Commission Implementing Decision (EU) 2016/376 of 11 March 2016 authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2016) 1423)
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 ↗
2′- O -Fucosyllactose as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the maximum levels established in Annex II without prejudice to the specific provisions of Directives 96/8/EC, 1999/21/EC, 2002/46/EC, 2006/125/EC, 2006/141/EC and Regulations (EC) No 1925/2006, (EC) No 41/2009 and Implementing Regulation (EU) No 828/2014
1. The designation of 2′- O -fucosyllactose authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘2′- O -fucosyllactose’. 2. Information shall be given to the consumer that food supplements containing 2′- O -fucosyllactose should not be used if other foods with added 2′- O -fucosyllactose are consumed the same day. 3. Information shall be given to the consumer that food supplements containing 2′- O -fucosyllactose intended for young children should not be used if breast milk or other foods with added 2′- O -fucosyllactose are consumed the same day.
This Decision is addressed to Glycom A/S, Diplomvej 373, 2800 Kgs. Lyngby, Denmark.
ANNEX I SPECIFICATION OF 2′- O -FUCOSYLLACTOSE Definition: Chemical name α-l-Fucopyranosyl-(1→2)-β-d-galactopyranosyl-(1→4)-d-glucopyranose Chemical formula C 18 H 32 O 15 Molecular weight 488,44 g/mol CAS No 41263-94-9 Description: 2′- O -fucosyllactose is a white to off-white powder. Purity: Test Specification Assay Not less than 95 % D-Lactose Not more than 1,0 w/w % L-Fucose Not more than 1,0 w/w % Difucosyl-d-lactose isomers Not more than 1,0 w/w % 2′-Fucosyl-d-lactulose Not more than 0,6 w/w % pH (20 °C, 5 % solution) 3,2-7,0 Water (%) Not more than 9,0 % Ash, sulphated Not more than 0,2 % Acetic acid Not more than 0,3 % Residual solvents (methanol, 2-propanol, methyl acetate, acetone) Not more than 50 mg/kg singly Not more than 200 mg/kg in combination Residual proteins Not more than 0,01 % Palladium Not more than 0,1 mg/kg Nickel Not more than 3,0 mg/kg Microbiological criteria: Aerobic mesophilic bacteria total count Not more than 500 CFU/g Yeasts Not more than 10 CFU/g Moulds Not more than 10 CFU/g Residual endotoxins Not more than 10 EU/mg
ANNEX II AUTHORISED USES OF 2′- O -FUCOSYLLACTOSE Food category Maximum levels Unflavoured pasteurised and sterilised (including UHT) milk-based products 1,2 g/l Unflavoured fermented milk-based products 1,2 g/l beverages 19,2 g/kg products other than beverages Flavoured fermented milk-based products including heat-treated products 1,2 g/l beverages 19,2 g/kg products other than beverages Dairy analogues, including beverage whiteners 1,2 g/l beverages 12 g/kg for products other than beverages 400 g/kg for whitener Cereal bars 12 g/kg Table-top sweeteners 200 g/kg Infant formulae as defined in Directive 2006/141/EC 1,2 g/l in combination with 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 Follow-on formulae as defined in Directive 2006/141/EC 1,2 g/l in combination with 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 Processed cereal-based food and baby food for infants and young children as defined in Directive 2006/125/EC 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 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 lacto- N -neotetraose, at concentrations 0,6 g/l, at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer Dietary foods for special medical purposes as defined in Directive 1999/21/EC In accordance with the particular nutritional requirements of the persons for whom the products are intended Foods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC (only for products presented as a replacement for the whole of the daily diet) 4,8 g/l for drinks 40 g/kg for bars Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009 ( 1 ) 60 g/kg Flavoured drinks 1,2 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 9,6 g/l ( 2 ) 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 ( 1 ) From 20 July 2016 the category ‘Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009’ shall be replaced by the following: ‘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’. ( 2 ) The maximum level refers to the products ready to use.
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