Overview
On August 7, 2023, FDA issued a draft guidance that explains the requirements of facilities registration and products listing with the FDA under the Modernization of Cosmetic Regulations Act 2022 (MOCRA).
Introduction
The Modernization of Cosmetics Regulatory (MoCRA) is legislation that regulates the safety of cosmetics in the United States.
The new update aims to expand the presence of the FDA, the jurisdiction in the cosmetics market.
MoCRA is in addition to the other current regulations and applies to all cosmetics manufacturers, importers, traders and distributors, as well as to the ingredients present in cosmetic products and the methods used in their production.
MOCRA requirements for manufacturers and processors of cosmetic products destined for the US market
– Proof of safety;
– Mandatory labeling of allergens;
– GMP (Good Manufacturing Practice) regulations;
– Reporting of adverse events;
– Recall;
– Registration of facilities and list of products before they begin distribution in the US.
PFAS regulations.
MoCRA Schedule Requirements:
Registration and Renewal Deadline
- 60 days: To Communicate to FDA all facility and/or product updates and changes.
- Renewal: Must be renewed every two years.
- Company Registrations: Companies must register their facilities and list their products before December 29, 2023.
- Small Businesses: Some small businesses may be exempt from these requirements unless their cosmetic products are injectable, for internal use, or used for eye contact or to prolong the appearance of a change.
FDA Projects & Requirements for MOCRA for 2023
- FDA plans to introduce an electronic registration and submission portal in October 2023.
- All existing facilities subject to FDA’s new MoCRA regulations must register within the year 2023.
- Development of paper form option.
- Facilities must obtain an FDA Establishment Identifier (FEI) before registering their facility and listing their product with the FDA.
- Listing submissions must be submitted by December 2023, while new cosmetics must be listed with the FDA 120 days after introduction to commerce in the United States.
- Adverse Event Reports must be submitted to the FDA within 15 working days, including any updates that follow within one year
Additional Information
Contact, Global Regulatory Partners at:
info@globalregulatorypartners.com
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about FDA. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.