Novel food: 3-Fucosyllactose from E. coli K-12 DH1
Published by AGRINFO on
EU authorises 3-Fucosyllactose produced from E. coli K-12 DH1 as a novel food
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
European Commission: Union list of novel foods
Commission Implementing Regulation (EU) 2017/2470 (Union list of novel foods)
Regulation (EU) 2015/2283 on novel foods
Sources
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