Commission Implementing Decision (EU) 2017/450 of 13 March 2017 authorising the placing on the market of lactitol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 1576)
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 ↗
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.
The designation of lactitol authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘lactitol’.
This Decision is addressed to DuPont Nutrition Biosciences ApS, Langebrogade 1, PO Box 17, DK-1001, Copenhagen, Denmark.
ANNEX SPECIFICATION OF LACTITOL Identity of lactitol Chemical name 4-O-β-D-Galactopyranosyl-D-glucitol Chemical formula C 12 H 24 O 11 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] D 20 = + 13° to + 16° Assay Not less than 95 % d.b ( 1 ) 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 ( 1 ) d.b — expressed on the dry weight basis
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.