Agency Response Letter GRAS Notice No. GRN 000182
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CFSAN/Office of Food Additive Safety
June 27, 2006
P.O. Box 8569
Fresno, CA 93747
Re: GRAS Notice No. GRN 000182
Dear Mr. Gahagan:
The Food and Drug Administration (FDA) is responding to the notice, dated October 26, 2005, that you submitted on behalf of Martin Vialatte 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 this notice on October 26, 2005, filed it on October 27, 2005, and designated it as GRAS Notice No. GRN 000182.
The subjects of the notice are hydrolyzed wheat gluten isolate and pea protein isolate. The notice informs FDA of the view of Martin Vialatte that hydrolyzed wheat gluten isolate and pea protein isolate are GRAS, through scientific procedures, for use as fining agents in wine making. Protein fining agents are used in the wine industry to clarify wines and to reduce astringency. During this treatment, tannins natural to grapes, which are responsible for astringency and haze, interact with hydrolyzed wheat gluten isolate or pea protein isolate to form insoluble complexes that precipitate from the wine.
As part of its notice, Martin Vialatte discusses the conclusions of a panel of individuals (Martin Vialatte's GRAS panel) who evaluated the data and information that are the basis for Martin Vialatte's GRAS determination. Martin Vialatte considers the members of its panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Based on this panel's conclusions, Martin Vialatte concludes that ingestion of hydrolyzed wheat gluten and pea protein isolates are not harmful when used under the conditions intended.
Martin Vialatte describes the methods of manufacture for hydrolyzed wheat gluten isolate and pea protein isolate. Wheat gluten is obtained by forming an aqueous mixture (ie. dough) of wheat flour, in which the wheat gluten is insoluble at neutral pH, and removing the soluble wheat flour components, including starch, by washing. The gluten is dried to preserve its physiochemical properties. A GRAS protease enzyme is used in a second step to hydrolyze the wheat gluten.
The pea protein isolate is obtained from pea flour using a process that primarily involves two steps. The first step consists of solubilizing the pea proteins in an aqueous medium at neutral pH and then separating the pea proteins from the insoluble substances (starch, parietal components) by centrifugation. In a second step, the pea proteins are recovered by ultrafiltration, after which the solution is concentrated and dried to yield the purified pea protein product. Specifications for hydrolyzed wheat gluten isolate and pea protein isolate include limits on fungal derived toxins, metals, lead, and microbiological contaminants.
Martin Vialatte provides estimated daily intakes of hydrolyzed wheat gluten isolate and pea protein isolate from their use as fining agents in wine making. The use of plant proteins during wine production results in the formation of insoluble protein-tannin complexes between the plant proteins and the tannins (polyphenols) found in wine. Since those complexes precipitate, Martin Vialatte concludes that there is no dietary exposure to hydrolyzed wheat gluten isolate and pea protein isolate for consumers of wine processed with these plant proteins.
Potential allergen issue: Alcohol and Tobacco Tax and Trade Bureau
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the Federal Food, Drug, and Cosmetic Act to require that the label of a food that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen (section 403(w)). FALCPA defines a "major food allergen" as one of eight foods or food groups (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein derived from one of those foods. The Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of the Treasury regulates, under the Federal Alcohol Administration Act, alcohol beverages. TTB subsequently announced that it is considering rulemaking to require allergen labeling for alcohol beverage products, (70 Federal Register 22274; April 29, 2005). If you have any questions about the appropriate labeling of beverage alcohol products, including products produced using a"major food allergen," you should direct your inquiry to, Alcohol and Tobacco Tax and Trade Bureau, Advertising, Labeling and Formulation Division, 1310 G Street, N.W., suite 400W, Washington, DC 20220. The telephone number for that office is (202) 927-8116.
Based on the information provided by Martin Vialatte, as well as other information available to FDA, the agency has no questions at this time regarding Martin Vialatte's conclusion that hydrolyzed wheat gluten isolate and pea protein isolate are 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 hydrolyzed wheat gluten isolate and pea protein isolate. As always, it is the continuing responsibility of Martin Vialatte 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 responding to GRN 000182, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (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
cc: Department of the Treasury
Labeling and Consumer Protection Staff
Alcohol and Tobacco Tax and Trade Bureau
Advertising, Labeling, and Formulation Division
1310 G Street, N.W., Suite 400W
Washington, DC 20220