Japan Wax; Affirmation of GRAS Status as an Indirect Human Food Ingredient; Reproposed Rule

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The Food and Drug Administration (FDA) is proposing to affirm Japan wax as generally recognized as safe (GRAS) as an indirect human food ingredient for use as a constituent of cotton and cotton fabrics used in dry food packaging. In light of this action, the agency is withdrawing its July 9, 1982 (47 FR 29965), proposal to delete this use of Japan wax from GRAS status as an indirect human food ingredient (hereinafter referred to as the July 1982 proposal). This action results from FDA's review of all available information on Japan wax, including documents located in food additive extension file no. 393 (FAX 393) supporting its history of common use in food contact cotton bags and an acute oral toxicity study on mice that has been obtained since the publication of the July 1982 proposal to delete this use from the GRAS list.