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What is MoCRA defined by the US (FDA)?

On December 29, 2022, the “Consolidated Appropriations Act of 2023” signed by U.S. President Biden included the “MoCRA – Modernization of Cosmetics Regulation Act of 2022”. This MoCRA law completely renewed U.S. cosmetic regulations. The law establishes new standards for cosmetic facility registration, product registration, mandatory labeling, Good Manufacturing Practices (GMP), and adverse event reporting and recording.

※ In accordance with the MoCRA, the FDA declared the termination of the VCRP Program (Voluntary Cosmetic Registration Program) on March 27, 2023, and VCRP product registration has been suspended. A new system has been opened for registration of facilities and products under MoCRA. Since existing VCRP data is not transferred to the MoCRA system, all cosmetics that were previously registered with VCRP must also be re-registered in accordance with these MoCRA regulations.

• Mandatory registration of cosmetic products

According to MoCRA regulations, registration of cosmetic products is mandatory in the future.
The Responsible Person (RP) must register all cosmetics sold in the United States.

All cosmetics sold in the United States before MoCRA’s enactment date (2022/12/29) must complete product registration by July 1, 2024.

If a product is marketed in the United States for the first time after the MoCRA enactment date (December 29, 2022), cosmetic product registration is required within approximately 120 days after marketing.

Product registration must be renewed every year.

※ Responsible Person – RP: This refers to the entity indicated on the label of the cosmetic product as a cosmetics manufacturer, packaging company, or distributor. The person in charge is responsible for cosmetic product listings, side effects, safety verification, labeling, and disclosure and recording of allergenic fragrances.)

• Mandatory registration of cosmetic facilities

All cosmetics manufacturers and processors located in the United States and abroad must register. Manufacturing facilities outside the United States must designate a U.S. Agent in the United States.

Existing facilities must complete facility registration by July 1, 2024.

New establishments must register their establishment within 60 days from the date of first manufacture.

Mandatory renewal every two years.

Any changes must be submitted within 60 days.

• MoCRA registration process

The U.S. CERT can provide customized technical support through collaboration with related organizations to meet customer needs and legal requirements in relation to US (FDA) drug manufacturing, export, or distribution licensing/permission.
The U.S. CERT can provide customized technical support through collaboration with related organizations to meet customer needs and legal requirements related to US (FDA) medical device manufacturing or export licenses and licenses.