Agency Response Letter GRAS Notice No. GRN 000439
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CFSAN/Office of Food Additive Safety
November 26, 2012
Dr. Elizabeth Lewis
Senior Scientific and Regulatory Consultant
2233 Argentia Road, Suite 308
CANADA L5N 2X7
Re: GRAS Notice No. GRN 000439
Dear Dr. Lewis:
The Food and Drug Administration (FDA) is responding to the notice, dated June 26, 2012, that Dr. Jan Meijer (Akzo Nobel Industrial Chemicals BV (Akzo Nobel)) 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 August 15, 2012, filed it on September 16, 2012, and designated it as GRAS Notice No. GRN 000439. In an electronic mail message dated August 15, 2012, Dr. Meijer authorized you as the agent for this notice.
The subject of the notice is iron complex of tartaric acid. The notice informs FDA of the view of Akzo Nobel that iron complex of tartaric acid is GRAS, through scientific procedures, for use as an anti-caking agent in salt at a maximum level of 12 parts per million.
In a letter dated November 9, 2012, you asked that FDA cease to evaluate the notice. Given your request, we ceased to evaluate GRN 000439, effective November 16, 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 000439, 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