How to Legally Sell Your Nail Brand Products in the EU

Who Is the Responsible Person?

Every cosmetic product sold in the European Union must have a Responsible Person (RP).

The RP is the company or individual who is legally responsible for the product's compliance. RP name and address must appear on the product label.

There are two common options.

• Some manufacturers can act as the RP for your products.

If you choose this option, the manufacturer's name and address will appear on the product label, while your company will be listed as the distributor. The manufacturer, as the RP, will also prepare the regulatory documentation and complete the CPNP notification before the products are placed on the EU market. This means there is less regulatory work for your company.

• You can also choose to be the RP yourself. In this case, your company name and address will appear on the product label, and your company will be legally responsible for the product and its compliance.

What Does the RP Do?

Being the RP means more than simply having your name on the label.

The RP is responsible for keeping the required documentation, registering the product before it is sold, and making sure it complies with EU Cosmetic Regulation.

The RP must have:

• Product Information File (PIF), including Cosmetic Product Safety Report (CPSR)

• CPNP registration

Let's look at each one.

What Is a Product Information File (PIF)?

The Product Information File (PIF) is the main document for a cosmetic product. It contains the information needed to show the product complies with the EU Cosmetic Regulation. 

A PIF includes:

• product description

• Cosmetic Product Safety Report (CPSR)

• manufacturing information

• packaging information

• product labels

• stability and compatibility information

• formula-related documentation

• other quality and technical documents

A PIF is prepared for each base formula, not for each colour or bottle size.

A base formula is the main composition of a product. For example, a gel polish, a rubber base, a hard base, and a top coat are all different base formulas.

One base formula can be available in many colours and bottle sizes.

If the formula stays the same, you only need one PIF, even if the product is sold in different colours and sizes.

The RP must keep the PIF for 10 years after the last batch has been placed on the market. If the authorities ask to see it, the RP must provide it.

What Is a CPSR?

The Cosmetic Product Safety Report (CPSR) is part of the PIF.

It is a safety assessment of the product. The report reviews all available information about the product and concludes whether it is safe when used as intended.

A qualified safety assessor prepares the report.

Can My Manufacturer Prepare These Documents?

This is one of the most common questions from new brand owners.

Your manufacturer should provide the formula-related documentation needed to prepare the regulatory documents. This may include information about the formula, raw materials, packaging, stability testing, safety data sheets, and other technical documents.

However, manufacturers do not usually issue the final PIF or CPSR in your company's name.

This is because these documents belong to the RP shown on the product label.

If your company is the RP, then the PIF and CPSR need to be prepared for your company, not for the manufacturer.

To prepare these documents, you can work with an independent cosmetic safety assessor. They use the technical information provided by your manufacturer to prepare the required documents in the name of the RP.

What Is CPNP Registration?

The Cosmetic Products Notification Portal (CPNP) is the European Union's online notification system for cosmetic products.

Before a cosmetic product can be sold in the EU, it must be registered in the CPNP. The registration is free of charge.

If your manufacturer is the RP, they will usually complete the CPNP registration before the product is placed on the market.

If your company is the RP, you must complete the registration yourself.

To register a product, you need a CPNP account and information about the RP and the product. If you prefer, a cosmetic regulatory consultant can complete the registration for you.

Without CPNP registration, a cosmetic product cannot legally be placed on the EU market.

What Is the Correct Order?

Many new brand owners ask what to do first. 

The usual process is: 

1. Choose the products you want to sell.

2. Decide who will be the RP

3. Prepare the PIF, including CPSR.

4. Complete the CPNP registration.

5. Place the products on the EU market.