a cosmetic product ready for safety substantiation

Understanding MoCRA: how to obtain a safety substantiation in the US 

Cosmetic products must be safe to use for consumers. Countries all over the world establish requirements to ensure such safety. Last year, the US President enacted a new federal law in the United States to increase the safety of cosmetic products sold on the American soil. This law is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) that will become effective on December 29, 2023.

MoCRA provides that each cosmetic product must have adequate substantiation of its safety, and associated records must be maintained to facilitate FDA’s’ inspections.

It is essential to be aware of the deadlines! Documentation proving the safety of a cosmetic product must be in place no later than December 29, 2023.

How to substantiate the safety of your cosmetic products

MoCRA defines adequate safety substantiation as “tests, studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a product is safe”. The law does not identify specific documents or tests a manufacturer must collect to substantiate the safety of its products. In case of queries from the FDA, the manufacturer will have to justify why it considered the documentation sufficient to demonstrate the safety of a product.

Our recommendation is to obtain – ahead of the deadline – an EU safety assessment report as the easiest way to align with the MoCRA requirement on safety substantiation of your cosmetics.

What producers of cosmetic products need to know

As a novelty, MoCRA also sets requirements for facilities, namely manufacturers and producers of cosmetic products, even if they do not sell products under their name. In particular, non-US facilities must appoint a US Agent to perform, at minimum, the following tasks:  

  • Handle communications with the authorities.
  • Register their activity with the FDA.

The US Agent will also help producers with safety substantiation, guiding them in collecting the necessary documentation, such as formula and data on ingredients, fragrances. If you are a manufacturer or producer of cosmetic products, contact us to receive information on how Obelis USA can support you with MoCRA compliance.

Francesca Santacatterina

Publications department


The information contained on obelis.net is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.

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