Agency Response Letter GRAS Notice No. GRN 000356
CFSAN/Office of Food Additive Safety
November 17, 2010
Richard F. Taylor, Ph.D.
TC Associates Inc.
PO Box 285
West Boxford, MA 01885
Re: GRAS Notice No. GRN 000356
Dear Dr. Taylor:
The Food and Drug Administration (FDA) is responding to the notice, dated September 13, 2010, that you submitted on behalf of Algatechnologies (1998) Ltd. (Algatechnologies), 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 September 21, 2010, filed it on September 28, 2010, and designated it as GRAS Notice No. GRN 000356.
The subject of the notice is Haematococcus pluvialis extract containing astaxanthin esters. The notice informs FDA of the view of Algatechnologies that H. pluvialis extract containing astaxanthin esters is GRAS, through scientific procedures, for use as an ingredient in baked goods, beverages, cereals, chewing gum, coffee and tea, dairy product analogs, frozen dairy desserts and mixes, hard candy, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soft candy at use levels of 0.5 milligrams astaxanthin per serving.
In a letter dated November 9, 2010, on behalf of Algatechnologies, you withdrew the notice. Given your letter, we ceased to evaluate Algatechnologies’s GRAS notice, effective November 15, 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 000356, 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 GRAS Notice Inventory 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