§7.6.2.4 Compliant products presenting a risk

In addition to the safeguard clause procedures allowing for market surveillance measures against non-compliant products to be applied consistently across the Union, Union harmonisation legislation generally foresees the possibility of, and requires for action to be taken against, products which are compliant with the essential requirements but which still present a risk. In particular, where the market surveillance authorities find that a product, while being compliant with the applicable Union harmonisation legislation, presents a risk to the health or safety of persons or to other aspects of public interest protection, they must take measures to require the economic operator to ensure that the product no longer presents that risk, to recall it or to withdraw it, depending on the risk. As soon as a market surveillance authority restricts or forbids the free movement of a product in such way, the Member State must notify (307) without delay the Commission and the other Member States of the provisional measures, indicating the reasons and justification for the decision. The information has to include all available details, in particular: — name and address of the manufacturer, the authorised representative, and in addition – if necessary – the name and address of the importer or other person responsible for making the product available on the market; — the data necessary for the identification of the product concerned and the origin of the product; — the nature of the risk involved; — the nature and duration of the national measures taken; — a reference to the Union harmonisation legislation; — the arguments put forward by the relevant economic operator; — information on the supply chain of the product; and — a copy of the decision taken by the Member State authorities. If possible, the notification should also include: — a comprehensive assessment and evidence to justify the measure (for example the test reports and identification of the testing laboratory); — a copy of the declaration of conformity; and — the name and number of any notified body that intervened in the conformity assessment procedure, if applicable. Where a market surveillance authority adopts such measures against products presenting a risk, the Commission is required without delay to enter into consultation with the Member States and the relevant economic operator or operators and must evaluate the national measure. On the basis of the results of this evaluation, the Commission decides whether the national measure is justified or not. The Commission addresses its decision to all Member States and immediately communicates it to them and the relevant economic operator or operators. If the measure is considered justified, the Commission may also consider adopting proposals to revise the legislation.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07