To the extent that a product that has not been harmonised or has not been fully harmonised has been lawfully placed on the market in one Member State, the sale of that product in another Member State may not, in principle, be prohibited (as we reported). This principle is based on the Cassis de Dijon decision of the European Court of Justice and, according to EU Regulation 2019/515 on the mutual recognition of goods, applies even if the technical product regulations in the various Member States differ.
Exceptions to the principle
However, this principle does not apply without restriction: Exceptions are to be permitted for compelling reasons of general interest, such as the protection of health or for other consumer protection reasons. Thus, the competent authorities of the Member States may implement different regulations and systems for the control of goods both before and after a product is placed on the market.
In some Member States, therefore, the placement of such products on the market is subject to formal approval by the competent authority of the Member State if there are specific national technical specifications for the product in that Member State. This prior authorisation procedure is an administrative procedure under which the authority formally decides on the admissibility of the placement of the product on the market of the Member State. If the competent authority refuses market access, it must inform the economic operator concerned and the Commission within 20 days.
However, even after being placed on the market, goods can be assessed by the competent market surveillance authorities to determine whether they were lawfully placed on the market in the Member State of origin or whether there are legitimate public interests that could, by way of exception, justify a restriction to market access.
Common to all these procedures is that the competent authorities must inform the economic operator concerned in advance of the assessment, the content of the assessment and the prior authorisation procedure.
Self-declaration by the economic operators
In response to an announced official product assessment, the economic operator concerned may issue a self-declaration (cf. Annex to Regulation 2019/515), thereby declaring that the goods have been lawfully placed on the market in another Member State. The factual effect of such a self-declaration is that the authority cannot demand any further evidence of the marketability of the product beyond the proof of product conformity. However, the voluntary self-declaration does not, as a result, prevent the authorities from ordering a restriction or denying market access.
If a product has been denied marketability in the Member State based on the competent authority’s assessment, the SOLVIT network can be used as a problem-solving mechanism in cases of dispute. SOLVIT is a European system of advice centres that seeks a case solution within a declared 10-week period in the case of regulations and decisions that violate applicable EU law, and can thus provide a speedy remedy.
Economic operators who market non-harmonised or not fully harmonised products across borders are advised to obtain timely information on the regulations and systems for control of these goods as well as on the technical requirements in all Member States where the product is to be marketed. For this purpose, the respective product contact points of the countries can be contacted to obtain information on the applicable technical product regulations free of charge upon request within 15 working days. In parallel, economic operators should make use of the possibility to issue a voluntary self-declaration in order to speed up the assessment procedure of authorities as well as to limit their own administrative burden. A specimen self-declaration can be found in the Annex to Regulation (EU) 2019/515. At a final level, the SOLVIT process provides a free and viable way to expeditiously resolve disputes with authorities.back