Agency Response Letter GRAS Notice No. GRN 000151
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CFSAN/Office of Food Additive Safety
October 29, 2004
Martin J. Hahn
Hogan & Hartson LLP
555 Thirteenth St. NW
Washington, DC 20004
Re: GRAS Notice No. GRN 000151
Dear Mr. Hahn:
The Food and Drug Administration (FDA) is responding to the notice, dated May 6, 2004, that you submitted on behalf of Frito-Lay Inc. (Frito-Lay) 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 May 12, 2004, filed it on May 14, 2004 and designated it as GRAS Notice No. GRN 000151.
The subject of the notice is ethanol. The notice informs FDA of the view of Frito-Lay that ethanol is GRAS, through scientific procedures, for use as a preservative in the filling of shelf-stable croissants at a concentration of 3000 parts per million (ppm) or 0.3%. Frito-Lay determined the estimated intake associated with the use of ethanol in a croissant filling in two ways: (1) using data from the Continuing Survey of Food Intakes by Individuals (CSFII 1994-96, 1998) and the USDA reference weight for croissants, and (2) using product-specific data for the filled croissants for which the ethanol is intended for use. Ultimately, Frito-Lay determined the daily consumption of filled croissants containing ethanol at a concentration of 3000 ppm results in an average daily intake of 17.1 mg/day ethanol.
Mr. Hahn, on behalf of Frito-Lay, stated in an electronic message sent on July 29, 2004, that the croissants will contain flavored fillings such as fruit and chocolate, and will not contain any meat or poultry. Frito-Lay stated that they are unaware of a specific self-limiting level of use for ethanol when used as a preservative in the fillings of shelf-stable croissants.
Frito-Lay includes in its notice the report of a panel of individuals (Frito-Lay's GRAS panel) who evaluated the data and information that supports Frito-Lay's GRAS determination. Frito-Lay considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of ethanol when added as a preservative, to the filling of shelf-stable croissants. Frito-Lay's GRAS panel discusses exposure, toxicological effects, and an appropriate toxicological endpoint on which they base their safety assessment. Frito-Lay and their GRAS panel have determined that the use of ethanol as a preservative, at a concentration of 3000 ppm, in the filling of shelf-stable croissants is generally recognized as safe.
Frito-Lay states that specifications for ethanol will conform to specifications in Food Chemical Codex (5th Edition). Frito-Lay provides specifications for ethanol with limits on composition, acidity (as acetic acid), alkalinity (as ammonia), fusel oil, ketones, isopropyl alcohol, heavy metals (as lead), methanol, non-volatile residues, solubility in water, substances darkened by sulphuric acid, and substances reducing permanganate.
Frito-Lay discusses the generally accepted adverse effects associated with excessive alcohol consumption including increased obesity, cardiovascular disease (including hypertension and stroke), coronary heart disease, alcoholic cardiomyopathy, liver diseases, cancer, diseases of the nervous system, and fetal alcohol syndrome. Many of the effects seen from alcohol consumption are seen only after chronic ingestion.
Frito-Lay states that ethanol will be declared on the label of those croissant products in which it is present. The declaration will appear in the list of ingredients for the food and will identify ethanol as a preservative.
Based on the information provided by Frito-Lay, as well as other information available to FDA, the agency has no questions at this time regarding Frito-Lay's conclusion that ethanol 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 ethanol. As always, it is the continuing responsibility of Frito-Lay 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).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition