MAJOR CHANGES TO US REGULATIONS: THE MOCRA is here…

It’s done! On 29 December 2022, Joe Biden promulgated the 2023 Consolidated Appropriations Act; this includes the MoCRA (Modernization of Cosmetics Regulation Act of 2022) which sets out a series of new regulations applicable for cosmetic products.

This will be the first major overhaul of US cosmetic product regulations since the FD&C act in 1938!

Some details have yet to be confirmed, but we already know that this law, the majority of which is expected to come into force by the end of 2023, will bring some major changes:

• Cosmetic facilities (cosmetic product manufacturers and processors) will now have to be registered with the FDA* 
• Cosmetic products will have to be listed with the FDA* by the responsible person
• New GMP in keeping with national and international standards
• New cosmetic product labelling requirements (coordinated by a responsible person, declaration of allergens, specific indication where products are intended for professional use only, etc.)
• Implementation of a cosmetovigilence procedure with the monitoring of undesired effects by the responsible person (declaration of all serious adverse events to the FDA, via the already operational Medwatch database).
• Safety substantiation for cosmetic products (tests, safety report, etc.)
• Cosmetic product safety records inspections by the FDA
• Recall by the responsible person whenever necessary or requested by the FDA (or direct recall by the latter)

* Renewable (every 2 years for registrations, yearly for listings)

It should be noted that smaller businesses will have some leeway concerning these new requirements. 

There will now be a new “stakeholder” in the US product marketing procedure: the Responsible Person.

This person will have a large number of responsibilities: similar to the Responsible Person referred to in the 1223/2009 EC European Regulation, they will be legally responsible for the safety, declaration and unwanted effects monitoring of the products for which they are responsible… Additionally, their contact details must be included on the labels of the cosmetic products.

This role can be filled by one of 3 stakeholders related to the product: 

• the manufacturer,
• the packaging company
• the distributer

Finally, a large part of this new regulation appears to be quite similar to the current European requirements: which represents major progress for American consumers since the application of the MoCRa will finally mean that a more solid safety framework will be applied to their cosmetic products.

We will be talking about this again at the end of 2023 when the regulation comes into force; 

For the moment, it will be important to anticipate these new changes and CLEAR will be here, as ever, to help you.