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FDA/CFSAN/OFAS: Agency Response Letter: GRAS Notice No. GRN 000184
Jams, jellies and spreads (21 CFR 170.3(n)(28)) 25-40
Nuts and peanut spreads (21 CFR 170.3(n)(32)) 45
Milk products (21 CFR 170.3(n)(31)) 3-20
Processed fruit and fruit juices or vegetable juices
(21 CFR 170.3(n)(35)), (21 CFR 170.3(n)(36))
The subject of GRN 000184 is 6-O-·-D-glucopyranosyl-D-fructofuranose, monohydrate
(CAS Reg No. 13718-94-0; molecular formula C 12 H 22 O 11 , referred to as isomaltulose.
Isomaltulose is a reducing disaccharide consisting of one glucose and one fructose moiety
linked by an ·-1,6- glycosidic bond, and is a water soluble, white or colorless crystalline
powder.
S‹DZUCKER describes the method of manufacture and provides product specifications for
isomaltulose. Isomaltulose is manufactured from food-grade sucrose. An aqueous sucrose
solution is applied to a column with an immobilized enzyme preparation consisting of nonviable
cells of Protaminobacter rubrum (strain designated by the Dutch culture collection
(Centraalbureau voor Schimmelcultures (CBS)) as CBS 574.77). (1) The enzyme sucrose-6glucosylmutase
(EC 5.4.99.11) converts the ·-1,2 glycosidic bond of sucrose into the ·-1,6
bond of isomaltulose. The resultant isomaltulose is crystallized, dried, then purified by
filtration and ion exchange. Specifications include an assay content of at least 98 % 6-O-·-
D-glucopyranosyl- D-fructofuranose and limits on lead (less than 0.1 milligrams per
kilogram). S‹DZUCKER intends isomaltulose to be used as a nutritive sweetener that
would totally or partially replace sucrose or other highly digestible carbohydrates.
Isomaltulose provides a moderate sweetness, bulk, and texture to foods. S‹DZUCKER
considers that the greater cost and lower solubility in water of isomaltulose compared with
sucrose would limit those foods in which it would replace sucrose.
The notice includes a published review summarizing published in vivo and in vitro studies
demonstrating that isomaltulose is completely hydrolyzed and absorbed in the small
intestine as glucose and fructose. The notifer concludes that the safety of isomaltulose is,
therefore, equivalent to that of sucrose, which, like isomaltulose, is a disaccharide composed
of glucose and fructose. The review discusses biological data, toxicological studies,
metabolic studies, and studies on gastrointestinal tolerance, and concludes that the use of
isomaltulose would not be a health concern.
S‹DZUCKER used the reported per capita refined sugar consumption in the United States
and assumed a five-to-ten percent market share replacement of isomaltulose for sucrose to
estimate daily intake of isomaltulose at approximately 3 to 6 grams (g)/person per day.
S‹DZUCKER notes that isomaltulose has been found at low concentrations in honey and
cane sugar juice. Dietary intake of isomaltulose from consumption of honey would likely be
1-10
Snack foods (21 CFR 170.3(n)(37)) 10-25
Sugar substitutes (21 CFR 170.3(n)(42)) 2 - >99
Sweet sauces, toppings, syrups (21 CFR 170.3(n)(43)) 15-30
Other categories:
nutritive formula
energy-reduced foods
meal replacements/slimming foods
http://www.cfsan.fda.gov/~rdb/opa-g184.html
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19.02.2008