Responsibilities of the Responsible Person

Responsible Person

In the European Union, only cosmetic products for which a Responsible Person (RP) has been designated may be placed on the market.

The Responsible Person is an individual or legal entity based in one of the EU Member States, tasked with ensuring the products’ compliance with Regulation (EC) Nº 1223/2009 on cosmetic products.

WHO CAN BE AN RP?

For products manufactured within the EU, the RP is, by default, the manufacturer. Conversely, for cosmetic products manufactured outside the EU and subsequently imported, the RP is the importer. However, both the importer and the manufacturer may appoint, in writing, any other person or company established in one of the EU Member States to assume the role of RP, provided that the appointed party expressly agrees in writing. Additionally, when a distributor places a cosmetic product on the market under their own brand or makes changes to a product beyond translating the labelling, they also become the RP for that cosmetic product.

RESPONSIBILITIES

The Responsible Person must ensure that the cosmetic products they place on the market comply with the applicable legislation and are safe for use under normal or reasonably foreseeable conditions. For that purpose, the RP must prepare and maintain a Cosmetic Product Safety Report (CPSR) and a Product Information File (PIF) containing all the specific details about the cosmetic product. These documents must be readily accessible to share with competent authorities upon request.

The RP is also responsible for ensuring that the labelling of cosmetic products includes all mandatory information in a clear, legible, and non-misleading way. It is important to note that the name and address of the RP are among the mandatory details that must appear on the product's label.

Finally, the RP must continuously collect and assess all information regarding adverse effects associated with the use of cosmetics, thereby ensuring post-market surveillance, also known as cosmetovigilance.

Have you appointed a Responsible Person for your products? Pharmilab is the PR for hundreds of brands operating on the European market. If you need support, we can help!