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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.)

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.)

Implementing Regulation (EU) 2019/1314 · Regulation · 3 articles

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 ↗

Article 1

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.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Supplementary provisions

ANNEXSupplementary provisions

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’

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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