附属書5 CEマーキングに関するよくある質問

By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.

No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.

No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.

Yes, the CE marking is always affixed by the manufacturer himself or his authorised representative after the necessary conformity assessment procedure has been performed. This means that, before being affixed with the CE marking and being placed on the market, the product must be subject to the conformity assessment procedure provided for in one or more of the applicable Union harmonisation acts. The latter establish whether the conformity assessment may be performed by the manufacturer him- self or if the intervention of a third party (the notified body) is required.

The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.

The EU Declaration of Conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product. The EU DoC shall also contain the name and address of the manufacturer along with information about the product, such as the brand and serial number. The EU DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EE Declaration of Conformity.

Yes, CE marking is mandatory. However, only the products that are covered by the scope of one or more of the Union harmonisation acts providing for CE marking shall be affixed with it in order to be placed on the Union market. Examples of products that fall under Union harmonisation acts providing for CE marking are toys, electrical products, machinery, personal protective equipment and lifts. Products that are not covered by CE marking legislation shall not bear the CE marking.

Information the products that are CE marked and the Union harmonisation legislation providing for CE Marking under

https://ec.europa.eu/growth/single-market/ce-marking_en

The CE marking is the only marking that indicates conformity to all the essential requirements of the Union harmonisation legislation that provide for its affixing. A product may bear additional markings provided that they do not have the same meaning as the CE marking, that they are not liable to cause confusion with the CE marking and that they do not impair the legibility and visibility of the CE marking. In this respect, other markings may be used only if they contribute to the improvement of consumer protection and are not covered by harmonisation legislation of the European Union.

In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.

The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.

While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers and distributors also play an important role in making sure that only products complying with legislation and bearing the CE marking are placed on the market. Not only does this help to reinforce the EU’s health, safety and environmental protection requirements, it also supports fair competition with all players being held accountable to the same rules.

When products are produced in third countries and the manufacturer is not represented in the EEA, importers must make sure that the products placed by them on the market comply with the applicable requirements and do not present a risk to the European public. The importer must verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.

Thus, importers must have an overall knowledge of the respective Union harmonisation acts and are obliged to support national authorities should problems arise. Importers should have a written assurance from the manufacturer that they will have access to the necessary documentation – such as the EU Declaration of Conformity and the technical documentation – and be able to provide it to national authorities, if requested. Importers should also make sure that contact with the manufacturer can always be established.

Further along in the supply chain, distributors play an important role in ensuring that only compliant products are on the market and must act with due care to ensure that their handling of the product does not adversely affect its compliance. The distributor must also have a basic knowledge of the legal requirements – including which products must bear the CE marking and the ac- companying documentation – and should be able to identify products that are clearly not in compliance.

Distributors must be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist the national authority in its efforts to receive the required documentation.

If the importer or distributor markets the products under his own name, he then takes over the manufacturer’s responsibilities. In this case, he must have sufficient information on the design and production of the product, as he will be assuming the legal responsibility when affixing the CE marking.

Information about CE marking, the products that are CE marked, the Union harmonisation legislation providing for CE Marking and the steps to follow under

https://ec.europa.eu/growth/single-market/ce-marking_en

Economic operators may contact the Enterprise Europe Network under

https://een.ec.europa.eu/