What Are the Different Regulations for Cosmetics Formulation?

Nicole Etolen

Cosmetics formulation regulations are governed by different organizations in different countries, and the rules vary significantly depending on the location. Most countries have laws regarding what types of ingredients are permitted when making cosmetics, although some are stricter than others. Aside from cosmetics formulation, laws also cover packaging and handling of formulations.

A woman applying mascara, a type of cosmetic.
A woman applying mascara, a type of cosmetic.

In the United States, the Food and Drug Administration (FDA) establishes different cosmetics formulation regulations. In general, the cosmetic itself and the packaging used to hold it cannot contain any ingredient that is poisonous to humans, although exceptions are made for hair dye, which may contain ingredients that can be harmful when used improperly. Certain artificial colorings that are known to cause ill effects are also banned from formulations, again except in hair dye. FDA cosmetic formulation regulations also prohibit the use of decayed or rotten ingredients.

Cosmetics regulations differ by country.
Cosmetics regulations differ by country.

In addition to the ingredients and packaging of a cosmetics formulation, the FDA also sets forth rules regarding where and how the formulation can be manufactured. Every process of creating the cosmetic, from mixing the ingredients to storing it in a container, must be done in clean and sanitary conditions. In the United States, a small number of substances are banned from use in cosmetics, including chloroform, certain ingredients derived from cattle, and chlorofluorocarbon propellants.

The European Union has slightly more restrictive cosmetics formulation regulations than the United States has. Although each country is free to expand upon the regulations as they see fit, the Union as a whole has agreed to certain overall policies. In excess of 10,000 ingredients are banned because they have been found to adversely affect users, with some ingredients found to potentially cause cancer or birth defects. While proponents for more cosmetics formulation regulations point to this as evidence that the European Union has better rules governing cosmetics, the majority of the ingredients banned in Europe have never been used in cosmetics in the United States.

The Japanese take their lists a step further by not only banning certain ingredients, but also putting out lists of both preservatives and ultraviolet ray protection agents that are deemed safe. Companies are free to use ingredients not found on the “safe” list as long as the ingredient does not appear on the banned list and is not harmful to humans in any way. Prior to 2001, new cosmetic manufacturers were required to submit their formulations to the Japanese Ministry of Health, Labor, and Welfare for pre-market approval, but that regulation is no longer in effect.

Throughout much of the world, the responsibility for following the cosmetics formulation regulations and ensuring that products are safe for consumers falls primarily on product manufacturers. Most regulatory agents will only step in once a product proves to be harmful to users. If an issue does arrive, the governing agency will participate in product recalls and perform further research to determine if a specific ingredient should be banned from further use in cosmetics.

In the United States, the Food and Drug Administration (FDA) regulates the formulation and manufacture of cosmetics.
In the United States, the Food and Drug Administration (FDA) regulates the formulation and manufacture of cosmetics.

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