Delayed Enforcement of facility registration and product listing under…
Page Information
Contents
Delayed Enforcement of facility registration and product listing under MoCRA
< Delayed Enforcement of facility registration and product listing under MoCRA > Background of Announcement of Delayed Enforcement
- In March 2023, FDA issued a Constituent Update FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP) as a result of the facility registration and product listing authorities mandated by MoCRA.
- In August 2023, FDA issued draft guidance for industry on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). And FDA stated that it intended to make a new electronic submission portal available in October 2023 for submitting registration and product listing information.
- In September 2023, FDA announced an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067).
- The new electronic submission portal has been not launched and it is not available yet. So on November 1, 2023, FDA announced that they would provide more information on the launch date for electronic submission and paper submission forms in the coming weeks. And FDA anticipates that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.
- On November 8, 2023, the U.S. Food and Drug Administration (FDA) issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.
< Delayed Enforcement and Compliance Policy >Delayed Enforcement and Compliance Policy
- The statutory deadline is December 29, 2023, however, FDA does not intend to enforce the requirements until July 1, 2024 according to the issued compliance policy and regulated industry has additional time to comply with the requirements.
- FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
< Draft Guidance of Facility Registration and Product Listing >
Draft Guidance of Facility Registration and Product Listing
- The draft guidance of facility registration and product listing issued by FDA in August 2023 provides recommendations and instructions to assist regulated industry and it is for to consider comment from industry. According to the draft guidance, the following information must be submitted. However, the draft guidance is not the final version of the guidance and is not for implementation.
- (a) Facility Registration
• the name of the owner and/or operator of the facility
• the facility’s name, physical address, email address, and telephone number
• with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email)
• the facility registration number, if any, previously assigned
• all brand names under which cosmetic products manufactured or processed in the facility are sold
• the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility
• type of submission: initial, amended, biennial renewal, or abbreviated renewal.
• (Optional) parent company name (if applicable)
• (Optional) facility DUNS Number
• (Optional) additional contact information for individuals associated with the registration
- (b) Product Listing
• the facility registration number of each facility where the cosmetic product is manufactured or processed
• the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label
• the applicable cosmetic category or categories for the cosmetic product
• a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient
• the product listing number, if any previously assigned
• type of submission: initial, update to content (annual), abbreviated renewal
• (Optional) parent company name (if applicable)
• (Optional) type of business (as listed on the label): manufacturer, packer, or distributor
• (Optional) image of the label
• (Optional) product webpage link
• (Optional) whether the cosmetic product is for professional use only
• (Optional) responsible person DUNS Number for address listed on product label
• (Optional) Unique Ingredient Identifiers (UNIIs)
• (Optional) additional contact information for individuals associated with the listing.
- For more information and to search for FEI number, please refer to the webpage at:
FEI
Search Portal.
- For more information and to search for UNIIs, please refer to the webpage at: FDA’s Global Substance Registration System.
- PreviousISO/IEC 27002:2022 Information security, cybersecurity and privacy protection — Information security controls 24.01.05
- NextFood Loss and Waste (FSSC 22000 Version 6) 23.12.21
Comment list
There are no registered comments.