3-Fucosyllactose (‘3-FL’) (produced by a derivative strain of E. coli BL21 (DE3)): authorised novel food in the EU
3-Fucosyllactose (‘3-FL’) (produced by a derivative strain of E. coli BL21 (DE3)) is on the Union list of authorised novel foods (Implementing Regulation (EU) 2017/2470). Conditions of use and maximum levels by food category: 7 entries, quoted below.
- Regulation
- Implementing Regulation (EU) 2017/2470, Annex, Table 1
- Listed as
- 3-Fucosyllactose (‘3-FL’) (produced by a derivative strain of E. coli BL21 (DE3))
- Text version
- Consolidated text of 10 August 2026
- Version
- Consolidated text of 10 August 2026
- Official source
- Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods
Conditions of use and maximum levels
Table 1, column "Conditions under which the novel food may be used", as written:
- Infant formula as defined under Regulation (EU) No 609/2013: 1,75 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
- Follow-on formula as defined under Regulation (EU) No 609/2013: 1,75 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
- Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013: 1,20 g/l or 1,20 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
- Milk based drinks and similar products intended for young children: 1,20 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
- Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013: In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 1,75 g/l or 1,75 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
- Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children: In accordance with the particular nutritional requirements of the persons for whom the products are intended
- Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children: 4 g/day
Additional specific labelling requirements
For Infant formula as defined under Regulation (EU) No 609/2013; Follow-on formula as defined under Regulation (EU) No 609/2013; Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013; Milk based drinks and similar products intended for young children; Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013; Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children: The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3-fucosyllactose’. The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that (a) they should not be consumed by children under 3 years of age; (b) they should not be used if other foods containing added 3-Fucosyllactose are consumed on the same day.
Source and version
Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.
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