EU Responsible Person
Looking for an EU cosmetics Responsible Person ?
Biorius acts as EU Responsible Person for cosmetic products placed on the European Union market. This is not a one-time administrative service, but a continuous legal responsibility covering the entire product lifecycle. It requires permanent regulatory oversight, scientific evaluation, and the ability to interact with EU authorities at any time.
The role of the EU Responsible Person
Under EU Regulation (EC) No 1223/2009, every cosmetic product must have a Responsible Person established within the European Union before it can be marketed. The Responsible Person is legally accountable for product compliance. This responsibility extends beyond market entry and remains active throughout the product’s lifecycle on the EU market.
-
Ensuring compliance with EU cosmetic legislation before market placement -
Maintaining the Product Information File (PIF) -
Ensuring the availability of a valid Cosmetic Product Safety Report (CPSR) -
Managing CPNP notifications -
Reviewing labelling, ingredients, and product claims -
Acting as the official point of contact for EU authorities -
Coordinating corrective actions, withdrawals, or recalls when necessary
Responsible Person services for international brands
For companies located outside the European Union, a Responsible Person established in the EU must be appointed. Biorius takes on this role for brands based in the US, UK, Canada, Asia, and other regions, ensuring their products can be legally placed on the EU market. We translate EU regulatory requirements into practical compliance solutions while aligning them with existing formulation, quality, and documentation systems used by manufacturers worldwide.
Trust Biorius to manage these crucial tasks with expertise.
Looking for a new Responsible Person ?
A change is simpler than you think.
A full regulatory lifecycle approach
The Responsible Person role goes far beyond document review. It requires continuous scientific and regulatory oversight. At Biorius, this responsibility is handled by in-house regulatory experts, toxicologists, and compliance specialists working together daily.
Product classification
Borderline assessment and classification for all product types
Ingredient safety
Toxicological evaluation and CPSR preparation and review
Claims substantiation
Compliance assessment of product claims and marketing statements
Regulatory monitoring
Continuous impact analysis and proactive compliance adaptation
Authority communication
Direct interaction with competent authorities, including inspections
Undesirable effects
Serious undesirable effect reporting and post-market surveillance
CPNP notification & Product Information File
CPNP notification
CPNP notification is a legal obligation and is not a standalone step but part of an integrated compliance system. Biorius ensures that CPNP data remains consistent with the Product Information File, formulation, and labelling. Any product change is assessed from a regulatory perspective, and updates are made where required.
PIF management
As Responsible Person, Biorius maintains a complete and continuously updated Product Information File, available to authorities upon request. The PIF is treated as a living regulatory file that reflects the product’s real market status. It covers product data, CPSR, GMP evidence, claims substantiation, animal testing statements, and post-market surveillance data.
MyApps and regulatory impact assessments
To support brands more efficiently throughout the product lifecycle, Biorius developed MyApps, a dedicated digital platform designed to centralize and simplify cosmetic compliance management.
Regulatory requirements evolve continuously. Ingredient restrictions, SCCS opinions, labelling requirements, and claims expectations can directly impact existing product portfolios. Biorius continuously monitors EU regulatory and scientific developments and evaluates their impact on products managed under our Responsible Person services. Clients can easily identify affected products, follow regulatory developments, and manage required actions, all within one platform.
Why brands choose Biorius
Our approach focuses on continuity of compliance across formulation changes, labelling updates, and regulatory evolution. For international brands, EU compliance is often part of a broader global regulatory strategy including the UK, US, Canada, and other markets. Biorius ensures consistency across regions while maintaining strict adherence to EU requirements.
-
Strong regulatory expertise and scientific depth -
In-house toxicology and compliance teams -
Structured post-market surveillance -
Integrated EU and UK Responsible Person services -
Proven ability to manage both larger and smaller portfolios -
Proactive monitoring of regulatory changes and impact assessments
Frequently asked questions
Is a Responsible Person mandatory?
Yes. Every cosmetic product placed on the EU market must have an EU Responsible Person.
Can a non-EU company act as RP?
No. The Responsible Person must be established in the EU.
Does liability continue after launch?
Yes. Responsibility applies for as long as the product is on the market and used by the end users.
Can the Responsible Person be changed?
Yes. The change must be documented and updated in regulatory systems such as the PIF and CPNP.
Get in Touch
Need a piece of advice, a quotation or answers to your questions?
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! -
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 50,000 products and have always successfully managed compliance over 15 years of existence