1. Certification Overview
In Regulation (EC) No 1223/2009, the term “cosmetics” means a substance or mixture intended to be applied to external parts of the human body (epidermis, hair, nails, lips and external genitalia) or to teeth and oral mucosa for the sole or primary purpose of cleansing, fragrance, altering appearance, protecting, maintaining in good condition, or correcting body odor.
CPNP stands for Cosmetic Product Notification Portal, which is an online registration portal for cosmetics.
Although CPNP is not a certification system, registration has been mandatory for all cosmetics distributed in Europe since 2013. Once a product is registered, it can be sold in 32 European Union countries.
The registration of a product on the CPNP is handled by the Responsible Person (RP) in Europe. The RP is responsible for ensuring the safety of product distribution within Europe, and for products exported to Europe, a specialized RP company or the importer typically takes on the role of RP. The RP prepares the Cosmetic Product Safety Report (CPSR) and the Product Information File (PIF) to register the product with the CPNP.
2. Regulatory Agencies and Basic Information
| Regulatory Agencies | European Commission (EC) |
| Certification (Registration) Authority | 1. European Commission 2. Cosmetic Products Notification Portal(CPNP) |
| Lead time / Price | Varies by product |
| Agent | RP required for the person in charge in Europe |
3. Registration Procedure
- Preparing the Product Information File (PIF)
- Preparation of Cosmetic Product Safety Report (CPSR)
- Selection of Responsible Person (RP), Labeling
- Ingredients and Label Review
- European Cosmetic Portal (CPNP) registration
4. Required Documents
1. Cosmetics Registration
| Product Information File (PIF) | • Detailed description of the cosmetic • Cosmetic Product Safety Report (CPSR) • Description of manufacturing methods and statements regarding GMP compliance • Evidence for the claimed effects of the cosmetic, where justified by the characteristics or effects of the cosmetic • Data on animal testing conducted by the manufacturer, their agents, or suppliers in connection with the development or safety assessment of the cosmetic or its ingredients |
| CPNP Registration Information | • Type and name that specifically identify the cosmetic • Name and address of the Responsible Person (RP) with easy access to the Product Information File (PIF) • Country of origin for imports • Member country where the cosmetic will be marketed • Contact information to be reached if necessary • Presence of nano-form materials and 1) Identification information including the chemical name (IUPAC) and other descriptive terms 2) Reasonably foreseeable exposure conditions • Name of the substance classified as carcinogenic, mutagenic, or reproductive toxic (CMR) and its CAS (Chemicals Abstract Service) or EC number • Framework configuration to enable prompt and appropriate medical treatment in the event of difficulty |
| Labeling Information | • Name of the person in charge • Nominal content at the time of packaging (indicated by weight or volume) • Expiration date • Precautions for use • Manufacturing batch number or reference for cosmetic identification • Function of the cosmetic • List of ingredients |
2. Cosmetic Product Safety Report (CPSR)
| Part A – Cosmetic Product Safety Information | • Quantitative and qualitative composition of the cosmetic • Physical and chemical properties and stability of the cosmetic • Microbiological quality • Information on impurities, traces, and packaging materials • Normal and reasonably predictable use • Exposure to the cosmetic 1) Application site 2) Area of application 3) Amount of product applied 4) Duration and frequency of use 5) Normal and reasonably predictable routes of exposure 6) Target (or exposed) population • Exposure to the substance • Toxicological profile of the substance 1) Particle size, including nanomaterials 2) Impurities in the materials and ingredients used 3) Interactions of the substance • Undesirable effects and serious undesirable effects • Information on the cosmetic |
| Part B – Cosmetic Product Safety Assessment | • Assessment Conclusion • Warnings and Usage Instructions • Inferences • Evaluator Credentials and Part B Approval |
▪ Source
Harmonized Standards
In vitro diagnostic medical devices Regulation (EU) 2017/746
MDCG Guidance