# 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), Division: Purity:

Extent: E+W+S+N.I.

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

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Source: https://www.legislation.gov.uk/eudn/2016/376/annex/I/division/2 (the official version)
Page: https://openlegislation.uk/eu-decision-2016-376/annex-I/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.