172.155—Natamycin (pimaricin).
(a)
Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an empirical formula of C33 H47 NO13 and a molecular weight of 665.7.
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 Division of Product Policy (HFS-206), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 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.