European market launch

The European cosmetics regulation (EC n°1223/2009) established 4 requirements in order to market a cosmetic product within the European Union:

  • A Product Information File (PIF) including, among other things, a safety report (CPSR) signed by a safety expert 
  • A compliant label
  • A CPNP number (Cosmetic Product Notification Portal)
  • A Responsible Person based on the European territory

BIORIUS propose to you to cope with the European registration process internally, from A to Z. 

Some countries out of the European Union acknowledge the requirements established within the European regulation. A product authorized to be launched within the European Union can therefore be registered more easily in Norway, Iceland, Liechtenstein, Switzerland and Turkey.

How do we proceed?

Our European registration process hinges on 5 steps:

1

Formula Analysis

Safety evaluation and regulatory status of each ingredient and INCI list redaction based on the European standards.
2

Redaction of the safety report (CPSR)

Redaction of the safety report of your cosmetic product signed by a toxicologist. Part A of this report includes all the data needed for the evaluation whereas part B is the actual evaluation of the safety of the cosmetic product and the conclusion of the evaluation.
3

Review of the labels and claims

Check of the presence and compliance of the mandatory elements and evaluation of the acceptability of the claims made on your packaging.

4

PIF and CPNP notification

Preparation of the PIF and notification of your product on the CPNP. A CPNP number is then assigned to your product by the European authorities.

5

Legal Representation

Possibility to design BIORIUS as your Responsible Person within the European Union for the regulatory aspect.