Cosmetics Regulatory Representation
Responsible Person for EU and UK Cosmetics
As your designated Responsible Person, we fulfil all legal obligations under EC 1223/2009 (EU) and the UK Cosmetics Regulation - so you can place your cosmetic products on the European market with confidence.
- Responsible Person for EU and UK markets
- CPNP and SCPN product notification
- PIF retention and authority access
- Serious Undesirable Effects (SUE) reporting
On this page
The Role of the Responsible Person
Under EC 1223/2009, every cosmetic product placed on the EU market must have a designated Responsible Person (RP) established within the EU. The RP bears legal responsibility for ensuring that the product complies with all applicable regulations before it reaches consumers.
The same principle applies in the UK under the UK Cosmetics Regulation, where a UK Responsible Person must be designated for products sold in Great Britain.
The Responsible Person is NOT the manufacturer, safety assessor, or formulator. The RP's role is to ensure that all required documentation exists, is accessible, and that the product meets regulatory requirements - not to create that documentation.
As your Responsible Person, MedNet EC-REP takes on the legal obligations defined in Article 5 of EC 1223/2009, acting as your official representative and point of contact for competent authorities.
What We Do as Your Responsible Person
All legal obligations under EC 1223/2009 Article 5
As your designated Responsible Person, we fulfil all obligations required by EU and UK cosmetics regulations. Our services cover everything the law requires from a Responsible Person—nothing more, nothing less.
Our Responsibilities Under EC 1223/2009
These are the legal duties we assume as your Responsible Person:
Product Notification (CPNP/UK SCPN): We register your cosmetic products in the EU Cosmetic Products Notification Portal (CPNP) and/or the UK Submit Cosmetic Product Notification (SCPN) system before market placement.
PIF Retention & Accessibility: We keep your Product Information File (PIF) readily accessible for competent authorities for 10 years after the last batch was placed on the market.
Label Compliance Check: We verify that all mandatory labelling elements are present on your product packaging (RP name and address, ingredients list, PAO/expiry, batch number, warnings, function).
Authority Liaison: We act as the official point of contact for competent authorities and respond to their inquiries on your behalf.
Serious Undesirable Effects (SUE) Reporting: We report serious undesirable effects to the competent authorities as required by Article 23.
Regulatory Monitoring: We monitor regulatory changes affecting your products and inform you of any actions required.
In summary: We ensure your products can legally be placed on the EU and UK markets by fulfilling all Responsible Person obligations. We verify that required documentation exists and is compliant.
Documentation Manufacturers Must Provide
Required before market placement:
Complete Product Information File (PIF) containing all elements required by Article 11 of EC 1223/2009
Cosmetic Product Safety Report (CPSR) prepared and signed by a qualified safety assessor (Part A and Part B)
Product description and formulation with quantitative composition of all ingredients
Proof of GMP compliance (ISO 22716) for manufacturing
Stability and microbiological test data supporting the PAO or expiry date
Label artwork in all required languages for target markets
Don't have all documentation ready?
We can recommend trusted partners for safety assessments, PIF compilation, and other specialised services. Contact us to discuss your specific situation.
How It Works
From first contact to market placement in 5 steps
- 1
Initial Consultation
We discuss your products, target markets (EU/UK), and verify your existing documents to identify any gaps.
- 2
Documentation Review
You provide your PIF, CPSR, and label artwork. We review completeness and identify any missing elements.
- 3
Gap Resolution
If documentation is incomplete, we guide you on what's needed. We can recommend partners for safety assessments or PIF compilation if required.
- 4
Notification & Label Check
Once documentation is complete, we perform CPNP/UK SCPN notification and verify all mandatory label elements are present.
- 5
Ongoing Compliance
We retain your PIF, handle authority inquiries, report SUEs, and keep you informed of regulatory changes affecting your products.
EU vs. UK: Understanding the Differences
Since Brexit, the EU and UK operate as separate regulatory markets for cosmetics. If you sell in both markets, you need representation in both jurisdictions.
European Union (EC 1223/2009)
Requires an EU-based Responsible Person. Products must be notified via CPNP. The RP must be established within an EU member state. MedNet EC-REP GmbH in Germany serves as your EU Responsible Person.
United Kingdom (EC 1223/2009)
Requires a UK-based Responsible Person. Products must be notified via UK SCPN. The RP must be established in Great Britain. Our UK subsidiary serves as your UK Responsible Person.
One Partner, Both Markets: MedNet EC-REP provides Responsible Person services for both the EU and UK through our established entities in Germany and the United Kingdom. One point of contact for seamless market access across Europe.
Frequently Asked Questions
Common questions about Responsible Person services
Can't find what you're looking for? Contact our team