Agency Response Letter GRAS Notice No. GRN 000057
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CFSAN/Office of Premarket Approval*
November 2, 2000
153 Michelle Drive
Santa Fe, NM 87501
Re: GRAS Notice No. GRN 000057
Dear Mr. Thorsen:
The Food and Drug Administration (FDA) is responding to the notice, dated September 5, 2000, that you submitted 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 your notice on September 8, 2000 and designated it as GRAS Notice No. GRN 000057.
The subject of the notice is argon gas. The notice informs FDA of the view of Permafresh Corporation that argon gas is GRAS, through scientific procedures, for use as a replacement for air in containers of wines, and fruit and vegetable juices.
Your notice describes generally available information about argon gas. Argon gas (CAS Registry Number 7440-37-1) is a chemically inert or noble gas, which is a normal component (0.94 per cent by volume, 1.3 per cent by weight) of atmospheric air, and is colorless, odorless and tasteless, noncorrosive, nonflammable, and nontoxic. It is stable as a gas. Argon gas is produced using cryogenic air separation, which employs liquefaction, distillation and purification. The specification for argon gas purified by this method is 99.998 per cent pure. Your notice compares the proposed use of argon gas with some current uses of nitrogen gas, which has been affirmed as GRAS for use as a propellant, aerating agent or gas (21 CFR 184.1540).
Your notice includes letters from individuals who concur that the data and information presented in your GRAS notice support your conclusion that argon gas is safe for its intended use. Permafresh Corporation considers these individuals to be qualified by scientific training and experience to evaluate the safety of substances added to food.
Based on the information provided by Permafresh Corporation, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Permafresh Corporation that argon gas 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 argon gas. As always, it is your continuing responsibility to ensure that food ingredients that you market 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://vm.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.