Back to Basics, Part II: Ensuring Product Safety via Cosmetics & Toiletries

Pascal Yvon, BioSciences Expansion, LLC, Newtown, PA U.S.

Editor’s note: This series serves as a primer for the cosmetic development process. This second installment covers product safety considerations in both the EU and U.S.; the first described crucial regulatory details. The next installment, on microbiological considerations, will appear in the September issue of Cosmetics & Toiletries.

Disclaimer: Check with your regulatory specialist to review your specific product and situation.

Cosmetic product safety for human health is a must. The European Commission (EC) Regulation and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the U.S. require cosmetic products to be safe for human health, outlined as follows.

EU: The EU states, “A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use.”¹
U.S.: The U.S. prohibits the marketing of adulterated or misbranded cosmetics. A cosmetic is considered adulterated if, “It bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual.”²

Manufacturers are responsible for ensuring the safety of their products, along with safety substantiation.