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Regulated Food and Feed Products for Great Britain

2′-Fucosyllactose

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Product details

Definition/Description
2′-fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process.
Authorised novel ID
NOVEL-4

Conditions of use

Conditions under which the novel food may be used
Food category Maximum levels
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 60 g/kg
Cereal bars 12 g/kg
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 9.6 g/l — the maximum level refers to the products ready to use
Dairy analogues, including beverage whiteners 1.2 g/l beverages; 12 g/kg for products other than beverages; 400 g/kg for whitener
Flavoured drinks 1.2 g/l
Flavoured fermented milk-based products including heat-treated products 1.2 g/l beverages; 19.2 g/kg products other than beverages
Follow-on formula as defined in Regulation (EU) No 609/2013 1.2 g/l alone or in combination with up to 0.6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants 3.0 g/day for general population; 1.2 g/day for young children
Foods 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
Infant formula as defined in Regulation (EU) No 609/2013 1.2 g/l alone or in combination with up to 0.6 g/l of lacto-N-neotetraose at a ratio of 2:1 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 1.2 g/l for milk-based drinks and similar products added alone or in combination with up to 0.6 g/l lacto-N-neotetraose, at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 12 g/kg for products other than beverages; 1.2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer
Table-top sweeteners 200 g/kg
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 4.8 g/l for drinks; 40 g/kg for bars
Unflavoured fermented milk-based products 1.2 g/l beverages; 19.2 g/kg products other than beverages
Unflavoured pasteurised and sterilised (including UHT) milk-based products 1.2 g/l
Additional specific labelling requirements
1. The designation of the novel food on the labelling of the foodstuffs containing it shall be '2′-fucosyllactose'.
2. The labelling of food supplements containing 2′-fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day.
3. The labelling of food supplements containing 2′-fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.
Other requirements
not specified
Data Protection
not specified

Dates

Date of authorisation
Pre-1 January 2021 (from retained EU regulations)
Last updated

Legislation