Sunscreen

Regimes engaged, per market

Standing when pasted with its name: reference

What the file has to hold

• Technical file (REACH, UK REACH, FDA OTC)
  The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market.
• Risk assessment (Cosmetics, UK Cosmetics)
  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 (Cosmetics, UK Cosmetics, FDA OTC, Prop 65)
  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 (5 of the 7 regimes, including Cosmetics, CLP, UK Cosmetics)
  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.
• Substance declarations (REACH, CLP, UK REACH, Prop 65)
  Safety data sheets for mixtures and supplier material declarations for articles: the trail that shows what is in the product against the restricted lists.
• Product information file (Cosmetics, UK Cosmetics)
  The cosmetic product information file with the safety report, kept by the responsible person and available to the authority.
• Post-market surveillance plan (FDA OTC)
  The plan and the periodic reports for collecting and acting on field experience, complaints and incidents, in the form the device rules set.
• Registrations (Cosmetics, CLP, UK Cosmetics, FDA OTC)
  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

• Market surveillance cooperation (Cosmetics, UK Cosmetics, FDA OTC)
  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.
• Incident reporting (Cosmetics, UK Cosmetics, FDA OTC)
  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.
• Substance list watching (REACH, UK REACH, Prop 65)
  Track additions to the restricted and candidate substance lists, re-check supplier declarations against them, and update customer communication and labels when a substance in the product is added.

This week

Do not put a US sunscreen on the cosmetics file; it needs the drug listing and the monograph formulation.