2025 North American Cosmetics Regulatory Updates (March)

2025 North American Cosmetics Regulatory Updates

1. US FDA Releases Latest MoCRA Facility Registration and Product Listing Data:

On March 15, 2025, the FDA released statistical data on MoCRA cosmetic facility registrations and product listings. As of January 1, 2025, 9,528 facilities had completed registration under the MoCRA framework, and a total of 589,762 cosmetic products had been listed. This surpasses the total number of products registered under its predecessor, the Voluntary Cosmetic Registration Program (VCRP), which operated for 51 years.

Chinese facilities demonstrated particularly strong participation: with 4,260 registrations, they accounted for 44.71% of the global total and 55.10% of registrations from outside the US, significantly outpacing other countries and regions in both metrics.

2. US FDA Rejects 101 Cosmetic Shipments:

In February 2025, the US Food and Drug Administration (FDA) rejected 101 cosmetic shipments from 16 countries.  South Korea had the highest number of rejections (41), followed by China and Japan (tied at 9). Skincare products comprised the largest portion of rejected shipments, followed by hair care products.  Reasons for rejection included: failure to submit a New Drug Application (NDA), unauthorized color additive use, mislabeling products as cosmetics (when they contained drugs), and failure to list products under MoCRA.

For notified products, if the notified party fails to demonstrate compliance or provide a corrective plan, the FDA may issue a final notice, resulting in product return or destruction.

3. Canada to Implement a Ban on PFAS in Cosmetics:

In March 2025, Environment and Climate Change Canada (ECCC) and Health Canada jointly released the "Per- and Polyfluoroalkyl Substances (PFAS) Status Report" and a "PFAS Risk Management Approach."  This approach plans to list most PFAS substances as toxic, with phased restrictions across various sectors. Phase 2 (2027) specifically targets cosmetics and natural health products, prohibiting the use of PFAS (excluding fluoropolymers).

4. Canada Revises Cosmetic Notification Form (CNF):

Health Canada announced a revision to the Cosmetic Notification Form (CNF) in March 2025.  A key change to Section 4 introduces a verification function requiring a Canadian address for the manufacturer or importer. This address serves as a local contact point for Health Canada and does not imply responsibility for product compliance.

For previously submitted products with unchanged information, resubmission is not required. However, any changes must be reported within 10 days of the change.

Remember to replace bracketed information with actual links.  Consider adding a concluding paragraph summarizing the overall implications for the North American cosmetics industry.