Expansion to America U.S. cosmetics market offers great growth opportunities for European companies, but it is accompanied by the introduction of new regulations and standards. MoCRA (Modernization of Cosmetics Regulation Act) is set to take effect in December 2022.
The Food and Drug Administration (FDA) has now imposed stricter conformity for all cosmetics that are sold in the United States. From registration of the facility to appointing a U.S. Agent and listing the product with the FDA, European cosmetic producers need to take certain steps to be compliant. This guide will guide you through the main duties under MoCRA to help your business navigate the regulatory environment without fear.
If you’re a European manufacturer or manufacturer of cosmetics and wish to sell your product in the US, there are some new rules you need to be aware of. In December 2022, it was the time that the United States passed the Modernization of Cosmetics Regulation Act (MoCRA) and introduced new responsibilities like registration of facilities to the FDA and the appointment of a US Agent.
How to gain access to the American market?
Under MoCRA, the beauty companies are deemed Responsible People and are subject to a range of obligations. Producers who do not sell under their brand name need to be aware of their obligations, particularly because of the new obligation to declare their facilities.
On the 29th of December 2023, European brand owners will have to:
Appoint a US Agent.
In the new law, the requirement to have the status of a US Agent is required, even if you’re already selling products or have suppliers or distributors in the USA. The economic agents are not automatically the US agents.
Be sure that FDA certification is in place at the facility.
It is the one that manufactures the product, and this registration is required regardless of where the facility is situated within either the EU, the US, or any other country.
European cosmetic brands looking to enter the U.S. cosmetics industry must comply with new regulatory standards set out under the Modernization of Cosmetics Regulation Act (MoCRA). One of the key steps involves US FDA MoCRA Cosmetics Registration, which requires brands to register their manufacturing facilities, list their products with the FDA, and appoint a U.S. Agent- all essential elements for market entry and long-term success in American cosmetics markets.
Check the list of cosmetics with the FDA.
These include products that are currently on the market.
Handle adverse events.
Begin to analyse, record as well and report any serious adverse incidents.
Make sure you have the proper documentation to prove the security that the products provide.
If you’re a European manufacturer, you likely already have extensive tests and safety documents that you can use to verify the quality of your cosmetics for the US market, provided that you can prove that your US products are similar enough to your European items to fall under the identical Cosmetic Safety Report on Products.
