Lacto-N-tetraose (‘LNT’) (produced by derivative strains of E. coli BL21(DE3)): 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: 1,82 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: 1,82 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: 1,82 g/L or 1,82 g/kg 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: 1,82 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
• 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 infants and young children for whom the products are intended but in any case not higher than 1,82 g/L or 1,82 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
• Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants and young children: 4,6 g/day

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:

Description:

Lacto-N-tetraose is a purified and concentrated white to off-white powder that is produced by a microbial fermentation process.

Definition:

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

Chemical formula: C26H45NO21

CAS No: 14116-68-8

Molecular mass: 707.63 Da

Source: Two genetically modified strains (a production strain and an optional degradation strain) of Escherichia coli BL21(DE3)

Characteristics/Composition:

Lacto-N-tetraose (% of dry matter): ≥ 75,0 % (w/w)

D-Lactose (% of dry matter): ≤ 5,0 % (w/w)

Lacto-N-triose II (% of dry matter): ≤ 5,0 % (w/w)

Para-lacto-N-hexaose (% of dry matter): ≤ 5,0 % (w/w)

D-galactose and D-glucose (% of dry matter): ≤ 5,0 % (w/w)

Sum of other carbohydratesa: ≤ 15,0 % (w/w)

Moisture: ≤ 9,0 % (w/w)

Ash: ≤ 1,0 % (w/w)

Residual protein: ≤ 0,01 % (w/w)

Heavy metals and contaminants:

Arsenic: ≤ 0,2 mg/kg

Aflatoxin M1: ≤ 0,025 μg/kg

Microbiological criteria:

Standard plate count: ≤ 1 000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella spp.: Absence in 25 g

Yeast and mould: ≤ 100 CFU/g

Cronobacter (Enterobacter) sakazaki: Absence in 10 g

Residual endotoxins: ≤ 10 EU/mg

a Sum of other carbohydrates = 100 (% (w/w) of dry matter) - quantified carbohydrates (% (w/w) of dry matter) - Ash (% (w/w) of dry matter). 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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