What are the regulations and procedures for importing my products into Europe?

You can import your cosmetic products into the European Union under certain conditions, chief among them compliance with EU Cosmetics Regulation No. 1223/2009. What rules must be followed and what are the steps involved? Let’s take a look at these now.

What regulations apply when importing cosmetic products into the European Union?

If you want to import a cosmetic product, and “a fortiori”, your own brand, into one or more Member States of the European Union, European Cosmetics Regulation no. 1223/2009 will apply. The cosmetic products you want to import under your brand name must comply with European Cosmetics Regulation no. 1223/2009:

• Regardless of their provenance,
• Regardless of their composition,
• Regardless of their regulatory and safety approval in the non-EU countries in which they are already sold.

This means that each cosmetic product imported must have a PIF (Product Information File) that includes:

• A Cosmetic Product Safety Report drawn up in accordance with Annex I of the Cosmetics Regulation,
• A description of the manufacturing and packaging methods,
• A declaration of compliance with the GMP (Good Manufacturing Practices),
• A declaration that the formulation complies with regulations (including the restrictions and prohibitions of certain substances listed in Annex II to VI of the cosmetics regulation),
• A declaration that its presentation and labelling comply with labelling rules pursuant to Article 19 of the Cosmetics Regulation, etc.

What steps must be taken to import your cosmetic products into Europe?

Step 1: Gather together all of the necessary documents for your PIF

As mentioned above, a certain amount of information must be included in the PIF to ensure future product compliance.
For example, product formulation information must prove that the product can be imported from a regulatory point of view.
To find out more about the documents that need to be included in the PIF, please see question 5 “What is a PIF (Product Information File)?”

Step 2: Make sure that your formula complies with the cosmetic regulations

This step is essential to determine whether a cosmetic product can be imported or not.
Consequently, the cosmetic product’s formulation must meet the regulatory requirements regarding prohibited, restricted, and authorised ingredients. Click here to see the complete list of ingredients.

Note, however, that the formula’s conformity is a necessary but not sufficient condition for a cosmetic product’s “importability”. Other tests (stability, microbiological) must be completed to determine whether a cosmetic product is “importable” or not.

Note: all annexes to the Cosmetic Regulations are updated quarterly. Remember to check them regularly

Step 3: Create the Product Information File

Necessary for market entry, the PIF contains in particular the safety report completed by a certified toxicologist.

To find out more about the PIF, please see question 5 “What is a PIF (Product Information File)?”

Step 4: Register your product(s) on the CPNP

This transfers the necessary cosmetic product information to the CPNP (Cosmetic Products Notification Portal).

Please see Question 9 “How do I submit my CPNP notification?”

Step 5: Become or designate a Responsible Person

When you decide to import your cosmetic line into the European market, by default, you become the Responsible Person for the product. However, you also have the option of appointing a Responsible Person who must ensure compliance with the Cosmetic Regulations provisions for the cosmetic product(s) they are placing on the market. The Responsible Person can be the manufacturer, the importer or even the distributor or any other person established in the European Union.

Once these steps have been completed, you can import your cosmetic products into Europe (into one or more EU member states).