Novel food: Lacto-N-tetraose
- Novel/traditional foods
Summary
The European Commission has authorised Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food.
European Commission authorises Lacto-N-tetraose produced by derivative strains of E. coli as a novel food
Commission Implementing Regulation (EU) 2023/7 of 3 January 2023 authorising the placing on the market of Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470
Update
The European Commission has authorised Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food.
Impacted Products
infant formulas, processed cereal-based foods, milk-based drinks, foods for special medical purposes, food supplements
What is changing?
The EU has authorised that Lacto-N-tetraose produced by derivative strains of E. coli BL21(DE3) may be placed on the EU market as a novel food. The food can be used in infant formula, follow-on formula, processed cereal-based foods, milk based drinks, foods for special medical purposes for infants and young children, foods for special medical purposes and food supplements. Details on the permitted use are set out in the Annex to the Regulation.
Only the company that applied for the authorisation, Chr. Hansen A/S, is authorised to place the novel food on the EU market for a period of 5 years, unless another company obtains a novel food authorisation for Lacto-N-tetraose produced by derivative strains of E. coli BL21(DE3) (without reference to scientific data protected by Chr. Hansen) or with the agreement of Chr. Hansen.
Timeline
The 5-year period of exclusive rights of Chr. Hansen to put this novel food on the market begins on 24 January 2023.
Background
This Regulation updates the Annex to Implementing Regulation (EU) 2017/2470 which lists authorised novel foods (see the Union list of novel foods).
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