The EU internal market comprises an area without internal frontiers in which the free movement of goods is ensured in the internal market by the harmonisation of rules at Union level in accordance with the Treaties. Restrictions or measures having equivalent effect on imports are prohibited between Member States. That prohibition covers any national measure which is capable of hindering, directly or indirectly, actually or potentially, intra-Union trade in goods.

The principle of Mutual recognition applies to products or aspects of products, which are not subject to Community harmonisation legislation. According to that principle, a. Member States may not prohibit the sale on its territory of products which are lawfully marketed in another Member State, even where those products were manufactured in accordance with technical rules different from those to which domestic products are subject, unless it compromises essential public interest requirements, particularly the health and safety of the individuals.

The producer (or his importer/distributor) of goods, or of goods of a given type, that are being made or are to be made available on the market may draw up a voluntary declaration of lawful marketing of goods for the purposes of mutual recognition (‘mutual recognition declaration’ in line with Article 4 and Annex of that same regulation) in order to demonstrate to the competent authorities of the Member State of destination that the goods, or the goods of that type, are lawfully marketed in another Member State.

This principle is regulated by the Mutual Recognition Regulation 2019/515. Article 5 therein lays down the procedures that Member States’ competent authorities should follow when assessing a product that fall within the scope of this Regulation.

The assessment process involves an exchange of information between the economic operator and the competent authority, to validate that the product is lawfully marketed in another Member State. Article 5 also stipulates timeframes by which the operator has to provide the information to the competent authority, and that by which the competent authority is required to take an administrative decision and communicate it to the operator, the other Member states and the Commission. To facilitate and accelerate the process the economic operator may draw a voluntary Mutual Recognition Declaration. 

The Declaration, whilst non-mandatory, helps national authorities verify that a product is currently lawfully marketed elsewhere in the European Union. It is therefore recommended to draw up the Mutual Recognition Declaration if your product falls outside of harmonized rules. For guidance on the content of this declaration, refer to Article 4 and the Annex of the regulation and follow this link for a more in-depth look at the declaration.  

In case of a dispute regarding an administrative decision, you can find the information on the remedies page. 

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