Title: Alternative Sweeteners

292 Kato and Moskowitz
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) first
reviewed maltitol in conjunction with hydrogenated starch hydrolysate in 1980,
when it concluded that the allocation of an ‘‘acceptable daily intake (ADI) need
not be specified’’ (39). A second review in 1983 resulted in the allocation of a
temporary ADI of 0–25 mg/kg body weight for hydrogenated glucose syrups
containing 50–90% maltitol, mainly because the panel did not have, but requested,
the results of chronic feeding studies (41).
In 1985, after the acquisition of lifetime feeding studies, JECFA reevaluated
the toxicity of maltitol and HSH and reverted to an ADI of ‘‘not specified’’
(31). As defined by JECFA, ADI ‘‘not specified’’ means that, ‘‘on the basis
of available scientific data, the total daily intake of a substance arising from its
use at levels necessary to achieve the desired effect, does not, in the opinion of
the Committee, represent a hazard to health.’’ Therefore, establishment of an
ADI in numerical terms was not necessary.
Another group of scientists, the Scientific Committee for Food of the European
Economic Community (EEC), in its December 1984 report on sweeteners,
found maltitol to be ‘‘acceptable.’’ The committee found it inappropriate to establish
an ADI for maltitol and other polyols (42).
VIII. REGULATORY STATUS
A. United States
Towa Chemical Industry Co., Ltd., filed a petition with the FDA on August 26,
1986, to affirm the generally recognized as safe (GRAS) status of maltitol (23).
The petition was accepted for filing on September 23, 1986, and was announced
in the Federal Register on December 23, 1986.
While the FDA is conducting their assessment of the petition, maltitol may
be used in the United States, although potential customers should make their own
assessment of the risk; that is, if the FDA rules adversely, products containing
maltitol may need to be recalled from the marketplace. In this case, the risk
is minimal, because maltitol is a principal component in hydrogenated starch
hydrolysate (hydrogenated glucose syrup), which has been used in the United
States since around 1977, and also the subject of a longstanding, prior FDA
GRAS petition.
The Towa petition asks for use of maltitol in a variety of applications,
including as a flavoring agent, formulation aid, humectant, nutritive sweetener,
processing aid, sequestrant, stabilizer and thickener, surface-finishing agent, and
texturizer. The ingredient shall be used in food at levels not to exceed current
good manufacturing practices: a maximum level of 99.5% in hard candy and
cough drops, 99% in sugar substitutes, 85% in soft candy, 75% in chewing gum,
55% in nonstandardized jams and jellies, and 30% in cookies and sponge cake.