Agency Response Letter GRAS Notice No. GRN 000299
CFSAN/Office of Food Additive Safety
September 30, 2009
Peter W. Fan, Ph.D.
Echem Hightech, Co., Ltd.
331 Bautista Place
San Jose, CA 95126
Re: GRAS Notice No. GRN 000299
Dear Dr. Fan:
The Food and Drug Administration (FDA) is responding to the notice, dated June 8, 2009, that you submitted on behalf of Echem Hightech Co., Ltd. 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 July 13, 2009, filed it on July 15, 2009, and designated it as GRAS Notice No. GRN 000299.
The subject of the notice is lycopene from Escherichia coli expressing lycopene biosynthetic enzymes. The notice informs FDA of the view of Echem Hightech Co., Ltd. that lycopene from E. coli expressing lycopene biosynthetic enzymes is GRAS, through scientific procedures, for use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, cheeses, frozen dairy desserts and mixes, milk products, processed fruits and fruit juices, snack foods, and soft candy at a level of not more than 50 milligrams of lycopene per kilogram of food.
In a letter dated September 18, 2009, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective September 22, 2009, 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 000299, 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