Do I need an Authorised Representative if I want to sell my products in Europe?

To export and sell most groups of products in the European Union, their conformity must first be assessed in accordance with European quality standards - EU directives - and marked with the CE mark.

According to the current EU regulations and directives, the CE certificate and the declaration of conformity can only be issued by a company residing in the European Union. Companies located outside the EU, e.g. in China, United Arab Emirates, Kazakhstan or Brazil, are not allowed to directly declare the conformity of their products with the EU directives nor affix the CE mark to their products.

There are several ways to resolve this:

  1. Setting up a subsidiary in the EU which will act as Authorised Representative

  2. Issuing certificates to the distributor’s or importer’s name

  3. Appointing an Authorised Representative in the EU

The first two options will turn out to be time-consuming and require important financial resources. For example, establishing a subsidiary in the EU implies that there is at least one employee within the company with corresponding experience.

The issuance of CE certificates and declarations mentioning the importer, or the distributor may involve high risks, as not every importer is ready to undertake the costs and hassle associated with CE certification. Secondly, upon termination of business relations or change of supplier, the importer or distributor will cancel valid certificates. In this case, all the documents would have to be reissued, which would create supplementary costs and take additional time.

Be reminded that an Authorised Representative is obliged to keep the technical documents related to product conformity assessment for at least 10 years since the last batch of products was made available on the market.

On the other hand, using the services of a “neutral” Authorised Representative in the EU can be an optimal solution. Acting on the basis of an agreement with the manufacturer, the Authorised Representative 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 Authorised Representative acts as the guarantor of the foreign organisation in the EU and is responsible for maintaining the right to use the CE mark of the manufacturer. However, the Authorised Representative must be a resident of the European Union.

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

What does an EU Authorised Representative do

The most important function of the Authorised Representative in the EU is to represent the foreign manufacturer in his dealings with the regulatory authorities and the authorities in the European Union when questions arise concerning the safety and quality of products and their compliance with EU directives. The Authorised Representative 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 products with the quality standards as quickly as possible.

The obligations of the Authorised Representative within the territory of the EU can be summarized as follows:

  • Drawing up the declaration of conformity on behalf of the manufacturer, on the basis of the technical documentation and 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.

  • Representing the manufacturer in the EU in cases of questions from national regulatory authorities regarding the safety and harmlessness of goods and their conformity with EU directives.

  • Representing the manufacturer in consumer accident investigations.

  • Informing the manufacturer about changes in EU standards and directives relevant to his product.

  • Informing consumers about the technical and consumer properties of a product.

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

Why choose CCIS as your EU Authorised Representative

CCIS-EXPERTISE is an EU resident, registered in France and is authorised under EU law to act as an Authorised Representative for CE certification for companies outside the EU. We guarantee:

  • 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 Authorised Representative service is calculated on a case-by-case basis and depends on the risk evaluation relating to the product.


Who is an Authorised Representative in EU?

An Authorised Representative 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 Authorised Representative?

The role of a European Authorised Representative 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 Authorised Representative?

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 Authorised Representative has the same duties as an EU Responsible Person within the framework of the rest of the European New Legislative Framework Directives (formerly known as "New Approach Directives") and European Regulations.