Selling cosmetics in the EU requires full compliance with Regulation 1223/2009. This guide covers CPSR, PIF, INCI labeling, prohibited substances, and how SEYE helps you navigate EU market entry.
Overview of EU Cosmetics Regulation 1223/2009
The EU Cosmetics Regulation (EC) No 1223/2009 is the primary legislation governing cosmetic products placed on the EU market. It applies to all cosmetics sold in the 27 EU member states plus Norway, Iceland, and Liechtenstein.
Key requirements:
- Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- Responsible Person (RP) designation
- CPNP notification
- INCI labeling compliance
- Prohibited and restricted substances compliance
1. Product Information File (PIF)
Every cosmetic product must have a PIF maintained by the Responsible Person. The PIF must contain:
| Document | Description |
|---|---|
| Product description | Name, intended use, target consumers |
| Formula | Full INCI list with concentrations |
| Physicochemical data | Appearance, pH, viscosity, density |
| Microbiological data | Challenge test results |
| Stability data | Minimum 12-month accelerated stability |
| Safety assessment | Full CPSR (see below) |
| Manufacturing data | GMP compliance documentation |
| Efficacy claims | Evidence for any claims made |
2. Cosmetic Product Safety Report (CPSR)
The CPSR is the most critical document. It must be prepared by a qualified safety assessor (typically a toxicologist with relevant EU qualifications) and consists of two parts:
Part A: Safety Information
- Formula with all ingredients and their concentrations
- Physical/chemical characteristics
- Microbiological quality
- Impurities and trace substances
- Packaging material compatibility
- Normal and reasonably foreseeable use
Part B: Safety Assessment
- Exposure assessment
- Toxicological profile of each ingredient
- Assessment of undesirable effects
- Safety conclusion and margin of safety calculation
Cost: CPSR preparation typically costs €300–800 per product, depending on formula complexity.
3. Responsible Person (RP)
Every cosmetic product needs a Responsible Person established in the EU. The RP:
- Maintains the PIF
- Notifies the product in CPNP
- Is the contact point for market surveillance authorities
If you are a non-EU brand, you must appoint an EU-based RP. SEYE can recommend trusted RP service providers in Germany, Netherlands, and UK (for GB market).
4. CPNP Notification
Before placing a product on the EU market, it must be notified in the Cosmetic Products Notification Portal (CPNP). This is a free, online system managed by the European Commission.
Required information:
- Product category
- Product name and photo
- Frame formulation or full formula
- Nanomaterial declaration (if applicable)
- CMR substances declaration
5. INCI Labeling Requirements
EU labels must include:
- Product name and function
- Net content (weight or volume)
- Best before date (if <30 months) or PAO symbol
- Precautions and warnings
- Batch number
- Country of origin
- Responsible Person name and address
- Full INCI ingredient list in descending order of concentration
Ingredients at ≤1% concentration may be listed in any order after those >1%.
6. Prohibited and Restricted Substances
The EU Regulation includes:
- Annex II: 1,328 prohibited substances
- Annex III: Restricted substances (with conditions of use)
- Annex IV: Permitted colorants
- Annex V: Permitted preservatives
- Annex VI: Permitted UV filters
Notable substances prohibited in EU but allowed elsewhere:
- Formaldehyde-releasing preservatives (above 0.1%)
- Certain parabens (isopropylparaben, isobutylparaben)
- Triclosan (above 0.3%)
- Hydroquinone (prohibited in cosmetics)
How SEYE Supports EU Market Entry
SEYE provides:
- EU-compliant formulas: All formulas pre-screened against Annexes II–VI
- PIF preparation: We prepare the technical dossier including stability and microbiological data
- CPSR coordination: We connect you with accredited EU safety assessors
- INCI documentation: Full INCI list with CAS numbers and concentrations
- GMP certification: ISO 22716 certificate for your PIF
SEYE Regulatory Team
Regulatory Affairs Specialist
Part of SEYE's expert team with deep expertise in cosmetic formulation, OEM manufacturing, and global regulatory compliance.
