FDA takes an active role in international activities related to cosmetics, ensuring that our public health mission is our top priority while also addressing industry and other stakeholder concerns.
On This Page:
- FDA’s International Activities Related to Cosmetics: Overview
- Ingredient Nomenclature
- Color Additives
- Animal Testing and Development of Alternatives
- Ultraviolet (UV) Filters (Sunscreens)
- More Resources
FDA has been involved in a number of cosmetic international activities, because of globalization of the market.
FDA works with regulatory authorities in other countries through the International Cooperation on Cosmetics Regulation (ICCR), an international group of regulatory authorities for cosmetics from the United States, the European Union, Japan, Canada, and Brazil:
- Participating in workshops and meetings to help government officials and members of industry in other countries understand U.S. laws and regulations.
- Developing lines of communication with government authorities in other countries to understand the differences between regulatory approaches.
- Exploring areas where U.S. requirements match those of other countries so that cooperation can be accomplished without compromising FDA's public health priorities and commitments.
Two FDA draft guidance documents for industry, “Safety of Nanomaterials in Cosmetic Products” and “Cosmetic Good Manufacturing Practices” are recent examples of how FDA takes international standards into account, consistent with our public health mission.
The following are other key international issues under consideration at FDA, within the framework of U.S. legal and regulatory requirements:
As the European Union (E.U.) has worked toward agreement on ingredient terms to ease marketing in countries representing nine different languages, the cosmetic industry has requested that FDA allow similar changes in ingredient labeling for cosmetics marketed in the U.S. FDA has considered these requests on a case-by-case basis, in line with its legal responsibilities under the Fair Packaging and Labeling Act (FPLA) to promulgate regulations "necessary to prevent the deception of consumers or to facilitate value comparisons."
FDA has received several requests regarding possible steps for harmonizing ingredient labeling for color additives. This is a complicated issue due to specific requirements for color additives and their use in cosmetics and other products. Although the lists of approved colors in the United States and other countries have some specific items in common, there are also differences that complicate formulation of products for the different markets.
FDA does not have a list of tests required for any particular cosmetic product or ingredient. However, companies and individuals who manufacture or distribute cosmetics are legally responsible for ensuring that their products are safe when consumers use them according to labeled directions or in the customary way. This is an important issue in light of the E.U. ban on animal testing.
Sunscreens pose a special challenge in international harmonization because they are considered drugs under U.S. law and cosmetics according to the E.U. However, there has been interest in exploring the approval processes in different countries for sunscreen active ingredients and sharing information about test procedures for measuring Sun Protection Factor (SPF).