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US FDA, MoCRA Registration Guidance

JNM Global 제이엔엠글로벌 2024. 9. 13. 16:47

The FDA has implemented the Voluntary Cosmetic Registration Program (VCRP) for general cosmetics, but the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022 for the safety of consumers.

Under MOCRA, manufacturers who manufacture or process cosmetics distributed in the United States are required to prepare safety reports, labeling requirements, and register their manufacturing facilities and products in the FDA Cosmetic Manufacturing Facility and Product Mandatory Registration Program.

 

The documents required for product registration are briefly as follows.

- Submission type (new registration/change/cancellation)

- Industry (manufacturing/packaging/distribution)

- Company information (company name/address/contact information)

- Representative information (name/contact information/position)

- Safety report preparation (comprehensive safety report for the product after collecting safety data such as safety calculation and toxicity risk assessment)

- Register facility in Cosmetic Direct Portal

- Register product in Cosmetic Direct Portal

 


If you have any questions about cosmetic,

Please contact us with the below.

info@jnmglobal.net

ra@jnmglobal.net