CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR184.1670]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B - Listing of Specific Substances Affirmed as GRAS

Sec. 184.1670 Propylparaben.

(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.

[42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984]