The registration of a cosmetic product is a key step to ensure its compliance with European Union (EU) legislation and to protect consumer health. In the EU, this process is governed by Regulation (EC) No. 1223/2009, which sets strict guidelines for all cosmetic products placed on the market.
1. Cosmetic product classification
Before starting registration, it is necessary to determine the correct classification of a cosmetic product. This includes identifying the type of product, its use and the category it falls into. An accurate classification helps determine the necessary testing and documentation and ensures that the product meets all legal requirements.
2. Formulation review
Formulation review or formula compliance check is the process of evaluating the composition of a cosmetic product. This includes checking whether the ingredients used are permitted, whether they are in permitted concentrations, and whether the product meets safety standards. This step is crucial to ensuring the safety and quality of the product.
3. Creating a PIF (Product Information File)
A cosmetic product information file (PIF) is a collection of all relevant data on a product, including its ingredients, manufacturing process, safety assessment and other important information. The PIF must be available to the competent authorities and must be kept for at least 10 years after the product has been withdrawn from the market.
4. Stability test
Stability testing evaluates how a product maintains its quality, safety, and efficacy over time under various storage conditions. This includes checking for changes in color, odor, texture, and any chemical changes in the product. Stability is key to ensuring the long-term quality of a product.
5. Challenge test or performance test
A challenge test or efficacy test is a procedure that evaluates the ability of a cosmetic product to maintain its microbiological quality during use. This includes testing the effectiveness of preservatives in the product and ensuring that the product does not cause adverse effects on the skin or other parts of the body.
6. Preparation of permitted statements on primary and secondary packaging
Cosmetic product labeling must comply with legislation and contain all necessary information, such as a list of ingredients, instructions for use, warnings and other relevant information. Correct labeling helps consumers choose and use the product safely.
7. Product notification to the European Commission on the CPNP (Cosmetic Products Notification Portal)
Before a cosmetic product is placed on the EU market, it must be registered via the Cosmetic Products Notification Portal (CPNP). This enables uniform notification of new products on the market to competent authorities in the EU and ensures product traceability and safety.
8. Designation of a responsible person (RP)
Each cosmetic product must have a designated responsible person in the EU who is responsible for the product's compliance with the legislation, for preparing the PIF, for registering the product on the CPNP, and for ensuring the safety and quality of the product.
Careful implementation of all the above steps ensures that cosmetic products are safe to use, compliant with legislation and of high quality, which is in the interest of both manufacturers and consumers.
The registration of a cosmetic product in the EU is a crucial process that ensures the safety, quality and compliance of products with the law. By following all the steps, from the correct classification of the product to the registration in the CPNP and the designation of the responsible person, manufacturers not only comply with the legal requirements, but also protect the health of consumers and contribute to greater confidence in cosmetic products on the market. By carefully implementing these procedures, companies can ensure that their products are not only effective and safe, but also fully compliant with European standards. It is important for companies to follow the latest legislative guidelines and regularly update their procedures in order to maintain a high level of quality and safety of their products.