Ingredients prohibited or restricted by regulation
Regulations specifically prohibit or restrict the use of the following
ingredients in cosmetics. For complete details, refer to the relevant
regulations:
• Hexachlorophene. Because of its neurotoxic effect and ability
to penetrate human skin, hexachlorophene (HCP) may be used only when an
alternative preservative has not been shown to be as effective. The HCP
concentration of the cosmetic may not exceed 0.1 percent, and it may not
be used in cosmetics that in normal use may be applied to mucous membranes,
such as the lips.
• Mercury compounds. Mercury compounds are readily absorbed through
the skin on topical application and tend to accumulate in the body. They
may cause allergic reactions, skin irritation, or neurotoxic manifestations.
The use of mercury compounds as cosmetic ingredients is limited to eye
area cosmetics at concentrations not exceeding 65 parts per million (0.0065
percent) of mercury calculated as the metal (about 100 ppm or 0.01 percent
phenylmercuric acetate or nitrate) and provided no other effective and
safe preservative is available for use.
All other cosmetics containing mercury are adulterated and subject to
regulatory action unless it occurs in a trace amount of less than 1 part
per million (0.0001 percent) calculated as the metal andits presence is
unavoidable under conditions of good manufacturing practice.
• Chlorofluorocarbon propellants. The use of chlorofluorocarbon
propellants (fully halogenated chlorofluoroalkanes) in cosmetic aerosol
products intended for domestic consumption is prohibited.
• Bithionol, because it may cause photo-contact sensitization.
• Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide),
because they may cause photocontact sensitization.
• Chloroform, because of its animal carcinogenicity and likely hazard
to human health.
• Vinyl chloride, as an ingredient of aerosol products, because
of its carcinogenicity.
• Zirconium-containing complexes, in aerosol cosmetic products,
because of their toxic effect on lungs, including the formation of granulomas.
• Methylene chloride, because of its animal carcinogenicity and
likely hazard to human health.
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