![\"MoCRA](\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/cover-mocra-fda-cosmetic-registration.png\")
<\/h2>\n<\/h2>\nThe MoCRA (Modernization of Cosmetics Regulation Act of 2022), signed into law by the President of the United States on December 29, 2022, brings the most significant changes to the FDA's cosmetics regulatory system in nearly 80 years. The Act requires cosmetic manufacturers and brand owners to maintain facility registration and product listing, as well as adverse event notification and safety data retention, and applies to all parties responsible for selling cosmetic products in the U.S., regardless of whether the products are of domestic or imported origin.<\/p>\n
(This chart organizes the core structure of the FDA's cosmetics registration system after the implementation of MoCRA to assist in understanding the three major axes of facility registration, product listing, and adverse event notification.)<\/p>\n The passage of MoCRA stems from the U.S. Congress's reflection on the lack of a mandatory regulatory mechanism for the cosmetics industry. Previously, the FDA's authority to regulate cosmetics was quite limited, as it was unable to require product registration or ingredient declarations, and could only intervene passively through market surveillance and consumer complaints after a product was released on the market.<\/p>\n The following entities are subject to registration and reporting obligations under MoCRA:<\/p>\n Products sold in the U.S. market are subject to MoCRA requirements regardless of whether they are manufactured in the U.S. or imported from abroad.<\/p>\n The MoCRA statute provides partial exemptions for the following situations:<\/p>\n Actual eligibility for exemptions should be determined based on the most current standards announced by the FDA and should not be assumed to apply.<\/p>\n (This diagram illustrates the complete process of FDA cosmetics registration under MoCRA, including the four steps of identification, facility registration, product listing, and adverse event notification.)<\/p>\n Facility registration is a primary obligation under MoCRA, and all facilities that manufacture, process or package cosmetics are required to register with FDA and obtain a Facility Registration Number.<\/p>\n The following information is required for facility registration:<\/p>\n Any changes to the registration information must be updated within 60 days of the change.<\/p>\n Product listing is an extension of facility registration that requires a responsible party to report every cosmetic product sold in the U.S. market.<\/p>\n![\"FDA](\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/process-fda-cosmetic-registration-flow.png\")
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\nLegislative Background and Scope of the MoCRA Statute<\/h2>\n
To whom the statute applies<\/h3>\n
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exemptions<\/h3>\n
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\n![\"FDA](\"https:\/\/greenoo.tw\/wp-content\/uploads\/2026\/01\/comparison-cosmetic-vs-otc-drug.png\")
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\nCore Requirements for Facility Registration<\/h2>\n
Registration Time Requirements<\/h3>\n
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Registration Information<\/h3>\n
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\nLogic of Product Listing<\/h2>\n
Product list declaration content<\/h3>\n
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Product List Update Obligation<\/h3>\n
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\n\ud83d\udcca Form Note: FDA Cosmetics Registration Obligations vs. Timing Nodes (Compendium: Cross-Border Security Determinations - Green Circle)<\/h2>\n
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