Obligations of economic operators

The horizontal regulation setting out the obligations of economic operators is Decision No. 768/2008/EC of the European Parliament and of the Council (as corrected on July 1, 2015) on a common framework for the marketing of products. This Decision establishes common principles to be applied in sector-specific legislation. Decision No. 768/2008/EC defines economic operators involved in the placing of products on the market. Economic operators include manufacturers, authorized representatives, importers, and distributors.

A manufacturer is a natural or legal person who manufactures a product or has a product designed or manufactured and places that product on the market under their own name or trademark
An importer is a natural or legal person established in the Community who places a product from a third country on the Community market
An authorized representative is a natural or legal person established in the Community who has been authorized in writing by the manufacturer to act on their behalf in performing defined tasks
A distributor is a natural or legal person in the supply chain, other than the manufacturer or importer, who supplies a product to the market

These terms are also defined in the Czech Republic by Act No. 22/1997 Coll. , on Technical Requirements for Products (amended by Act No. 87/2023 Coll., effective as of April 6, 2023), Act No. 90/2016 Coll., on the conformity assessment of specified products (amendment by Act No. 87/2023 Coll. applies from April 6, 2023) and in the Slovak Republic, Act No. 56/218 Coll. on the conformity assessment of products, the making available of specified products on the market, and on amendments to certain acts

In Part II of Act No. 90/2016 Coll. "Special Provisions on Certain Products," a new term is introduced for recreational craft and personal watercraft:

a private importer is a natural or legal person established in the Union who, in the course of non-commercial activities, imports a product from a third country into the Union for the purpose of putting it into service for their own use

. Obligations of economic operators
: at the request of market surveillance authorities, for a period specified by the relevant legislation based on the product’s lifespan and the level of risk, they must identify:

every economic operator who has supplied them with a product;
every economic operator to whom they have supplied a product.

Manufacturers must

ensure that their products are designed and manufactured in accordance with the requirements set out in the relevant legislation
ensure, when placing products on the market, that the product complies with the relevant requirements
prepare the required technical documentation and carry out or have carried out the relevant conformity assessment procedure
when demonstrating the product’s compliance with the relevant requirements, they must draw up an EU declaration of conformity and affix the conformity
marking; retain the technical documentation and the EU Declaration of Conformity from the time the product is placed on the market for a period specified by the relevant legislation based on the product’s expected lifespan and the level of risk
; ensure compliance with the specified requirements throughout the entire production process in the case of serial production, even if there is a change in the product’s design or parameters; in the event of changes to harmonized standards or technical specifications,
conduct testing of product samples placed on the market and investigations to protect consumer health and safety in light of the risks posed by the product; where applicable, maintain a record of complaints regarding non-compliant products, records of product recalls
keep distributors informed of these control activities
ensure that product identification details and information (type number, serial number, serial number); if the nature or size of the product does not allow for the inclusion of this information on the product, the required information must be provided on the packaging or in a document accompanying the product
; indicate on the product their name, registered trade name, or registered trademark and address (the single point of contact for the manufacturer); if the nature or size of the product does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product
ensure that the product is accompanied by comprehensible instructions and safety information for consumers and other end-users in a language (to be determined by the Member State concerned)
take the necessary corrective measures in the event of the placing on the market of a product that does not comply with the relevant Community harmonization legislation or, if necessary, withdraw the product from the market or from circulation
immediately inform, in the event of the supply of a hazardous product to the market, the national authorities of the Member States where the product was placed on the market,
upon a reasoned request from the competent national authority,
provide all information and documentation necessary to demonstrate the conformity of the product, always in a language understandable to that authority
,
and
cooperate with that national authority at its request in the event of a requirement to eliminate the risks posed by products they have placed on the market

An importer or distributor, if they place a product on the market under their own name or trademark, or if they modify a product that has already been placed on the market in a way that affects compliance with the relevant requirements, is considered a manufacturer and must fulfill the obligations of a manufacturer set forth in Decision No. 768/2008/EC .

Authorized representatives must
perform the tasks specified in the mandate received from the manufacturer, including at a minimum:

retaining the technical documentation and the EU Declaration of Conformity from the date the product is placed on the market for a period specified by the relevant legislation based on the product’s lifespan and the level of risk
provide
,
upon a reasoned request from the competent national authority
,
all information and documentation necessary to demonstrate the product’s conformity
cooperate with the competent national authority, at its request, in the event of a requirement to eliminate risks posed by products which they have placed on the market

. The mandate of the authorized representative must not include the design and manufacture of products in accordance with the requirements set forth in the relevant legislation, nor the preparation of technical documentation.

Importers must

place only products that comply with the legislation on the Community market
place only products that comply with the relevant provisions of the legislation
ensure that, prior to placing the product on the market, the manufacturer has carried out the appropriate conformity assessment procedure
ensure that the manufacturer has prepared the technical documentation
ensure that the product bears the required conformity marking
ensure that the product is accompanied by all required documents
ensure that the manufacturer provides identification details and product information (type number, series, serial number) and, if the nature or size of the product does not allow this on the product itself, then the manufacturer must provide the required information on the packaging or in a document accompanying the product
ensure that the manufacturer indicates on the product their name, registered trade name, or registered trademark and address (the single location where the manufacturer can be contacted); if the nature or size of the product does not allow for the indication of this information, the required information must be indicated on the packaging or in a document accompanying the product
; indicate on the product their name, registered trade name or registered trademark, and the address at which they can be contacted; if the nature or size of the product does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product
ensure that the product is accompanied by clear instructions and safety information for consumers and other end-users in a language (to be determined by the relevant state)
bear full responsibility for the transport and storage of the product so that transport and storage conditions do not affect the product’s compliance with the requirements set forth in the relevant provisions of the law
conduct tests on samples of products placed on the market and investigations to protect consumer health and safety in light of the risks posed by the product, if necessary, maintain a register of complaints regarding non-compliant products and records of product recalls
keep distributors informed on an ongoing basis of these control activities
take the necessary corrective measures in the event that a product is placed on the market that does not comply with the relevant Community harmonization legislation or
,
if necessary
,
withdraw the product from the market or from circulation
immediately inform the national authorities of the Member States where the product was placed on the market in the event of the supply of a hazardous product to the market of this non-compliance and the corrective measures taken
keep the technical documentation and the EU declaration of conformity from the date the product was placed on the market for a period specified by the relevant legislation based on the product’s lifespan and the level of risk
provide, upon a reasoned request from the competent national authority
,
all information and documentation necessary to demonstrate the product’s conformity, always in a language understandable to that authority
cooperate with the competent national authority at its request in the event of a requirement to eliminate risks posed by products which they have placed on the market

Distributors must

act with due care when making a product available on the market with regard to the relevant requirements;
verify, before making the product available on the market, that the product bears the required conformity markings
; verify, before making the product available on the market, that the product is accompanied by the required documents, instructions and safety information in a language easily understandable to consumers and other end-users in the Member State where the product is to be placed on the market
verify, before placing the product on the market, that the manufacturer has provided identification details and product information (type number, batch number, serial number); if the nature or size of the product does not allow for the inclusion of this information on the product, the required information must be provided on the packaging or in a document accompanying the product
verify, prior to placing the product on the market, that the manufacturer has indicated on the product their name, registered trade name, or registered trademark and address (the single point of contact for the manufacturer), if the nature or size of the product does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product
verify, prior to placing the product on the market, whether the importer has indicated on the product their name, registered trade name, or registered trademark and the address at which they can be contacted; if the nature or size of the product does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product
place on the market only products that comply with the relevant provisions of the legislation
inform the manufacturer or importer
,
as well as the market surveillance authorities
,
in the event of a dangerous product being placed on the market
bear full responsibility for the transport and storage of the product so that that the conditions of transport and storage do not affect the product’s compliance with the requirements set forth in the relevant provisions of the legislation
take the necessary corrective measures in the event of placing on the market a product that does not comply with the relevant Community harmonization legislation, or, if necessary, withdraw the product from the market or from circulation
immediately inform the national authorities of the Member States where the product was placed on the market in the event of the placing on the market of a product presenting a risk,
provide, upon a reasoned
request from the competent national authority, all information and documentation necessary to demonstrate the conformity of the product, always in a language understandable to that authority
cooperate with the competent national authority, at its request, in the event of a requirement to eliminate the risks posed by products they have placed on the market