Agency Response Letter GRAS Notice No. GRN 000006
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CFSAN/Office of Premarket Approval
December 28, 1998
Ralph A. Simmons
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001
Re: GRAS Notice No. GRN 000006
Docket No. 98S-0104
Dear Mr. Simmons:
This is in response to your notice dated July 20,1998, which was received by the Food and Drug Administration (FDA) on July 21, 1998. This notice was submitted to FDA on behalf of Cytec Industries, Inc., in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997). FDA designated your notice as GRAS Notice No. GRN 000006.
Your notice states that Cytec Industries, Inc., has determined that dioctyl sodium sulfosuccinate (DSS) is generally recognized as safe (GRAS) for use as a wetting agent or solubilizer for flavor emulsion stabilizers in carbonated and non-carbonated soft drinks at levels up to 10 parts per million (ppm) of the finished beverage. Your notice further states that the basis for the GRAS determination is through scientific procedures. In a letter dated September 3, 1998, you amended your notice to clarify that the intended use of DSS is as a dispersing agent and stabilizer in flavor emulsions used in the production of carbonated and non-carbonated soft drinks. According to your September 3, 1998, letter, this amended description of the intended use more accurately describes the function of DSS in the production of soft drinks than the description in the original notice.
According to your notice, DSS is produced by reaction of 2-ethylhexyl alcohol with maleic anhydride followed by addition of sodium bisulfite. It is a waxy white solid that is soluble in many organic solvents but dissolves slowly in water. It is an anionic surface-active agent. Its purity complies with the specifications set forth in the Food Chemicals Codex, 3rd Ed. (1981), pp. 102-104. DSS currently is approved for use as a food additive in 21 CFR 172.810 as a wetting agent in fumaric acid-acidulated foods, as a processing aid in the production of unrefined cane sugar, as a solubilizing agent on gums and hydrophilic colloids, as an emulsifying agent for cocoa fat, and as a dispersing agent in cocoa. Your notice includes calculations that estimate the daily intake by the 90th percentile consumer from the current food uses of DSS and from the additional use of DSS that is the subject of your notice. According to these calculations, such intake of DSS from the current food uses is 130 µg/person/day (or 0.13 mg/person/day). In addition, such intake of DSS from the additional use of DSS in carbonated and noncarbonated soft drink beverages at levels that will not exceed 10 ppm in the finished beverage (i.e., at the same maximum use level as is currently used in fumaric acid-acidulated foods) would be 5.6 mg/person/day. Based on these calculations, the cumulative intake by the 90th percentile consumer of DSS from all food uses would be the total of these two values, which is approximately 5.7 mg/person/day.
Your notice states that a large volume of toxicological data on DSS is publicly available and that these data have previously been reviewed by experts at FDA and by the Joint Food and Agriculture Organization/World Health Organization's (FAO/WHO) Expert Committee on Food Additives (JECFA). According to your notice, these publicly available studies provided the basis for FDA's determination, using a 100-fold safety factor, that an acceptable daily intake for DSS is 30 mg/person/day. According to your notice, these publicly available data also provided the basis for JECFA's determination, using a 500-fold safety factor, that an acceptable daily intake for DSS is 6 mg/person/day.
Based on the information provided by your notice, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Cytec Industries, Inc., that DSS is GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the notified use of DSS. As always, it is the continuing responsibility of Cytec Industries, Inc., to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
We are concerned, however, that certain statements in your notice suggest that FDA approval of a use of a food additive, combined with public availability of the data that FDA relied on in reaching its safety conclusion, constitutes general recognition of safety within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. FDA does not agree with this suggestion. The Act requires premarket approval of the use of a substance in food unless that use is GRAS, and requires that FDA publish its conclusion regarding safety. Such an agency conclusion, even if based upon generally available data and information, is not necessarily equivalent to general recognition by qualified experts that the subject use is safe. FDA currently intends to present its evaluation of this matter in the preamble to any final rule that the agency issues in response to that proposed regulation.
In accordance with proposed 21 CFR 170.36(f), a copy of this letter has been made available for public review and copying at the agency's Dockets Management Branch (Docket No. 98S-0104). As mentioned in our letter dated August 19, 1998, which acknowledged receipt of your GRAS notice, a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1) is likewise available in Docket No. 98S-0103.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition