Commission Implementing Regulation (EU) 2026/397 of 23 February 2026 authorising the placing on the market of lacto-N-tetraose produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2026/397
• Articles: 5

Article 1

1.   Lacto- N -tetraose produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) is authorised to be placed on the market within the Union.

Lacto- N -tetraose produced by a derivative strain of Escherichia coli K-12 MG1655 (ATCC 700926) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Inbiose N.V.  ( 12 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 16 March 2026, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Inbiose N.V.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of Inbiose N.V.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Lacto- N -tetraose (“LNT”)

(produced by a derivative strain of Escherichia coli K-12 MG1655)

Specified food category

Maximum levels (expressed as lacto-N-tetraose)

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.

Authorised on 16 March 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: “Inbiose N.V.”, Technologiepark 82, bus 41, 9052 Zwijnaarde, Belgium. During the period of data protection, the novel food Lacto- N- tetraose is authorised for placing on the market within the Union only by “Inbiose N.V.” unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “Inbiose N.V.”.

End date of the data protection: 16 March 2031.’

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

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised Novel Food

Specification

‘ Lacto- N -tetraose (‘LNT’)

(produced by a derivative strain of Escherichia coli K-12 MG1655)

Definition:

Chemical formula: C 26 H 45 NO 21

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  ( *1 ) : ≤ 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

( *1 )

N -Acetylglucosaminyl lacto- N -tetraose (GlcNac-LNT); galacto-oligosaccharides (GOS); galactosyllacto- N -tetraose (Gal-LNT); para-lacto- N -hexaose II (pLNH II).

CFU: Colony Forming Units; EU: Endotoxin Units.’