Lacto-N-tetraose (‘LNT’) (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: 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 food, baby food 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 intended for young children: 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)
• Food 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 infants: 2,0 g/day for young children, children, adolescents, and adults

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 shall bear a statement that they should not be used if breast milk or 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 purified, white to off-white amorphous powder or agglomerates that is produced by a microbial process.

Source:

Genetically modified strain of Escherichia coli strain K-12 DH1

Characteristics/Composition:

Appearance: White to off white powder or agglomerates

Sum of lacto-N-tetraose, D-Lactose and lacto-N-triose II (% of dry matter): ≥ 90.0 % (w/w)

Lacto-N-tetraose (% of dry matter): ≥ 70.0 % (w/w)

D-Lactose: ≤ 12.0 % (w/w)

Lacto-N-triose II: ≤ 10.0 % (w/w)

Para-lacto-N-hexaose-2: ≤ 3.5 % (w/w)

Lacto-N-tetraose fructose isomer: ≤ 1.0 % (w/w)

Sum of other carbohydrates: ≤ 5.0 % (w/w)

Moisture: ≤ 6.0 % (w/w)

Ash, sulfated: ≤ 0.5 % (w/w)

pH (20 °C, 5 % solution): 4.0 -6.0

Residual protein: ≤ 0.01 % (w/w)

Microbiological criteria:

Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella spp.: Negative/25 g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Residual endotoxins: ≤ 10 EU/mg

CFU: Colony Forming 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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