The United States and European Union

The United States and European Union: Strictly Regulating Cosmetic Safety

The United States (US) and European Union (EU) both work to ensure the safety of cosmetics for consumers through rigorous regulation. In the United States, the cosmetics industry is regulated by the U.S. Food and Drug Administration (FDA) which has been granted broad regulatory authority under the federal Food, Drug and Cosmetic Act (FD&C Act), enacted in 1938, and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The 27 European Union Member States have transposed the European Union Cosmetics Directive, enacted in 1976, into national law. Each Member State has health authorities which then regulate cosmetics within their respective national boundaries according to the law.

In both the United States and the European Union, cosmetics manufacturers ensure product safety prior to marketing, list all ingredients on the product label and comply with any restrictions that are established for cosmetic ingredients and products. Any potential risk from a product is assessed as part of its safety evaluation.

In the U.S., the Cosmetic Ingredient Review (CIR) Expert Panel conducts independent safety reviews of ingredients as a part of the cosmetic safety process, with the results published in the International Journal of Toxicology and on the CIR website. The EU Scientific Committee on Consumer Safety is responsible for reviewing all special and active cosmetic ingredients and assessing conditions for safe use. The results are subsequently published on the Committee’s website.

In the United States, cosmetic and personal care products companies work with leading scientific and medical experts every day and invest millions of dollars in sophisticated laboratory equipment and facilities to ensure cosmetic product safety. In addition to this strong commitment to safety, federal law requires that every cosmetic product be substantiated for safety before it goes to market. The FDA statistics confirm that cosmetics are one of the safest product categories used by Americans today.

The U.S. and EU have slightly different ways of regulating the cosmetic and personal care industry, but both systems provide consumers with a high degree of safety. Some argue that cosmetics are more strictly regulated in the EU, citing recent actions taken in the EU to red flag or ban certain chemicals from use in cosmetics. However, an examination of Annex II of the EU Cosmetics Directive, a list of approximately 1,300 banned ingredients, reveals that a large number of those chemicals are not used and never have been used in cosmetics in the U.S. or Europe. For example, the EU list includes substances such as jet aircraft fuel, various petroleum refinery byproducts and carbon monoxide.

Another difference between the EU and U.S. systems of regulating cosmetics is that the EU allows the marketing of cosmetic products with certain medicinal effects, while the United States has required extra regulatory hurdles because they are classified as drugs. Some of the substances include sunscreens, anti-caries toothpaste and lip balms. Even though color additives are not classified as over-the-counter (OTC) drug actives, they are also subject to more regulatory scrutiny in the U.S. than they are in Europe.