Agency Response Letter GRAS Notice No. GRN 000361
CFSAN/Office of Food Additive Safety
February 4, 2011
Sharon Choi, Ph.D.
Scientific and Regulatory Consultant, Food and Nutrition
Cantox Health Sciences International
2233 Argentia Road
Mississauga, ON L5N 2X7
Re: GRAS Notice No. GRN 000361
Dear Dr. Choi:
The Food and Drug Administration (FDA) is responding to the notice, dated October 7, 2010, that you submitted on behalf of Ezaki Glico Co., Ltd. (Ezaki) 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 November 12, 2010, filed it on November 18, 2010, and designated it as GRAS Notice No. GRN 000361.
The subject of the notice is 1,4-alpha-D-glucan branching enzyme preparation. The notice informs FDA of the view of Ezaki that 1,4-alpha-D-glucan branching enzyme preparation is GRAS, through scientific procedures, for use as an enzyme to catalyze the production of modified food starch ingredients including highly branched cyclic dextrins and enzymatically-synthesized glycogen.
In a letter dated January 31, 2011, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective January 31, 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 GRAS Notice No. GRN 000361, 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 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