Modernization of Cosmetics Regulation Act (MoCRA)
The publication of the Modernization of Cosmetic Regulation Act (MoCRA 2022) in the USA is expected to have a large impact on the cosmetic industry both for USA manufacturers and importers from 2024 onwords. For the consumers, this will means greater protection, quality controls and greater transparency.
Safety
The safety substantiation is an important point of the Modernization of Cosmetic Regulation Act in the USA. The new requested “Responsible Person” must ensure and maintain records supporting that there is an adequate evaluation and justification of the safety of the cosmetic product. Indeed, this request is not completely new, as a TRA (Toxicological Risk Assessment) was already compulsory to have the right to sell cosmetics in the USA.
CHEMSAFE USA toxicologists have the knowledge to create a review of the toxicological profile of each ingredient and finished product, which will enable to determine the warnings/indications which must be reported on the product’s labels.
Responsible Person
The Responsible Person appointed for each cosmetic product and communicated to FDA, is requested to guarantee the following:
- Ensure and keep records supporting the safety of the cosmetic product. This dossier must be available to the authorities on demand
- Receive and take care of the adverse reactions (including reporting to the FDA on demand)
- Keep and maintain up to date a Cosmetovigilance dossier
- Give the opportunity to the FDA to see the component of the fragrance on demand
- Notify the products and maintain this notification updated
- Ensure that allergens are correctly labeled on the packaging
- Organize a market recall when needed/requested by the FDA
FDA Registration (MoCra Section 607)
Each facility where a cosmetic product is manufactured or processed, and each cosmetic product made available on the USA market must be registered from December 29, 2023. From that moment, the existing Voluntary Cosmetic Registration Portal has been closed and new notification or requests are no longer processed. VCRP data has not be automatically migrated to the new system but is archived by the FDA. A new FDA portal called Cosmetic Direct will allow the registration of facilities and products. Facilities registration must be updated every two years, while product listing must be updated annually. When the Producer is located outside the USA, Product Listing is in charge to a company located in USA which act as importer and/or distributor (and therefore as a Responsible Person) and which contacts are reported on product label. With respect to a foreign facility, a United States agent (“US agent”) is required for registration purposes. The US agent is the person, which includes an individual or business entity, that resides in the US or maintains a US place of business and is physically present in the US.
GMP application
It is expected that the USA cosmetics MoCRA will ask for an obligation to comply with Good Manufacturing Practices (GMPs) on the production of cosmetic product sold in USA. The GMP specific requirements will have to be published by the FDA probably in late 2024 or early 2025.
CHEMSAFE USA can help your company offering scientific and toxicological expertise, FDA Agent appointment, Label revision, product safety and GMP application/audits.
With the help of partner company, Chemsafe USA can help international companies to set their USA subsidiary to fulfill all regulatory requests.
Contact us: Chemsafe@chemsafeusa-consulting.com
