EU Safety Assessment of 3-fucosyllactose (3-FL) produced by E. coli as Novel Food

Posted By: Trace One

On May 25th, 2022, the European Food Safety Authority on Nutrition, Novel Foods, and Food Allergens published an assessment on the “Safety of 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283”.


The document on the Novel Food outlines the below:

  • 3-FL is Produced by fermentation with a genetically modified strain of E. coli BL21 (DE3);
  • The addition to a variety of foods including infant formula, follow-on formula, food for infants and young children, food for special medical purposes, and food supplements;
  • The maximum use level for Infant formulae is 720 mg/100 g; follow-on formula powder is 960 mg/100 g and liquid follow-on formula is 120 mg/100 g etc.;
  • The daily intake of 3-FL at the proposed maximum use levels does raise safety concerns.

To view the document, check out the Food News Monitoring System.