Launching your cosmetic product in the EU
Expanding your brand to Europe, the largest cosmetics and personal care market in the world, may seem a challenging task at first. However, retail sales valued at €77 billion in 2016 is worthy incentive for any company considering this market.
Pre-market registration is required for cosmetics in the European Union (EU), where the EU cosmetic regulations define requirements to be fulfilled before entering the market. One set of regulations for multiple countries simplifies the overall process, but executing the requirements without experienced help can be frustrating.
The EU cosmetic regulations require a Product Information File (PIF) and product notification via the CPNP (Cosmetic Product Notification Portal) before you can bring the product to market. Just two requirements seems like a short road to compliance, but these necessary items are more involved then they first appear. Let’s have a look step-by-step at how to prepare for this venture.
1 – Product Information File (PIF)
The PIF describes all elements of the cosmetic product from product identity and quality to safety background, and it must be kept by the Responsible Person (more on the Responsible Person below). Specifically, the PIF should include:
- A description of the cosmetic product, including details of the ingredients used in the formulation, raw material data, finished product data, and more.
- Cosmetic Product Safety Report (CPSR) – This is a two-part report that consists of safety information and a safety assessment for the cosmetic product (more on this below).
- A description of the method of manufacturing and statement on GMP compliance of the manufacturing site.
- Evidence supporting the product benefits claim(s) (if applicable)
- Animal testing data
2 – Cosmetic Product Safety Report (CPSR)
The CPSR includes information about the product’s composition, stability, microbiological quality, packaging materials, foreseeable use and exposure, and toxicological profile of the ingredients. CPSRs include a large amount of data, so it is important to gather the required information for evaluation well in advance of potential launch dates. A qualified safety assessor must review and attest to the contents of the CPSR by evaluating the safety profile of each ingredient as well as the product as a whole to ensure the product poses to risk to human health. The qualified safety assessor must hold a degree in pharmacy, toxicology, medicine or a similar discipline.
3 – Designate a Responsible Person
The Responsible Person is an individual or company accountable for the safety and compliance of the product in Europe. The Responsible Person must be established in the EU and may either be the manufacturer, importer, distributor or another person with acceptable credentials who accepts accountability for the product.
4 – Cosmetic Notification
The Cosmetic Product Notification Portal (CPNP) is an electronic notification system where cosmetic products must be notified prior to placing the product in the EU. The CPNP notification includes the product categorization and a copy of the label, as well as the details of the Responsible Person and formulation including the presence of nanomaterials and/or substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances). Once the CPNP notification has been completed, and the other requirements mentioned above are in place, the product can be sold anywhere in the EU. Congratulations!
Stepping into the EU market doesn’t have to be overwhelming. We can compile your PIF, including the CPSR, and we have a qualified safety assessor on staff who can sign the safety assessments for your products. We can also submit CPNP notifications and advise on compliant product labelling and packaging for the EU, including translation into local language(s). If you’re eager to explore sale of your product in the EU, please contact us for more information.