With Implementing Regulation (EU) 2023/1583 of 1 August 2023, the Commission has amended the Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto-N-neotetraose (microbial source).
In the Annex to Implementing Regulation (EU) 2017/2470, in Table 2 (Specifications), the entry for Lacto-N-neotetraose (microbial source) is replaced by the following:
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: C26H45NO21
CAS No: 13007-32-4
Molecular weight: 707,63 g/mol
Lacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process using genetically modified strain of Escherichia coli K-12, and/or of Escherichia coli BL21(DE3). An additional optional genetically modified degradation strain of Escherichia coli BL21(DE3) may be used in the production process to degrade intermediate carbohydrate by-products and remaining starting carbohydrate substrates.
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 %
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’
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