Agency Response Letter GRAS Notice No. GRN 000018
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CFSAN/Office of Premarket Approval
May 12, 1999
Nancy A. Higley, Ph.D.
Vice President, Product Safety & Regulatory Assurance
Givaudan Roure Flavors Corporation
1199 Edison Drive.
Cincinnati, OH 45216
Re: GRAS Notice No. GRN 000018
Dear Dr. Higley:
The Food and Drug Administration (FDA) is responding to your notice, dated March 9, 1999, 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)). FDA received your notice on March 12, 1999 and designated it as GRAS Notice No. GRN 000018.
Your notice states that Givaudan Roure Flavors Corporation has determined, through scientific procedures, that mesquite wood extract is GRAS for use as a flavoring ingredient in alcoholic beverages.
According to your notice, mesquite wood extract is prepared by stirring one pound of wood chips from mesquite (Prosopis spp.) in 400 gallons of 80 proof alcohol for 2 hours without heat. The final product is obtained by removing the chips with filtration. The color of the product ranges from tan to brown.
Your notice indicates that mesquite wood extract is used primarily as an alternative to oak chip extract (which is regulated under 21 CFR 172.510). The population that is expected to consume alcoholic beverages containing mesquite wood extract is an adult population who have taste preferences for southwestern cuisine. As is true with oak chip extract, the use of mesquite wood extract is self-limiting, with high concentrations resulting in an undesirable astringent taste.
Your notice states that twelve volatile constituents of mesquite wood extract were identified and quantitatively measured. All of these constituents are present in oak chip extract at similar concentrations. Your notice also states that 1.8 gallons of spirits are consumed per adult (for those older than 21 years) per year based on 1995 USDA Economic Research Survey. Your notice concludes that by using the per capita x 10 calculation, which provides a conservative estimate, exposure to these volatile constituents are estimated to range from approximately 0.2 to 30 µg/person/day.
You state that you have conducted a safety evaluation using a method similar to methods employed by the Flavor and Extract Manufacturers' Association (FEMA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). We are familiar with the JECFA model. In our view, the safety evaluation that you describe differs from the JECFA model. However, we do not see this statement to be an essential part of your notice.
Based on the very low estimated human exposure to mesquite wood extract and the information regarding the similarity of mesquite wood extract to oak chip extract, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Givaudan Roure Flavors Corporation that mesquite wood extract is GRAS for use as a flavoring ingredient in alcoholic beverages. The agency has not, however, made its own determination regarding the GRAS status of the notified use of mesquite wood extract. As always, it is the continuing responsibility of Givaudan Roure Flavors Corporation 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 this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), is available for public review and copying in the public reading room of the agency's Freedom of Information Staff.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition