Voted by the US Congress on December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) will profoundly change the regulatory framework for cosmetics in the United States from the end of 2023. During the International Meetings organised by Cosmed on March 22, 2023, Béatrice Muhl, in charge of European clients at Registrar Corp, an American firm specialised in all aspects of compliance with the US FDA, gave an overview of the new rules to follow.
The United States was known until now for having very few rules for cosmetics (except for those applying to dyes or OTC which will remain in force), and for having an authority (the Food and Drug Administration - FDA) with very few enforcement powers. MoCRA will change this, by establishing a comprehensive framework to regulate all cosmetic products.
This law has therefore been passed by Congress and signed by the President of the United States. But it is still largely a “work in progress”.
Indeed, although the MoCRA already contains some very concrete elements, many others will be specified by the FDA through “Regulations”. It is to be expected that the administration will issue “Proposed rules” which will give rise to open comment periods before the “Final rules” are adopted. Each will contain an implementation date and a date by which companies must comply with the new rule.
Key definitions of MoCRA
Responsible Person
The Responsible Person is not strictly speaking a person, but rather an entity. It is the manufacturer, packager or distributor whose name appears on the label of the cosmetic product.
It is this entity that will be in charge of:
• The registration of products, according …
