Mutual Recognition: making it easier to sell in multiple EU countries

The importance of mutual recognition in EU law

The Single Market is a fundamental component of the EU and it aims at guaranteeing the four freedoms of movement for goods, services, capital and labor in the EU. The free movement of goods can only be fulfilled if Member States do not discriminate against products coming from different countries of origin, placing additional technical obstacles at a national level, especially in those sectors where the legislation is not fully harmonized on at a EU level.

In this regard, manufacturers may certainly benefit from using the principle of mutual recognition and the new instruments offered by the  Regulation 2019/515/EU, which became fully applicable on April 19, 2020, replacing the previously applicable Regulation 764/2008/EC.

Although there are clearly exceptions to mutual recognition of products among Member States, especially when there are questions of public safety, it is a very useful instrument for companies interested in placing their products in several EU countries.

The novelties of Regulation 2019/515/EU

  • National Competent Authorities (CA) must follow the specific assessment procedure provided by the Regulation’s Art. 5 in order to assess the applicability of mutual recognition in relation to goods; should the decision be a negative one, justification will need to be provided in order to duly support the existing reasons and concerns that prevent mutual recognition from applying;
  • Companies which believe that a CA has wrongly refused access to the sale of their products in a given Member State, may make use of the SOLVIT instrument, provided that the dispute has not already been brought to Court;
  • Product Control Points (PCPs) have been set out in each Member State in order to provide clarity regarding the existing rules under the new Regulation. The PCPs must provide a response within 15 days from the reception of any queries regarding the Regulation.

The Mutual Recognition Declaration

Companies are also given the possibility to compile a mutual recognition declaration, which enables them to use it as a supporting document upon request of the Competent Authorities as a proof that their products are lawfully marketed in another Member State.

The mutual recognition declaration is easy to compile and it is divided in two separate parts, to be filled in either by the producer or, according to the case, the producer/representative and the importer/distributor. The declaration requires to list the company name, product type and legal references of the national legislation the product is claiming compliance with. The receiving CA may request to translate the declaration in the language of their choice.

Although compiling the declaration is purely voluntary, the main advantage of doing so is that, upon its submission to the relevant CA, they may not request additional information. On the contrary, should a manufacturer choose not to submit the declaration, the CA may request information regarding the products’ characteristics and supporting documents that the goods were lawfully marketed in another EU Member State. In such cases, companies have at least 15 working days to provide the information to the relevant CA.

It is interesting to note that during the assessment period, a company may still sell their products freely on the concerned EU country. However, the products’ sale shall be halted should the company receive a negative administrative decision from the concerned Member State.

Alessandro Polimeno

Regulatory Affairs Expert Consultant

R&D Department


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If you wish to know more about how to apply for mutual recognition of your products, please do not hesitate to contact us. Obelis Expert Consultants, having more than 30 years of experience with EU Regulations, will gladly answer any question you may have and will gladly assist you in safeguarding and achieving your products’ compliance.

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