Agency Response Letter GRAS Notice No. GRN 000450
CFSAN/Office of Food Additive Safety
April 30, 2013
Ray Matulka, Ph.D.
801 North Orange Avenue, Suite 710
Orlando, FL 32801
Re: GRAS Notice No. GRN 000450
Dear Dr. Matulka:
The Food and Drug Administration (FDA) is responding to the notice, dated November 30, 2012, that you submitted on behalf of Solazyme Roquette Nutritionals, LLC 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 December 5, 2012, filed it on December 12, 2012, and designated it as GRAS Notice No. GRN 000450.
The subject of the notice is Chlorella protothecoides S106 flour with 40-70% lipid (C. protothecoides S106 flour). The notice informs FDA of the view of Solazyme Roquette Nutritionals, LLC that C. protothecoides S106 flour is GRAS, through scientific procedures, for use as an ingredient in baked goods, beverages and beverage bases, breakfast cereals, cheese, non-diary, egg products, fats and oils, frozen dairy, desserts and mixes, meal replacements, milk and milk products, snack foods, vegetable and seafood soups, and sweet sauces at levels ranging from 10 to 120 grams per kilogram of food.
In a letter dated April 18, 2013, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective April 19, 2013, 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 000450, 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 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