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What Is MoCRA?

MoCRA 

Modernization of Cosmetics Regulation Act



MoCRA (Modernization of Cosmetics Regulation Act)

On December 29, 2022, President Joe Biden signed the “Consolidated Appropriations Act, 2023,” 

which includes the Modernization of Cosmetics Regulation Act (MoCRA) of 2022.



This law significantly expands the authority of the U.S. Food and Drug Administration (FDA) over cosmetics for the first time since 1938.

What Is MoCRA? 

MoCRA 

Modernization of Cosmetics Regulation Act

MoCRA

(Modernization of Cosmetics Regulation Act) 

On December 29, 2022, President Joe Biden signed the “Consolidated Appropriations Act, 2023,” which includes the Modernization of Cosmetics Regulation Act (MoCRA) of 2022.


This law significantly expands the authority of the U.S. Food and Drug Administration (FDA) over cosmetics for the first time since 1938. 

MoCRA
(Modernization of Cosmetics Regulation Act)


Under MoCRA, the following requirements must be met 

Good Manufacturing Practice
Safety Substantiation
Serious Adverse Event Reporting
Facility Registration, Cosmetic Product Listing
Additional Labeling Requirements (e.g., fragrance allergens, professional-use only statements)
Record-Keeping (adverse events)


MoCRA(Modernization of Cosmetics Regulation Act)


Under MoCRA, the following requirements must be met



  Good Manufacturing Practice


  Safety Substantiation


  Serious Adverse Event Reporting


  Facility Registration, Cosmetic Product Listing


  Additional Labeling Requirements (e.g., fragrance allergens, professional-use only statements)


 Record-Keeping (adverse events)


The Process of Preparing Safety Substantiation

(FDA-Required Documentation)


The most fundamental aspect of MoCRA compliance is Safety Substantiation—evidence proving product safety. Preparation typically follows these steps



The Process of Preparing Safety Substantiation 
(FDA-Required Documentation)




The most fundamental aspect of MoCRA compliance is Safety Substantiation—evidence proving product safety. Preparation typically follows these steps





1.Analyze the cosmetic ingredient list: Using a Formula Review Worksheet, cross-check each ingredient against 12 criteria.
For any ingredient that raises concerns (e.g., safety, skin/eye irritation, respiratory issues), obtain the necessary safety documentation (SDS, COA, TDS).
2.Examine the cosmetic label: Check for mislabeling or misbranding—key targets of FDA scrutiny—and revise any problematic claims or language.
3.Prevent the product from being classified as adulterated: Compile the following test reports to demonstrate compliance.
4.Microbial limits and specific microorganism tests: Conducted by an international testing organization according to USP 61/62 standards to ensure the reliability of test results.
5.Preservative effectiveness test: Performed in accordance with USP 51.
6.Heavy metals test: Testing for lead, mercury, and other heavy metals.
7.Clinical studies for specific label claims (e.g., Dermatologist Tested, Hypoallergenic, Non-Comedogenic): Must be conducted by an organization that complies with 21 CFR 50/56 under U.S. federal regulations.
8.Prepare the product’s SDS: Must adhere to OSHA (Occupational Safety and Health Administration) guidelines for safety data sheets.


In addition, MoCRA grants the FDA Mandatory Recall Authority, and requires the establishment of regulations for GMP, fragrance allergen labeling, and testing methods for talc-containing products.

Building on decades of experience in the U.S. market, Resource of K.Beauty pledges to
provide accurate and dependable services to help you comply with MoCRA.

In addition, MoCRA grants the FDA Mandatory Recall Authority, and requires the establishment of regulations for GMP, fragrance allergen labeling, and testing methods for talc-containing products.

Building on decades of experience in the U.S. market, Resource of K.Beauty pledges to provide accurate and dependable services to help you comply with MoCRA.

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr