3-Fucosyllactose (3-FL) (microbial source): authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products: 0,85 g/L
• Unflavoured and flavoured fermented milk-based products including heat-treated products: 0,5 g/L (beverages)
• Unflavoured and flavoured fermented milk-based products including heat-treated products: 5,0 g/kg (products other than beverages)
• Dairy analogues: 0,85 g/L (beverages)
• Dairy analogues: 8,5 g/kg (products other than beverages)
• Flavoured drinks, energy and sports drinks: 1,0 g/L
• Cereal bars: 30,0 g/kg
• Infant formula as defined under Regulation (EU) No 609/2013: 0,85 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: 0,85 g/L 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: 0,85 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013: 0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013: 3,0 g/kg for products other than beverages
• Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013: 2,0 g/L (beverages)
• Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013: 30,0 g/kg (products other than beverages)
• Foods for special medical purposes as defined under Regulation (EU) No 609/2013: 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, excluding food supplements for infants and young children: 5,0 g/day

Additional specific labelling requirements

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 they should not be consumed: a) if foods containing added 3-Fucosyllactose are consumed on the same day; b) by infants and children under 3 years of age.

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.

• Consolidated text on EUR-Lex

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