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The European Commission (EC) has provided the following frequently asked questions on its website. Keystone Compliance has reproduced this information for the benefit of manufacturers, importers and distributors seeking additional information on the CE Mark.

What does the CE marking on a product indicate?

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

Is a product affixed with the CE mark always produced in the European Union (EU)?

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 mark may have been produced anywhere in the world.

Are all CE marked products tested and approved by authorities?

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 EC 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.

Can we be sure that a product affixed with the CE marking is safe?

Unfortunately due to counterfeiting or misuse of the marking, there is never a 100% guarantee that a product affixed with the CE mark is safe. However, with the adoption of the New Legislative Framework, the obligations of the manufacturers have been spelled out and it is clearly stated that by affixing the CE marking to a product, the manufacturer assumes the full responsibility of its conformity to all applicable requirements in EU legislation. Although the manufacturer may well be the only person responsible for the affixing of the CE marking, it is still the system behind the CE marking that provides for its proper functioning. The entire system, consisting of manufacturers, importers, distributors, notified bodies and market surveillance authorities, has been strengthened through the New Legislative Framework, which aims to further reduce the burdens to trade while, at the same time, ensure a high level of safety and protection for the public interest.

Can I, as a manufacturer, affix my products with the CE marking myself?

Yes, the CE marking is always affixed by the manufacturer himself/herself or his/her authorized 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 directives. The directives establish whether the conformity assessment may be performed by the manufacturer himself or if the intervention of a third party (the notified body) is needed.

Where should the CE mark be affixed?

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.

What is a manufacturer’s Declaration of Conformity?

The EC Declaration of Conformity (DoC) is a document that accompanies a product and in which the manufacturer, or his authorized representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the directives applicable to the specific product. The 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 DoC must be signed by an individual working for the manufacturer or his/her authorized 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 EC Declaration of Conformity.

Is CE marking mandatory, and if so; for what products?

Yes, CE marking is mandatory. However, only the products that are covered by the scope of one or more of the New Approach Directives shall be affixed with it in order to be placed on the EU market. Examples of products that fall under New Approach Directives 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.

What is the difference between the CE marking and other markings, and can other markings be affixed on the product if there is a CE marking?

The CE mark is the only marking that indicates conformity to all the essential requirements of the Directives that provide for its affixing. A product may bear additional markings provided that they do not have the same significance 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 harmonization legislation of the European Union.

Who supervises the correct use of the CE mark?

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.

What are the sanctions for counterfeiting the CE marking?

The procedures, measures and sanctions that apply to counterfeiting of the CE marking vary according to the respective 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.

What implications may the affixing of the CE mark have for the manufacturer/importer/distributor?

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 goods 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 directives 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 EC 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 accompanying 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 or her own name, he/she then takes over the manufacturer’s responsibilities. In this case, he/she must have sufficient information on the design and production of the product, as he/she will be assuming the legal responsibility when affixing the CE marking.

Keystone Compliance assists manufacturers with CE Mark compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your CE Mark needs.

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