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FDA/CFSAN/OFAS: Agency Response Letter: GRAS Notice No. GRN 000184
less than one gram. S‹DZUCKER notes that isomaltulose has been in use as a food
ingredient in Japan since 1985 and has recently been authorized as a novel food or food
ingredient in Europe. (2)
Based on the information provided by S‹DZUCKER, as well as other information available
to FDA, the agency has no questions at this time regarding S‹DZUCKER's conclusion that
isomaltulose is GRAS under the intended conditions of use. The agency has not, however,
made its own determination regarding the GRAS status of the subject use of isomaltulose.
As always, it is the continuing responsibility of S‹DZUCKER to ensure that food
ingredients that the firm markets are safe, and are otherwise in compliance with all
applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a
copy of the information in your notice that conforms to the information in proposed 21 CFR
170.36(c)(1), is available for public review and copying on the homepage of the Office of
Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Sincerely,
Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
(1) Non-viable cells of P. rubrum are immobilized by entrapment in beads of calcium
alginate gel, formed from calcium chloride (21 CFR 184.1193) and sodium alginate (21
CFR 184.1724). S‹DZUCKER notes that the immobilization system is consistent with 21
CFR 173.357.
(2) (European Commission decision of 25 July 2005 authorizing the placing on the market of
isomaltulose as a novel food or novel food ingredient under Regulation (EC) No 258/97 of
the European Parliament and of the Council).
Food Ingredients and Packaging † | † Summary of all GRAS Notices
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FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by rxm April 24, 2006
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19.02.2008