Cosmetic Regulation In The European Union: The European Union Cosmetics Directive defines a cosmetic as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition. “The European Union requires that cosmetic products placed on the EU market be safe; that is, they “must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.” As in the U.S., manufacturers are responsible for ensuring that cosmetic products comply with the law before they are marketed. The manufacturer or importer of cosmetics is responsible for demonstrating that the product is safe for its intended use. Regulations are enforced at the national level, and each country in the EU has an authoritative body that is responsible for upholding compliance. 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 that then regulate cosmetics within their respective national boundaries according to the law.
The United States and European Union: 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, enacted in 1938. In both the United States and the European Union, cosmetics manufacturers ensure product safety before 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 US 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 being used 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 US than they are in Europe.
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