Commission Implementing Regulation (EU) 2023/1583 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Lacto-N-neotetraose (microbial source) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1583
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with 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 .

Schedules & Appendices

ANNEX

ANNEX

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:

‘ 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

Description/Source

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.

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’