Since July 11, 2013, to sell cosmetics in Europe, an EU Responsible Person (with offices in EU) is legally mandatory (Regulation EC No 1223/2009). It indeed requires a Responsible Person (RP), established within the European Union to be designated for each cosmetic product marketed within the European territory. The role of the Responsible Person (often also called an EU Legal Representative or the EU Legal Representation), is to ensure continued product compliance with cosmetics regulations and safety regarding human health.
Definition EU Responsible Person
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.
Obligations EU Responsible Person
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.
It is important to note that being a Responsible Person implies many responsibilities and is an important and delicate matter that should not be taken lightly, check out why.
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.
If you wish to develop the sales of your cosmetic products in EU, this is something Biorius can help you with. Biorius can indeed support the complete EU Cosmetics regulation process.
- Specialized in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries.
- A Responsible Person in Europe (and the UK).
- Mainly composed of 50 regulatory experts, specialists, toxicologists and scientists (chemists and biologists)
- Reassuring and comfortable: we have more than 1,500 international clients, we have already evaluated more than 100,000 products and we never had any compliance issues (fines, withdrawals of the market, etc.) in 15 years of existence.
Need a piece of advice, a quotation or answers to your questions? Contact us…
Fill in this form or contact us directly: firstname.lastname@example.org – We will answer as soon as possible!
As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:
- First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
- 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
- A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
- No hidden costs: Biorius does not charge you for any question, call, or meeting.
- A best-in-class IT tool, free of charge, and saving a lot of your time.
- More than 1,500 international clients have already chosen Biorius!
- We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.
"*" indicates required fields