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CFSAN/Office of Food Additive Safety
December 13, 2004
Melvin S. Drozen
Keller and Heckmann LLP
1001 G Street, NW, Suite 500 West
Washington, D.C., 20001
Re: GRAS Notice No. GRN 000157
Dear Mr. Drozen:
The Food and Drug Administration (FDA) is responding to the notice, dated August 11, 2004, that you submitted on behalf of Solutia, Inc. (Solutia) 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 August 12, 2004, filed it on August 13, 2004, and designated it as GRAS Notice No. GRN 000157.
The subject of the notice is calcium propionate that is prepared by a method different from that described in 21 CFR 184.1221. The notice informs FDA of the view of Solutia that calcium propionate is GRAS, through scientific procedures, as an antimicrobial agent at levels not exceeding current good manufacturing practice for use in baked goods, cheeses, confections and frostings, gelatins, puddings and fillings, and jams and jellies as described in 21 CFR 184.1221.
Solutia describes generally available information about the manufacture of calcium propionate. Calcium propionate is prepared by hydrolyzing propionitrile with calcium hydroxide, resulting in calcium propionate and ammonia. After the removal of ammonia, the reaction mixture is neutralized with propionic acid, which reacts with excess calcium hydroxide to form additional calcium propionate. In comparison, 21 CFR 184.1221 specifies that calcium propionate be prepared by neutralizing propionic acid with calcium hydroxide. Solutia estimates the daily intake of calcium propionate at 0.22 grams per person per day. Because Solutia's calcium propionate will substitute for the uses of calcium propionate prepared as in 21 CFR 184.1221, total daily intake of calcium propionate is not expected to change from the current level.
Solutia's calcium propionate is chemically identical to calcium propionate affirmed as GRAS in 21 CFR 184.1221, and meets the specifications for calcium propionate in the Food Chemical Codex, 5th ed., 2003. Solutia notes that the new manufacturing process results in impurities that are different from those produced by the manufacturing process specified in 21 CFR 184.1221. These impurities include substances that are food ingredients as well as acrylic acid, methacrylic acid, and propionamide. Solutia calculates that the concentrations of acrylic acid and methacrylic acid in the diet derived from calcium propionate will be much less than the dietary concentration calculated from the acceptable daily intake of acrylic acid. Solutia concludes that neither acrylic acid nor methacrylic acid, which Solutia assumed to be toxicologically equivalent to acrylic acid, presents a safety risk at this level. Solutia further states that in the human body propionamide is likely to metabolize to propionic acid, which is affirmed as GRAS in 21 CFR 184.1081. Therefore, Solutia concludes that propionamide is safe at the expected low levels.
Based on the information provided by Solutia, as well as other information available to FDA, the agency has no questions at this time regarding Solutia's conclusion that calcium propionate prepared by a method different from that described in 21 CFR 184.1221 is GRAS for use as an antimicrobial agent in various foods. The agency has not, however, made its own determination regarding the GRAS status of the subject use of calcium propionate prepared by a method different from that described in 21 CFR 184.1221. As always, it is the continuing responsibility of Solutia 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 Solutia's 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).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition