Every regime ยท United Kingdom
UK Cosmetics Regulation (retained Regulation 1223/2009)
A responsible person in the UK, a product information file, notification on the UK Submit Cosmetic Product Notification service, ingredient labelling and serious undesirable effect reporting.
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. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - 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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