7.6.2 セーフガード条項の適用

The safeguard clause procedure, based on Article 114(10) TFEU and included in a large part of sectoral Union harmonisation legislation, requires Member States to take provisional measures in relation to products presenting a risk to health and safety or other aspects of public interests protection and obliges them to notify those measures to the Commission and other Member States. The safeguard clause procedure is designed to provide a means to notify all national market surveillance authorities and the Commission about measures taken on products presenting a risk to health and safety or other aspects of public interests protection, including the grounds for the decision, and, accordingly, to have the necessary restrictions extended to all Member States, so as to ensure an equivalent level of protection throughout the EU. Furthermore, it allows other Member States and the Commission to take a position on the national measures restricting the free movement of products with a view to ensuring the functioning of the internal market.

It is to be noted that the safeguard procedure is different from RAPEX notification procedure because of their different notification criteria and different methods of application. The safeguard clause procedures under the Union harmonisation legislation apply independently from RAPEX. Accordingly, RAPEX does not necessarily have to come into play before the safeguard clause procedure is applied. However, the safeguard clause procedure has to be applied, in addition to RAPEX, when a Member State takes a decision to prohibit or restrict the free movement of products covered by Union harmonisation legislation on the basis of a danger or other serious risk presented by the product.

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restrict or forbid the making available on the market and, possibly, the putting into service of the product, or has it withdrawn from the market where the relevant economic operator does not take adequate corrective action himself.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.

As soon as a market surveillance authority restricts or forbids the free movement of a product in such way that the safeguard clause is applied, the Member State must notify (305) 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 alleged non-compliance and the risk involved;

—the nature and duration of the national measures taken;

—a reference to the Union harmonisation legislation, and in particular to the essential requirements, against which the non-compliance has been established;

—An indication of whether the non-compliance is due to either:

a)failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection; or

b)shortcomings in the harmonised standards conferring a presumption of conformity.

—the arguments put forward by the relevant economic operator; and

—a copy of the decision taken by the Member State authorities.

If possible, the notification should also include:

—information on the supply chain of the product;

—a comprehensive assessment and evidence to justify the measure (for example harmonised standards or other technical specifications used by the authority, 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 objections are raised against a measure taken by a Member State (306), or where the Commission considers a national measure to be contrary to Union harmonisation legislation, the Commission must without delay 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 national measure is considered justified, all Member States must take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and must inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned must withdraw the measure.

Member States other than the Member State initiating the procedure must without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the notified national measure, of their objections. Member States must ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.

Where, within the period of time of receipt of the information specified in the Union harmonisation legislation, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure should be deemed justified.

Whether the action taken by the Member State is considered justified or not, in either case, the Commission keeps the Member States informed of the progress and the results of the procedure.

Once the decision is taken by the Commission, it can be legally challenged by Member States on the basis of Article 263 TFEU. The economic operator directly concerned by the decision may also challenge it on the basis of Article 263 TFEU.

If the initiating Member State does not withdraw the measure in case of non-justification, in this case, the Commission will consider initiating the infringement procedure provided for by Article 258 TFEU.

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.