3.4 販売業者

Along with manufacturers and importers, distributors are the third category of economic operators who are subject to specific obligations. The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor.

Distributor must act with due care (146) in relation to the applicable requirements (147). They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU Declaration of Conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the applicable Union harmonisation legislation as listed in the obligations for distributors.

Conformity assessment, drawing up and keeping the EU declaration of conformity and the technical documentation remain the responsibility of the manufacturer and/or the importer for keeping the declaration of conformity in the case of products from third countries. It is not part of the distributor’s obligations to check whether a product already placed on the market is still in conformity with the legal obligations that are currently applicable in case these have changed. The obligations of the distributor refer to the legislation applicable when the product was placed on the market by the manufacturer or the importer unless specific legislation provides otherwise.

The distributor must be able to identify the manufacturer, his authorised representative, the importer or the person who has provided him with the product in order to assist the market surveillance authority in its efforts to obtain the EU Declaration of Conformity and the necessary parts of the technical documentation. Market surveillance authorities have the possibility to address their request for the technical documentation directly to the distributor. The latter is however not expected to be in possession of the relevant documentation.

Before making a product available on the market, the distributor must verify the following formal requirements (148):

—that the product bears the required conformity marking(s) (e.g. CE marking);

—that the product is accompanied by the relevant documents (e.g. EU Declaration of Conformity (149)) and by instructions and safety information (150) in a language which can be easily understood by consumers and other end-users if required by the applicable legislation;

—that the manufacturer and importer have indicated their (1) name, registered trade name or trademark and (2) the address at which they can be contacted on the product or when not possible because of the size or physical characteristics of the products, on its packaging and/or on the accompanying documentation (151), and that the product bears a type, batch or serial number or other element allowing the identification of the product.

Distributors must not supply products that they know or should have assumed, on the basis of information in their possession and as a professional, not to be in compliance with the legislation. Further, they must cooperate with the competent authority in actions taken to avoid or minimise these risks, inform the manufacturer or the importer as well as the competent national authorities (152).

Similar obligations bind distributors once a product is made available. If they have reasonable grounds to believe that a product is not in conformity, they have to make sure that corrective measures to bring the product into conformity are taken by the manufacturer or the importer and inform the competent national authorities. Distributors have to contact the importer or manufacturer to clarify any doubt about the conformity of the product.

In addition to controlling the conformity of the product with the formal requirements, the distributor must:

1.initiate corrective measures where there is suspicion of a non-conformity (153);

2.assist market surveillance authorities in identifying the manufacturer or importer responsible for the product;

3.upon a reasoned request (154) from a competent authority, cooperate with that authority and provide it with all the information and documentation necessary to demonstrate the conformity of a product (155);

4.on request by market surveillance authorities, identify any economic operator who has supplied them and to whom they have supplied the product. They must be able to present this information for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product (156).

The distribution conditions (for example transport or storage) may have an impact on maintaining the compliance with the provisions of the applicable Union harmonisation legislation. Thus, the person in charge of the distribution conditions must take the necessary measures to protect the compliance of the product. This is to ensure that the product complies with the essential or other legal requirements at the moment of first use within the Union (157).

The distribution conditions may, in the absence of Union harmonisation legislation, be regulated to some extent on the national level in accordance with Articles 34 and 36 TFEU. National legislation that grants to members of a specific profession the exclusive right to distribute certain products is capable, insofar as it restricts sales to certain channels, of affecting the possibilities of marketing imported products. Accordingly, such legislation may constitute a measure having an effect equivalent to a quantitative restriction on imports. However, it can be justified for instance on grounds of the protection of public health, if the measure is appropriate for the purpose and does not go beyond what is necessary to achieve it (158).