Guide to the mutual recognition of goods

Philipp Reusch

Regulation (EU) 2019/515 of the European Parliament and of the Council on the mutual recognition of goods lawfully marketed in another Member State has been in effect since 19 April 2020.

The EU Commission has now issued a Guide to help companies and competent national authorities apply the Regulation.

Mutual recognition principle

The mutual recognition principle means that:

  • Member  States  cannot  forbid  the  sale  on  their  territories of products which are  lawfully  marketed in another Member State;
  • Member States may restrict or refuse the marketing of products which are lawfully marketed in another Member States if the restriction or refusal is justified.

How mutual recognition works

In general, goods falling within the scope of the Regulation may be placed on the market in another Member State as soon as they are lawfully marketed in another Member State.

Goods are considered to be lawfully marketed in another Member State if they comply with relevant rules applicable in the Member State of origin or are not subject to any such rules in that Member State, and are made available to end users in that Member State.

If a competent authority in the Member State of destination intends to conduct an assessment of the aforementioned goods, it must notify the economic operator without delay so that the latter can issue a mutual recognition declaration.

If the economic operator decides not to issue the aforementioned declaration, the competent authority may request the economic operator to submit appropriate documents and information for the assessment within a period of at least 15 working days.

Otherwise, the rule is that the aforementioned goods may be made available on the market of the Member State of destination, even while the assessment by the competent authority is ongoing, unless the authority rules differently (e.g. in a temporary decision).

Possible grounds for restriction or refusal of market access

Restriction or refusal of market access is justified e.g. for the protection of public health and consumers, although the measures must satisfy the principle of proportionality, meaning that they must be necessary and suitable to accomplish the relevant goal.

Practical notes

For economic operators which distribute goods in the EU which are not subject to harmonization at the EU level, the mutual recognition principle may provide considerable relief.

In order to use this system safely, however, it is absolutely necessary to check before placing goods on the market to ascertain whether they may be subject to prior authorization procedures and whether national technical rules may exist, e.g. for the protection of consumer health and safety. Economic operators may turn to so-called product contact points for this purpose.

[April 2021]