3-Fucosyllactose (‘3-FL’) (produced by derivative strain of E. coli K-12 DH1): 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:

• 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
• Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products: 2,0 g/L
• Unflavoured fermented milk-based products: 2,0 g/L (beverages)
• Unflavoured fermented milk-based products: 4,0 g/kg (products other than beverages)
• Flavoured fermented milk-based products including heat-treated products: 2,0 g/L (beverages)
• Flavoured fermented milk-based products including heat-treated products: 12,0 g/kg (products other than beverages)
• Cereal bars: 25,0 g/kg
• Milk based drinks and similar products: 2,0 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: 12,0 g/kg (products other than beverages)
• Beverages (flavoured drinks, excluding drinks with a pH less than 5): 1,25 g/L
• 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: 25,0 g/kg (products other than beverages)
• 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 persons for whom the products are intended but, in any case, not higher 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 but, in any case, not higher 4,0 g/L or 4,0 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
• Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children: 4,0 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 (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.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description:

3-Fucosyllactose (3-FL) is a purified and concentrated white to off-white powder produced by microbial fermentation and contains limited levels of D-Lactose, 3-Fucosyllactulose, and L-Fucose.

Definition:

Chemical name: β-D-Galactopyranosyl-(1→4)- [α-L-fucopyranosyl-(1→3)]- D-glucopyranose

Chemical formula: C18H32O15

Molecular mass: 488,44 Da

CAS No: 41312-47-4

Source: Genetically modified strain of Escherichia coli K-12 DH1

Characteristics/Composition:

3-Fucosyllactose (% w/w of dry matter): ≥ 90,0

D-Lactose (% w/w): ≤ 5,0

3-Fucosyllactulose (% w/w): ≤ 1,5

L-Fucose (% w/w): ≤ 1,0

Sum of 3-Fucosyllactose, 3-Fucosyllactulose, D-Lactose and L-Fucose, (% w/w dry matter): ≥ 92,0

Sum of other carbohydrates (% w/w): ≤ 5,0

Moisture (% w/w): ≤ 6,0

pH (20 °C, 5 % solution): 3,2 -7,0

Ash (% w/w): ≤ 0,5

Acetic acid (% w/w): ≤ 1,0

Residual protein (% w/w): ≤ 0,01

Heavy metals and contaminants:

Arsenic: ≤ 0,2 mg/kg

Aflatoxin M1: ≤ 0,025 μg/kg

Microbiological criteria:

Total plate count: ≤ 1 000 CFU/g

Enterobacteriaceae: Absence in 10 g

Salmonella spp.: Absence in 25 g

Yeast and mould: ≤ 100 CFU/g

Cronobacter spp.: Absence in 10 g

Listeria monocytogenes: Absence in 25 g

Presumptive Bacillus cereus: ≤ 50 CFU/g

Endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units

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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