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|Effective region||European Economic Area|
|Website||CE Marking homepage|
|Effective region||European Economic Area|
|Website||CE Marking homepage|
The CE marking or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1993. The CE marking is found even on products sold outside the EEA, because they are either products manufactured in the EEA and have been exported, or they were manufactured in other nations which have EEA as a prime market. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is similar then, in that sense, to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
It consists of the CE-Logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure.
The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.
The actual words signified by "CE" have been disputed. It is often taken to be an abbreviation of Conformité Européenne, meaning "European Conformity". However, "CE" originally stood for "Communauté Européenne", French for "European Community". In former German legislation, the CE marking was called "EG-Zeichen" meaning "European Community mark". The CE marking is a symbol of free marketability in the European Economic Area (Internal Market).
Existing in its present form since 1993, the CE marking indicates the compliance with EU legislation of a product, wherever in the world manufactured, and enables its free movement within the European market. By affixing the CE marking on a product, a manufacturer is declaring, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking which allows free movement and sale of the product throughout the European Economic Area. CE marking is intended for national market surveillance and enforcement authorities.
CE marking signifies that the product conforms with all EC directives that apply to it. For example, most electrical products must comply with the Low Voltage Directive and the EMC Directive; electrical toys must also comply with the Toy Safety Directive. The marking does not indicate EEA manufacture. The manufacturer of CE-marked goods has verified that the product complies with all applicable EC requirements, such as safety, health, and environmental protection, and, if stipulated in any directive, has had them examined by a notified conformity assessment body.
Not all products need CE marking to be traded in the EC; only product categories subject to relevant directives are required (and allowed) to bear CE marking. Most CE-marked products can be placed on the market subject only to an internal production control by the manufacturer (Module A; see Self-certification, below), with no independent check of the conformity of the product with EU legislation; ANEC has cautioned that, amongst other things, CE marking cannot be considered a "safety mark" for consumers.
CE marking is a self-certification scheme. Retailers sometimes refer to products as "CE approved", but the mark does not actually signify approval. Certain categories of products require type-testing by an independent body to ensure conformity with relevant technical standards, but CE-marking in itself does not certify that this has been done.
CE marking is mandatory for certain product groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries Iceland, Norway, Switzerland and Liechtenstein, plus Turkey). The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards.
As of 2013[update] CE marking was not required by countries of the Central European Free Trade Agreement (CEFTA), but members Republic of Macedonia, Serbia, and Montenegro had applied for membership of the European Union, and were adopting many of its standards within their legislation (as did most Central European former member countries of CEFTA that joined the EU, before joining).
Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer.
The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up an electromagnetic comprehensiveness technical file and sign an EC declaration of conformity. The documentation has to be made available to authorities on request.
Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.
Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.
If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.
There are certain rules underlying the procedure to affix the marking:
Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a Notified Body, is of great importance throughout the entire CE-marking process, from Design Verification, and set up of Technical File to the EC Declaration of Conformity.
Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified where manufacturers a Declaration of Conformity and affixes the CE marking to their own product. Manufacturer then must do several things:
These will often ask questions about the product to classify the level of risk and then refer to the "Conformity Assessment Procedures" chart. This shows all the acceptable options available to a manufacturer to certify the product and affix the CE marking.
Products considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member State and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose its own notified body in any Member State of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.
In reality the self-certification process consists of the following stages:
Stage 1: Identify the applicable Directive(s)
The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral directives requiring CE marking. There are more than 20 sectoral product directives requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.
Identifying which directive(s) may be applicable, as there may be more than one, involves a simple exercise of reading the scope of each directive to establish which apply to the product (An example of the scope of the Low Voltage Directive below). If the product does not fall within the scope of any of the sectoral directives, then the product does not need to bear CE marking (and, indeed, must not bear CE marking).
Low Voltage Directive (2006/95/EC)
Article 1 states the Directive covers "any equipment designed for use with a voltage rating of between 50 and 1000 V for A.C. and between 75 and 1500 V for D.C, other than the equipment and phenomena listed in Annex II."
Stage 2: Identify the applicable requirements of the Directive(s)
Each Directive has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market.
The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable ‘harmonised standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonised standards can be identified by searching the ‘Official Journal’ on the European Commission’s website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.
Stage 3: Identify an appropriate route to conformity
Although the process is always a self-declaration process,there are various ‘attestation routes’ to conformity depending on the Directive and classification of the product. Some products (such as invasive medical devices, or fire alarm and extinguisher systems) may, to some extent, have a mandatory requirement for the involvement of an authorised third party or "notified body".
There are various attestation routes which include:
Stage 4: Assessment of the product's conformity
When all of the requirements have been established, the conformity of the product to the essential requirements of the Directive(s) needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2.
Stage 5: Compile the technical documentation
Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.
Technical documentation will usually include:
Stage 6: Make a Declaration and affix the CE marking
When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable Directives, an EC Declaration of Conformity must be completed or, for partly completed machinery under the Machinery Directive, an EC Declaration of Incorporation.
The requirements for the Declaration vary slightly, but will at least include:
Purpose for safety issues.
The DoC must include: manufacturer's details (name and address, etc.); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the Notified Body; and a legally binding signature on behalf of the organization.
The directives requiring CE marking affect the following product groups:
For a complete listing, see the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.
There are numerous 'Agreements on Mutual Recognition of Conformity Assessment' between the European Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and Israel. Consequently, CE marking is now found on many products from these countries.
Switzerland and Turkey (which are not members of the EEA) also require products to bear CE marking as an affirmation of conformity.
The CE logo must be at least 5 mm high (except on small-scale equipment/machinery such as spectacles). Where it cannot be placed on the product itself (e.g. contact lens solution), it must be placed on the packaging.
The letters "CE" are not enough. The logo must not be modified.
On motor vehicles and related parts the UNECE "e mark" or "E mark", rather than the CE logo, has to be used. Other than the CE logo, the UNECE marks are not self-certified. They are not to be confused with the estimated sign on food labels.
The European Commission is aware that CE marking, like any other mark, is misused. CE marking is sometimes affixed to products that do not fulfill the requirements and conditions for its affixing, or is affixed to products for which the affixing is not required. In one case it was reported that "Chinese manufacturers were submitting well-engineered electrical products to obtain conformity testing reports, but then removing non-essential components in production to reduce costs". A test of 27 electrical chargers found that all the eight legitimately branded with a reputable name met safety standards, but none of those unbranded or with minor names did, despite bearing the mark; non-compliant devices were actually potentially unreliable and dangerous, presenting electrical and fire hazards.
There are also cases in which the product complies with the applicable requirements, but the form, dimensions, or proportions of the mark itself are not as specified in the legislation.
A very similar CE marking has been alleged to stand for China Export because some Chinese manufacturers apply it to their products. However, the European Commission says that this is a misconception. The matter was raised at the European Parliament in 2008. The Commission responded that it was unaware of the existence of any "Chinese Export" mark and that, in its view, the incorrect application of the CE marking on products was unrelated to incorrect depictions of the symbol, although both practices took place. It had initiated the procedure to register CE marking as a Community collective trademark, and was in discussion with Chinese authorities to ensure compliance with European standards.
There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling products bearing CE marking is the responsibility of public authorities in Member States, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or if a product's safety is questioned.
The procedures, measures and sanctions applying 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 an opportunity to ensure that the product is in conformity to the applicable legislation before it is obliged to take the product off the market.