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  1. Generally Recognized as Safe (GRAS)

Agency Response Letter GRAS Notice No. GRN 000621

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See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

May 21, 2016

Volker Berl
MyCell Technologies, LLC
160 Summit Avenue, Suite 101
Montvale, NJ 07645

Re: GRAS Notice No. GRN 000621

Dear Mr. Berl:

The Food and Drug Administration (FDA) is responding to the notice, dated January 5, 2016, 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 January 12, 2016, filed it on February 11, 2016, and designated it as GRAS Notice No. GRN 000621.

The subject of the notice is emulsified algal oil consisting of algal oil (minimum 3.23 percent docosahexaenoic acid (DHA)) derived from Schizochytrium sp. algae, polyethylene glycol (PEG)-40 hydrogenated castor oil, water, ascorbic acid, calcium disodium EDTA, ascorbyl palmitate, and a tocopherol-based antioxidant mix. The notice informs FDA of the view of MyCell Technologies, LLC that emulsified algal oil is GRAS, through scientific procedures, for use as an ingredient in a variety of food categories as listed in the notice.

In an email dated May 13, 2016, your authorized agent Dr. David Bechtel withdrew your notice to collect information regarding the subjects FDA raised in an email sent on May 11, 2016. Given his email, we ceased to evaluate your GRAS notice, effective May 13, 2016, the date that we received his email.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000621, 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 www.fda.gov/grasnoticeinventory.

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: David Bechtel
Intertek Scientific & Regulatory Consultancy
100 Davidson Avenue, Suite 102
Somerset, NJ 08873