Agency Response Letter
GRAS Notice No. GRN 000176

Dr. Luis A. Mejia
Archer Daniels Midland Company
1001 N. Brush College Road
Decatur, IL 62521

Re: GRAS Notice No. GRN 000176

Dear Dr. Mejia:

The Food and Drug Administration (FDA) is responding to the notice, dated July 7, 2005, that you submitted on behalf of Archer Daniels Midland Company (ADM) 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 July 12, 2005, filed it on July 14, 2005, and designated it as GRN 000176. In a letter dated September 9, 2005, you provided additional clarifying information.

The subjects of the notice are plant sterols and plant sterol esters from vegetable oils or sterols/stanols from tall oil (hereinafter referred to as phytosterols in this letter). The notice informs FDA of the view of ADM that phytosterols are GRAS, through scientific procedures, for use as an ingredient in margarines and vegetable oil spreads, dressings for salads, beverages, snack bars, dairy analogs (including soy milk, ice cream and cream substitutes), cheese and cream, baked foods, ready-to-eat breakfast cereals, mayonnaise, pasta and noodles, sauces, salty snacks, processed soups, puddings, yogurt, confections, vegetarian meat analogs at a level up to 0.4 gram (g) sterol equivalents per serving; in fruit/vegetable juices at a level up to 1 g sterol equivalents per serving. In edible vegetable oils, including diacylglycerol oil, the use level could be up to 4 g/100g sterol equivalents per serving.

As part of its notice, ADM includes the report of a panel of individuals (ADM's GRAS panel) who evaluated the data and information that are the basis for ADM's GRAS determination. ADM considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. ADM's GRAS panel evaluated estimates of dietary exposure, the method of manufacture, specifications for the ingredient, and published and unpublished studies on phytosterols, derived from either edible vegetable oils or from tall oil. ADM's GRAS panel concluded that phytosterols meeting food-grade specifications are GRAS by scientific procedures for their intended use.

Phytosterols from vegetable oils were the subject of GRN 000061. GRN 000176 incorporates GRN000061 by reference. GRN 000061 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 and stigmasterol. The sterols are derived from oil seeds such as corn, palm, soy, rape, and sunflower. The fatty acids are preferentially derived from soy, sunflower, safflower, and canola. Corn, peanut, cottonseed and palm may also be used as sources. GRN 000061 also includes food grade specifications for phytosterols from vegetable oil.

GRN 000176 discusses the identity and composition of, as well as, the method of manufacture for phytosterols from tall oil. The tall oil, derived from pine trees, (Pinus pinaster and/or P. syvestris) was the subject of GRN 000112. The main components of these phytosterols are beta-sitosterol, beta-sitostanol, campesterol, and campestanol. ADM provides food grade specifications for the phytosterols from tall oil.

In GRN 000176, ADM intends to use 0.4 g of sterol per serving in most food categories. ADM bases this level on the interim health claim rule (65 FR 54685; September 8, 2000), and the agency's enforcement discretion letter (Ref 1). ADM estimates that the sterol intake for individuals, including the already existing and newly proposed food categories, is 3.9 g/day at the 90th percentile intake.

In its notice, ADM states its intention to use phytosterols in several food categories for which a standard of identity exists. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.

Based on information provided by ADM, as well as other information available to FDA, the agency has no questions at this time regarding ADM's conclusion that phytosterols 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 phytosterols. As always, it is the continuing responsibility of ADM 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 M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

References

1. Letter dated February 14, 2003, from Christine L. Taylor of FDA to Fred L. Shinnick.