In a guidance published on November 8, 2023, the U.S. FDA announced that they will not enforce the cosmetic product facility registration and cosmetic product listing requirements for an additional six months, until July 1, 2024. The Agency said the postponement aims to help ensure that industry has sufficient time to submit such information.
The cosmetic product facility registration and cosmetic product listing requirements are replacing the voluntary registration program for cosmetics establishments and products (VCRP), which was officially ended on March 2023.
Electronic submission portal
For the fulfilment of these formalities, the FDA has developed a draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067), which were initially announced to be ready for October 2023. FDA now anticipates that electronic submission, technical assistance documents, and paper submission forms will be available “in early December 2023.“
The Personal Care Products Council (PCPC), the trade association, which represents the cosmetics industry in the U.S., said it supports the FDA announcement to exercise enforcement discretion on MoCRA’s facility registration and product listing compliance deadline for six months.
“PCPC provided feedback to the FDA on the development of an efficient electronic submission program (Cosmetics Direct) and recognizes that the FDA’s development of Cosmetics Direct is ongoing. PCPC will continue to offer feedback to the FDA on the agency’s implementation of MoCRA and is encouraging member companies to prepare for registration and listing,” added the organization.
Other deadlines remain unchanged
“It’s important to note that this extension exclusively pertains to facility registration and product listing. The original deadline of December 29, 2023, still applies to all other MoCRA requirements (safety substantiation, adverse event reporting, etc.),” commented Morgane Mondon, Regulatory Affairs Manager, USA & Canada at EcoMundo.
Indeed, among other things, the MoCRA provides that the responsible person has the obligation to maintain safety substantiation records and to implement an adverse event recording and reporting process. Furthermore, by the end of 2024, new labeling requirements will come into effect.