CPSR, PIF and CPNP: the documents a cosmetic needs before entering the EU market
Three acronyms without which a cosmetic cannot be legally sold in the EU. What CPSR, PIF and CPNP are and who is responsible for them.
Every cosmetic sold in the European Union is governed by Regulation (EC) No 1223/2009. Whether it is a cream from a large factory or 500 units of lotion from a new brand, the requirements are the same. Here are the three terms every small brand needs to know.
The Responsible Person
Before the documents: every cosmetic on the EU market must have a Responsible Person (Article 4 of the Regulation). This is a company or individual established in the EU who is responsible for the product’s compliance. It is usually the brand owner.
If your company is based outside the EU, you must appoint a Responsible Person in the EU, for example a specialised service provider.
CPSR – the safety report
The CPSR (Cosmetic Product Safety Report) is required by Article 10 and Annex I. It has two parts:
- Part A – product information: quantitative composition, physical and chemical properties, stability, microbiological quality, packaging, normal use and exposure, toxicological profile of the ingredients;
- Part B – the safety assessment: conclusion, label warnings, reasoning and the assessor’s signature.
Part B is signed by a safety assessor with appropriate qualifications (e.g. pharmacy, toxicology, medicine). The report covers a specific formula, so changing the composition usually means updating the CPSR.
PIF – the product information file
The PIF (Product Information File, Article 11) includes, among other things:
- a description of the product,
- the CPSR,
- a description of the manufacturing method and a statement of compliance with good manufacturing practice (GMP, ISO 22716),
- proof of the claimed effect where justified by the nature or effect of the product,
- data on any animal testing.
The Responsible Person keeps the PIF for 10 years after the last batch was placed on the market. It must be available to the authorities at the address shown on the label.
CPNP – notification
The CPNP (Cosmetic Products Notification Portal) is the EU portal where a cosmetic is notified before it is placed on the market (Article 13). One notification covers the whole European Union.
The notification includes the product category and name, the Responsible Person’s details, the country of origin (for imports), the presence of nanomaterials and CMR substances, and an image or file of the label and packaging.
The label
A cosmetic label must include the information listed in Article 19, such as the name and address of the Responsible Person, nominal content, date of minimum durability or period after opening, precautions, batch number, function and the list of ingredients (INCI). Some of this information must be in the language of the country where the product is sold.
What this means for a small brand
| Item | Prepared by | Responsibility |
|---|---|---|
| CPSR | safety assessor, using data from the manufacturer | Responsible Person |
| PIF | manufacturer and assessor supply documents, then compiled | Responsible Person |
| CPNP notification | data from the PIF and the label | Responsible Person |
| Label | designed on the basis of the CPSR and formula | Responsible Person |
At Beldavia we prepare the full pack: documentation, label and notification data, with instructions. As the brand owner, you notify the product and keep the file.
This article is for information only and does not replace legal advice or the safety assessment of a specific product.