[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR700.19]

[Page 129]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 700--GENERAL--Table of Contents
 
         Subpart B--Requirements for Specific Cosmetic Products
 
Sec. 700.19  Use of methylene chloride as an ingredient of cosmetic products.

    (a) Methylene chloride has been used as an ingredient of aerosol 
cosmetic products, principally hair sprays, at concentrations generally 
ranging from 10 to 25 percent. In a 2-year animal inhalation study 
sponsored by the National Toxicology Program, methylene chloride 
produced a significant increase in benign and malignant tumors of the 
lung and liver of male and female mice. Based on these findings and on 
estimates of human exposure from the customary use of hair sprays, the 
Food and Drug Administration concludes that the use of methylene 
chloride in cosmetic products poses a significant cancer risk to 
consumers, and that the use of this ingredient in cosmetic products may 
render these products injurious to health.
    (b) Any cosmetic product that contains methylene chloride as an 
ingredient is deemed adulterated and is subject to regulatory action 
under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic 
Act.

[54 FR 27342, June 29, 1989]