§172.155 食品添加剂纳他霉素(匹马菌素)(Natamycin (pimaricin))

　　§ 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 C33H47NO13and 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, 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.

　　[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]

　　更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规，请点击美国FDA 21 CFR 第172部分已批准的直接用于人类食品的添加剂种类汇总