Lacto-N-tetraose (‘LNT’) (produced by a derivative strain of Escherichia coli K-12 MG1655): 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: 1,0 g/L
• Unflavoured fermented milk-based products: 1,0 g/L (beverages) 10 g/kg (products other than beverages)
• Flavoured fermented milk-based products including heat-treated products: 1,0 g/L (beverages) 10 g/kg (products other than beverages)
• Beverages (flavoured drinks): 1,0 g/L
• Cereal bars: 10 g/kg
• Infant formula as defined under Regulation (EU) No 609/2013: 0,8 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: 0,6 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013: 0,6 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 5 g/kg for products other than beverages
• Milk based drinks and similar products: 0,6 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer 5 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) 20 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, for the general population, excluding infants and young children: 2,0 g/day for the general population above 3 years

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-tetraose’. The labelling of food supplements containing lacto-N-tetraose (LNT) 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 lacto-N-tetraose are consumed the same day.

Specification (Table 2)

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

Definition:

Chemical formula: C26H45NO21

Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

Molecular mass: 707,63 Da

CAS No 14116-68-8

Description:

Lacto-N-tetraose is a white to off-white powder produced by microbial fermentation and further isolated, purified and concentrated.

Source: Genetically modified strain of Escherichia coli strain K-12 MG1655 (ATCC 700926)

Characteristics/Composition:

Sum of lacto-N-tetraose, D-Lactose and lacto-N-triose II (% of dry matter): ≥ 90 % (w/w)

Lacto-N-tetraose (% of dry matter): ≥ 85 % (w/w)

D-Lactose: ≤ 7 % (w/w)

Lacto-N-tetraose fructose isomer: ≤ 1 % (w/w)

Lacto-N-triose II: ≤ 7 % (w/w)

Sum of other carbohydrates (38): ≤ 5 % (w/w)

Water: ≤ 7 % (w/w)

Protein: ≤ 0,01 % (w/w)

Ash: ≤ 0,5 % (w/w)

pH (20 °C, 10 % solution): 4,0-6,5

Contaminants:

Arsenic: ≤ 0,2 mg/kg

Cadmium: ≤ 0,1 mg/kg

Lead: ≤ 0,02 mg/kg

Mercury: ≤ 0,1 mg/kg

Aflatoxin M1: ≤ 0,025 μg/kg

Microbiological criteria:

Aerobic plate count: ≤ 1 000 CFU/g

Yeasts and moulds: ≤ 100 CFU/g

Enterobacteriaceae: Absence in 10 g

Salmonella sp.: Absence in 25 g

Cronobacter spp.: Absence in 10 g

Listeria monocytogenes: Absence in 25 g

Bacillus cereus: ≤ 50 CFU/g

Endotoxins: ≤ 10 EU/mg

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

Want the whole list as one table?

If we publish the Union list as one table (name, food category, maximum level), we write to you once. We use the email for nothing else.