Who is a Responsible Person

According to Article 4 of the Regulation (EC) No. 1223/2009 on cosmetic products which came into force in July 2013 a Responsible Person (RP) is a legal or natural person established in the European Union. The RP is responsible for the safety and legal compliance of cosmetic products to the EU safety standards. A Responsible Person should be designated for each cosmetic product put on the European market.

All inspections will always be carried out at the address of the Responsible Person, as stated on the product label. The Responsible Person is the one in contact with the supervisory authorities of the European Union.

Usually, on the cosmetics market the manufacturer, importer or distributor of cosmetic products act as RP.

What does an EU Responsible Person do

The most important function of the Responsible Person in the EU is to deal with the regulatory authorities when questions arise concerning the safety and quality of cosmetic products and their compliance with Regulation (EC) No. 1223/2009 on cosmetic products. The Responsible Person shall therefore be accessible at the contact details provided in the declaration and shall be able to provide the regulatory authorities with the technical documentation and information relating to the conformity of the cosmetic products with the quality standards as quickly as possible.

The obligations of the Responsible Person within the territory of the EU can be summarized as follows:

  • Drawing up the declaration of conformity on the basis of the technical documentation, test reports and expert opinions provided by the manufacturer and EU notified laboratories.

  • Keeping of the technical documentation for at least 10 years, even in case of discontinuation of cooperation.

  • Communicating with the EU regulatory authorities regarding the safety and harmlessness of cosmetic products and their conformity with Regulation (EC) No. 1223/2009.

  • Participating and representing the manufacturer in consumer accident investigations.

  • Keeping up with the changes in EU standards and cosmetics regulation in particular.

  • Participating in product recalls initiated by supervisory authorities or the manufacturer.

CCIS-EXPERTISE as your EU Responsible Person

CCIS-EXPERTISE is an EU resident registered in France and is authorised under EU law to act as an Responsible Person for EU conformity assessment of cosmetic products according to Regulation (EC) No. 1223/2009 for companies outside the EU.

Besides, having a “neutral” Responsible Person in the EU can be an optimal solution in comparison to choosing one distributor or importer as one.

Acting on the basis of an agreement with the manufacturer, the Responsible Person issues a declaration of conformity for the products in his own name and under his full responsibility. The declaration states the entity's address and contact details. In this way, the Responsible Person acts as the guarantor of a foreign company in the EU.

The transfer of authority from the manufacturer to the Responsible Person is subject to a written mandate (contract) with an explicit indication of the Responsible Person's rights, obligations, and restrictions.

As your Responsible Person CCIS-EXPERTISE guarantees:

  • Quality advice and support throughout the process thanks to our 10+ years of experience in conformity assessment procedures worldwide.
  • Confidentiality of the information, technical or other, transferred to us.
  • Prompt and effective communication with competent authorities.
  • Optimization of conformity assessment processes thanks to our vast network of partners/notified laboratories

Cost of services

The cost of an EU Responsible Person service is calculated on a case-by-case basis and depends on the risk evaluation relating to the cosmetic product.

FAQs

Who is a Responsible Person in EU?

A Responsible Person is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their behalf with regards to CE legislation. This entity may be contacted by competent authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of the Directive(s)/Regulation(s) according to which the compliance of the products was assessed.

What are the duties of a European Responsible Person?

The role of a Responsible Person in Europe is important and challenging. The main duties include, but are not limited to, the following:

  • Providing a registered address within the European Union

  • Keeping all technical documentation available for inspection by the European Authorities

  • Completing notifications to European Authorities

  • Completing any registrations to national databases

  • Taking care of any incident reporting

  • Representing the manufacturer towards the European Commission, Authorities and Notified Bodies

  • Safeguarding and ensuring compliance with constant regulatory updates

  • Consulting on European Regulations

What is the difference between an EU Responsible Person or EU Responsible Person?

According to Article 4 of the Regulation (EC) No. 1223/2009 on cosmetic products, each cosmetic manufacturer not located in the European Union must designate a Responsible Person (RP) before making his cosmetic products available on the EU market.
The RP is responsible for ensuring that all the obligations related to cosmetic product conformity have been carried out prior to launching the product on the EU market. The RP is supposed to act as the contact point in Europe for competent authorities, controlling bodies, and customers with regards to safety of cosmetic product put on the European market.

An EU Responsible Person has the same duties as an EU Responsible Person within the framework of the rest of the European New Approach Directives and European Regulations.