Agency Response Letter
GRAS Notice No. GRN 000179

Blaine Byers, Ph.D.
Stepan Company
22 West Frontage Rd.
North Field, IL 60093

Re: GRAS Notice No. GRN 000179

Dear Dr. Byers:

The Food and Drug Administration (FDA) is responding to the notice, dated July 19, 2005, 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); the GRAS proposal). FDA received the notice on July 20, 2005, filed it on July 25, 2005, and designated it as GRAS Notice No. GRN 000179.

The subject of the notice is polyglycerol polyricinoleic acid (PGPR). The notice informs FDA of the view of Stepan Company that PGPR is GRAS, through scientific procedures, for use as an emulsifier in margarines, low fat margarines, spreads, creamers, and dairy analogs, at levels no greater than 1.0 percent by weight.

Stepan Company defines PGPR as an interesterified polymer of polyricinoleic acid and polyglycerol and describes the manufacture of each of these components and PGPR. The first, polyricinoleic acid, is prepared by heating castor oil fatty acids, with or without a catalyst, to promote self-condensation of castor oil fatty acids (80 to 90 percent ricinoleic acid). Any catalysts used would include those currently used in the manufacture of food grade fats and oils. The second, polyglycerol, may be obtained either by polymerization of glycerin with a strong base catalyst⁽¹⁾ or by polymerization of epichlorohydrin. Stepan Company states that the polymerization of epichlorohydrin is the preferred method of manufacture; this method includes steam distillation at temperatures between 150 and 200 degrees Celsius, under vacuum conditions, to remove residual epichlorohydrin monomer. The resulting polymeric chlorohydrin is then hydrolyzed under basic conditions to produce polyglycerol. Stepan Company describes generally available information about the formation of PGPR from the interesterification of polyricinoleic acid and polyglycerol. Briefly, these two components, at specified levels, are heated to 200 degrees Celsius and allowed to react for a period of 12 hours. Stepan Company states that its PGPR product is consistent with the methods of manufacture and the specifications established for polyglycerol polyricinoleic acid in the Food Chemicals Codex (5th edition, 2004).

In an amendment dated January 9, 2006, Stepan Company addresses the issue of the potential for residual epichlorohydrin in PGPR obtained from the preferred method of manufacture of polyglycerol, stating that under the steam distillation conditions used, residual monomer is typically reduced to levels below 1 part per million (milligram per kilogram) in polyglycerol. Stepan Company notes that further reductions in concentration of epichlorohydrin are expected in the PGPR product, due in part to the limited level of polyglycerol (9 percent) used to produce PGPR, but also as a result of the 12 hour interesterification reaction. The final PGPR ingredient is used at a level of 1 percent or less in a formulated product, thus further diluting any residual epichlorohydrin. Stepan Company concludes that the residual epichlorohydrin levels in formulated products are expected to be negligible and far below detectable limits.

Stepan Company intends to use PGPR as an emulsifier in margarines, low fat margarines, spreads, creamers, and dairy analogs, at levels no greater than 1.0 percent by weight. Stepan Company states that the typical use levels of PGPR are 0.4 to 0.8 percent of the total weight of the food formulation, and describes the role of PGPR, often used in combination with lecithin and mono- and di-glycerides, in stabilizing emulsions with high ratios of water to fat. As the levels of fat decrease in the spread formulation, greater levels of emulsifiers are required to achieve a stable water-in-oil emulsion.

Stepan Company states that its determination that PGPR is GRAS for the intended conditions of use is based upon scientific procedures following its review of information on their method of manufacture, applications, exposure, animal toxicology and metabolism, and human consumption of PGPR from current use in chocolate. In its safety evaluation, Stepan Company references GRAS Notice No. GRN 000009 (PGPR for use as an emulsifier in chocolate) and a review by the Food and Agriculture Organization/World Health Organization Joint Expert Committee on Food Additives (JECFA). Stepan Company provides references to published studies and other relevant publications.

In the notice, Stepan Company states its intention to use PGPR in low fat margarine. FDA notes that margarine has a standard of identity specifying fat content (21 CFR 162.110) and that the term "low fat" is a nutrient content claim, the use of which is specified by regulation (21 CFR 101.62 (b)(2)). If you have any questions about the appropriate label for this food, we recommend that you contact the Office of Nutritional Products, Labeling, and Dietary Supplements in the Center for Food Safety and Applied Nutrition.

Based on the information provided by Stepan Company, as well as other information available to FDA, the agency has no questions at this time regarding Stepan Company's conclusion that PGPR 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 PGPR. As always, it is the continuing responsibility of Stepan Company 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

---

⁽¹⁾FDA notes that Stepan Company cites a published reference providing greater detail regarding the method of manufacture of polyglycerol by polymerization of glycerin.