MoCRA (Modernization of Cosmetics Regulation Act of 2022) is the new US cosmetics legislation that cosmetic products placed on the US market need to comply with. MoCRA represents a significant overhaul of the regulatory framework governing cosmetics in the U.S., aiming to enhance product safety, transparency, and accountability within the industry. As a trusted partner, CE.way combines its extensive know-how with state-of-the-art in-house laboratory facilities to ensure your cosmetic products are MoCRA compliant. CE.way’s comprehensive regulatory and testing services guarantee the safety, efficacy, and regulatory adherence of your products.
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In the realm of U.S. legislation, cosmetics oversight is managed by the FDA, which serves as the primary regulatory authority. Businesses operating within this sector must align with federal cosmetics regulations to distribute their products nationwide. The cornerstone federal statutes governing cosmetics are the Federal Food, Drug and Cosmetic Act (FD'C Act) and the Fair Packaging and Labelling Act (FPLA). Additionally, it's critical to consider state-level regulations, such as California's Proposition 65, which introduces further compliance requirements.
A pivotal moment in cosmetics regulation was the enactment of the Modernization of Cosmetics Regulation Act (MoCRA) within the Consolidated Appropriations Act 2023, signed into law on December 29, 2022. This legislation marks the most significant update to the FD'C Act since 1938, introducing several key provisions aimed at modernizing and enhancing the regulatory framework for cosmetics in the U.S. These provisions include mandatory FDA registration for cosmetic facilities, both domestic and international, and mandatory product listings for all cosmetics sold in the U.S. MoCRA also stipulates adherence to Good Manufacturing Practices (GMPs), the declaration of fragrance allergens on product labels, and enhanced labeling requirements for products intended for professional use.
Furthermore, MoCRA mandates the inclusion of Responsible Person (RP) contact information on labels, establishes comprehensive record-keeping protocols, requires the reporting of adverse events, and grants the FDA mandatory recall authority. It also lays the groundwork for new regulations concerning ingredients such as talc, asbestos, and PFAS.
These provisions include:
mandatory FDA registration for cosmetic facilities, both domestic and international
mandatory product listings for all cosmetics sold in the U.S.
adherence to Good Manufacturing Practices (GMPs)
declaration of fragrance allergens on product labels
enhanced labeling requirements for products intended for professional use
inclusion of Responsible Person (RP) contact information on labels
establishes comprehensive record-keeping protocols
reporting of adverse events
grants the FDA mandatory recall authority
groundwork for new regulations concerning ingredients such as talc, asbestos, and PFAS.
Cosmetic products, as defined by the FD&C Act, cover a broad spectrum of articles applied to the body for cleansing, beautifying, promoting attractiveness, or altering appearance, excluding soap. Under MoCRA, a cosmetic product is specifically defined as a formulation composed of cosmetic ingredients intended for incorporation into a final product.
This detailed overview highlights the layered regulatory landscape for cosmetics in the U.S., underscored by MoCRA's introduction, which aims to ensure safety, efficacy, and transparency in the cosmetics industry.
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Facilities must be registered. Existing products must be listed (by 1 July 2024)
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Section 609 of the Modernization of Cosmetics Regulation Act (MoCRA) represents a pivotal shift towards enhanced consumer protection in the cosmetics industry, with a specific focus on the clear communication of potential allergens. In a move to bolster consumer health and safety, this section mandates the explicit identification of fragrance allergens on cosmetic product labels. By June 29, 2024, the FDA is tasked with providing a comprehensive list of these fragrance allergens, marking a significant step forward in the journey towards greater transparency and safety in cosmetics.
This new allergen labeling requirement underscores MoCRA's commitment to safeguarding consumer health. Furthermore, this regulation insists that labels must not only include but also highlight any known allergens in a clear and prominent manner. This approach mirrors international standards for consumer safety, aiming to minimize the risks associated with allergic reactions. Such a requirement signifies a broader initiative to foster transparency within the cosmetics industry, encouraging manufacturers to prioritize the health and well-being of their consumers.
By implementing these more stringent labeling requirements, MoCRA not only enhances the protection of consumers but also encourages cosmetic manufacturers to adopt more responsible practices in both product formulation and communication. This alignment with global safety practices signifies a proactive stance in reducing adverse reactions and ensuring that consumer health is at the forefront of cosmetic product development and labeling.
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Cosmetics GMP proposition
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The Modernization of Cosmetics Regulation Act (MoCRA) marks a significant advancement in the regulatory oversight of cosmetic products in the United States, introducing rigorous standards to safeguard consumer safety. A critical component of MoCRA is outlined in Section 606, which emphasizes the importance of implementing Good Manufacturing Practices (GMP) across the cosmetics industry. This provision is designed to prevent the adulteration of cosmetic products, ensuring that they meet the highest quality standards before reaching consumers.
Under Section 606, MoCRA mandates strict adherence to GMP, tasking the FDA with the development of these requirements within two years following MoCRA's enactment, setting a target date of December 29, 2024, for the drafting phase, with finalization expected within three years. The development of GMP standards under MoCRA is intended to be in harmony with both national and international benchmarks, wherever feasible, ensuring a cohesive and standardized approach to cosmetic product safety worldwide.
Furthermore, the FDA is granted the authority to conduct reviews of records from cosmetic manufacturing facilities, an essential step in verifying compliance with GMP guidelines. This oversight function is pivotal in maintaining the integrity of the cosmetics market, offering consumers reassurance about the products they use daily.
Notably, MoCRA acknowledges the diverse landscape of the cosmetics industry, recognizing the particular challenges that smaller businesses may encounter. As such, the regulation mandates that the FDA considers these challenges, requiring the adaptation of GMP requirements to accommodate the needs and capacities of small business operators within the industry.
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