What do the changes to the Modernisation of Cosmetics Regulation Act of 2022 (’MoCRA’) mean to you?

The Modernisation of Cosmetics Regulation Act of 2022 (’MoCRA’) has changed the requirements for supplying cosmetic products in the USA.

Notification

The major new requirements are that both Cosmetic Products and the Facilities that manufacture them (regardless of geographical location) will need to be notified on their respective US FDA portals.

Each Cosmetic Product will need a Responsible Person whose details are shown on the label.

Non-US Responsible Persons will need to appoint a US-based agent as point of contact for the FDA.

Cosmetic Product notifications will need to be updated annually.

Cosmetic Product notifications will need to reference the corresponding Manufacturing Facility notification.

Manufacturing Facility notifications will need to be updated every two years.

Exemptions may apply for small businesses.

Compliance with Cosmetic Product and Manufacturing Facility notification will be enforced from 1st July 2024

Safety Substantiation

Additionally, MoCRA has codified companies’ legal requirement for the safety substantiation of products based on studies, analysis or other evidence by suitably qualified experts.

Adverse Events Reporting

Companies will be required to collect and maintain records of reports of Adverse Events caused by their products.

Companies will be required to report to the FDA any Serious Adverse Events caused by their products.

Cosmetic Product Labelling Requirements

In the near future Cosmetic Product Labelling Requirements for products sold in the US will be updated to include, amongst other things, INCI lists which include fragrance allergens present in the product above threshold levels.