Novel food: 3-Fucosyllactose produced by a derivative strain of E. coli BL21 (DE3)
- Novel/traditional foods
Summary
The European Commission is increasing the permitted maximum levels of the novel food 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3). This novel food was first authorised under Regulation 2023/52.
EU amends specifications for the novel food 3-Fucosyllactose produced by a derivative strain of E. coli BL21 (DE3)
Commission Implementing Regulation (EU) 2025/1537 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’
Update
The European Commission is increasing the permitted maximum levels of the novel food 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3). This novel food was first authorised under Regulation 2023/52.
Impacted Products
Infant formula, follow-on formula, processed cereal-based foods, milk-based drinks, foods for special medical purposes, food supplements
What is changing?
The European Union (EU) has amended the conditions of use of E. coli BL21 (DE3) in infant and follow-on formula, processed cereal-based foods and baby foods for infants and young children, milk-based drinks, and foods for special medical purposes.
The maximum authorised levels of use for this ingredient have been increased to:
- 1.75 g/l in infant formula (up from 0.9 g/l), follow-on formula (up from 0.9 g/l), and foods for special medical purposes for infants and young children (up from 1.2 g/l)
- 4.0 g/day in food supplements intended for the general population, excluding infants and young children (up from 3.0 g/day).
Only the company that applied for the initial novel food authorisation, Chr. Hansen A/S, is authorised to place the novel food on the EU market until 25 January 2028, unless another company obtains a novel food authorisation for 3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) (without reference to scientific data protected by Chr. Hansen) or with the agreement of Chr. Hansen.
Timeline
The newly approved conditions of use for this novel food apply 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
Commission Implementing Regulation (EU) 2023/52 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food
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) 2025/1537 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’
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 amends specifications for the novel food 3-Fucosyllactose produced by a derivative strain of E. coli BL21 (DE3)
Commission Implementing Regulation (EU) 2025/1537 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)’
What is changing and why?
The European Union (EU) is increasing the permitted maximum levels of the novel food 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3). This novel food was first authorised under Regulation 2023/52.
The conditions of use have been amended for E. coli BL21 (DE3) in infant and follow-on formula, processed cereal-based foods and baby foods for infants and young children, milk-based drinks, and foods for special medical purposes.
The maximum authorised levels of use for this ingredient have been increased to:
- 1.75 g/l in infant formula (up from 0.9 g/l), follow-on formula (up from 0.9 g/l), and foods for special medical purposes for infants and young children (up from 1.2 g/l)
- 4.0 g/day in food supplements intended for the general population, excluding infants and young children (up from 3.0 g/day).
These conditions of use apply only to the company Chr. Hansen A/S, which applied for the initial authorisation.
Timeline
The newly approved conditions of use for this novel food apply 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.