Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019 authorising the change of the specifications of the novel food Lacto-N-neotetraose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission 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 produced with Escherichia coli strain K-12 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 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 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 % pH (20 C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 0,4 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts: ≤ 10 CFU/g Moulds: ≤ 10 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.