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      U. S. Food and Drug Administration
      Center for Food Safety and Applied Nutrition
      Office of Cosmetics Fact Sheet
      March 30, 2000


      Prohibited Ingredients and Related Safety Issues

      By law, FDA does not have the authority to approve cosmetic products or ingredients, except for color additives. However, regulations prohibit or restrict the use of several ingredients because of safety concerns.

      In addition, cosmetic and fragrance trade associations have recommended avoiding or limiting the use of some substances. Contaminants raise additional concerns. The following is an introduction to special safety and regulatory issues related to cosmetic ingredients.

      Substantiation of safety

      It is the responsibility of the manufacturer and distributor to assure the safety of each ingredient and finished product. Without substantiation of safety, Title 21 of the Code of Federal Regulations (21 CFR), Part 740.10 requires that the product carry the following warning on the label:

      "Warning: The safety of this product has not been determined."


      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 (21 CFR, Parts 250.250 and 700.11 through 700.23):

      • 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.

      Methyl methacrylate monomer: The subject of a court ruling

      In the early 1970s, FDA received a number of complaints of personal injury associated with the use of fingernail extenders containing methyl methacrylate monomer. Among these injuries were reports of fingernail damage and deformity, as well as contact dermatitis. On the basis of its investigations of the injuries and discussions with medical experts in the field of dermatology, FDA concluded that liquid methyl methacrylate was a poisonous and deleterious substance that should not be used in fingernail preparations. The agency chose to remove products containing 100 percent liquid methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls.

      Although there is no specific regulation prohibiting the use of liquid methyl methacrylate monomer in cosmetic products, FDA continues to believe that this substance, when used in cosmetic fingernail preparations, is a poisonous and deleterious substance.

      Color additives

      Color additives are strictly regulated. In order to protect consumers from harmful contaminants, many cannot be used unless the color comes from a batch certified by FDA and that batch is provided with its own individual certification lot number. Their uncertified counterparts are not allowed and addition of the color to a product will make the entire product adulterated. While colors exempt from certification are not subject to such testing, manufacturers must assure that each color additive complies with the identity, specifications, labeling requirements, use, and restrictions of color additive regulations. With the exception of coal-tar hair dyes, all color additives - whether or not they are subject to certification - must be approved by FDA for their intended use. Check FDA's color listings to determine whether a color additive is approved for your intended use and whether it is subject to certification requirements.

      Trade associations recommend eliminating or limiting the use of some substances

      In addition to the ingredients that are controlled by regulation or were the subject of a court ruling, cosmetic and fragrance trade associations have recommended eliminating or limiting maximum levels of certain ingredients associated with health risks. For example, the Cosmetic Ingredient Review (CIR) Expert Panel, an independent panel of scientific experts, regularly assesses the safety of numerous cosmetic ingredients and publishes its findings. (The CIR was established by the Cosmetic, Toiletry, and Fragrance Association.) According to its 1999 Annual Report, CIR has found the following ingredients unsafe:

      • Chloroacetamide (a preservative), because of sensitization (development of allergic reactions).
      • Ethoxyethanol and Ethoxyethanol Acetate (a solvent), because of reproductive and developmental toxicity.
      • HC Blue No. 1 (a hair coloring ingredient), because of possible carcinogenicity.
      • p-Hydroxyanisole (an antioxidant), because of skin depigmentation.
      • 4-Methoxy-m-Phenylenediamine, 4-Methoxy-m-Phenylenediamine HCl, and 4-Methoxy-m-Phenylenediamine Sulfate (hair dye ingredients), because of possible carcinogenicity.
      • Pyrocatechol (used in hair dyes and skin care preparations), because of carcinogenic and co-carcinogenic potential. (CIR describes this substance as unsafe for leave-on products and considers available data insufficient to assure safety for use in hair dyes.)

      CIR also has recommended limits for the use of a number of other ingredients. You can contact CIR at:

      Cosmetic Ingredient Review
      1101 17th St. N. W. Suite 310
      Washington D. C. 20036-4702
      phone: 202-331-0651 fax: 202-331-0088

      Web site: http://www.cir-safety.org/

      Similarly, the International Fragrance Association (IFRA) establishes usage guidelines for fragrance materials. IFRA's Code of Practice currently recommends against the use of more than 30 substances as fragrance materials and advises limiting the use of many more. Among the many that IFRA recommends avoiding are:

      • Acetylethyltetramethyltetralin (AETT), because of neurotoxicity.
      • Musk Ambrette, because of photocontact sensitization.
      • 6-Methylcoumarin (6-MC), because of photocontact sensitization.

      The IFRA member organization in the United States is:

      Fragrance Materials Association (FMA)
      1620 I St., NW, Suite 925
      Washington, DC 20006
      Phone: (202) 293-5800
      Fax: (202) 463-8998

      Contaminants raise concerns

      The risk of introducing contaminants into a product is always a concern in cosmetic manufacture, whether they are introduced through contaminated raw ingredients or form during the manufacturing process. Nitrosamines and dioxane are among those contaminants that may form during the manufacturing process and raise safety issues. Research also has raised safety questions about diethanolamine (DEA) and related ingredients that may contain residual levels of this substance.

      • Nitrosamines. Many nitrosamines have been determined to cause cancer in laboratory animals. They also have been shown to penetrate the skin.

      FDA expressed its concern about the contamination of cosmetics with nitrosamines in a notice published in the Federal Register of April 10, 1979 (44 FR 21365). It stated that cosmetics containing nitrosamines may be considered adulterated and subject to enforcement action.

      Cosmetics containing as ingredients amines or amino derivatives, particularly diethanolamine, or ingredients that are derived from diethanolamine or possibly contain diethanolamine as a contaminant, may form nitrosamines if they also contain an ingredient that acts as a nitrosating agent, such as 2-bromo-2-nitropropane-1,3-diol (Bronopol), 5-bromo-5-nitro-1,3-dioxane (Bronidox L) or tris(hydroxymethyl)nitromethane (Tris Nitro), or if they are contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their derivatives are mostly present in creams, cream lotions, hair shampoos, and cream hair conditioners. Nitrosamines are avoidable by proper formulation: by not using amines or amino derivatives in combination with a nitrosating agent and by testing the product under use conditions to make sure that nitrosamines do not form under customary conditions of use.

      • Dioxane. In rodent feeding studies conducted for the National Cancer Institute, 1,4-dioxane was found to produce cancer of the liver and the nasal turbinates. It also caused systemic cancer in a skin painting study. Skin absorption studies demonstrated that dioxane readily penetrates animal and human skin from various types of vehicles, although it is uncertain how much is available for absorption and how much evaporates instead of penetrating the skin.

      Cosmetics containing as ingredients ethoxylated surface active agents, including detergents, foaming agents, emulsifiers and certain solvents identifiable by the prefix, word, or syllable "PEG," "Polyethylene," "Polyethylene glycol," "Polyoxyethylene," "-eth-," or "-oxynol-," may be contaminated with 1,4-dioxane. It may be removed from ethoxylated compounds by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost.

      Avoiding prohibited ingredients through FDA's Cosmetic Voluntary Registration Program

      Although cosmetic manufacturers are not required to register with FDA, companies are encouraged to register their establishments and list their products and ingredients through the agency's Cosmetic Voluntary Registration Program (CVRP). If a cosmetic manufacturer files a product formulation with the CVRP, FDA can advise the manufacturer if he or she is inadvertently using a non-permitted color additive or other prohibited or restricted ingredients. In this way, manufacturers can correct their formulations before attempting to import or distribute them, thus avoiding the risk of detention or recall due to ingredient-related violations. Products containing prohibited ingredients are not accepted into the registration program.

      The information received by FDA from the CVRP is evaluated and entered into a computer database. If it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the product's manufacturer or distributor by using a mailing list generated from the CVRP database. If your products are not in the registration database, you won't be on the notification mailing list.


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