Agency Response Letter GRAS Notice No. GRN 000050
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CFSAN/Office of Premarket Approval
August 31, 2000
George M. Burditt
BELL, BOYD & LLOYD LCC
70 West Madison St., Ste. 3300
Chicago, IL 60602
Re: GRAS Notice No. GRN 000050
Dear Mr. Burditt:
The Food and Drug Administration (FDA) is responding to your letter, dated June 14, 2000, that you submitted on behalf of Fuji Oil Co., Ltd (Fuji Oil). In your letter, you requested that FDA convert the filed GRAS affirmation petition GRP 4G0407 to a GRAS notice 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 this conversion request on June 20, 2000 and designated it as GRAS Notice No. GRN 000050.
The subject of your conversion request is bohenin. The conversion request informs FDA of the view of Fuji Oil that bohenin is GRAS, through scientific procedures, for use as a tempering aid and as an anti-bloom agent in the manufacture of chocolate and chocolate coatings. According to your conversion request, bohenin would be used at levels not to exceed current good manufacturing practice, which corresponds to a level not to exceed 5 percent by weight of the total fat in chocolate and chocolate coatings.
According to GRP 4G0407, bohenin is a triglyceride containing behenic acid at the 1- and 3- positions and oleic acid at the 2-position. According to GRP 4G0407, bohenin is hydrolyzed to behenic acid and 2-oleoyl glycerol prior to absorption. Behenic acid is a saturated fatty acid that occurs naturally in peanuts, most seed fats, animal milk fat and marine oils. Oleoyl monoglyceride is a common product of human digestion of edible fats and oils typically used in western diets.
Bohenin is produced by the interesterification of 1, 2, 3-triglycerides derived from oleic acid and ethyl behenate in the presence of a suitable lipase enzyme preparation . All starting materials and reagents are food grade. The manufacturing process is identical to that used to produce a similar triglyceride, cocoa butter substitute, which FDA has affirmed as GRAS (21 CFR 184.1259). The specifications for bohenin are consistent with the Food Chemical Codex specifications for edible fats and oils.
According to GRP 4G0407, bohenin's high melting temperature (around 52 degrees C), and its ability to form beta-2-crystalline polymorphic structures are important properties that bear on its functionality as an anti-bloom agent, and facilitate the chocolate tempering process.
In GRP 4G0407, Fuji Oil discusses published scientific articles relating to (1) the physical characteristics and functionality of bohenin; (2) sampling, detection and analysis of commercial fats and oils; (3) detection and analysis of bohenin in food; (4) consumption of behenic acid from currently consumed fats and oils; (5) metabolism of triglycerides containing behenic acid; (6) hydrolysis of bohenin to behenic acid and 2-oleoyl glycerol prior to absorption; (7) safety of other triglycerides containing behenic acid; and (8) safety of behenic acid. The petition further discusses unpublished toxicity and mutagenicity studies conducted with bohenin and a recent history of use of bohenin in Japan.
In GRP 4G0407, Fuji Oil estimates that per-capita chronic exposure to bohenin would be 100 milligrams/person/day (mg/p/d), based on disappearance data for cocoa butter and an assumption that 5 percent of cocoa butter would be replaced by bohenin. In its evaluation of GRP 4G0407, FDA calculated the "eaters-only" mean estimated daily intake (EDI) of bohenin from the intended use to be 198 mg/p/d for the "all-ages" group and 322 mg/p/d for the 2-5 year old group; the intake of bohenin at the 90th percentile would be approximately twice the mean (i.e., 396mg/p/d for the "all-ages" group and 644 mg/p/d for the 2-5 year old group).
Based on the information provided by Fuji Oil, as well as the information in GRP 4G0407 and other information available to FDA, the agency has no questions at this time regarding the conclusion of Fuji Oil that bohenin 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 bohenin. As always, it is the continuing responsibility of Fuji Oil to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
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. Standards of identity regarding chocolate products are described in 21 CFR Part 163 (Cacao Products). As OPA discussed with you during its review of GRP 4G0407, FDA would separately evaluate how your proposed use of bohenin in products subject to a standard of identity would impact those standards. If you have any questions regarding whether the use of bohenin as a tempering aid and as an anti-bloom agent in the manufacture of chocolate and chocolate coatings would be permitted by these standards, we suggest that you contact the Office of Nutritional Products, Labeling, and Dietary Supplements at (202)205-5229.
In accordance with the interim policy discussed in the GRAS proposal (62 FR 18938 at 18954), FDA has not committed any resources to review of GRP 4G0407 since June 20, 2000, the date that we received your conversion request. At this time, we request that you formally withdraw GRP 4G0407.
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 Office of Premarket Approval's homepage on the Internet (at http://vm.cfsan.fda.gov/~lrd/foodadd.html).
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition