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Laws & Regulations

MoCRA

Definition

MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — is a major expansion of the U.S. FDA's cosmetics authority and the most significant change to U.S. cosmetics oversight since the FD&C Act was enacted in 1938.[1]

MoCRA adds or strengthens duties for U.S. cosmetics businesses, including facility registration, cosmetic product listing, serious adverse-event reporting, safety-substantiation records and GMP-related requirements. Facilities that manufacture or process cosmetics generally register with the FDA and renew every two years; the Responsible Person submits the Cosmetic Product Listing and updates it at least annually.[1][2]

Facility Registration and Product Listing are not the same as FDA Approval or FDA Certification. The FDA states that it does not issue a compliance certificate for a cosmetics facility registration or product listing.[2]

References

  1. [1]U.S. Food and Drug Administration (FDA). Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
  2. [2]U.S. Food and Drug Administration (FDA). Registration & Listing of Cosmetic Product Facilities and Products.

Other Glossary Terms

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Laws & Regulations terms A–Z

12 terms

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    CLP Regulation — Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, the EU Classification, Labelling and Packaging Regulation. CLP is based on the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).[1][2]

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  • Cosmetic Products Notification Portal (CPNP)

    The Cosmetic Products Notification Portal (CPNP) is a free online cosmetic product notification system established by the European Commission.[1][2]

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  • EPA

    EPA — the United States Environmental Protection Agency — is the U.S. federal agency responsible for protecting human health and the environment. Its responsibilities include administering and enforcing multiple federal laws related to environmental and public-health protection.[1]

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  • EU BPR

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  • EU Cosmetics Regulation

    EU Cosmetics Regulation — Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. It establishes the common rules for placing cosmetics on the EU market, supporting the functioning of the internal market and a high level of protection for human health.[1]

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  • FD&C Act

    FD&C Act — the Federal Food, Drug, and Cosmetic Act — is one of the foundational U.S. federal laws used by the FDA to regulate foods, drugs, medical devices and cosmetics. Its current statutory provisions are primarily codified in Title 21, Chapter 9 of the United States Code.[1]

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  • FIFRA

    FIFRA — the Federal Insecticide, Fungicide, and Rodenticide Act — is a core U.S. federal law regulating the production, registration, distribution, sale and use of pesticides. FIFRA gives the U.S. Environmental Protection Agency (EPA) legal authority over pesticide products.[1]

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  • MoCRA

    MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — is a major expansion of the U.S. FDA's cosmetics authority and the most significant change to U.S. cosmetics oversight since the FD&C Act was enacted in 1938.[1]

    Laws & Regulations

  • PPWR

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  • REACH

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  • SDS / MSDS

    SDS — Safety Data Sheet — is a standardized document used to communicate chemical hazards, safe use, storage, emergency response and protective measures. MSDS — Material Safety Data Sheet — is the historical name; as GHS systems and national regulations have become more aligned, SDS is the current standard term. OSHA's HazCom 2012 also changed the name from “Material Safety Data Sheet” to “Safety Data Sheet”.[1]

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