Agency Response Letter GRAS Notice No. GRN 000331
CFSAN/Office of Food Additive Safety
June 9, 2010
Anthony Day, Ph.D.
561 Eccles Avenue, South
San Francisco, CA 94080
Re: GRAS Notice No. GRN 000331
Dear Dr. Day:
The Food and Drug Administration (FDA) is responding to the notice, dated March 12, 2010, 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 March 16, 2010, filed it on March 31, 2010, and designated it as GRAS Notice No. GRN 000331.
The subject of the notice is algal oil (Chlorella protothecoides). The notice informs FDA of the view of Solazyme, Inc. that algal oil (C. protothecoides) is GRAS, through scientific procedures, for use as a substitute for vegetable oils in baked goods and baking mixes, beverages and beverage bases, confections and frostings, frozen dairy desserts and mixes, gelatins, pudding, and fillings, grain products and pastas, milk products, nut and nut products, processed fruit and fruit juices, snack foods, soft candy, soups and soup mixes, and sweet sauces, toppings, and syrups. Use-levels range from 1.8 percent to 26 percent, depending on the intended technical effect in the food, with the exception of frying, cooking, and specialty oils where use-levels will be 100 percent.
In a letter dated May 27, 2010, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective June 1, 2010, 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 000331, 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. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: John M. Hicks, Jr. DVM, MPH
Risk and Innovations Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
United States Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Ave., Mailstop 5271
Beltsville, MD 20705-5271