Novel food: 3-Fucosyllactose from E. coli K-12 DH1

Commission Implementing Regulation (EU) 2023/2210 of 20 October 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food and amending Implementing Regulation (EU) 2017/2470

Update

The European Commission has authorised a new source of 3-Fucosyllactose produced from Escherichia coli K-12 DH1 as a novel food.

Impacted Products

unflavoured, pasteurised and sterilised (including UHT) milk products, fermented milk-based products (including heat-treated), cereal bars, milk-based drinks, foods for special medical purposes, beverages (flavoured drinks, excluding with pH < 5), total diet replacement for weight control, food supplements

What is changing?

The EU has authorised 3-Fucosyllactose produced with a derivative strain of E. coli (K-12 DH1) as a novel food that may be sold on the EU market. It can be used as an ingredient in processed cereal-based foods, milk-based drinks, foods for special medical purposes, and food supplements.

Only the company that applied for the authorisation, Glycom A/S, is authorised to sell this novel food on the EU market over the next 5 years, unless Glycom permits it, or if another company obtains a novel food authorisation for 3-Fucosyllactose produced with a derivative strain of E. coli (K-12 DH1) without reference to scientific data protected by Glycom.

Timeline

The 5-year period of Glycom’s exclusive right to put this novel food on the market begins on 9 November 2023.

End date of the data protection: 12 November 2028.

Background

This Regulation updates the Annex to Implementing Regulation (EU) 2017/2470 which lists authorised novel foods (see the Union list of novel foods).

Resources

Sources

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Regulation

Commission Implementing Regulation (EU) 2023/2210 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1

What is changing and why?

The EU has approved Glycom A/S’s novel food 3-Fucosyllactose from E. coli (K-12 DH1) for use in cereals, milk drinks, medical foods, and supplements. Only Glycom can sell it in the EU for 5 years, unless another company gets approval from Glycom to sell it, or successfully applies for EU authorisation on the basis of its own scientific data without using Glycom's protected data.

Timeline

Glycom’s 5-year period of exclusive right to put this novel food on the EU market begins in November 2023.

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