A product that has been lawfully marketed in an EU Member State may be marketed in another EU Member State. In practice, however, the functioning of this mutual recognition is not optimal. Regulation 2019/515 aims to revamp and facilitate the use of mutual recognition through a number of adjustments to the regulatory framework.

The framework

According to the principle of mutual recognition, a product may be marketed in an EU Member State ("Member State of destination") if it has been lawfully marketed in another EU Member State, even if it has not been manufactured in accordance with the technical rules in force in the Member State of destination.

Member States can only avoid the application of that principle if they demonstrate that the product may not be marketed on their territory for a reason referred to in Article 36 TFEU or for an overriding reason of public interest.

Regulation 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State already aimed at improving the application of the principle of mutual recognition through the establishment of procedural rules and product contact points. However, following evaluation, that Regulation was found to have contributed only in a limited way to a better application of the principle of mutual recognition. Many companies which aim to market a product in another Member State verify the technical rules in force in that Member State and adjust their product to those rules. When invoking the principle of mutual recognition, national authorities often deny market access to those products, according to the European Commission.

The Commission's aim in its Goods Package (2017) was therefore to revamp and facilitate the use of mutual recognition. The result is Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State, which replaces Regulation 764/2008. It applies to any product to the extent that it contains non-harmonised aspects. It affects any administrative decision which prohibits or restricts the marketing of that product on the market of the Member State of destination.

We will briefly discuss the main innovations introduced by Regulation 2019/515 compared to Regulation 764/2008.

Introduction of a declaration of mutual recognition

Economic operators must prove that their product has been lawfully marketed in another Member State. Today, Member States of destination require different means of proof from the economic operator, ranging from an invoice to an official declaration from the Member State in which the product was lawfully marketed. In order to reduce the administrative burden on economic operators, Regulation 2019/515 provides for a voluntary declaration of mutual recognition. A model for the declaration is annexed to Regulation 2019/515. The declaration enables economic operators to immediately provide the Member State of destination with all information on the product and its conformity with the technical rules in force in another Member State. The Member State of destination must accept the declaration as sufficient to prove that the product has been lawfully marketed in another Member State. The declaration is thus a standardised means of proof which must be accepted by the Member State of destination, but nothing prevents the Member State from denying the product market access, provided that the principle of mutual recognition and Regulation 2019/515 are respected.

The use of SOLVIT

In order to combat an administrative decision denying market access, economic operators currently have to rely on an often costly and lengthy procedure before national courts and tribunals. Regulation 2019/515 promotes the use of SOLVIT (the Internal Market Problem Solving System), an existing service offered at the national level which mediates free of charge and informally in a dispute between inter alia an economic operator and a Member State of destination. Regulation 2019/515 lays down a specific procedure according to which the SOLVIT centre can request the non-binding opinion of the Commission in a specific case.

New procedural rules

Today, a Member State of destination has to inform an operator of its intention to take an administrative decision denying market access. Under Regulation 2019/515, a Member State of destination will have to notify an economic operator of its intention to carry out an assessment in order to verify whether the product has been lawfully marketed in another Member State and the legitimate public interests, as guaranteed by the national technical rule, are sufficiently protected. The administrative decision itself must obviously be notified to the economic operator. The information to be included in that decision has been slightly modified as compared to Regulation 764/2008 and is laid down in Article 5 of Regulation 2019/515.

As is the case today, the economic operator may, in principle, continue to market the product in the Member State of destination during the assessment, except under a prior authorisation procedure. The possibilities for that Member State to temporarily suspend the marketing of the product during the assessment have changed slightly. Under Regulation 2019/515, a Member State will be able to temporarily suspend the marketing of the product if the product poses a serious risk to the safety or health of humans or the environment and requires rapid intervention, whereas today a suspension is only possible in case of a serious risk to the safety and health of users. The possibility of suspension where the marketing of the product is generally prohibited on grounds of public morality or public security is maintained.

Improvement of cooperation between Member States

Under Regulation 2019/515, a Member State of destination will have to notify the administrative decision denying a product market access not only to the Commission, but also to the other Member States. The same applies to an administrative decision temporarily suspending the marketing of the product during the assessment.

Furthermore, the Commission will ensure efficient cooperation between Member States and the existing product contact points, for example by:

  • coordinating the exchange of information;
  • supporting the functioning of the product contact points; and
  • organising training and awareness raising programmes.

Finally, Regulation 2019/515 specifies that a Member State of destination may submit a request for the release of information to (the product contact points of) the Member State in which the economic operator claims to have lawfully marketed his product, thus allowing the Member State of destination to verify the accuracy of the information provided by the economic operator. The approached Member State must provide the requested information within 15 working days.

Such cooperation between Member States will be carried out through the Information and Communication System for Market Surveillance established by Regulation 765/2008 and amended by Regulation 2019/1020.

Regulation 2019/515 will apply from 19 April 2020 onwards.