Agency Response Letter
GRAS Notice No. GRN 000129

John S. Eldred
Keller and Heckman, LLP
1001 G Street, N.W.
Washington, D.C. 20001

Re: GRAS Notice No. GRN 000129

Dear Mr. Eldred:

The Food and Drug Administration (FDA) is responding to the notice, dated May 15, 2003, that you submitted on behalf of Mitsubishi Chemical Corporation (Mitsubishi) 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 May 19, 2003, filed it on May 21, 2003, and designated it as GRAS Notice No. GRN 000129.

The subject of the notice is sucrose fatty acid esters (SFAE). The notice informs FDA of the view of Mitsubishi that SFAE are GRAS, through scientific procedures, for use as an emulsifier in beta-carotene, beta-apo-8-carotenal (apocarotenal), and canthaxanthin color preparations when they are added to beverages, crackers, soups, and sauces. Mitsubishi states that the maximum use level of SFAE in these carotenoid color preparations will be no more than 4 percent and a single food will contain no more than one added carotenoid color preparation.

Mitsubishi previously informed FDA of its view that SFAE are GRAS, through scientific procedures, for use as an emulsifier in beta-carotene color preparations intended for use in orange colored beverages such as soft drinks and juices at a level not more than 2 percent of the beta-carotene color preparation. FDA received this earlier notice on December 6, 2001, filed it on December 12, 2001, and designated it as GRAS Notice No. GRN 000092. FDA responded on February 4, 2002, stating that GRAS Notice No. GRN 000092 did not provide a basis to conclude that SFAE were GRAS for their intended use. In its letter, FDA explained that data and information cited by Mitsubishi in support of the GRAS determination were not generally available to the expert scientific community and thus did not satisfy common knowledge elements required for GRAS status. In GRAS Notice No. GRN 000129, Mitsubishi has provided additional published data and information that were not generally available at the time GRAS Notice No. GRN 000092 was submitted.

Mitsubishi describes SFAE as a grayish white powder, stiff gel or soft solid. SFAE are a mixture of mono-, di-, and tri-esters of sucrose with fatty acids that are derived from edible vegetable or hydrogenated edible vegetable oils and fats. SFAE are manufactured by inter-esterification of sucrose with methyl esters of fatty acids in the presence of food-grade solvents and comply with the specifications in the Food Chemicals Codex, Fourth Edition, First Supplement (1997).

Mitsubishi describes published studies relating to the absorption, distribution, metabolism and excretion (ADME) of SFAE in humans. Mitsubishi concludes that these studies demonstrate that pancreatic lipase in the small intestine completely converts SFAE to sucrose and fatty acids prior to absorption. Mitsubishi describes other published studies conducted with SFAE, including a subchronic 13-week rodent feeding study and a two-year chronic toxicity rodent feeding study. Mitsubishi reports that there were no observed treatment-related adverse effects in either the 13-week study or two-year study.

Mitsubishi reports that SFAE have been considered to be safe by several regulatory bodies in Japan, Europe and North America. The Joint Food and Agriculture Organization/World Health Organization’s Expert Committee on Food Additives (JECFA) has reviewed SFAE on eight occasions and most recently concluded that the data supports an acceptable daily intake of 30 milligrams per kilogram of body weight per day, which would correspond to 1800 milligrams per person per day (mg/person/day) for a 60 kilogram adult. FDA has approved SFAE as a food additive for use as an emulsifier, stabilizer, and texturizer in multiple food categories (21 CFR 172.859).⁽¹⁾

Mitsubishi estimates that its use of SFAE would result in the consumption of approximately 8 mg/person/day at the 90th percentile of intake and that the cumulative exposure to SFAE arising from all uses in the U.S. would be no more than 60 mg/person/day.

Based on the information provided by Mitsubishi, as well as other information available to FDA, the agency has no questions at this time regarding Mitsubishi’s conclusion that SFAE 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 SFAE. As always, it is the continuing responsibility of Mitsubishi 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 Mitsubishi’s notice that conforms to the information proposed in 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,    /s/ Laura M. Tarantino, Ph.D. Acting Director Office of Food Additive Safety Center for Food Safety      and Applied Nutrition

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⁽¹⁾Mitsubishi notes that the specifications for the SFAE that are the subject of its notice comply with the specifications for SFAE that are currently in 21 CFR 172.859 as well as with the specifications for SFAE that are in the Food Chemicals Codex, Fourth Edition, First Supplement (1997).