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(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an empirical formula of C33H47NO13 and a molecular weight of 665.7.
(b) The additive shall conform to the following specifications:
Purity: 97 percent +/-2 percent on an anhydrous basis.
Arsenic: Not more than 1 part per million.
Heavy metals (as Pb): Not more than 20 parts per million.
(c) The additive may be applied on cheese, as an antimycotic, in amounts not to exceed 20 milligrams per kilogram (20 parts per million) in the finished product as determined by International Dairy Federation (IDF) Standard 140A:1992, "Cheese and Cheese Rind-Determination of Natamycin Content-Method by Molecular Absorption Spectrometry and by High-Performance Liquid Chromatography," which is incorporated by reference. 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. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or 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/code_of_federal_regulations/ibr_locations.html.
[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar. 24, 2023]
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