Sunday, January 20, 2019

Are harmful ingredients allowed in cosmetics?

As part of Beauty Care Choices ongoing efforts to keep our customers and followers informed, we have taken the information below directly from the FDA's website.  When reading this it is important to remember that the FDA controls are for manufacturing in the United States.  The manufacture of cheap imitation and knock-off products from companies outside the US are not controlled, although laws apply.  Learn more about chemicals in beauty care.


With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA. The Federal Food, Drug, and Cosmetic Act requires that color additives used in cosmetics must be tested for safety and be listed by FDA for their intended uses.

It’s against the law for a cosmetic to contain any ingredient that makes the product harmful when consumers use it according to directions on the label, or in the customary or expected way. This is true whether or not there is a regulation that specifically prohibits or restricts the use of the ingredient in cosmetics.

The one exception is for coal-tar hair dyes, which the law treats differently. Under the law, FDA cannot take action against a coal-tar hair dye for safety reasons as long as it has a special warning statement on the label and directions for a skin test. The caution statement reads as follows:
Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do may cause blindness.
It’s also important to understand that some cosmetics that are safe when people use them correctly may be unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example, some ingredients may be safe in products such as cleansers that we wash off the skin immediately, but not in products that we leave on the skin for hours. Similarly, ingredients that are safe for use on the hair or nails may be unsafe when used on the skin or near the eyes.
Under U.S. law, cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market. Cosmetic manufacturers have a legal responsibility for the safety and labeling of their products.  FDA can and does take action against cosmetics on the market that do not comply with the law.
What ingredients are prohibited or restricted by FDA regulations?
Although it’s against the law to use any ingredient that makes a cosmetic harmful when used as intended, FDA has regulations that specifically prohibit or restrict the use of the following ingredients in cosmetics:
  • Bithionol. The use of bithionol is prohibited because it may cause photo-contact sensitization (21 CFR 700.11).
  • Chlorofluorocarbon propellants. The use of chlorofluorocarbon propellants in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23).
  • Chloroform. The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to be harmful to human health, too. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18).
  • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause serious skin disorders (21 CFR 700.15).
  • Hexachlorophene. Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when no other preservative has been shown to be as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250).
  • 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 problems. The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available. 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 and its presence is unavoidable under conditions of good manufacturing practice (21 CFR 700.13).
  • Methylene chloride. It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19).
  • Prohibited cattle materials. To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials*, material from non-ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products  (21 CFR 700.27).
  • Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be subject to regulation as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labelling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products.
  • Vinyl chloride. The use of vinyl chloride is prohibited as an ingredient of aerosol products, because it causes cancer and other health problems (21 CFR 700.14).
  • Zirconium-containing complexes. The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin (21 CFR 700.16).

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