Agency Response Letter GRAS Notice No. GRN 000104
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CFSAN/Office of Food Additive Safety
August 16, 2002
Joan Sylvain Baughan
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: GRAS Notice No. GRN 000104
Dear Ms. Baughan:
The Food and Drug Administration (FDA) is responding to the notice, dated April 3, 2002, that you submitted on behalf of Eastman Chemical Company (Eastman) 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 April 17, 2002, filed it on April 17, 2002, and designated it as GRAS Notice No. GRN 000104.
The subject of the notice is sucrose acetate isobutyrate (SAIB). The notice informs FDA of the view of Eastman that SAIB is GRAS, through scientific procedures, for use as a stabilizer of emulsions of flavoring oils used in alcoholic beverages such that the level of SAIB in the finished beverage will not exceed 300 milligrams/kilogram (mg/kg). The intended use encompasses such beverages as premixed liquid or solid cocktail products, malt beverage coolers including flavored products containing beer, and alcoholic "cooler beverages" or wine coolers.
Sucrose acetate isobutyrate is the common name for alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-oxopropyl)-beta-D-fructofuranosyl, acetate tris-(2-methyl propanoate) (Chemical Abstracts Services Reg. No.: 27216-37-1). SAIB is a clear, viscous, practically odorless liquid that is slightly yellow in color. Eastman describes the method of manufacture for SAIB as the reaction of food grade sucrose with acetic anhydride and isobutyric anhydride in the presence of a catalyst. The typical ratio of acetyl:isobutyryl substitution on the sucrose is 2:6, and the esterified product is purified by filtration and distillation. Manufactured SAIB product will comply with specifications as described in the Food Chemicals Codex, Fourth Edition (FCC IV), Third Supplement (2001).
Eastman provides detailed summaries of published studies conducted with SAIB. These include investigations of pharmacokinetics, teratogenicity, carcinogenicity and toxicity in animal models, as well as assessment of genotoxicity in mammalian and bacterial cell cultures. Eastman also describes studies of metabolic function during chronic SAIB exposure in humans.
These data have been reviewed by the Joint Food and Agriculture Organization/World Health Organization's Expert Committee on Food Additives (JECFA). JECFA has concluded that sufficient evidence exists for assignment of an acceptable daily intake for SAIB of 20 mg/kg body weight per day (mg/kg bw/day) (Ref. 1). This acceptable daily intake corresponds to a total daily SAIB intake of 1,200 mg/day for a reference 60-kg person.
According to Eastman, SAIB is also considered safe by various regulatory bodies. Eastman notes that FDA has approved SAIB as a food additive for use as a stabilizer of emulsions of flavoring oils used in non-alcoholic beverages such that the level of SAIB in the finished beverage will not exceed 300 mg/kg (21 CFR 172.833; 64 Fed. Reg. 29949, 4 June 1999). As part of its review, FDA concluded that the acceptable daily intake for SAIB is 20 mg/kg bw/day. Eastman further notes that the European Commission's Scientific Committee for Food (SCF) has reviewed the toxicology of SAIB and concluded that it is safe for use as a stabilizer in beverages. In addition, Eastman notes that SAIB is permitted for use in Canada as an ingredient in citrus- and spruce-flavored drinks at levels up to 300 mg/kg, and that as of 1998, SAIB was permitted for use in carbonated and non-carbonated beverages in at least 28 countries worldwide.
Eastman presents 226 mg SAIB per day as a worst-case estimation of the average intake of SAIB via consumption of beer and ale, wine coolers, and cocktails, employing what they consider conservative methods and assumptions.(1) Eastman also notes that FDA had previously estimated the exposure to SAIB from its use in non-alcoholic beverages would be 82 mg/day (average) and 170 mg/day (90th percentile) (64 Fed. Reg. 29949-29950, 1999). Eastman considers that consumption via alcoholic beverages is unlikely to exceed that via non-alcoholic beverages.
Based on the information provided by Eastman, as well as other information available to FDA, the agency has no questions at this time regarding Eastman's conclusion that SAIB 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 SAIB. As always, it is the continuing responsibility of Eastman 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).
Alan M. Rulis, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
1. Sucrose acetate isobutyrate. 797. WHO Food Additives Series 32, 12-18-01, and JECFA, 1997. Forty-sixth Report. Evaluation of Certain Food Additives and Contaminants. WHO Technical Report Series 868, WHO, Geneva.
(1)FDA independently estimated that the daily intake of SAIB from use in all alcoholic beverages at a level of 300 mg/kg would be approximately 170 mg/day (average) and 430 mg/day (90th percentile).