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.)

• CELEX: Implementing Regulation (EU) 2019/1314
• Articles: 3

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.

Schedules & Appendices

ANNEX

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’