
Article 1 
Without prejudice to Directive 2002/46/EC, lactitol as specified in the Annex to this Decision may be placed on the market in the Union as a novel food ingredient to be used in food supplements in capsule or tablet form intended for the adult population with a maximum dose of 20 g lactitol per day as recommended by the manufacturer.
Article 2 
The designation of lactitol authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘lactitol’.
Article 3 
This Decision is addressed to DuPont Nutrition Biosciences ApS, Langebrogade 1, PO Box 17, DK-1001, Copenhagen, Denmark.
Done at Brussels, 13 March 2017.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX

Chemical name 4-O-β-D-Galactopyranosyl-D-glucitol
Chemical formula C12H24O11
Molecular weight 344,31 g/mol
CAS No 585-86-4

Description: Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.


Parameters Specification value
Solubility (in water) Very soluble in water
Specific rotation [α] D20 = + 13° to + 16°
Assay Not less than 95 % d.b
Water content Not more than 10,5 %
Other polyols Not more than 2,5 % d.b
Reducing sugars Not more than 0,2 % d.b
Chlorides Not more than 100 mg/kg d.b
Sulphates Not more than 200 mg/kg d.b
Sulphated ash Not more than 0,1 % d.b
Nickel Not more than 2 mg/kg d.b
Arsenic Not more than 3 mg/kg d.b
Lead Not more than 1 mg/kg d.b

