Economic operators, such as manufacturers, importers and distributors, who place products on the market of the European Community (“Community”), are responsible for the compliance of their products with all applicable legislation.
To indicate the conformity of the product, the CE marking will be affixed to the product. This CE marking is the only marking which attests the conformity of the product with the applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
By affixing the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
If, for example, a toy manufacturer affixes a CE marking to a toy, he clearly indicates that the toy in question meets the essential safety requirements as set out in Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys.
Provisions for the affixing of the CE marking are further elaborated in Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products. This Regulation shall apply from 1 January 2010.
Consequences of non-fulfilment of obligations
The producer (this also includes any person who, by putting his name, trade mark or other distinguishing feature on the product presents himself as its producer) is, on the basis of the Directive on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (“Directive 85/374/EEC”), held liable for damage caused by a defect in his product. This defect in a product also includes a product which is not in accordance with the Community harmonisation legislation.
Obligations set out in Community legislation
Decision No 768/2008/EC (“Decision”) sets out the common framework for the Community harmonisation legislation on the conditions for the marketing of products. This Decision provides an overview of the obligations for every economic operator as determined in Community legislation.
An economic operator refers to either the manufacturer, the authorised representative, the importer or the distributor.
The obligation to draw up the required technical documentation and carry out the conformity assessment procedure applicable (or have it carried out) shall rest with the manufacturer. Where compliance of the product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity and affix the conformity marking.
The manufacturer must also ensure that its product, or the packaging or document accompanying the product, bears an element allowing its identification, as well as indicate the (trade) name or trade mark and the address at which he can be contacted. Moreover, the manufacturer must make sure that the product is accompanied by instructions and safety information in a language which can be easily understood by the end-user.
The importer ensures that the manufacturer has drawn up the required technical documentation for the product and has carried out the correct conformity assessment procedure as well as having affixed the required conformity marking to the product.
The obligation that the (trade) name or trade mark as well as the address at which the person in question can be contacted must be mentioned on the product, or on the packaging or the document accompanying the product, also applies to the importer. Furthermore, the importer is also responsible for supplying instructions and safety information accompanying the product in a language which can be easily understood by the end-user.
Before making a product available on the market, the distributor must verify that the product bears the required conformity marking and is accompanied by the required documents and by instructions and safety information in a language which can easily be understood by consumers and other end-users in the Member States in which the product is to be made available on the market.
An importer or distributor shall be considered a manufacturer, and must therefore fulfil the aforementioned obligations for manufacturers, if he:
- places a product on the market under his name or trade mark; or
- modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.
In addition, every economic operator (this thus includes the manufacturer, the importer as well as the distributor) who considers or has reason to believe that a product which he has made available on the market is not in conformity with the Community harmonisation legislation applicable, shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it are taken.