Since July 11, 2013, to sell cosmetics in Europe, an EU Responsible Person (RP) with offices in the EU is legally required (Regulation EC No 1223/2009). This person ensures compliance with cosmetics regulations and product safety.
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.
Responsibilities Legal Representation
- Ensure product safety and produce a Cosmetic Product Safety Report (CPSR)
- Comply with labeling and claims substantiation
- Adhere to Good Manufacturing Practices (GMP)
- Maintain the Product Information File (PIF)
- Notify products in the Cosmetic Product Notification Portal (CPNP)
- Manage compliance related to nanomaterials
- Monitor and report undesirable effects
Biorius Expertise
Founded in 2008, Biorius serves as the Responsible Person for over 300 brands and 10,000 products. Their team of over 40 experts addresses regulatory questions and ensures ongoing compliance. Biorius represents brands, manages complaints, performs regulatory monitoring, and updates Product Information Files.
Benefits of Choosing Biorius:
- Representation and defense of your brand to authorities
- Assistance with legal questions related to EU Cosmetics Regulation
- Regulatory monitoring and compliance assurance
- Management of undesirable effects and customer complaints
Please pay attention that being a Responsible Person implies many responsibilities and is an important and delicate matter that should not be taken lightly.
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.
Get in Touch
Need a piece of advice, a quotation or answers to your questions? Contact us…
Fill in this form or contact us directly: info@biorius.com – 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 have always successfully managed compliance over 15 years of existence
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