EU Responsible Person (RP)
€500.00
EU Responsible Person service ensuring full regulatory compliance and market readiness for cosmetic products. Mandatory for non-EU brands and available as an independent third-party option for EU-based manufacturers.
Description
Açıklama
The EU Responsible Person (RP) is a legal requirement under Regulation (EC) No 1223/2009, ensuring that every cosmetic product placed on the European Union market complies with applicable safety and regulatory standards.
The Responsible Person acts as the official representative within the EU, guaranteeing that products meet all obligations defined by the Regulation; including safety, labeling, documentation, and market surveillance readiness.
For non-EU manufacturers, appointing an EU-based Responsible Person is a legal obligation, a product cannot be placed on the EU market without a designated RP established within the European Union.
For EU-based manufacturers, having a third-party Responsible Person is optional, but often preferred. Many brands choose to work with an independent consultancy like Lexora for added expertise, impartial compliance checks, and secure handling of confidential product information.
At Lexora, we act as your trusted EU Responsible Person, providing end-to-end support to ensure your cosmetic products are fully compliant and market-ready.
Key Responsibilities of the EU Responsible Person
-
Ensuring the Product Information File (PIF) is complete, up to date, and available to competent authorities upon request.
-
Verifying that a Cosmetic Product Safety Report (CPSR) is prepared and signed by a qualified safety assessor.
-
Confirming product labeling and claims comply with Article 19 and Annex III–VII of the Regulation.
-
Managing notification to the Cosmetic Products Notification Portal (CPNP) before the product is placed on the market.
-
Acting as the point of contact for competent authorities and cooperating in any market surveillance or post-market action.
-
Monitoring and reporting Undesirable Effects (UE) and Serious Undesirable Effects (SUE).
-
Maintaining regulatory correspondence and ensuring ongoing compliance for all marketed products.
F.A.Q
Ek bilgi
| What does the EU Responsible Person service fee cover? | The fee for this service is €500 per product, which covers the designation of Lexora Consultancy as your EU Responsible Person for a period of one year. During this time, we assume full legal responsibility for the product under Regulation (EC) No 1223/2009 and handle compliance oversight, CPNP notifications, and communication with competent authorities. The exact scope of our services, rights, and obligations is detailed in the mutually signed mandate, which clearly specifies all responsibilities covered by the fee. Any additional services outside this mandate can be arranged separately. |
|---|---|
| Who needs to appoint an EU Responsible Person? | Under Article 4 of Regulation (EC) No 1223/2009, every cosmetic product made available on the EU market must have a designated Responsible Person (RP) established within the European Union. |
| Can Lexora act as Responsible Person for both EU and non-EU companies? | Yes. We serve as the mandatory Responsible Person for brands outside the EU and as an independent third-party Responsible Person for EU-based manufacturers who prefer external regulatory representation. With over 5 years of regulatory expertise and know-how, our team ensures full compliance, clear communication, and smooth market access for your cosmetic products. |