Commission Implementing Regulation (EU) 2021/912 of 4 June 2021 authorising changes in the specifications of the novel food Lacto-N-neotetraose (microbial source) and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 referring to the substance Lacto- N -neotetraose (microbial source) shall be amended as specified in the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEX In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Lacto- N -neotetraose (microbial source)’ is replaced by the following: ‘ Lacto- N -neotetraose (microbial source) Definition: Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose Chemical formula: C 26 H 45 NO 21 CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Source: — Genetically modified strain of Escherichia coli K-12, or — a combination of the genetically modified strains PS-L N nT-JBT and DS-L N nT-JBT of Escherichia coli BL21(DE3) Description: Lacto- N -neotetraose is a white to off-white powder that is produced by a microbiological process. Purity: Assay (water free): ≥ 80 % D-Lactose: ≤ 10,0 % Lacto- N -triose II: ≤ 3,0 % para -Lacto- N -neohexaose: ≤ 5,0 % Lacto- N -neotetraose fructose isomer: ≤ 1,0 % Sum of saccharides (Lacto- N -neotetraose, D-Lactose, Lacto- N -triose II, para -Lacto- N -neohexaose, Lacto- N -neotetraose fructose isomer): ≥ 92 % (% w/w dry matter) pH (20 °C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 1,0 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts and moulds: ≤ 50 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.