USA - Modernisation of Cosmetics Regulation Act of 2022

New Concept

Requirement

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.