Lacto-N-tetraose ('LNT') (microbial source)

Definition/Description: Lacto-N-tetraose is a white to off-white powder that is produced by a microbial process.

Authorised novel ID: NOVEL-81

Specification: https://www.legislation.gov.uk/eur/2017/2470/annex/paragraph/2

Traditional food: No

Status: Authorised

Applies in: England, Scotland, Wales

Status change date: 31 December 2020 The date the status was last changed.

Conditions under which the novel food may be used: Food category Maximum levels

Beverages (flavoured drinks) 1.0 g/l

Cereal bars 10 g/kg

Flavoured fermented milk-based products including heat-treated products 1.0 g/l (beverages) ; 10 g/kg (products other than beverages)

Follow-on formula as defined in 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

Food for special medical purposes as defined in 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

Infant formula as defined in 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

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

Processed cereal-based food and baby food for infants and young children as defined in 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

Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013 2.0 g/l (beverages) ; 20 g/kg (products other than beverages)

Unflavoured fermented milk-based products 1.0 g/l (beverages) ; 10 g/kg (products other than beverages)

Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products 1.0 g/l

Food category	Maximum levels
Beverages (flavoured drinks)	1.0 g/l
Cereal bars	10 g/kg
Flavoured fermented milk-based products including heat-treated products	1.0 g/l (beverages) ; 10 g/kg (products other than beverages)
Follow-on formula as defined in 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
Food for special medical purposes as defined in 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
Infant formula as defined in 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
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
Processed cereal-based food and baby food for infants and young children as defined in 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
Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013	2.0 g/l (beverages) ; 20 g/kg (products other than beverages)
Unflavoured fermented milk-based products	1.0 g/l (beverages) ; 10 g/kg (products other than beverages)
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	1.0 g/l

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.

Other requirements: not specified

Data protection: 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 GB 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.

Legislation links: England, Scotland, Wales: Assimilated EU Regulations 2017/2470 , Assimilated EU Regulations 2020/484

Last updated: 01 April 2025 The date the item authorisation was last updated.

Lacto-N-tetraose ('LNT') (microbial source)

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