MoCRA Cosmetics and the Modernization of the Cosmetics Regulation Act 2022
The Modernization of the Cosmetics Regulation Act 2022 (MoCRA) was enacted on December 29th, 2022, marking the most significant update to cosmetic regulations in the United States since 1938. This pivotal legislation introduces new obligations for the cosmetics industry under MoCRA, significantly impacting cosmetic brands operating in the USA. MoCRA is seen as a paradigm shift in how cosmetic products are regulated, increasing surveillance, inspection, and injunction powers of the FDA to ensure public health.
Under MoCRA, the FDA can now suspend the registration of facilities and order product recalls. This alignment with European law philosophies indicates a more stringent regulatory approach to MoCRA cosmetics in the USA.
MoCRA Turnkey Solution for Cosmetic Brands
Biorius is prepared to support the cosmetics industry with our “MoCRA Turnkey Solution.” This comprehensive service covers everything from formula analysis to legal representation of MoCRA cosmetics in the USA through our agent, Biorius Inc. We are here to support your MoCRA cosmetics activities with the same efficacy demonstrated over 15 years in the EU and the UK. For any inquiries about MoCRA and how it affects your cosmetic products, please contact us.
Responsible Person / US Agent for MoCRA Cosmetics
Every cosmetic product under MoCRA must have a designated Responsible Person, who could be the manufacturer, packager, or distributor, with clear labeling on the product. As per the FDA’s clarification in June 2023, this person does not need to be US-based but must designate a US Agent for MoCRA cosmetics. For more details on these roles, visit our dedicated page on US Agent.
EU and UK Responsible Person for many years, Biorius is now ready to extend its support as US Agent with the introduction of MoCRA cosmetics.
Registration and Listing of MoCRA Cosmetics
MoCRA mandates the registration of facilities and the listing of cosmetic products:
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Facility Registration: As per Sec. 607, all facilities involved in manufacturing, processing, or distributing MoCRA cosmetics must register via the FDA's IT platform and keep this registration current. Registrations for existing facilities are due by July 2024, with renewals every 2 years and new facilities registering within 60 days of starting operations. -
Cosmetic Product Listing: The responsible person must maintain an updated annual listing of marketed MoCRA cosmetics with the FDA. Initial listings are due by July 2024, and new products must be listed within 120 days of marketing. This process is facilitated by an IT platform provided by the FDA, with the VCRP database being archived.
Safety Substantiation for MoCRA Cosmetics
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Section 608 of MoCRA requires cosmetic product safety substantiation. Methods to substantiate the safety of MoCRA cosmetics may include tests, studies, or other expert-approved evidence. A Cosmetic Product Safety Report (CPSR) as per European regulations or a Toxicological Risk Assessment is required for products not marketed in the EU or UK.
Labeling Requirements for MoCRA Cosmetics
New labeling requirements under Sec. 609 include:
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A contact address or information for the Responsible Person, with a compliance deadline of December 29th, 2024. -
Disclosure of identified fragrance allergens by the FDA, with rulemaking to follow public commentary. -
Labels for professional-use products to indicate FDA compliance starting December 29th, 2023.
States like California may maintain additional ingredient reporting requirements under initiatives like Prop. 65.
Ingredients and Standards for MoCRA Cosmetics
Talc (Sec. 3504)
Standardized testing for asbestos in talc-containing MoCRA cosmetics to be drafted by the FDA by December 29th, 2023.
PFAS [Perfluoroalkyl and Polyfloroalkyl substances] (Sec. 3506)
The FDA will evaluate the safety of PFAS in MoCRA cosmetics and publish results by December 29th, 2025.
No limitation
Sec. 614 (b) lays down that the MoCRA does not prevent any state from prohibiting the use of limiting the amount of an ingredient in a cosmetic product. Therefore, States provisions remain fully applicable.
Adverse Events and GMPs under MoCRA for Cosmetics
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Adverse Events (Sec. 605): Serious Adverse Events must be reported within 15 days, with records kept for 3 to 6 years. The FDA will inspect these records. -
Good Manufacturing Practices (GMPs) (Sec. 606): The FDA will draft specific GMP requirements by December 29th, 2024, with finalization within three years, considering the needs of smaller businesses.
Timeline
As these changes will not all occur simultaneously, here is a summary of the next steps and compliance :
- Mandatory elements labeling required for professional-use products.
- Obligation to track, record, and report adverse events.The safety of all products must be adequately substantiated.
- Talc-testing standardized methods proposed by the FDA.
- Allergen labeling Rulemaking proposed by the FDA
- Facility registration and product listing requirements
- Talc-testing standardized methods finalized
- GMPs rulemaking proposed
- Mandatory elements labeling required for all products
- Allergen labeling regulation finalized
- Publication of the PFAS report on the FDA website
- GMP regulation finalized
*Estimated based on a 60-day comment period and a directive to finalize no later than 180 days after the close of the public comment period.
Get in Touch
Need a piece of advice, a quotation or answers to your questions?
Fill in this form or contact us directly: info@biorius.com – We will answer as soon as possible!
As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmeticproducts in various markets:
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First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries -
50 regulatory experts, toxicologists, pharmacists, and chemists to serve you. -
A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more! -
A best-in-class IT tool, free of charge, and saving a lot of your time. -
More than 1,500 international clients have already chosen Biorius! -
We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.
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