Regulatory Framework
Cosmetics placed on the EU market are governed by Regulation (EC) No. 1223/2009. The framework requires a qualified Responsible Person in the European Union, a compliant Product Information File, a Cosmetic Product Safety Report, and pre-market notification through the CPNP before the product is first placed on the market.
Cosmetic Definition
Any substance or mixture intended to be placed in contact with the external parts of the human body, or with the teeth and oral mucosa, mainly to clean, perfume, change appearance, protect, keep in good condition, or correct body odours.
Responsible Person Requirements
The Responsible Person must be a manufacturer, importer, distributor, or formally appointed third party established in the EU. Its name and address must appear on the label, and it is accountable for formula compliance, safety assessment, notification, technical file retention, market surveillance response, and serious undesirable effect reporting.
Compliance Process
- Account and Role Setup
- Confirm the EU Responsible Person and define document custody, claim substantiation ownership, and notification authority.
- Open or align the CPNP access profile that will be used for product submissions.
- Formula and Label Review
- Check the full formula against prohibited, restricted, nanomaterial, and CMR substance rules.
- Review artwork, mandatory label statements, claims, multilingual presentation, and importer or RP details.
- CPNP Notification
- Prepare product identity, category, packaging visuals, origin details, and nanomaterial information where applicable.
- Submit the product record in CPNP before launch in the EU market.
- PIF and Ongoing Control
- Compile the PIF, including CPSR, formula, GMP evidence, testing, and claim support.
- Maintain the file for 10 years after the last batch is placed on the market and support post-market follow-up when needed.
The PIF must be complete before launch and retained for 10 years from the date the last batch is placed on the EU market.
Deliverables
- EU formula screening against Annex II to Annex VI restrictions
- Artwork and mandatory label compliance review
- CPNP account setup and submission support
- CPSR preparation and safety assessor coordination
- PIF assembly, gap tracking, and maintenance checklist
- EU Responsible Person coordination service
Official Sources
| # | Authority | Document | Locator | Published / Effective | Link |
|---|---|---|---|---|---|
| 1 | European Parliament and Council | Regulation (EC) No 1223/2009 on cosmetic products | Articles 3–5, 8, 10–13, 19–20, 23 and applicable Annexes | 2026-05-01 / 2013-07-11 | Official source |
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