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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000165

CFSAN/Office of Food Additive Safety

November 9, 2005

Nancy Rachman, Ph.D.
Exponent, Inc.
1730 Rhode Island Ave., NW
Suite 1100
Washington, D.C. 20036

Re: GRAS Notice No. GRN 000165

Dear Dr. Rachman:

The Food and Drug Administration (FDA) is responding to the notice, dated March 4, 2005, that you submitted on behalf of the American Beverage Association (ABA) 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 March 8, 2005, filed it on March 10, 2005, and designated it as GRAS Notice No. GRN 000165.

The subject of the notice is Quillaia Extract Type 1 (Quillaia). The notice informs FDA of the view of ABA that Quillaia is GRAS, through scientific procedures, for use as a foaming agent in semi-frozen carbonated and non-carbonated beverages at levels not to exceed 500 milligrams/kilogram (dried basis) in beverage concentrate prior to the incorporation of water and carbon dioxide or air in retail establishments.

ABA describes the identity, composition, and method of manufacture of Quillaia. Quillaia is obtained by aqueous extraction of the milled inner bark or the wood of pruned stems and branches of Quillaia saponaria. ABA states that the extract is treated with a stabilizing agent such as polyvinylpyrrolidone (PVP) and then filtered through diatomaceous earth. Following filtration, the liquid is concentrated. The resulting concentrate may be sold as such or spray-dried and sold as a powder containing carriers such as lactose and maltodextrin. ABA notes that the liquid form of the product is reddish brown and the powdered form is light brown with a pinkish tinge. Quillaia is composed of triterpenoid saponins consisting of glycosides of quillaic acid. Other components include polyphenols, tannins, calcium oxalate, and sugars such as glucose, galactose, arabinose, xylose, and rhamnose.

As part of its notice, ABA provides specifications for Quillaia established by Joint Expert Committee on Food Additives (JECFA) and the European Commission. These specifications include limits for arsenic, lead, and mercury that may be present in Quillaia.

ABA notes that the safety of Quillaia has been evaluated by JECFA and provides a copy of JECFA's safety evaluation as part of the GRAS notice. JECFA evaluated the publicly available scientific literature and determined an acceptable daily intake of 0-5 milligrams/kilogram body weight/day (mg/kg bw/d). FDA has approved Quillaia extract as a food additive for use as a flavor in multiple food categories (21 CFR 172.510). In addition, ABA states that recent search of the publicly available scientific literature revealed no new information indicative of any adverse effects associated with the consumption of Quillaia.

ABA estimates the total daily intake of Quillaia from its proposed use as 1.4 mg/kg bw/d at the mean and 2.2 mg/kg bw/d at the 90th percentile level. As part of its evaluation of GRN 000165, FDA asked ABA to include the estimated daily intake of Quillaia for its current use as a flavoring agent. In an amendment dated May 31, 2005 and a revision to the May amendment dated June 17, 2005, ABA reported that the daily per capita intake of Quillaia from its uses in all food applications as 0.18 mg/kg bw/d as determined by the total poundage of Quillaia extract reported to have been used in food in 1995 per consumer.

Based on the information provided by ABA, as well as other information available to FDA, the agency has no questions at this time regarding ABA's conclusion that Quillaia 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 Quillaia. As always, it is the continuing responsibility of ABA to ensure that food ingredients that 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, as well as a copy of the information in your notice that conforms to the information in proposed 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).

Sincerely,

Laura Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition