MoCRA – What does it mean for safety substantiation?

By Joseph Scognamiglio, Director of Operations Cosmetics & Hygiene, SGS North America

May 2024

The arrival of the Modernization of Cosmetics Regulation Act (MoCRA) in December 2022 was a pivotal moment in reshaping cosmetics regulations in the US.
Signed into law within the Consolidated Appropriations Act 2023, the bill gave the US Food and Drug Administration (FDA) the authority to make long-overdue and impactful changes to the existing Food, Drug, and Cosmetic Act.
This has raised the barrier for entry for cosmetics companies, requiring them to ensure that:

  • All cosmetics are manufactured in registered facilities
  • They formally list their cosmetics with the FDA
  • They allow the FDA more oversight and authority to regulate and recall cosmetics products

One requirement included in this bill stands out in particular:
“Each responsible person for a cosmetic product must maintain records (e.g., tests and studies) that support a reasonable certainty that the product is safe.”
However, the FDA still needs to provide further guidance on what requirements need to be met to prove the safety of any particular product, within a reasonable amount of certainty.
Much of the new protocol mirrors the Product Information File (PIF) and Cosmetic Product Safety Report (CPSR) required in European legislation, as this design is considered to provide a very responsible profile of product safety.
However, many organizations in the personal care market have been left scratching their heads, especially as the requirement of documentation for substantiating product safety is a novel concept in the US.
The big question is, what does it mean to have a safe product?



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