The concept of Responsible Person (RP) has been introduced in the US, referring to the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label. Brands distributing in the EU or the UK are already familiar with a similar concept, where comparable obligations are in place. However, a significant difference is that the US RP can be outside the USA.
On March 27, 2023, the FDA announced the end of the voluntary registration program for cosmetics establishments and products (VCRP), which will be replaced by mandatory formalities through the new portal, Cosmetic Direct. The FDA presented screenshots of the portal in September 2023 and announced it to be accessible starting October 2023 (which is not the case to date). Responsible Persons are required to register their products on this portal as soon as it becomes available, with a deadline set by the end of the year.
On August 7, 2023, the FDA published a draft guidance on product listing and facility registration. Pending the availability of the portal, the necessary information can be gathered to anticipate these new requirements.
The RP also has an obligation to ensure safety of the consumers by maintaining safety substantiation records and implementing an adverse event recording and reporting process. Ensuring cosmetic products are safe is not something new in the USA, as the FDA requests safe cosmetics, not misbranded and not adulterated, but now this shall be clearly documented.
Brand owners can work with their contract manufacturers or third parties experts to help them meet the new obligations.
By the end of 2024, new labeling requirements will come into effect, including the provision of information of the responsible person and clear labeling of professional products. The FDA is also tasked with determining a list of allergens to be included in the ingredient list. We anticipate that the FDA’s cosmetic labeling guide will be updated with this new information.
On the cosmetic manufacturer’s side, MoCRA mandates the establishment of mandatory Good Manufacturing Practices (GMP). These requirements shall be finalized by the end of 2025 and should take into account existing national and international standards. Simplified GMPs requirements or longer compliance times will be available for small businesses.
In the meantime, establishments that manufacture or process cosmetic products distributed in the United States must be registered. It concerns filler, but not (re)labeler, (re)packer, holder or distributor, and some exemptions apply for small businesses. A US contact is required for this registration, foreign facilities must contract a US agent. To prepare this registration, they must request a FDA Establishment Identifier (FEI) number that will be the Facility Registration Number.
On November 1st, 2023, in the absence of news regarding Cosmetic Direct, the FDA provided an update mentioning they will provide more information on the launch date for electronic submission and paper submission forms in the coming weeks. The entire industry is currently eagerly awaiting publication of Cosmetic Direct and hope to meet product listing and facility registration requirements, in less than 2 months…
UPDATE – Nov. 8, 2023: On November 8, 2023, The 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. 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.).
Stay informed on MoCRA and ask your questions during EcoMundo’s Webinar Nov. 14, 2023. Details and registrations: https://form.ecomundo.eu/en/en/webinar-mocra-regulation