If you are a European brand owner or producer of cosmetics and want to sell in the US, there are important new requirements you have to respect. In December 2022, the United States passed the Modernization of Cosmetics Regulation Act (MoCRA), introducing new obligations such as facility registration with the FDA and appointing a US Agent.
Steps to take to access the American market
Under MoCRA, beauty brands are considered Responsible Persons and have a set of responsibilities. Producers that do not sell under their name also have to take actions, in particular, in light of the new requirement to register their facilities.
By 29 December 2023, European brand owners have to:
- Appoint a US Agent.
- Under the new law, having a US Agent is mandatory even if you are already selling or have your distributors or suppliers in the USA. These economic operators do not act automatically as your US Agent.
- Make sure facilities are registered with the FDA.
- The facility is the product manufacturer, and this registration is mandatory independently from where the facility is located, in the EU, US, or elsewhere.
- List the cosmetics with the FDA.
- This includes products already on the market.
- Handle adverse events.
- Start analysing, recording, but also reporting serious adverse events.
- Keep the documentation that shows the safety of the product.
- As a European operator, you probably already have exhaustive tests and safety reports that you can use to substantiate the safety of your cosmetics for the US market provided your US products are sufficiently similar to your European products to be covered by the same Cosmetic Product Safety Report.
MoCRA for European beauty brands
Obelis USA as your US Agent will guide you step-by-step towards MoCRA compliance and verify that you meet the new requirements. Most importantly, brand owners and producers need to consider that being compliant in the EU represents an advantage for the American market access, but it does not necessarily mean straight market access to the US. Together with the new obligations to register products, facilities, and adverse events, there are certain key differences between US law and EU Regulation. The most relevant one concerns classification, as some products classified as cosmetics in Europe are not cosmetics in the USA.
Simona Varrella
Publications department
13.09.2023
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