MoCRA (Modernization Of Cosmetics Regulations Act Of 2022) goes into effect December 29, 2023. Not all of MoCRA’s requirements will go into effect immediately on that date and will be phased-in over the next 3 years.

Mandatory Product Registration (by December 29, 2023).

The FDA will be publishing the Mandatory Product Registration Portal in October, 2023. All cosmetic products must be registered in the portal by December 29, 2023. The only exemption from Product Registration are small companies with revenues of less than $1.0 million for the previous 3 years.

Product Safety Substantiation Dossier (by December 29, 2023).

All companies, regardless of size, will be required to maintain Safety Substantiation Dossiers on all of their cosmetic products. The Safety Substantiation Dossier should include Preservative Challenge Testing, 48 Hour or HRIPT (Human Repeat Insult) Patch Testing and Ingredient Toxicology Safety Assessment. For more detailed information read: https://www.linkedin.com/feed/update/urn:li:activity:7098994266193940480/

Adverse Event & Serious Adverse Event Reporting (by December 29, 2023)

All companies, regardless of size, will be required to file Adverse Event and Serious Adverse Event reports with the FDA. The FDA has modified product Labeling Rules to allow companies to list a website and e-mail for consumers to contact the Responsible Person (ie: The Brand) to report AEs and SAEs. All Adverse Events must be reported to the FDA within 15 days of receipt of the AE/SAE notification from a consumer. The FDA is establishing an Adverse Event reporting portal to electronically files AE/SAE reports.

Listing Of Fragrance Allergens On Product Labels (by December 29, 2024)

All companies, regardless of size, will be required to list Fragrance Allergens on their product labels whether you are using a manufactured fragrance or essential oil blends. For more detailed information read: https://www.linkedin.com/feed/update/urn:li:activity:7099174697283526657/

If you need assistance with Safety Substantiation or any other aspect of MoCRA compliance, email us at contactus@bloomcosmetictestlab.com and we can guide you through MoCRA Compliance with our MoCRA Compliance Officer service.