3.6 規則（EU）2019/1020第4条にいう経済事業者

Article 4 of Regulation (EU) 2019/1020 requires in essence that for certain products placed on the EU market there must be an economic operator in the EU who on request provides the authorities with information or takes certain action. This applies from 16 July 2021.

An economic operator referred to in Article 4 is required when a product falls within the scope of one or more Directives or Regulations listed in paragraph 5 of Article 4 of Regulation (EU) 2019/1020 or other legislation that makes explicit reference to Article 4 (164), in order to place the product on the Union market.

Four types of economic operator can act as the economic operator referred to in Article 4: i) a manufacturer established in the Union; ii) an importer (by definition established in the Union), where the manufacturer is not established in the Union; iii) an authorised representative (by definition established in the Union) who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in Article 4(3) on behalf of the manufacturer; or iv) a fulfilment service provider established in the Union where there is no manufacturer, importer or authorised representative established in the Union.

The (1) name, registered trade name or registered trademark, and (2) contact details, including the postal address, of the economic operator referred to in Article 4 have to be indicated on the product or on its packaging, the parcel or an accompanying document (165). In case the economic operator referred to in Article 4 is an EU manufacturer or an importer, this information is normally already required under Union harmonisation legislation (see Sections 3.1 and 3.3) within the scope of Article 4 (166).

The name and contact details of the economic operator referred to in Article 4 have to be present when the product is declared for free circulation at customs (as confirmed by Article 26(1)(d) of Regulation (EU) 2019/1020). Therefore, in case the product is aimed for release for free circulation in the EU and no further processing on the product is foreseen after its shipment (167), economic operators outside the EU offering products for sale should make sure that the required information on the economic operator referred to in Article 4 is indicated in the way described above, adding them (or having them added) prior to shipping if necessary. It is possible that there are multiple economic operators’ names and contact details indicated on or with the product. While there may be no explicit requirement that these be preceded by ‘manufactured by’, ‘imported by’, ‘represented by’ or ‘fulfilled by’, the information should not mislead the market surveillance authorities.

The economic operator referred to in Article 4 has a number of tasks which may already be fully or partly covered by their obligations under Union harmonisation legislation depending on the type of economic operator they are.

First, 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 has been drawn up and keep it for 10 years after the product has been placed on the market (168) or for the period specified in the relevant Union harmonisation act;

—Verify that the technical documentation has been drawn up 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.

Second, where the economic operator referred to in Article 4 has reason to believe that a product presents a risk, it must:

—Inform the relevant market surveillance authorities. It should do this in each Member State in which the product was made available; it is important also 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.

—Finally, the economic operator referred to in Article 4 must take certain actions when asked to do so by the market surveillance authorities:

—provide that authority with the EU declaration of conformity;

—provide the authority with 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 which can be easily understood by that 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; and

—make sure that the necessary corrective action is taken to remedy any non-compliance with the Union harmonisation legislation applicable to the product in question or, if that is not possible, to mitigate the risks presented by that product.

—The action could involve bringing the product into conformity, withdrawing it or recalling it, as appropriate (169). 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 manufacturer remains responsible for the compliance of the product with Union harmonisation 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.