Novel food: 3-Fucosyllactose from E. coli K-12 DH1
- Food safety
- Novel/traditional foods
Summary
The European Commission has authorised a new source of 3-Fucosyllactose produced from Escherichia coli K-12 DH1 as a novel food.
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
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.
EU authorises 3-Fucosyllactose produced from E. coli K-12 DH1 as a novel food
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.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.