Lacto-N-neotetraose: 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 sterilised (including UHT) milk-based products: 0,6 g/l
• Unflavoured fermented milk-based products: 0,6 g/l for beverages
• Unflavoured fermented milk-based products: 9,6 g/kg for products other than beverages
• Flavoured fermented milk-based products including heat-treated products: 0,6 g/l for beverages
• Flavoured fermented milk-based products including heat-treated products: 9,6 g/kg for products other than beverages
• Dairy analogues, including beverage whiteners: 0,6 g/l for beverages
• Dairy analogues, including beverage whiteners: 6 g/kg for products other than beverages
• Dairy analogues, including beverage whiteners: 200 g/kg for whitener
• Cereal bars: 6 g/kg
• Table-top sweeteners: 100 g/kg
• Infant 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
• 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: 6 g/kg for products other than beverages
• Processed cereal-based foods and baby foods for infants and young children as defined under Regulation (EU) No 609/2013: 0,6 g/l for liquid food 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 for milk-based drinks and similar products 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: In accordance with the particular nutritional requirements of the persons for whom the products are intended
• Total diet replacement for weight control as defined in Regulation (EU) No 609/2013: 2,4 g/l for drinks
• Total diet replacement for weight control as defined in Regulation (EU) No 609/2013: 20 g/kg for bars
• Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014: 30 g/kg
• Flavoured drinks: 0,6 g/l
• Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products: 4,8 g/l - the maximum level refers to the products ready to use
• Food Supplements as defined in Directive 2002/46/EC, for the general population, excluding infants: 1,5 g/day for general population 0,6 g/day for young children

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-neotetraose’. 2. The labelling of food supplements containing lacto-N-neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day. 3. The labelling of food supplements containing lacto-N-neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-N-neotetraose are consumed the same day.

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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