To access the European Union (EU) market as a cosmetics product manufacturer based in the United States, you need to comply with the EU regulations and follow specific steps:
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 (Obelis EU): As a non-EU manufacturer, you need to appoint an EU-based Responsible Person (RP) who will act as your point of contact with EU authorities.
3. Verify Product Compliance: Ensure that your cosmetics products comply with the EU’s safety requirements. This includes conducting safety assessments, determining product labelling requirements, and verifying the absence of prohibited substances.
4. Notification on the EU Cosmetic Product Notification Portal (CPNP): This is an online database where the responsible person must submit specific information about the product, including its composition, labelling, and safety assessment.
5. Implement Good Manufacturing Practices (GMP): Adhere to Good Manufacturing Practices (GMP) while producing your cosmetics products. GMP ensures that your manufacturing processes follow strict quality standards to guarantee the safety and quality of the products.
6. Labelling and Packaging Compliance: 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 country where the product is marketed, and they must contain essential information, such as ingredients, warnings, batch numbers, and contact details of the RP.
7. Provide Product Information to Authorities: Keep records of product information, including safety assessments, labelling, and any relevant documentation. EU authorities have the right to request this information to ensure compliance and product safety.
8. Stay Updated on Regulatory Changes: EU regulations related to cosmetics may evolve over time. Stay informed about any regulatory changes or updates that may affect your products and adapt your practices accordingly.
It’s important to note that this is a general guide, and you should consult with Obelis EU for specific guidance tailored to your product and situation.