7.4.2 市場監視措置

Where, having performed an evaluation, a market surveillance authority finds that a product is non-compliant or that a product is compliant but presents a risk to the health or safety of persons or to other aspects of public interest protection (297), it has to follow a sequence of procedures aimed at ensuring that appropriate and proportionate action is undertaken across the EU. These procedures are laid down in Articles 16, 18, 19 and 20 of Regulation (EU) 2019/1020 and, for a large part, in more detail in Union harmonisation legislation, in line with the safeguard procedures laid down in Articles R31 and R32 in Annex I of Decision No 768/2008/EC. (298)

Market surveillance authorities must first contact the relevant economic operator, informing it about the findings and giving an opportunity to provide its view within period of no less than 10 working days (299). This step is skipped in case of urgency based on health, safety or other aspects of public interest grounds. In such case, the economic operator must be given such opportunity as soon as possible afterwards.

The next step (300) is to require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk. The market surveillance authorities must also inform the relevant notified body (if any) in case an applicable safeguard procedure in the Union harmonisation legislation concerned specifies so (301).

If there is a manufacturer, authorised representative or importer in the EU, the market surveillance authority should address them directly, unless the issue specifically relates to a distributor or another economic operator (302). If there is none of these economic operators in the EU, then, for certain categories of products, the market surveillance authority has the option of contacting the fulfilment service provider in the EU, if there is one. Otherwise, the market surveillance authority should attempt to contact the manufacturer in the third country.

There is a range of actions possible, including but not limited to the actions listed in Article 16(3) of Regulation (EU) 2019/1020. These range from rectifying formal non-compliance to withdrawing or recalling the products. The action must be in accordance with the degree of risk or non-compliance, and the impact on the free circulation of products may not go beyond what is necessary for achieving the objectives of market surveillance (see Section 7.4.2.2). A different approach may apply in the case of serious risk. Market surveillance authorities carry out a risk assessment in order to verify if products present a serious risk. According to Article 19(2) of Regulation (EU) 2019/1020, an appropriate risk assessment ‘takes account of the nature of the hazard and the likelihood of its occurrence’. In case the risk is deemed to be ‘serious’, market surveillance authorities must adopt a rapid intervention following the specific provisions of Articles 19 and 20 of Regulation (EU) 2019/1020. The types of actions in this case consist in withdrawing or recalling the products, except where there is another effective way to eliminate the serious risk. Market surveillance authorities may, in these urgent cases, adopt restrictive measures without waiting for the economic operator to take corrective action. In such case, the economic operator must be given an opportunity to provide its view as soon as possible after a decision, order or measure taken, which shall then be reviewed promptly by the market surveillance authority (Article 18(3) of Regulation (EU) 2019/1020).

Economic operators must ensure that the corrective action is taken throughout the EU. If the non-compliance or risk relates only to part of a series of products manufactured that can be reliably identified, only that part needs to be addressed. If there is a doubt about either the risk being limited to a certain part or the reliable identification of that part, the corrective action should concern all the products/series. For an isolated error, limited to the territory of the Member State that has discovered the non-compliance, there is no need to take action throughout the EU.

Market surveillance authorities have to verify that corrective action has been taken. If an economic operator does not take adequate corrective action within the period indicated by a market surveillance authority, the market surveillance authorities have to take appropriate measures to prohibit or restrict the making available of the product on their national market, to withdraw the product from that market or to recall it. These measures have to be communicated to the relevant economic operator without delay.

Market surveillance authorities must inform the Commission and the other Member States about the results of the compliance evaluation and about the actions required of the economic operator or the measures adopted. In case of serious risk, market surveillance authorities notify to the Commission through RAPEX system of any voluntary or compulsory measure according to the procedure laid down in Article 20 of Regulation (EU) 2019/1020 and/or Article 12 of Directive 2001/95 on general product safety. In the case of products that do not present a serious risk, the Commission and the other Member States will be informed by means of the information support system provided for in Article 34 of Regulation (EU) 2019/1020 and, where appropriate, Article 11 of Directive 2001/95 on general product safety.

Market surveillance authorities in the other Member States will normally have to follow up on the notification by verifying whether the same product has been made available on their territories and by adopting appropriate measures. Additional information on this is provided in Sections 7.5.1 and 7.5.2, as well as in the RAPEX guidelines.

Any measure, decision or order taken or made by national market surveillance authorities must state the exact grounds on which it is based. The relevant economic operator must be notified. They must also be informed about the remedies available under the national law in force in the Member State in question, and of the time limits for such remedies.

Requirements in Union harmonisation legislation include both the essential requirements, and a number of administrative and formal requirements. When competent national authorities discover that a product is not in compliance with the provisions of the applicable Union harmonisation legislation, they must take action to ensure it is brought into conformity or taken off the market or recalled.

The corrective action depends on the risk or non-compliance and, thus, must be in accordance with the principle of proportionality. Non-conformity to essential requirements must generally be considered as a substantial non-compliance, because this may lead to the product presenting a potential or actual risk to the health and safety of persons or to other aspects of public interest.

If a product covered by Union harmonisation legislation is not CE marked, it is an indication that the product does not comply with the essential requirements or that the conformity assessment procedure has not been applied and, consequently, the product may endanger the health and safety of persons or harm other public interests protected by that legislation. Only if, following further investigation, the product proves to be compliant with the essential requirements, the absence of the CE marking is to be considered as a formal non-compliance (i.e. the product does not present a risk).

Unless there are reasons to believe that the product presents a risk, there are cases where non-compliance with a number of administrative or formal requirements are defined as formal non-compliance by certain Union harmonisation legislation. The incorrect affixing of the CE marking as regards, for instance, the design, size, visibility, indelibility or legibility, can usually be considered as a formal non-compliance. Further examples include situations where other conformity markings provided for in the Union harmonisation legislation are incorrectly affixed, or where the EU declaration of conformity cannot be provided for immediately or it does not accompany the product when this is mandatory, or the requirement to accompany other information provided for in sectoral Union harmonisation legislation is complied with insufficiently, or, where applicable, the identification number of the notified body has not been affixed to the CE marking.

PROSAFE (303) ‘Guidelines for Businesses to manage Product Recalls & Other Corrective Actions’ have been designed to assist businesses to ensure, whenever necessary, the appropriate corrective actions and follow-up once a product has been already made available on the EU market or is coming from third countries.

Actions to prohibit or restrict the placing on the market may first be temporary to allow the market surveillance authority to obtain sufficient evidence about the risk or other substantial non-compliance of the product.