
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 2 August 2019.
For the Commission
The President
Jean-Claude JUNCKER
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) 
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

Genetically modified strain of Escherichia coli K-12

Lacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process.

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 %

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’
