MoCRA facility registration and product listing

January 17, 2023. In December 2023, the U.S. Food and Drug Administration (FDA) issued the final guidance on cosmetic product listing and facility registration. The document aims at helping the cosmetic industry to understand the new MoCRA registration requirements and to comply with them. Therefore, it addresses the following topics:

Applicable definitions
Responsibilities for facility registration and product listing
Submission information
How to perform the registrations
Timelines for compliance

Timelines for compliance

As anticipated, facility registration and cosmetic product listing shall be done according to the following timelines:

For cosmetics on the US market and facility operating on December 29, 2022: by December 29, 2023.
For cosmetics marketed after December 29, 2022: within 120 days of marketing such products or within 120 days of December 29, 2023 (i.e. April 27, 2024), whichever is later.
For facilities started operating after December 29, 2022: within 60 days of first engaging of activities or by February 27, 2027, whichever is later.

However, in November 2023, the FDA informed the industry that they will not enforce the registration requirements until July 1, 2024. Nevertheless, the other requirements applicable as of December 29, 2023, remain in place.

Frequently Asked Questions and Answers

As a novelty compared to the draft version, the guidance includes Appendix B with frequently asked questions and answers. In this section, the FDA confirms that the US Responsible Person is the manufacturer, packer, or distributor whose name appears on the labels, even if based outside the United States. Thus, a consultancy cannot become the US Responsible Person, unless it is the manufacturer, packer, or distributor indicated on the labels. Hence, the US Responsible Person can delegate other entities to execute its duties, but it remains accountable for such activities.

Regarding adverse events reporting, the FDA affirms that the labels can include an email address or website (foreign or domestic). Simultaneously, they remind companies that they have to consider how the FDA inspection right is met.

Furthermore, the Guidance clarifies that laboratories that perform cosmetic product batch release testing need to register as facilities because such tests are part of the manufacturing process. Batch release testing is essential for the quality control of products, and it checks the microbial levels before the release to the market. At the same time, laboratories conducting only challenge, stability, and other tests are not considered to fall within the MoCRA definition of facility. As such, they are not required to comply with registration requirements.

Lastly, the FDA affirms that there is no need to provide any certificates confirming the status of small businesses.

Do you need help in complying with MoCRA requirements or understanding how they apply to your company? Contact Obelis USA for more information on how we can support you.