§7.6.2.1 Compulsory restrictive measure taken

The application of the safeguard clause requires that the national market surveillance authority takes one or more compulsory measures to restrict or forbid the making available on the market and, possibly, the putting into service of the product, or has it withdrawn from the market where the relevant economic operator does not take adequate corrective action himself. The contents of the decision should relate to all products belonging to the same type/model, batch or series. It must also have binding legal effect: it is followed by sanctions, if not respected, and can be subject to an appeal procedure. Court decisions, which restrict the free movement of CE marked product within the scope of the relevant Union harmonisation legislation, do not invoke the safeguard clause. However, where administrative proceedings initiated by the surveillance authority must be, according to the national law, confirmed by a court, such court decisions are not excluded from the safeguard clause procedure. The findings that justify the national measure are established either by the market surveillance authority on its own initiative or based on information received from a third party (such as consumers, competitors, consumer organisations, labour inspectorates). Further, the national measure must be based on evidence (for example tests or examinations) that constitutes sufficient proof of errors in the product design or the manufacture to indicate a foreseeable potential or actual danger or other substantial non-compliance, even when the products are correctly constructed, installed, maintained and used in accordance with their intended purpose or in a reasonably foreseeable way. There is a grey zone between correct and incorrect maintenance and use, and it can be considered that, to a certain extent, products should be safe, even if maintained and used for their intended purpose in an incorrect way that can reasonably be expected. In evaluating this, the data supplied by the manufacturer on the labelling, in the instructions, in the user’s manual or in promotion materials are to be taken into consideration. The reason for taking restrictive measures may result, for instance, from differences or failures in the application of essential requirements, incorrect application of harmonised standards or shortcomings in them. The surveillance authority can add or specify other motives (for example failure to comply with good engineering practice) when invoking the safeguard clause, provided that they are directly linked with these three reasons. Where non-compliance with harmonised standards that would imply a presumption of conformity is established, the manufacturer, or the authorised representative, must be requested to provide evidence about compliance with essential requirements. The decision of the market surveillance authority to take measures must always be based on an established non-compliance with the essential requirements. The measures taken by authorities have to be proportionate with the seriousness of the risk and the non-compliance of the product and have to be notified to the Commission.

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