Isomaltulose: 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:

• Not specified

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Isomaltulose’. 2. The designation of the novel food on the labelling shall be accompanied by indication that the ‘Isomaltulose is a source of glucose and fructose’.

Specification (Table 2)

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

Description/Definition:

A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obtained from sucrose by an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white crystals with a sweet tasteChemical name: 6-O-α-D-glucopyranosyl-D-fructofuranose, monohydrate

CAS No.: 13718-94-0

Chemical formula: C12H22O11 · H2O

Structural formula

Formula weight: 360,3 (monohydrate)

Purity:

Assay: ≥ 98 % on the dry basis

Loss on drying: ≤ 6,5 % (60 °C, 5 hours)

Heavy metals:

Lead: ≤ 0,1 mg/kg

Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5(1), ‘Instrumental methods’

(1) Food and Nutrition Paper 5 Rev. 2 - Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1.

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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