21 CFR § 172.862 - Oleic acid derived from tall oil fatty acids.
The food additive oleic acid derived from tall oil fatty acids may be safely used in food and as a component in the manufacture of food-grade additives in accordance with the following prescribed conditions:
(a) The additive consists of purified oleic acid separated from refined tall oil fatty acids.
(b) The additive meets the following specifications:
(1) Specifications for oleic acid prescribed in the Food Chemicals Codex, 7th ed. (2010), pp. 743-744, which is incorporated by reference, except that titer (solidification point) shall not exceed 13.5 °C and unsaponifiable matter shall not exceed 0.5 percent. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or 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/cfr/ibr-locations.html.
(2) The resin acid content does not exceed 0.01 as determined by ASTM method D1240-82, “Standard Test Method for Rosin Acids in Fatty Acids,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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.
(3) The requirements for absence of chick-edema factor as prescribed in § 172.860.
(c) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and defoaming agent in accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(d) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:
(1) The common or usual name of the acid.
(2) The words “food grade” in juxtaposition with and equally as prominent as the name of the acid.