Agency Response Letter GRAS Notice No. GRN 000160
CFSAN/Office of Food Additive Safety
April 8, 2005
Dr. Bernd Haber
Head Scientific and Regulatory Affairs
Nutrinova Nutrition Specialities & Food Ingredients GmbH
Industriepark Höchst, D 706
65926 Frankfurt, GERMANY
Re: GRAS Notice No. GRN 000160
Dear Dr. Haber:
The Food and Drug Administration (FDA) is responding to the notice, dated November 11, 2004, 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)). FDA received the notice on November 17, 2004, filed it on November 19, 2004, and designated it as GRAS Notice No. GRN 000160.
The subject of the notice is micro-algal oil (Ulkenia sp.). The notice informs FDA of the view of Nutrinova Nutrition Specialities & Food Ingredients GmbH (Nutrinova) that micro-algal oil (Ulkenia sp.) is GRAS, through scientific procedures, for use as a direct food ingredient in the food categories listed in 21 CFR 184.1472(a)(3) at levels that are no more than 40 percent of the levels specified in 21 CFR 184.1472(a)(3) and not to be combined with any other added oil that is a significant source of eicosapentaenoic acid or docosahexaenoic acid.
In a letter dated March 29, 2005, you withdrew your notice. Given your letter, we ceased to evaluate Nutrinova's GRAS notice, effective April 1, 2005, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program, and Employee Development
Food Safety and Inspection Service
1400 Independence Ave., SW, Suite 602, Annex
Washington, DC 20250-3700