Your questions about MoCRA, our answers!
How do we get started? Where and when to register for MoCRA?
Starting December 18, 2023, the FDA's Cosmetics Direct portal for the Modernization of Cosmetics Regulation Act (MoCRA) is now live.
Contact us for expert registration.
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
Start by doing a gap analysis (GMP, registration, labeling requirements). Contact us to get help for the gap analysis.
Is there a template for the safety report? Is it similar to the EU Safety Assessment?
At this time, FDA has not been exhaustive on how to create this safety substantiation.
A EU/UK CPSR created by a safety assessor should cover US Safety Substantiation.
EcoMundo's safety assessors can help you prove the safety of your products. Contact us to know more.
What is the difference between the US Agent and the Responsible Person?
A US agent is required for foreign cosmetic facilities. It should be a person based in the US. EcoMundo can provide this service, contact us to know more.
The responsible person could be the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.
Which elements must appear on cosmetic labels?
Each cosmetic label must include a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
The elements listed above have to appear on both the outer and inner packaging.
You can overlabel packaging to make it compliant with the new requirements.
Our regulatory experts can help you review your labels, contact us to check your packaging.
Do the facilities need to be GMP certified by an official authority?
Facilities will have to follow GMP for cosmetics published by FDA by the end of 2025, under the deadline that FDA will determine.
It is not expected that certification from a third party will be required, but authorities can run an audit at any time.
What about small businesses?
Small businesses are responsible persons, owners and operators of facilities, whose average gross annual sales in the
United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products.
Small businesses are exempted from facility registration, product listing. They might also benefit from simplified GMP, or extended deadlines.
Do you have other questions or concerns?
Need help for MoCRA?
Our regulatory experts are by your side to ensure a smooth adoption of MoCRA standards. We can help you with: Safety substantiation, US agent assistance for foreign facilities, labeling review, products’ portfolio management, etc.
Guide to understand MoCRA
You will find in this guide a summary of the upcoming deadlines concerning the Modernization of Cosmetics Regulation Act of 2022 and all the key information you need to know to anticipate the changes to come.