mg/kg; Enterobacteriaceae and Cronobacter spp. absent in 10 g, B. cereus ≤ 50 CFU/g, endotoxins ≤ 10 EU/mg.
- The aflatoxin M1 limit in the English and German versions of the annex and in the EFSA opinion is ≤ 0.025 µg/kg, whereas the Polish version reads “≤ 0,025 μg/g”, a value a thousand times higher. Laboratories working with the Polish text should check the unit against another language version.
- Methods in the EFSA opinion (10 July 2025) for 5 batches: carbohydrates — UPLC-RI (validated in-house method; LNT 91.92–94.11 % DM), water — Karl Fischer titration, protein — Bradford assay (< 0.0025 %), ash — NEN 6810, metals — ICP-MS, mercury — FIMS, aflatoxins and ochratoxin A — LC-MS/MS, endotoxins — kinetic chromogenic LAL assay according to Ph. Eur. 2.6.14 (< 5 EU/g).
- Microbiology was tested according to ISO 4833, ISO 21527-2, ISO 4832-1 and -2, ISO 21528-1, ISO 6579 and ISO 22964 (Cronobacter) and AFNOR BRD methods. The absence of DNA and viable cells of the production strain was shown according to the 2018 FEEDAP guidance. Supplements with LNT are not to be given to children under 3 or on a day when other food with added LNT is consumed.