Beauty and Cosmetics Regulation: US and EU

The US Food and Drug Administration (FDA) oversees cosmetics [1]. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was the biggest expansion of the FDA's authority over cosmetics in decades [1].

• Facility registration and product listing with the FDA
• Reporting serious adverse events
• Keeping evidence that products are safe
• Power for the FDA to order recalls

The FDA's cosmetics pages list the current requirements and deadlines [1].

In the EU, cosmetics are governed by Regulation (EC) No 1223/2009 [2]. Because it is a regulation, it applies directly and in the same way in every member state.

Each product must have a 'responsible person' in the EU, a product safety report and a notification in the EU's cosmetic products portal. The regulation also keeps lists of banned and restricted ingredients [2].

Brands selling in both markets need to meet both sets of rules. In practice, many build a single safety file to the stricter standard for each ingredient, then adapt labelling and registration to each market.

This report summarises the legal framework from primary regulatory sources [1][2]. It is general information, not legal advice. Market size figures are not included because we have not yet added a verified source for them.