On December 29th, 2022, the biggest amendment of the U.S. Cosmetic Regulation since 1938 has been enacted. The publication of the Modernization of Cosmetic Regulation Act (MoCRA) in the USA is expected to have a large impact on the cosmetic industry, while it implies the reinforcement of FDA’s power.
In this article, you will learn the consequences of the Modernization of Cosmetic Regulation Act (MoCRA) and how it will change the current legislation.
1) Impact of the USA MoCRA on cosmetic ingredients and finished products
First of all, an official method to detect the presence of asbestos in products containing talc will be published soon. PFAS are also impacted as the DFA must evaluate the use and safety of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, including any risks associated with such use.
Besides, the USA cosmetics reform provides with an obligation to comply with Good Manufacturing Practices (GMPs). The GMP specific requirements will have to be published by the FDA within 3 years.
Next, the safety substantiation is also an important point of the Modernization of Cosmetic Regulation Act in the USA. Indeed, the Responsible Person must ensure and maintain records supporting that there is an adequate justification of safety. This point is not new, as a TRA ( Toxicological Risk Assessment) was already compulsory to have the right to sell cosmetics in the USA. BIORIUS experts have the knowledge to create a review of the toxicological profile of each ingredient and finished product, which will enable our toxicologists to determine the warnings that must be included on the cosmetics’ labels.
2) The USA MoCRA and the mandatory Responsible Person for cosmetics
As you may have seen in the previous paragraph, a Responsible Person is now a requirement in the USA for each cosmetic product. It must be the manufacturer, the packager or the distributor. Its name and address have to appear on the label.
Moreover, according to the USA Modernization of Cosmetic Regulation Act, the responsible person must:
- Ensure and maintain records supporting the safety of the cosmetic product. This dossier must be available to the authorities if needed
- Receive and take care of the adverse reactions (including reporting to the FDA when needed)
- Keep and maintain up to date a cosmetovigilance dossier
- Give the opportunity to the authorities to consult the component of the fragrance if needed
- 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
3) The USA MoCRA and the mandatory cosmetics registration
Each company and cosmetic product made available on the USA market must be registered from December 29, 2023. At this occasion, the current Voluntary Cosmetic Registration Portal has been closed and new notification or requests are no longer processed. VCRP data will not be automatically migrated to the new system but will be archived by the FDA.
The mandatory cosmetics registration enacted by the MoCRA will take place through a new portal that will allow the registration of establishments and products. Both systems will be implemented simultaneously.
4) The USA MoCRA and Registration of company and product listing
Besides, the USA Modernization of Cosmetic Regulation Act provides an obligation:
- For each establishment that manufacture, process, or import cosmetic products distributed in the U.S to register and maintain a valid registration with FDA. One registration must occur per facility, and it must be renewed on a regular basis.
- for the Responsible Person to maintain up-to date on a yearly basis the listing of their marketed cosmetic products with FDA. Listing includes details about the cosmetic product such as product ‘s name, type, ingredients…
This obligation will be effective before the end of 2023. Details about the platform are not yet known but one might expect the voluntary cosmetic registration program to be the basis of this system.
5) The USA MoCRA and cosmetics labelling requirements
Eventually, labelling is also impacted by the publication of the USA Modernization of Cosmetic Regulation Act. On top of the existing requirements, each cosmetic product shall be labeled with some additional mandatory information:
- Contact details, and the possibility of a website through which the Responsible Person can receive adverse reaction reports.
- A cosmetic product intended to be used only by a professional must be labeled with clear and prominent statement that the product is to be administered or used only by licensed professionals.
Last but not least, a list of ingredients including “allergens” must appear on pack. The precise list of labeled allergens shall be established by regulation.
HOW BIORIUS CAN HELP YOU TO SELL COSMETICS IN THE USA
As a cosmetics regulatory expert of 13 years of experience, BIORIUS can help your brand to sell in the USA by checking the compliance of your formulas and labels on both state and federal levels, on top of leading a safety assessment.
Moreover, our experts can provide any information you might need on the Publication of the USA Modernization of Cosmetic Regulation Act (MoCRA). Since all the changes will not occur at the same time, we can provide the next steps and different compliance deadlines for the new GMP, labelling requirements, safety substantiation of the publication of the PFAS Report on FDA website for instance.
Need a piece of advice, a quotation or answers to your questions? Contact us…
Fill in this form or contact us directly: firstname.lastname@example.org – We will answer as soon as possible!