Cosmetics Regulation Compliance in European Union (EU / EEA)
Essential Requirements
| Article | Requirement |
|---|---|
| Essential Requirements | Harmonised standards |
Conformity Assessment
No CE conformity module. Cosmetic Product Notification Portal (CPNP) notification required before placing on market. Product Information File (PIF) retained by Responsible Person.
Harmonised Standards
Applying these standards creates a presumption of conformity with the applicable essential requirements.
| Standard |
|---|
| EN ISO 17516 |
| EN ISO 22716 |
Required Testing & Evidence
Cosmetic GMP and safety assessment
Cosmetics Regulation requires compliance with GMP (ISO 22716) and a safety report.
Typical artifacts: Product Information File (PIF), safety assessment, GMP certificates.
Cosmetic microbiological quality
Cosmetics microbiological standards establish verification of microbiological limits and preservation adequacy.
Typical artifacts: Microbiological test reports, preservative efficacy support, batch release records.
Data sourced from official EU legislation and the Official Journal. Verify current status before placing products on the market.
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