Agency Response Letter GRAS Notice No. GRN 000203
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CFSAN/Office of Food Additive Safety
November 28, 2006
William A. Olson, Ph.D.
Center for Regulatory Services, Inc.
5200 Wolf Run Shoals Road
Woodbridge, VA 22192-5755
Sacramento, CA 95834
Re: GRAS Notice No. GRN 000203
Dear Dr. Olson:
The Food and Drug Administration (FDA) is responding to the notice, dated May 24, 2006, that you submitted on behalf of Stepan Company 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 June 5, 2006, filed it on June 9, 2006, and designated it as GRAS Notice No. GRN 000203.
The subject of the notice is erythritol fatty acid esters. The notice informs FDA of the view of Stepan Company that the ingredient, erythritol fatty acid esters, is GRAS, through scientific procedures, for use as a surface active agent or microencapsulant in certain foods at the minimum level required to achieve the intended technical effect.
In a letter dated November 15, 2006, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective November 15, 2006, 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 000203, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (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