CE mark


CE mark
The CE marking

CE marking (originally EC mark[1]) is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives.[2] The letters "CE" stand for "Conformité Européenne" ("European Conformity").[3]

However originally "CE" stood for ("Communauté Européenne", "Comunidad Europea", "Comunidade Europeia" and "Comunità Europea") "European Community". In former German legislation the CE-marking was called "EG-Zeichen" meaning "European Community mark". According to the European Commission the CE logo has become a symbol for free marketability of industrial goods within the EEA without any literal meaning, which appears contradictory to what they say today (cf. above reference no. 2).

Legally, the CE marking is no quality mark. But depending on the applicable directive the CE marking factually can be considered to be a quality mark. Deviating from sectoral directives regulating other industrial goods, medical devices have to comply with "essential requirements" as described in Annex I of Directive 93/42/EEC, according to which medical devices have to be not only safe but also function in a medical-technical way as described in the manufacturer's "intended purpose". Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485.

Contents

Meaning

Existing in its present form since 1993, the CE marking is a key indicator of a product's compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on ones sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area. This also applies to products made in third countries which are sold in the EEA.

CE marking does not indicate that a product was made in the EEA[4] but states only that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (such as safety, health, environmental protection requirements) of the applicable directive(s) or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. CE marked products are bought not only by professionals (such as medical devices, lifts, machinery and measuring equipment) but also by consumers (such as toys, PCs, mobile phones and light bulbs).

Countries requiring the CE marking

The CE marking is mandatory for certain product groups in the European Economic Area (EEA), consisting of the 27 Member States of the EU and EFTA countries Iceland, Norway, Switzerland and Liechtenstein. It is also obligatory for all products made in third countries (non-member states) sold in the EEA. In that case, the importer has to make sure that the manufacturer outside the EU has taken the necessary steps that allow him to affix the CE marking.

It is still not required within the member countries of the Central European Free Trade Agreement (CEFTA), but some of them (Republic of Macedonia, Croatia, Serbia, Montenegro) are official candidates for membership to the European Union, and are already adopting many of its standards within their legislation (like most of the former Central European countries that were members of CEFTA before joining the EU).

Rules underlying CE marking

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 a 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:

  • Products subject to certain EC directives providing for CE marking have to be affixed with the CE marking before they can be placed on the market.
  • Manufacturers have to check, on their sole responsibility, which EU directives they need to apply for their products.
  • The product may be placed on the market only if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly.
  • The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product.
  • If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure.
  • If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking.

Self-certification

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:

1. Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:
  • Module A – Internal production control.
  • Module A – Intervention of a Notified Body.
  • Module B – EC type-examination.
  • Module C – Conformity to type.
  • Module D – Production quality assurance.
  • Module E – Product quality assurance.
  • Module F – Product verification.
  • Module G – Unit verification.
  • Module H – Full quality assurance.

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 Government 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.

Declaration of conformity

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.

Product groups

The EC directives for CE marking[5] affect the following product groups:

  • Active implantable medical devices
  • Appliances burning gaseous fuels
  • Cableway installations designed to carry persons
  • Eco-design of energy related products
  • Electromagnetic compatibility
  • Equipment and protective systems intended for use potentially explosive atmospheres
  • Explosives for civil uses
  • Hot-water boilers
  • In vitro diagnostic medical devices
  • Lifts
  • Low voltage
  • Machinery
  • Measuring Instruments
  • Medical devices
  • Noise emission in the environment
  • Non-automatic weighing instruments
  • Personal protective equipment
  • Pressure equipment
  • Pyrotechnics
  • Radio and telecommunications terminal equipment
  • Recreational craft
  • Safety of toys
  • Simple pressure vessels

Mutual recognition of conformity assessment

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, the CE mark is now found on many products from these countries.

Turkey (which is not a member of the EEA) also requires products to show CE marking as affirmation of conformity.

Characteristics of the CE marking

  • The CE marking has to be affixed by the manufacturer or its authorized representative in the European Union according to its legal format visibly, legibly and indelibly to the product
  • The size of the CE marking must be at least 5 mm, if enlarged its proportions have to be kept
  • If the appearance and workmanship of a product do not allow for the CE marking to be affixed on the product itself, the marking has to be affixed to its packaging or accompanying documents
  • If a directive requires the involvement of a Notified Body in the conformity assessment procedure, its identification number has to be put behind the CE marking. This is done under the responsibility of the Notified Body.[6]

Dimensions

The CE logo must be at least 5 mm high (This minimum is waived for small-scale equipment/machinery (e.g. spectacles) and where it cannot be placed on the product itself, it must be placed on the packaging (e.g. contact lens solution). The letters "CE" are not enough. The logo must not be modified.

The e mark

The similar "e mark", rather than the CE logo, is used on motor vehicles and electronic components used in motor vehicles.[7]

(The "e mark" for motor vehicles is not to be confused with the estimated sign on food labels.[8])

Misuse

Proximal location of CE mark and Made in China text

The European Commission is aware that CE marking, like any other mark, is misused. CE marking may sometimes be affixed to products that do not fulfil the requirements and conditions for its affixing or it is affixed to products for which the affixing is not foreseen. There are also cases in which the product is in compliance with the applicable requirements, the CE marking itself does not respect the formal requirements, namely the form of the CE marking or the dimensions and proportions prescribed in the legislation.[9]

China Export

The CE symbol has been alleged or believed to stand for China Export or China Electronics because some Chinese manufacturers apply a very similar marking to their products.[10] As Chinese exporters have used the CE logo incorrectly, the matter was raised at the European Parliament in 2008.[11] The Commission responded that it will look into trade-marking the logo and that it is in discussion with Chinese authorities to ensure compliance with European standards.[12] In the end, it just turned out to be a bad fake of the CE marking.

Legal implications

There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling CE marked products 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 a second opportunity to ensure that the product is in conformity with the applicable legislation before it is obliged to take the product off the market.

See also

References

  1. ^ Directive 93/68/EEC
  2. ^ "What does the CE marking on a product indicate?". European Union. http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/faq/index_en.htm. 
  3. ^ "What does CE marking stand for?". European Union Enterprise and Industry. http://ec.europa.eu/enterprise/faq/index_en.htm#09012624859cd715. 
  4. ^ European Commission: CE marking: further information
  5. ^ "The EC directives for CE marking". CE marking Nordic AB. http://www.cemarkingnordic.se/pdf/english/what_is_ce_marking.pdf. 
  6. ^ Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits)
  7. ^ Jarvis, Tim. ""e" is for Automobile Electronics". Compliance Engineering. http://www.ce-mag.com/archive/03/ARG/jarvis.html. Retrieved 28 December 2008. 
  8. ^ "estimated" sign for food weight/volume, information by the UK government.
  9. ^ Misconception attributing CE marking the meaning ‘Chinese export’
  10. ^ CE China Export/Electronics (mark) ;Be Aware of the China Export mark !!!; The CE mark; The Inquirer: Fake Chinese chargers could kill
  11. ^ Question to EU parliament about China Export
  12. ^ "Answer to a written question – China Export (CE) mark feeding off the reputation of the European Conformité européenne (CE) mark – P-5938/2007". www.europarl.europa.eu. http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2007-5938&language=EN. Retrieved 9 March 2011. 

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