3 第4条に規定する経済事業者の任務

This section categorises and provides guidance on the tasks of the economic operator referred to in Article 4. That economic operator, especially if it is an EU manufacturer or importer, may already have obligations under sector-specific legislation (depending on how it is classified) that fully or partly cover those tasks (see Section 4).

First, in accordance with Article 4(3)(a), the economic operator referred to in Article 4 has to perform a number of tasks when it takes up its duties or when a new product is added to its portfolio:

—verify that the declaration of conformity/performance has been drawn up and keep it – all sector-specific legislation covered by Article 4 requires such declarations (23). As specified in the legislation covered by Article 4, they have to be kept for 10 years after the product has been placed on the market (24). Where more than one legislative act applies to a product, a single declaration conformity is drawn up for all applicable acts together (25), and

—verify that the technical documentation has been drawn up (26) and ensure that it can be made available to market surveillance authorities on request – where the economic operator referred to in Article 4 does not keep the documentation itself, this implies checking that the documentation exists and obtaining assurances from the manufacturer that it will share it on request, either with the economic operator referred to in Article 4 or with the market surveillance authorities directly (see below).

Second, in accordance with Article 4(3)(c) and (d), where the economic operator referred to in Article 4 has reason to believe that a product presents a risk (27), it must:

—inform the relevant market surveillance authorities. It should do this in each Member State in which the product has been made available (28); it is also important to inform them of the corrective action that has been or will be taken, and

—make sure that the necessary corrective action is taken immediately to remedy any case of non-compliance or, if that is not possible, to mitigate the risk (see below).

Finally, in accordance with Article 4(3)(a), (b) and (d), the economic operator referred to in Article 4 must take certain action when asked to do so by a market surveillance authority:

—provide that authority with the declaration of conformity/performance,

—provide the authority with the technical documentation or, where the economic operator referred to in Article 4 does not keep this documentation, ensure that the technical documentation is provided to the authority (in particular by the manufacturer),

—provide other information and documentation to demonstrate the conformity of the product (this may include e.g. certificates and decisions from a notified body) in a language that can be easily understood by the authority (to be negotiated with the authority – this could be a language other than the national language(s)),

—cooperate with the authority. The action required will depend on the authority’s request, which has to be in accordance with the principle of proportionality (Article 14(2) of the Regulation), and

—make sure that the necessary corrective action is taken immediately to remedy any non-compliance with the EU harmonisation legislation applicable to the product in question or, if that is not possible, to mitigate the risks presented by the product. The action could involve bringing the product into conformity, withdrawing it or recalling it, as appropriate (29). The economic operator referred to in Article 4 does not have to take corrective action or mitigate the risk itself if that economic operator is not obliged to do so under the sector-specific legislation, but must ensure that action is taken, e.g. by asking the manufacturer to respond to the request and verifying that it has done so.

The economic operator referred to in Article 4 should act within a reasonable timeframe or within any deadline set by the market surveillance authorities. It should provide the declaration of conformity/performance without delay and other documents within a reasonable period of time (30).

If the economic operator referred to in Article 4 finds that it cannot fulfil one or more of its tasks due to a problem in its relations with the manufacturer (31) (e.g. the manufacturer does not respond to a request), an appropriate follow-up would be to remind the manufacturer of its obligations under EU legislation. If the problem persists, the logical consequence could be for it to take the necessary measures to cease being the economic operator referred to in Article 4 for the products in question, on the basis that it is unable to carry out its tasks under Article 4. In other words, in the case of:

—an importer – it could no longer place the products on the market,

—an authorised representative – it could try to end its relationship with the manufacturer,

—a fulfilment service provider – it could no longer handle the products, i.e. not dispatch them to end-users.

The economic operator referred to in Article 4 can be sanctioned (32) if it does not fulfil its tasks under Article 4. Any penalties must be effective, proportionate and dissuasive (Article 41(2) of the Regulation). The manufacturer remains responsible for the compliance of the product with sector-specific legislation and (like other actors in the supply chain) retains any legal obligations it has as regards products, guarantees, liability for defective products, etc. Article 4 does not impose additional legal obligations vis-à-vis consumers or other end-users.