Throughout the world, cosmetic and personal care products manufacturers work to create and market safe and elegant products that help consumers to look and feel their best. To further ensure the safety of cosmetic products, different countries employ different measures to achieve this goal. However, the stringent regulations governing cosmetics in each country or jurisdiction, have one common goal: To protect the consumer by ensuring safe ingredients and finished products.
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, enacted in 1938. 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.
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 odours 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.
Cosmetic Regulation in Japan
The Japanese government regulates the cosmetics industry through its Ministry of Health, Labor and Welfare according to the Pharmaceutical Affairs Law (Law No. 145) established August 10, 1960. Japan has adopted a list of prohibited ingredients, a list of restricted ingredients, a positive list of UV filters and a positive list of preservatives.
Other than these restrictions, the burden of ensuring product safety has been shifted to cosmetic manufacturers. As such, any ingredient that can be shown to be safe may be used in a cosmetic product. Until recently, a manufacturer or importer of cosmetics was required to obtain a pre-market approval and license from the Ministry of Health, Labor and Welfare. Since 2001, however, Japanese cosmetics companies are required only to provide notification of the product’s brand prior to manufacturing or importing.
Japan is an excellent example of a nation where costly pre-market registration procedures were replaced with manufacturer responsibility for product safety and with post-market surveillance (similar to the systems in the U.S. and EU) without compromising consumer safety.
Cosmetic Regulation in Canada
The Canadian government regulates the cosmetics industry through Health Canada’s Cosmetics Program. The basis for the regulatory authority for the Cosmetics Program comes from the Food and Drugs Act and Cosmetic Regulations. Cosmetics are defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.” This definition also includes cosmetics used by professional esthetic services, as well as bulk institutional products (e.g. hand soap in school restrooms).
Health Canada’s Cosmetics Program has the mandate to protect the health of Canadians by minimizing the risk associated with the use of cosmetics marketed in Canada. The program defines and communicates requirements for the manufacture, labelling, distribution and sale of cosmetics, and evaluates compliance.
As in the U.S., manufacturers are responsible for ensuring that 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 by Health Canada and is overseen by Product Safety Officers who manage inspections, investigations, seizures, recalls and prosecutions from regional offices.
This information was originally published on the Cosmeticsinfo.org website.
Cosmeticsinfo.org is an information Web site that includes factual, scientific information on ingredients most commonly used in cosmetics and personal care products in the United States. The Personal Care Products Council (the Council) and its member companies sponsor this Web site to provide consumers with easily accessible comprehensive safety information on cosmetics and personal care products and to help consumers make informed purchases.