Lactitol: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC intended for the adult population: 20 g/day

Additional specific labelling requirements

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Lactitol’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

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.

Chemical name: 4-O-β-D-Galactopyranosyl-D-glucitol

Chemical formula: C12H24O11

Molecular weight: 344,31 g/mol

CAS No: 585-86-4Purity:

Solubility (in water): Very soluble in water

Specific rotation [α]D 20 = + 13o to + 16o

Assay: ≥ 95 % d.b (d.b - expressed on the dry weight basis)

Water: ≤ 10,5 %

Other polyols: ≤ 2,5 % d.b

Reducing sugars: ≤ 0,2 % d.b

Chlorides: ≤ 100 mg/kg d.b

Sulphates: ≤ 200 mg/kg d.b

Sulphated ash: ≤ 0,1 % d.b

Nickel: ≤ 2,0 mg/kg d.b

Arsenic: ≤ 3,0 mg/kg d.b

Lead: ≤ 1,0 mg/kg d.b

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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