21 CFR 700.19 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 600.2 To Parts 741-799) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 600.2 To Parts 741-799) — Cosmetics (§ 700.3 To Parts 741-799) — General (§ 700.3 To § 700.35) — Requirements For Specific Cosmetic Products (§ 700.11 To § 700.35) — 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.