Agency Response Letter GRAS Notice No. GRN 000617

Recently Published GRAS Notices and FDA Letters

CFSAN/Office of Food Additive Safety

May 5, 2016

Vincent Sewalt, Ph.D.
Danisco US, Inc.
925 Page Mill Road
Palo Alto, CA 94304

Re: GRAS Notice No. GRN 000617

Dear Dr. Sewalt:

The Food and Drug Administration (FDA) has received the notice, dated December 18, 2015, 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 this notice on December 21, 2015, filed it on January 21, 2016, and designated it as GRN No. 000617.

The subjects of the notice are alpha amylase enzyme preparations produced in Bacillus licheniformis carrying an alpha amylase gene from Cytophaga sp. (alpha amylase enzyme preparations). The notice informs FDA of the view of Danisco US, Inc. (Danisco), that alpha amylase enzyme preparations are GRAS, through scientific procedures, for use as enzymes in carbohydrate processing, in the production of sugar syrups, manufacture of potable alcohol, organic acids, and amino acids, at levels up to 42.5 milligrams Total Organic Solids/kilogram starch raw material.

In telephone conversations on March, 21, 2016, and March, 31, 2016, we discussed with you our review of the estimated dietary exposure and the calculated margins of safety for the two enzyme preparations described in the notice (whole broth alpha amylase enzyme preparation and clarified alpha amylase enzyme preparation), as well as the method of manufacture of the whole broth alpha amylase enzyme preparation. In addition, we noted that the use of amino acids as dietary supplements does not fall under the purview of the Office of Food Additive Safety’s voluntary GRAS Notification Program.

In an e-mail dated April 8, 2016, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, without prejudice to future filing, effective April 8, 2016, the date that we received your letter. We look forward to your resubmission of this notice with the clarifications we discussed.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000617, 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 via the FDA home page at www.fda.gov/grasnoticeinventory.

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology
and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition