(a) Propylparaben is the chemical propyl p-hydroxybenzoate. It is produced by the n-propanol esterification of p-hydroxybenzoic acid in the presence of sulfuric acid, with subsequent distillation.

(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), p. 258, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The ingredient is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter.

(d) The ingredient is used in food at levels not to exceed good manufacturing practices. Current good manufacturing practice results in a maximum level of 0.1 percent in food.

(e) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.