Since the implementation of the Cosmetic Regulation EC 1223/2009 on July 11, 2013, each cosmetic product placed on the European market must now have a designated “Responsible Person”. Their job is to guarantee product compliance in front of the relevant European authorities, therefore ensuring that the product is safe for human health.
What is a Responsible Person?
The definition of a Responsible Person is found in Article 4 of the Regulation which states that a Responsible Person is a legal or natural person based in the European Union who will act as the unique representative for that product throughout the EU. Only cosmetic products with a designated Responsible Person may be circulated on the EU market.
Who can be a Responsible Person?
The framework of the Cosmetic Regulation introduces several entities which may be designated as the Responsible Person. The most common are:
- The manufacturer: Defined in the Regulation as ‘any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark.’
- This option is only available to those that are located within the EU territory and is only advisable in the scenario that the Brand Owner has the Regulatory expertise in order to do so.
- The importer: Defined in the Regulation as ‘any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market.’
- The distributor: Defined in the Regulation as ‘any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the community market’
- A third party: Product compliance consultants, like Obelis, can also act as a Responsible Person on behalf of a manufacturer. They must be given a written mandate by the manufacturer to do so and also accept the nomination in writing.
- Any third party entity should be professional and carefully evaluating concerning their Regulatory expertise, set-up, ongoing training, service outside of their own EU Member State, etc.
What does the Responsible Person do?
The Responsible Person is charged with ensuring the cosmetic product complies with the Cosmetic Regulation 1223/2009. This means they are heavily involved in a number of areas, including:
- Product Safety Reports
- The Product Information File
- CPNP Notification
- Samples and Analysis
- Good Manufacturing Practices
- Informing the General Public
The role of a Responsible Person is one that requires extensive experience and an in-depth knowledge of the often complex world of product regulation. Located minutes from the EU Commission in Brussels, our regulatory experts and consultants have the knowledge and expertise to guide you through the compliance process and see your cosmetic products introduced to the EU marketplace. Get in touch for a free quote today!