Agency Response Letter GRAS Notice No. GRN 000358
CFSAN/Office of Food Additive Safety
February 3, 2011
Ezaki Glico Co., LTD.
4-6-5, Utajima Nishioyogogawa
Osaka, Japan 555-8502
Re: GRAS Notice No. GRN 000358
Dear Mr. Kuriki:
The Food and Drug Administration (FDA) is responding to the notice, dated October 08, 2011, that you submitted in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on October 29, 2011, filed it on November 05, 2011, and designated it as GRAS Notice No. GRN 000358.
The subject of the notice is cyclic dextrin, highly branched. The notice informs FDA of the view of Ezaki Glico Co., LTD. that cyclic dextrin, highly branched is GRAS, through scientific procedures, for use as a food ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, tea, grain products, seasonings, milk and plant protein products, processed fruits and vegetables, fruit and vegetable juices, soft candy, and powdered soups at a level of up to 30 percent in ready-to-eat foods and beverages and up to 75 percent in mixes requiring further preparation prior to consumption.
In a letter dated January 31, 2011, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective February 1, 2011, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000358, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at http://www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition