Since July 11, 2013, Regulation EC No 1223/2009 requires that a Responsible Person (RP) established within the European Union be designated for each cosmetic product marketed within the European territory.
The role of the Responsible Person is to ensure continued product compliance with cosmetics regulations and safety regarding human health.
As defined in Article 4 of Regulation EC No 1223/2009, a Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product in the EU market with relevant obligations as set forth in this Regulation. It can be the manufacturer (if based in the EU), the importer, the distributor or a third party located in the EU who has been designated by a written mandate.
The Responsible Person is in charge of ensuring that cosmetic products marketed in the European Union comply with Regulation EC No 1223/2009.
Among the numerous obligations, the Responsible Person for a cosmetic product must ensure:
- Safety with respect to human health and the production of a Cosmetic Product Safety Report (CPSR)
- Compliance of labeling, including a claims substantiation
- Compliance with good manufacturing practices (GMP)
- Proper maintenance of the Product Information File (PIF)
- Notification in the Cosmetic Product Notification Portal (CPNP)
- Compliance related to nanomaterials
- Ongoing monitoring of the product, including the reporting of any undesirable or serious side effects to the relevant authorities.
In addition to ensuring compliance with the requirements, the Responsible Person, in some EU member states, must demonstrate that it has the expertise and the financial resources to carry out its duties.
Founded in 2008 and serving in the role of Responsible Person for more than 300 brands (and more than 10,000 products), BIORIUS has acquired in-depth expertise from local authorities within each EU member state.
With a team of more than 40 multicultural experts, BIORIUS has the ability to address all potential questions from these local authorities.
We have the expertise and resources at BIORIUS. We can effectively fulfill this role for your cosmetics company.
As Responsible Person within the European Union, BIORIUS:
- Represents and defends your cosmetic brand to the authorities
- Assists your cosmetic brand with any legal questions related to the European Cosmetics Regulation
- Manages customer complaints if and when they arise
- Performs regulatory monitoring and guarantees the ongoing compliance of your cosmetic products by taking into consideration any regulatory changes
- Manages any undesirable effects from your cosmetic products
- Ensures that your Product Information File is up to date
Your cosmetics brand has the option of using the BIORIUS name and address on its labels. This means that BIORIUS is designated as a contact for local authorities who, in the event of a regulatory inspection or consumer complaint, would have us handle the case on your behalf.
The United Kingdom: Brexit and Cosmetics Compliance
As of January 31, 2020, the United Kingdom is officially no longer part of the European Union.
Any company marketing or wishing to market cosmetic products in the United Kingdom, therefore, needs to designate a Responsible Person located in the UK.