Code of Federal Regulations Title 21. Food and Drugs § 21.172.155 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 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 Division of Product Policy (HFS–206), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, 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.