Agency Response Letter
GRAS Notice No. GRN 000181

Dr. Hershell R. Ball
Vice President
Michael Foods Inc.
120 Tower Street South
Gaylord, MN 55334

Re: GRAS Notice No. GRN 000181

Dear Dr. Ball:

The Food and Drug Administration (FDA) is responding to the notice, dated August 18, 2005, that you submitted on behalf of Michael Foods, Inc. (hereinafter referred to as Michael Foods) in accordance with the agency's proposed regulations, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997); Substances Generally Recognized as Safe (GRAS)). FDA received the notice on August 19, 2005, filed it on August 23, 2005, and designated it as GRN 000181. In letters dated August 18, 2005, September 1, 2005, and January 30, 2006, you provided additional clarifying information.

The subject of the notice is plant phytosterols. The notice informs FDA of the view of Michael Foods that phytosterols are GRAS, through scientific procedures, for use as an ingredient in egg products, including egg whites and egg substitutes, at levels up to 20 milligrams (mg) plant sterol per gram (g) of egg product, providing 1100 mg phytosterol per serving.

In a letter dated January 30, 2006, Michael Foods amended its notice to limit use to egg substitutes and other similar or related products that are not "egg products" within the meaning of 9 CFR 590.5. This amendment limits the GRAS notice to cover only products that contain eggs in a relatively small proportion or historically have not been considered by consumers as products of the egg food industry.

As part of its GRAS notice Michael Foods includes the report from a panel of individuals (Michael Foods' GRAS panel) who evaluated the data and information that are the basis for its GRAS determination. Michael Foods considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Michael Foods' GRAS panel evaluated previously submitted GRAS notices GRN 000039, 000048, 000053, 000061, 000112, Food Master Files 000625 and 000626, estimates of dietary exposure, methods of manufacture, specifications for the ingredient, and published and unpublished studies on phytosterols and phytostanols derived from vegetable oils or tall oil.

GRN 000181 includes the identity and composition of, as well as, the method of manufacture for phytosterols from vegetable oil. The main sterol components of these phytosterols are beta-sitosterol, campesterol, brassicasterol, and stigmasterol. Food grade specifications for phytosterols from vegetable oil are provided in the notice.

The product may also contain phytosterols and phytostanols derived from tall oil. However, the total addition of phytosterols and phytostanols from tall oil is expected to be less than 5% of the total volume of vegetable oil derived product on a weight/weight basis. The main sterol and stanol components of tall oil derived from tall oil pitch are beta-sitosterol, campesterol, stigmasterol, brassicasterol, campestanol, and sitostanol.

Michael Foods provides a cumulative estimate of intake for phytosterols in the diet from the intended use described in its notice in addition to the phytosterol intake that may occur from other foods that have been the subject of previous submissions. Michael Foods notes that its intended use in egg products will not add significantly to the overall intake of phytosterols in food.

Based on information provided by Michael Foods, and other information available to FDA, the agency has no questions at this time regarding Michael Foods' conclusion that phytosterols are GRAS under the intended conditions of use in egg products that are regulated by FDA and, thus, are not egg products within the meaning of 9 CFR 590.5. The agency has not, however, made its own determination regarding the GRAS status of the subject use of phytosterols. As always, it is the continuing responsibility of Michael Foods 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 CRF 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 M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition