COSMETICSEuropean Union (EU / EEA)

Cosmetics Regulation Compliance in European Union (EU / EEA)

1essential requirements
10 yrretention
Not requiredNotified Body

Essential Requirements

ArticleRequirement
Essential Requirements

Harmonised standards

Conformity Assessment

Notified BodyNot required
Route

No CE conformity module. Cosmetic Product Notification Portal (CPNP) notification required before placing on market. Product Information File (PIF) retained by Responsible Person.

Retention10 years after last unit placed on market

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.

Related pages

More compliance requirements and references on Krono Compliance

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