Export to EU
Exporting to EU
The cosmetics market in the European Union (EU) is one of the largest and most developed in the world. According to data from the European Cosmetics Association (Cosmetics Europe), the EU’s cosmetics market was valued at €80 billion at retail sales price in 2021, making it the largest cosmetics market in the world. The European Union (EU) Cosmetic Regulation 1223/2009 establishes the regulatory framework for the manufacture, import, and sale of cosmetic products within the EU. Here are the general 5 steps for registration of cosmetic products under this regulation:
Step 1: Formula Review
The formula review is a meticulous process that ensures the safety and regulatory compliance of a cosmetic product, including the establishment of the INCI list and confirmation of mandatory lab tests, before the preparation of CPSR and verification of product label.
Step 2: Cosmetic Product Safety Report (CPSR)
The CPSR (Cosmetic Product Safety Report) is a comprehensive document produced by a qualified toxicologist that includes two distinct sections, Part A containing all data needed for the evaluation of the cosmetic product and Part B providing an assessment of the product’s safety and conclusions, which is essential to certify the effectiveness and safety of a product before it can be placed on the EU market.
Step 3: Product Information File (PIF) and CPNP Notification
A Product Information File (PIF) is a complete regulatory dossier that includes the formula, CPSR A&B, and labels of a cosmetic product, and once completed, the product can be notified in the EU via the CPNP (Cosmetic Product Notification Portal) to obtain a unique CPNP number, and while the EU does not require pre-approval of cosmetic products, the selection of a competent Responsible Person is crucial for post-launch verification by competent authorities.
Step 4: Labels and Claims Review
Complying with EU cosmetic labelling rules can be confusing and costly for cosmetic brand owners, as certain elements may need to be translated into different languages depending on the country, and distributors have the right to refuse non-compliant products, making a Label Review by a recognized and experienced company like Influentive is essential for ensuring clear and compliant labels that are easily accessible, readable, and understandable by consumers at the time of purchase.
Step 5: Responsible Person
The Responsible Person is the legal representative for cosmetic products in Europe and is responsible for ensuring compliance with EU regulations, as well as being the contact point for authorities and consumers in case of issues or concerns regarding the product.