Novel food: 3-Fucosyllactose from E. coli K-12 DH1
- Food safety
- Novel/traditional foods
Summary
In 2023, the European Commission authorised a new source of 3-Fucosyllactose produced from Escherichia coli K-12 DH1 as a novel food.
When authorising this novel food, the Commission omitted to include foods for special medical purposes intended for infants and young children. Annex 1 of Regulation 2023/2210 has now been modified to correct this error.
EU corrects novel food authorisation for 3-Fucosyllactose produced from E. coli K-12 DH1
Commission Implementing Regulation (EU) 2025/1549 of 30 July 2025 correcting Implementing Regulations (EU) 2023/2210 as regards the conditions of use of the novel foods 3-Fucosyllactose produced by a derivative strain of Escherichia 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
In 2023, the European Commission authorised a new source of 3-Fucosyllactose produced from Escherichia coli K-12 DH1 as a novel food.
When authorising this novel food, the Commission omitted to include foods for special medical purposes intended for infants and young children. Annex 1 of Regulation 2023/2210 has now been modified to correct this error.
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 pH <5), total diet replacement for weight control, food supplements, foods for special medical purposes intended for infants and young children
What is changing?
In 2023, the European Union (EU) 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 for use as an ingredient in processed cereal-based foods, milk-based drinks, foods for special medical purposes, and food supplements (Regulation 2023/2210).
In July 2025, Annex I to Regulation 2023/2210 was modified to include foods for special medical purposes intended for infants and young children, with a maximin level of 1.75 g/l in the final product ready for use.
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.
Why?
The original authorisation in 2023 erroneously omitted foods for special medical purposes intended for infants and young children.
Timeline
The use of this novel food in foods for special medical purposes intended for infants and young children is permitted from 19 August 2025.
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 establishing the Union list of novel foods
Regulation (EU) 2015/2283 on novel foods
Sources
Commission Implementing Regulation (EU) 2025/1549 as regards the conditions of use of the novel foods 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1
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 corrects novel food authorisation for 3-Fucosyllactose produced from E. coli K-12 DH1
Commission Implementing Regulation (EU) 2025/1549 as regards the conditions of use of the novel foods 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1
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?
In 2023, the European Union (EU) authorised the novel food 3-Fucosyllactose produced from Escherichia coli K-12 DH1. However, the European Commission omitted to include foods for special medical purposes intended for infants and young children in that authorisation. This has now been corrected to include these products, with a maximum level of 1.75 g/l in the final product ready for use.
Timeline
The use of this novel food in foods for special medical purposes intended for infants and young children is permitted from 19 August 2025.
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.