EU Responsible Person for cosmetics

Support for manufacturers and importers meeting the requirements for selling cosmetic products in the EU.

Following a product and documentation review, we agree the terms for acting as your EU Responsible Person. We connect compliance review, CPSR, PIF, CPNP and labelling with the ongoing obligations that apply after launch.

How we help

The scope depends on your products, your role and the available documentation. We take on the role only after an appropriate review and written appointment.

Review before appointment

We review formulations, safety documentation, manufacturing information, labels and claims, and identify any gaps.

CPSR and PIF

We prepare or review the safety report and product information file, and arrange for them to remain current and accessible.

CPNP notification

We handle notification and the required updates to product and Responsible Person information in the CPNP portal.

Details on your label

We review the Responsible Person name, address and other mandatory information. Use of BiSafe details is subject to agreement and appointment.

Product changes

We agree how you notify us of changes to formulations, suppliers, manufacturing, labels and claims, and review the impact on compliance.

Support after launch

We arrange cooperation with competent authorities, the handling of safety information and procedures for required corrective measures.

Who needs an EU Responsible Person?

Every cosmetic product needs a designated Responsible Person established in the EU before it is placed on the market. For EU-made products, this is generally the EU manufacturer. For imported products, each importer is generally the Responsible Person for the specific product they place on the market.

In the cases provided for in Article 4, the manufacturer or importer may appoint another EU-established person by written mandate, which must be accepted in writing. For imports from South Korea or other countries outside the EU, we first review the roles of the manufacturer and importers and arrange the appropriate appointment.

The Responsible Person takes on legal obligations.

The service involves ensuring compliance within the Responsible Person’s duties. An EU address or a CPNP entry alone is insufficient. CPNP notification is not a marketing authorisation or a safety certificate.

Responsibilities during and after sale

  • Ensure the safety assessment, appropriate PIF, compliant labelling and notification are in place before market launch.
  • Keep the PIF current and accessible to the competent authority at the address shown on the label for ten years after the last batch was placed on the market.
  • Ensure compliance with requirements on ingredients, good manufacturing practice and product claims.
  • Handle serious undesirable effects, fulfil notification duties and take corrective action, withdraw or recall products when necessary.

Legal framework: Regulation (EC) No 1223/2009, particularly Articles 4, 5, 10, 11, 13, 19 and 23.

What do we need for a quotation?

Send us your product list and the documentation you already have.

  • Manufacturer and importer details, and planned markets.
  • Product list, formulations and intended uses.
  • CPSR, PIF, manufacturing information and available test results.
  • Labels, claims and existing CPNP notification details.
  • Current Responsible Person details, if you are arranging a transfer.

Appointment and fees are defined in a quotation and agreement following product review. Any required documentation updates and procedures are agreed separately.

Looking for an EU Responsible Person?

Tell us about your products, manufacturer and planned sales. We will review the documentation and propose the next steps for working together.

Related services

CPSR, PIF and CPNP for cosmetic products →

The Only Representative is a different role under REACH. Explore REACH representation →

Send an enquiry

Describe your product and select Cosmetic products.

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