Cosmetic compliance: CPNP, PIF and labelling.
Selling a cosmetic product in the European Union means meeting specific requirements. We explain what they are and give you regulatory and legal support to meet them.
Under Regulation (EC) No 1223/2009, placing a cosmetic on the market in Spain and across the EU requires: a Responsible Person established in the EU, a Product Information File (PIF) including a Cosmetic Product Safety Report (CPSR), CPNP notification on the EU portal before sale, compliant labelling and manufacturing in line with GMP.
- Responsible Person
- PIF and CPSR
- CPNP notification
- Labelling
Requirements for selling cosmetics in Spain and the EU
Across the EU, cosmetics are governed by Regulation (EC) No 1223/2009 on cosmetic products; in Spain it is complemented by Royal Decree 85/2018. These are the key elements:
1. Responsible Person
Every cosmetic sold in the EU must have a Responsible Person (an individual or a company) established in the EU, who ensures the product complies with the regulations. This is usually the brand, although another company can be designated. Their name and address must appear on the label.
2. Product Information File (PIF)
This is the technical documentation for each cosmetic: product description and formula, a Cosmetic Product Safety Report (CPSR) signed by a qualified safety assessor, the manufacturing method and GMP statement, proof of the claimed effects and data on animal testing. It must be available to the authorities.
3. CPNP notification
Before placing the product on the market, the Responsible Person notifies it on the EU Cosmetic Products Notification Portal (CPNP). A single notification is valid across the whole EU.
4. Labelling
Among other things, the label must include: the Responsible Person, nominal content, date of minimum durability or period after opening, precautions for use, batch number, the product’s function and the ingredient list (INCI), in the language of the country of sale.
5. Claims
What the product says it does (“moisturises”, “firms”, “anti-wrinkle”…) must be substantiated according to the criteria in Regulation (EU) No 655/2013.
How we help
- We provide the technical information on the formula and manufacturing that your PIF requires.
- We give you regulatory and legal support for the notification and market launch of your products.
- We advise on labelling and on how to build your claims in from the formulation stage.
What is the CPNP?
The EU Cosmetic Products Notification Portal. The Responsible Person must notify each cosmetic on it before placing it on sale in the EU.
What is a cosmetic PIF?
The Product Information File: the technical documentation proving that the cosmetic is safe and compliant. It includes the safety report (CPSR), the product description, the manufacturing method and the substantiation of claims.
Who can be the Responsible Person?
An individual or company established in the EU. It’s usually the brand selling the product, although another company can be designated in writing.
Do cosmetics need a CE mark?
No. Cosmetics do not carry a CE mark. Their compliance is based on the Product Information File, the safety report and the CPNP notification.
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