Agency Response Letter GRAS Notice No. GRN 000297
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CFSAN/Office of Food Additive Safety
December 15, 2009
Dr. William Olson
Center for Regulatory Services, Inc.
5200 Wolf Run Shoals Road
Woodbridge, VA 22192-5755
Re: GRAS Notice No. GRN 000297
Dear Dr. Olson:
The Food and Drug Administration (FDA) is responding to the notice, dated June 30, 2009, that you submitted on behalf of Stepan Company 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 1, 2009, filed it on July 13, 2009, and designated it as GRAS Notice No. GRN 000297.
The subject of the notice is erythritol fatty acid esters. The notice informs FDA of the view of Stepan Company that erythritol fatty acid esters is GRAS, through scientific procedures, for use as a microencapsulant of ingredients such as baking powder in certain foods, primarily baked goods, at the minimum level required to achieve the intended technical effect.
Stepan Company describes the identity of, and manufacturing methods for, erythritol fatty acid esters. Erythritol fatty acid esters are described as pale yellow flakes. Stepan Company employs a catalyzed esterification reaction where a 2:1 molar ratio of fatty acids to erythritol yields mono-, di-, and tri-fatty acid esters, and water, with erythritol distearate being the predominant reaction product. Following completion of the reaction, the mixture is cooled, and if desired filtered, to remove any unreacted erythritol.
Stepan Company provides specifications for its erythritol fatty acid esters, including specifications for the fatty acid profile, acid value, saponification value, hydroxyl value, and lead. Stepan Company also notes that erythritol fatty acid esters will meet appropriate food-grade specifications and will be manufactured in accordance with good manufacturing practices.
Stepan Company provides an estimated daily intake (EDI) for its erythritol fatty acid esters based on the use of the ingredient as a microencapsulant for ingredients such as baking powder and fats or oils. When used as a microencapsulant for baking powder, Stepan Company notes that erythritol fatty acid esters will be used in a limited range of baked products where the 80 degree Celsius melting point of erythritol fatty acid esters is desirable. Examples of such products include pancakes, waffles, quick breads, and cakes. In these instances, Stepan Company estimates that erythritol fatty acid esters would replace a maximum of 30 percent of all encapsulants, resulting in an EDI of 6 milligrams per kilogram body weight per day (mg/kg bw/d). Stepan Company estimates that use as a microencapsulant for fats or oils would be at a 10 percent level of baking powder uses, leading to a total intake of 6.6 mg/kg bw/d of erythritol fatty acid esters, based on a 60 kg individual. Stepan Company states that erythritol fatty acid esters are comprised of 18 percent erythritol, resulting in a maximum intake for erythritol of 1.2 mg/kg bw/d.
Stepan Company discusses the safety of erythritol fatty acid esters. Stepan Company states that erythritol fatty acid esters are easily hydrolyzed to fatty acids and erythritol and cites a published reference in support of this. Furthermore, Stepan Company states that the primary fatty acid moiety is stearic acid, an ingredient affirmed as GRAS in 21 CFR 184.1090 for use as a flavoring agent and adjuvant, provided it meets the specifications of the Food Chemicals Codex (FCC) and its levels do not exceed current good manufacturing practices. FCC defines stearic acid as a mixture of solid organic acids consisting primarily of stearic (C18) and palmitic (C16) acids. Stepan Company summarizes the published data on the erythritol moiety from animal and human clinical studies. Stepan Company notes that there are no effects on reproduction, mutagenicity, carcinogenicity, and teratogenicity. Stepan Company notes that erythritol was the subject of GRN 000076, for use as a flavor enhancer, formulation aid, humectant, nutritive sweetener, stabilizer and thickener, sequestrant, and texturizer. As a result of a review of the literature, Stepan Company also discusses the issues of diabetes and allergenicity as they relate to erythritol and concludes that there is no additional information that would preclude the safe use of erythritol fatty acid esters as a microencapsulant. Based on the totality of the evidence Stepan Company considers erythritol fatty acid esters safe for the intended uses.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Stepan Company's notice that erythritol fatty acid esters is GRAS for use as a microencapsulant of ingredients such as baking powder in certain foods, primarily baked goods, at the minimum level required to achieve the intended technical effect, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing erythritol fatty acid esters. Accordingly, this response should not be construed to be a statement that foods that contain erythritol fatty acid esters, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
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 erythritol fatty acid esters 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 erythritol fatty acid esters. 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 responding to GRN 000297, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition