Agency Response Letter GRAS Notice No. GRN 000060
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Office of Premarket Approval*
January 19, 2001
Ms. Betty J. Pendleton
15505 Country Ridge Drive
Chesterfield, MO 63017-7455
Re: GRAS Notice No. GRN 000060
Dear Ms. Pendleton:
The Food and Drug Administration (FDA) is responding to the notice, dated October 12, 2000, that you submitted on behalf of Jones-Hamilton Co. 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)). FDA received the notice on October 31, 2000 and designated it as GRAS Notice No. GRN 000060.
The subject of the notice is potassium bisulfate, which is the potassium salt of sulfuric acid. The notice informs FDA of the view of Jones-Hamilton Co. that potassium bisulfate is GRAS, through scientific procedures, for use as (1) a pH control agent and leavening agent in cake mixes at a level of 0.1 per cent to 1.0 per cent by weight and (2) a pH control agent and a processing aid in foods in general at levels not to exceed good manufacturing practices. In its notice, Jones-Hamilton Co. incorporates by reference its previous GRAS notice (GRN 000003) regarding the use of sodium bisulfate, which is the sodium salt of sulfuric acid.
The notice describes the manufacturing process for potassium bisulfate. The manufactured potassium bisulfate conforms to the specification limits for Heavy Metals (as Pb), Lead, Loss on Drying, Selenium, and Water-insoluble Substances as given in the monograph for sodium bisulfate in the Food Chemical Codex, Fourth Edition (1996). Its main characteristic is its acidity in water solutions.
When used as a leavening agent, potassium bisulfate reacts with sodium bicarbonate to produce a salt (potassium sulfate), carbon dioxide gas, and water. When used as a pH control agent and a processing aid in foods in general, potassium bisulfate would be used as a substitute for sulfuric acid, which is affirmed as GRAS for these uses (21 CFR 184.1095). Under 21 CFR 184.1095, current good manufacturing practice results in a maximum level of sulfuric acid, as served, of 0.014 per cent for alcoholic beverages and 0.0003 per cent for cheeses.
Based on the information provided by Jones-Hamilton Co., as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Jones-Hamilton Co. that potassium bisulfate 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 potassium bisulfate. As always, it is the continuing responsibility of Jones-Hamilton Co. 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 Office of Premarket Approval's homepage on the Internet (at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
* The Office of Premarket Approval became the Office of Food Additive Safety on June 18, 2001