Agency Response Letter GRAS Notice No. GRN 000330
CFSAN/Office of Food Additive Safety
June 8, 2010
Anthony Day, Ph.D.
561 Eccles Avenue, South
San Francisco, CA 94080
Re: GRAS Notice No. GRN 000330
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 000330.
The subject of the notice is algal flour (Chlorella protothecoides). The notice informs FDA of the view of Solazyme, Inc. that algal flour (C. protothecoides) is GRAS, through scientific procedures, for use an ingredient in baked goods and baking mixes, beverages and beverage bases, dairy product analogs, egg products, fats and oils, gravies and sauces, and meat and poultry containing soup and soup mixes at levels ranging from 3.5 to 50% of the reference amounts customarily consumed.
In a letter dated May 26, 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 000330, 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