Before an EU cosmetic sunscreen is marketed, the responsible person, product information file, safety assessment, labelling and notification must be coordinated.
Why this matters in a sunscreen project
A responsible brief aligns performance, user experience, manufacturing, packaging, documentation and market requirements. Commercial statements should only be finalised when the evidence matches the finished product.
A product-specific file
The PIF brings together product description, safety report, manufacturing method and GMP compliance, evidence of claimed effects and other required information.
Protection evidence
SPF, UVA and water-resistance reports where relevant support communication and safety review. Reports should identify samples, methods and results.
CPNP notification
Notification is not pre-market approval. Submitted information must align with the formula, responsible person, category and label.
Maintenance after launch
Formula, supplier, claim, packaging or label changes may require updates to assessments and documentation.
Briefing checklist
- Responsible person
- Quantitative formula
- CPSR and PIF
- GMP evidence
- Claims and label
Frequently asked questions
Does CPNP certify SPF?
No. It is a notification system; SPF evidence follows its own route.
Can the manufacturer support the PIF?
Yes, by supplying technical documentation under defined responsibilities.
Does an imported product need an EU responsible person?
EU placement requires a responsible person established under the applicable framework.
Development and manufacturing with OKT GLOBAL
OKT GLOBAL integrates R&D, quality, regulatory support, packaging, scale-up and manufacturing in Spain under UNE-EN ISO 22716 certified by Bureau Veritas.