Every regime ยท United States
Modernization of Cosmetics Regulation Act
Cosmetics on the US market: facility registration, product listing, safety substantiation records, adverse event reporting, fragrance allergen and other labelling rules, and good manufacturing practice as the FDA finalises it.
named This regime is named, not quoted: what it covers and the documents it expects are described in our own words, and no requirement text is reproduced. On the sheet its chip is outlined; a product whose regimes are all named stands as reference.
What it expects in the file
- Product information file
The cosmetic product information file with the safety report, kept by the responsible person and available to the authority. - Risk assessment
The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes. - Labelling and instructions
Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market. - Registrations
Producer, establishment, device or product registrations in the databases the regime names (EUDAMED, EPREL, CPNP, the WEEE and battery registers, FDA registration and listing).
Duties that continue after sale
- Incident reporting
Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock. - Market surveillance cooperation
Answer an authority's request for the technical file, the declaration and the supply chain within the time it sets, in a language it accepts, and cooperate with any corrective measure it requires.
Product categories that engage it
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