JNM Global

Global Approval Partner

JNM Global/Cosmetic

US Cosmetics Regulation Modernization Act (MoCRA)

JNM Global 제이엔엠글로벌 2023. 9. 25. 11:04

The Cosmetics Regulation Modernization Act (MoCRA) is important to the chapter VI of the Federal Food, Drugs and Cosmetics Act (FDCA) and adds new information (GMP, safety proof, critical adverse event reporting, facility registration, product registration, additional labeling marks, record keeping, etc.). 

It also gives the FDA the authority to order compulsory recalls. 
MoCRA's facility registration and product listing platform (site) will open in October. 
Facilities operated by existing manufacturers and distributors (until 2022, 10.29) must be registered by 2023.12.29, and products that were previously registered must also be listed through MoCRA. 
Below is a brief guide to the data necessary for facility registration and product registration.

Facility
registration
- Name of the owner and/or operator of the facility
- Name, address, email address, and phone number of the facility
- Contact information of a U.S. agent
- Facilities (name and phone number) and electronic contacts where possible
- About (email)
- Previously assigned facility registration number (if any)
- Name of all brands where cosmetics manufactured or processed in the facility are sold
- Product category for each cosmetic manufactured or processed in the facility
- Submission Type (initial, amended, biennial renewal, or abbreviated renewal) (initial, amended, biennial renewal, or abbreviated renewal)
product 
listing
- Facility registration number of each facility where cosmetics are manufactured or processed
- Name and contact information of the Director and the name of the cosmetic 
 (if such name appears on the label)
- Corresponding cosmetic category
- List of ingredients (including flavouring, flavoring or color)
 : identified by the name or generic name of each ingredient as required under section 701.3 of title 21
- Product list number if previously assigned
- Submission Type (initial, update to content (annual), abbreviated renewal)

In this regard, the Korea Cosmetics Association will hold a free webinar as follows to provide accurate information on the Cosmetics Regulation Modernization Act (MoCRA).

 

A. Date and time: October 10, 2023, 2:30 to 4:30 p.m.
B. Target: U.S. export companies or companies planned to export
C. Participation fee: Free
D. How to attend: Live video transmission via online platform (webina)
E. Main contents: Refer to the attached webinar program for details
- Key points of the American Cosmetics Regulation Modernization Act (MoCRA)
· Facility registration, product listing, etc
- Real-time Q&A
F. Application for participation: Apply through the pre-registration link below
- Pre-registration link: https://forms.gle/S3QdBm3zik5AYNEM9
G. Application period: By Thursday, October 5, 2023
※ We would like to inform you that this webinar will be held only for pre-registered people within the application period.
H. How to attend
I. URL link will be mailed to pre-applicants one day before the webinar is held. Access the webinar through the URL link

 

Please refer to the website of the Korea Cosmetics Association for details on the webinar.

https://kcia.or.kr/home/notice/notice.php?type=view&no=15597&ss=page%3D2%26skind%3D%26sword%3D%26ob%3D