The EU is an attractive market for cosmetic and personal care product brands; in 2022, it was valued at 88 billion euros. Are you interested in expanding your business to the European Union? Starting to sell cosmetic products in a new territory is a complex operation that requires good planning. Among the things to take care of is regulatory compliance: your products need to comply with the relevant EU laws to access the EU market.
1. Familiarize yourself with the EU Cosmetics Regulation (Regulation (EC) No 1223/2009).
This regulation sets the legal framework for cosmetic products in the EU market. It defines the responsibilities of manufacturers, importers, and distributors, as well as the requirements for product safety and labelling.
2. Appoint an EU Responsible Person. As a non-EU manufacturer, you need to appoint an EU-based Responsible Person (RP) who will guide you through the EU compliance process and ensure your products meet the regulatory requirements. Additionally, the RP will be your point of contact with EU authorities and consumers.
3. Implement Good Manufacturing Practices (GMP) according to the international standard ISO 22716. GMP covers the production, control, storage, and shipment of cosmetic products, and adhering to it ensures that your manufacturing processes follow strict quality standards to guarantee the safety and quality of the products.
4. Compile a Product Information File (PIF) with all safety information about your products, including laboratory testing, the safety assessment report, finished product and raw materials details. The PIF is a living document that you must update every time there is a change in the product or a regulatory restriction.
5. Verify compliance with your labels. You shall ensure that your product labels and packaging meet the requirements specified by the EU Cosmetics Regulation. The labels should be in the official language(s) of the countries where the product is marketed, and they must contain safety information, such as a list of ingredients, warnings, batch number, and contact details of the RP.
6. Notify product to the EU Cosmetic Product Notification Portal (CPNP). After verifying your products are compliant, the Responsible Person must notify your products to the CPNP. This is a pre-market notification valid at the EU level. From the moment of the notification, you will be able to place your products on the EU market.
7. Keep up with regulatory updates. The lists of banned and restricted substances for use in cosmetic products (the Annexes to the EU Cosmetics Regulation) are constantly being updated in light of the latest scientific findings. Hence, you must remain updated on regulatory changes and take the necessary steps to ensure that your products remain compliant.
Obelis has 35 years of experience in EU regulatory affairs for cosmetic products. Over the decades, our team of professionals helped thousands of brands to achieve compliance and smoothly enter the EU market. If you appoint Obelis as your Responsible Person, we will be your regulatory partner and support your business in Europe, taking care of all the points mentioned above. Don’t let regulatory challenges hold your business back!