
Article 1 
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
Article 2 

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.
Article 3 
This Decision is addressed to Glycom A/S, Diplomvej 373, 2800 Kgs. Lyngby, Denmark.
Done at Brussels, 11 March 2016.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX I

Chemical name α-l-Fucopyranosyl-(1→2)-β-d-galactopyranosyl-(1→4)-d-glucopyranose
Chemical formula C18H32O15
Molecular weight 488,44 g/mol
CAS No 41263-94-9
Description: 2′-O-fucosyllactose is a white to off-white powder.


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 singlyNot 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


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

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 beverages19,2 g/kg products other than beverages
Flavoured fermented milk-based products including heat-treated products 1,2 g/l beverages19,2 g/kg products other than beverages
Dairy analogues, including beverage whiteners 1,2 g/l beverages12 g/kg for products other than beverages400 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 beverages1,2 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 drinks40 g/kg for bars
Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009 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
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants 3,0 g/day for general population1,2 g/day for young children

