Agency Response Letter GRAS Notice No. GRN 000433
CFSAN/Office of Food Additive Safety
August 9, 2012
Mr. Jerry Cook
Chemical Products Corporation
102 Old Mill Road SE
P.O. Box 2470
Cartersville, GA 30120-1692
Re: GRAS Notice No. GRN 000433
Dear Mr. Cook:
The Food and Drug Administration (FDA) is responding to the notice, dated May 29, 2012, 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 May 29, 2012, filed it on May 29, 2012, and designated it as GRAS Notice No. GRN 000433.
The subject of the notice is poloxamer fatty acid esters. The notice informs FDA of the view of Chemical Products Corporation that poloxamer fatty acid esters are GRAS, through scientific procedures, for use as a pulping agent in the alkaline pulping of lignocellulosic material used in food packaging at a level not to exceed 0.5% by weight of the raw lignocellulosic material.
In an electronic mail message dated August 3, 2012, you withdrew your notice. Given your request, we ceased to evaluate your GRAS notice, effective August 3, 2012, 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 000433, 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/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition