Published: 22 August 2023  (Updated: 22 August 2023)

USA - Modernisation of Cosmetics Regulation Act of 2022

On 29 December 2022, US President Joe Biden signed into law the Consolidated Appropriations Act of 2023, which includes the Modernisation of Cosmetics Regulation Act of 2022 (MOCRA) in Subtitle E – Cosmetics.  The amendments to the Federal Food, Drug and Cosmetic (FD&C) Act will take effect one year after the enactment date of the MOCRA, that is on 29 December 2023

MOCRA will require cosmetics sold in the US to comply with several new requirements, such as serious adverse events reporting, Good Manufacturing Practices (GMPs), and mandatory facility registration and product listing. 

The key requirements are summarised as below:

New Concept


Responsible Person (RP)

RP means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product

Facility Registration

  • Existing facilities manufacturing or processing cosmetics for the US must register with the Food and Drug Administration (FDA) before 29 December 2023;
  • Facilities manufacturing or processing cosmetics in the US for the first time after 29 December 2022 have an additional 60 days to register;
  • FDA registrations should be renewed every two years;
  • Exemptions apply for small businesses.

Mandatory Product Listing

  • RP must submit to FDA a cosmetic product listing before 29 December 2023;
  • For products first marketed after 29 December 2023, RP must submit a product listing within 120 days of marketing such products in interstate commerce;
  • Updates to such listing should be made annually.

Serious Adverse Event Reporting

  • From 29 December 2023, RP must submit serious adverse events along with a copy of the label to FDA within 15 business days after a report is received;
  • Each serious adverse event report should be kept for six years (exemption apply for small businesses).

Mandatory Recall

FDA may order a recall if an RP refuses to or does not voluntarily cease distribution or recall a cosmetic within the time and manner requested.

Additional Labelling Requirements

  • Professional use cosmetics should bear specific labelling information before 29 December 2023;
  • A domestic address, domestic phone number, or electronic contact information through which the RP can receive adverse event reports is required on the product’s label before 29 December 2024.


In addition, MOCRA requests FDA to work on:

  • Establishing standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products within the next one year and 180 days;
  • Publishing a rulemaking on fragrance allergens labelling within the next two years;
  • Issuing new regulations to establish GMP requirements for facilities within the next three years;
  • Assessing the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and publish a report summarising the results within the next three years.

For further details, please visit FDA's dedicated page on MoCRA.

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