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Agency Additional Correspondence Letter GRAS Notice No. GRN 000323

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CFSAN/Office of Food Additive Safety

March 4, 2011

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

Re: GRAS Notice No. GRN 000323

Dear Dr. McQuate:

The Food and Drug Administration (FDA) is responding to the supplement dated July 28, 2010, that you sent regarding specifications for the subject of GRAS Notice No. GRN 000323. You initially submitted GRN 000323, on behalf of PureCircle USA, Inc. (PureCircle), 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 February 5, 2010, filed it on February 18, 2010, and designated it as GRN No. 000323.

The subject of the notice is purified steviol glycosides with rebaudioside A and stevioside as the principal components (hereinafter referred to as SG-RS). PureCircle SG-RS is obtained from the leaves of Stevia rebaudiana (Bertoni) Bertoni. The notice informs FDA of the view of PureCircle that SG-RS is GRAS, through scientific procedures, for use as a general-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by good manufacturing practices, as well as use as a table top sweetener. In a letter dated July 9, 2010, FDA informed PureCircle that the agency had no questions at that time regarding PureCircle’s conclusion that the subject of the notice is GRAS under the intended conditions of use.

In the supplement dated July 28, 2010, you informed FDA that PureCircle intends to make a revision of the specifications for SG-RS described in the original notice. The revision specifically involves removal of the list that individually specifies the names and percentage ranges for nine steviol glycosides and, instead, replaces the list with a specification for total steviol glycosides content. In the original notice, the SG-RS specifications list included a ≥95% specification for the total steviol glycosides content. PureCircle states that, in the revised specifications for SG-RS, the total steviol glycosides content specification will still remain at ≥95% (anhydrous basis), with rebaudioside A and stevioside as the principal components. PureCircle states that the SG-RS product meets the specifications for steviol glycosides established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 73rd meeting in June 2010. PureCircle concludes that this revision of the specifications for SG-RS raises no safety concerns and concludes that SG-RS, meeting the revised specifications, is GRAS for the intended use.

Based on the information provided by PureCircle in GRN 000323, the supplement dated July 28, 2010, and other information available to FDA, the agency has no questions at this time regarding PureCircle’s conclusion that SG-RS is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of SG-RS. As always, it is the continuing responsibility of PureCircle to ensure that food ingredients the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to the supplement to GRN 000323, 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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