Agency Response Letter GRAS Notice No. GRN 000443

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory

CFSAN/Office of Food Additive Safety

March 11, 2013

Robert McQuate, Ph.D.
GRAS Associates, LLC
20482 Jacklight Lane
Bend, OR 97702-3074

Re: GRAS Notice No. GRN 000443

Dear Dr. McQuate:

The Food and Drug Administration (FDA) is responding to the notice, dated August 21, 2012, that you submitted on behalf of Primex, ehf 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 August 24, 2012, filed it on September 4, 2012, and designated it as GRAS Notice No. GRN 000443.

The subject of the notice is shrimp-derived chitosan. The notice informs FDA of the view of Primex, ehf that shrimp-derived chitosan is GRAS, through scientific procedures, for multiple technical effects in several food categories.

In a letter, delivered by email, dated February 11, 2013, you asked that FDA cease to evaluate the notice. Given your request, we ceased to evaluate the GRAS notice, effective February 11, 2013, 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 000443, 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 at


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

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