EU Responsible Person - A Reliable Contact for Full Compliance
To sell cosmetics in the EU, each product must have a designated Responsible Person (RP) based in the European Union. Sobel takes on this responsibility for you, ensuring your products remain compliant before and after entering the EU market.
Compliance Becomes Predictable With a Reliable RP
- When your brand needs an EU-based legal representative before market entry
- When CPNP notifications and label reviews become difficult to manage internally
- When your PIF must be accessible, traceable, and retained for 10 years
- When post-market vigilance requires consistent monitoring and timely reporting
- When you want a single, dependable address on pack for your full portfolio
We serve as your fully mandated EU Responsible Person, handling pre-market, on-market, and post-market obligations.
A Strong RP Is the Anchor of EU Market Access
The Responsible Person is not administrative support — it is the legal gatekeeper of EU cosmetic compliance.
From notification and labeling to safety documentation and vigilance, your RP is responsible for presenting evidence, answering authorities, and ensuring each product remains compliant throughout its lifecycle.
Your Path to a Fully Compliant EU RP Setup
Our RP workflow brings order and clarity to every regulatory obligation, helping your products move into and remain on the EU market without gaps or delays.
We formalize the Article 4 mandate, confirm pack details, and set up the RP contact channels with authorities.
We review your PIF location, CPSR, GMP statement, label texts, claims evidence, and any prior notifications to prepare your portfolio for the RP role.
We notify each product under Article 13 before market entry and coordinate any nanomaterial submissions that require prior notification.
We verify mandatory particulars under Article 19, including correct RP name/address placement and alignment with claims and PIF content.
We operate your RP inbox, triage undesirable effects, prepare SUE reports, and communicate with competent authorities as required under Article 23.
We keep CPNP entries, RP records, and product documentation aligned whenever your formulation, label, distribution or regulatory obligations change.
Ensure Your Products Have a Trusted EU RP
A single, trusted contact for authorities and a consistent process across your entire cosmetics portfolio.
RP Appointment & Label Address: Official Article 4 appointment, RP contact details, and the EU address to print on pack.
CPNP Notifications & Updates: Complete Article 13 submissions, amendments, nanomaterial notifications, and communication with authorities whenever required.
PIF Access & Retention Management: Confirmation of PIF location and completeness, 10-year retention alignment, and clear access notes for authorities.
Label & Claims Checks (Text): Verification of Article 19 particulars and RP name/address placement, aligned with the claims and PIF content.
Post-Market Vigilance Coordination: Monitoring of the RP inbox, triage of undesirable effects, preparation of initial/final SUE reports, authority submissions, and support for corrective actions.
Change Control & Portfolio Hygiene: SKU/variant tracking, CPNP updates, and consistency checks across PIF, CPSR, labels, and notifications.
Partner With Sobel as Your EU RP
With Sobel as your RP, your regulatory responsibilities are handled with clarity, consistency, and the expertise needed to support safe, compliant market access.
A Consistent RP Process Makes EU Compliance Smoother
With a single, experienced RP managing notifications, files, labels, and vigilance, your products move into the EU market with more predictability and far less administrative burden. We’re ready to guide your brand through every requirement!
FREQUENTLY ASKED QUESTIONS
The EU manufacturer, the importer, or a mandated EU-based third party. Sobel acts as this third party when appointed.
Yes. A non-EU manufacturer must appoint an EU-based Responsible Person before placing products on the market.
Before market entry. Nanomaterials require additional prior notification, often 6 months before launch.
10 years after the last batch is placed on the market, accessible at the RP address.
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