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FAQ Regulamento cosmético nos Estados Unidos

US Cosmetic Regulation


  • MoCRA is the Modernization of Cosmetics Regulations of 2022 and was signed into law on December 29, 2022. MoCRA is the largest reform of existing cosmetics regulations in the United States in 84 years and establishes many new requirements, such as:


    • Facility registration

    • Product listing

    • Good manufacturing practices (GMP)

    • Safety substantiation

    • New labeling requirements

    • Reporting adverse events

    • Record keeping

  • According to the MoCRA, the major changes for cosmetics manufacturers are the need to register facilities and comply with GMP, which will be issued by the FDA at the end of 2025.

  • The term "responsible person" means the manufacturer, packager or distributor of a cosmetic product whose name appears on the product's label, in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

    Under the MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product placed on the US market, who is responsible for:


    • Listing cosmetic products

    • Managing adverse effects

    • Substantiating the safety of cosmetic products

    • Labeling

  • Yes, small businesses will have more flexible and simplified requirements, being exempt from the obligation to register facilities and list products. The FDA defines a small business as a company with average annual gross sales in the US of less than $1,000,000 for the previous 3-year period, adjusted for inflation.
    However, regardless of their sales volume, companies involved in the manufacture or processing of the following cosmetic products are not exempt:

    • Cosmetic products that come into contact with the eyes

    • Cosmetic products that are injected

    • Cosmetic products intended for internal use

    • Cosmetic products that alter appearance for more than 24 hours under normal conditions of use and whose removal by the consumer is not part of those conditions.

  • For existing facilities, facility registration and product listings must be completed by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product. product or 60 days after the deadline for existing installations, whichever is later.

  • The MoCRA allows for "flexible listings". In these cases, it is possible to submit a single listing for cosmetic products with identical formulations, or formulations that differ only in terms of colors, fragrances or flavors, or nominal content.

  • Contact Pharmilab to determine what responsibilities your company will need to meet to be compliant with the new legislation.

  • Section 609 of the MoCRA establishes new labeling requirements for cosmetic products, in addition to the requirements imposed by the FD&C Act and the Fair Packaging and Labeling Act:
    The addition of a U.S. address, a U.S. telephone number, or electronic contact information through which the Responsible Person can receive adverse event reports. This labeling requirement is mandatory as of December 29, 2024.
    The labeling of fragrance allergens, which will be identified by the FDA in a proposed regulation by June 29, 2024.
    On products for professional use, a clear and prominent indication that they must be administered or used by authorized professionals. This labeling requirement comes into force on December 29, 2023.

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