Commission Implementing Regulation (EU) 2020/484 of 2 April 2020 authorising the placing on the market of lacto-N-tetraose as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/484 of 2 April 2020 authorising the placing on the market of lacto-N-tetraose as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Lacto-N-tetraose as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial applicant:
Company: Glycom A/S;
Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of the applicant.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.
The data contained in the application file on the basis of which lacto-N-tetraose has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of the applicant.
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”)
(microbial source)
Specified food category
Maximum levels
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.
Authorised on 23.4.2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food lacto- N- tetraose is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S.
End date of the data protection: 23.4.2025.’
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
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised Novel Food
Specification
‘Lacto- N -tetraose (“LNT”)
(microbial source)
Definition:
Chemical formula: C 26 H 45 O 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 purified, white to off-white amorphous powder 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
Sum of lacto- N -tetraose, D-Lactose and lacto- N -tetraose 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 -tetraose 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 sp.: Negative/25 g
Yeast: ≤ 100 CFU/g
Mould: ≤ 100 CFU/g
Residual endotoxins: ≤ 10 EU/mg
CFU:
Colony Forming Units; EU: Endotoxin Units.’
