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)
(Only the Danish text is authentic)
Article 1
Article 2
Article 3
ANNEX I
SPECIFICATION OF 2′-
O
-FUCOSYLLACTOSE
Definition:
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 |
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 |