[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.2180]
 
 [Page 376-377]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                           Subpart C--Cosmetics
 
 Sec. 73.2180  Guaiazulene.
 
     (a) Identity. (1) The color additive, guaiazulene, is principally
 1,4-dimethyl-7-isopropyl-azulene.
     (2) Color additive mixtures of guaiazulene for cosmetic use may
 contain the following diluent:
 
 Polyethylene glycol-40 castor oil (PEG-40 castor oil).
 Saponification No., 60 to 70.
 Hydroxyl No., 63 to 78.
 Acid No., 2.
 Specific gravity, 1.05 to 1.07.
 
     (b) Specifications. Guaiazulene shall conform to the following
 specifications and shall be free from impurities, other than those
 named, to the extent that such other impurities may be avoided by good
 manufacturing practice.
 
 Melting point, 30.5 deg.C to 31.5 deg.C.
 
 [[Page 377]]
 
 Lead (as Pb), not more than 20 parts per million.
 Arsenic (as As), not more than 3 parts per million.
 Mercury (as Hg), not more than 1 part per million.
 Total color, not less than 99 percent.
 
     (c) Uses and restrictions. Guaiazulene may be safely used in
 externally applied cosmetics in amounts consistent with good
 manufacturing practice.
     (d) Labeling. The label of the color additive and any mixtures
 prepared therefrom intended solely or in part for coloring purposes
 shall conform to the requirements of Sec. 70.25 of this chapter.
     (e) Exemption from certification. Certification of this color
 additive for the prescribed use is not necessary for the protection of
 the public health and therefore batches thereof are exempt from the
 certification requirements of section 721(c) of the act.