[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.155]

[Page 37]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION--Table of Contents
 
                      Subpart B_Food Preservatives
 
Sec. 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, 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]