EU Responsible Person (RP) for Cosmetics

 500.00

EU Responsible Person (RP) for Cosmetics

Ensure EU compliance for your cosmetics with a trusted EU Responsible Person. Lexora provides end-to-end regulatory support, including PIF management, CPSR verification, labeling checks, and CPNP notification, helping your products enter the EU market quickly and legally.

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Info Product

SKU: RP-001 Categories: ,

Description

The EU Responsible Person (RP) is a legal requirement under Regulation (EC) No 1223/2009. Therefore, every cosmetic product placed on the EU market must have a designated Responsible Person.

The Responsible Person acts as the official legal representative in the EU. In addition, they ensure full compliance with EU safety and regulatory requirements. These obligations include product safety, labeling compliance, technical documentation, and market surveillance readiness. Moreover, they provide a clear point of contact for authorities.

For non-EU cosmetic manufacturers, appointing an EU-based Responsible Person is mandatory. Without one, a product cannot be legally placed on the EU market.

For EU-based manufacturers, appointing a third-party Responsible Person is optional. However, many brands prefer this approach. This is because independent consultancies provide expert oversight and impartial compliance checks. Additionally, they ensure secure handling of confidential product data.

Key Responsibilities of the EU Responsible Person

As your EU Responsible Person, we manage all required regulatory obligations:

  • Ensure the Product Information File (PIF) is complete and up to date
  • Make the PIF available to competent authorities upon request
  • Verify that a valid Cosmetic Product Safety Report (CPSR) is prepared
  • Confirm the CPSR is signed by a qualified safety assessor
  • Check that product labeling and claims meet Article 19 requirements
  • Ensure compliance with Annexes III–VII of the Regulation
  • Submit product notifications via the CPNP before market placement
  • Act as the main contact for EU competent authorities
  • Support market surveillance and post-market actions
  • Monitor and report Undesirable Effects (UE) and Serious Undesirable Effects (SUE)
  • Maintain regulatory correspondence
  • Ensure ongoing compliance for all marketed products

Furthermore, we keep you updated on regulatory changes and provide guidance to maintain compliance. Ultimately, this minimizes risk and allows your products to succeed in the EU market.

At Lexora, we act as your trusted EU Responsible Person. We provide end-to-end regulatory support. Our goal is to keep your products compliant and market-ready.

Additional information

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. The Responsible Person can be either a natural or legal person, depending on the company structure. For non-EU manufacturers, appointing an EU-based Responsible Person is mandatory. Without one, the product cannot be legally placed on the EU market. In such cases, the manufacturer must formally designate a third-party company through a written mandate. For EU-based entities, including manufacturers, importers, or distributors, the RP role can be fulfilled internally by the company itself or externally by an appointed third-party organization such as Lexora.

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.