CE mark
From Wikipedia, the free encyclopedia
For other uses, see CE.
The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.
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[edit] Significance
By affixing the CE marking, the manufacturer, or in certain cases another legal person responsible for the product, asserts that the item meets all the essential "Health and Safety" requirements of the relevant European Directive(s) that provide for the CE marking. Examples of European Directives requiring CE marking include toy safety, machinery, low-voltage equipment, medical devices and electromagnetic compatibility. There are about 25 directives requiring CE marking.[1]
The CE marking is an acronym for the French "Conformité Européenne". [2]
[edit] Countries requiring the CE marking
The marking is mandatory for products sold not only within the 27 countries of the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) but more generally within all countries of the European Economic Area (EEA) which also includes the 4 countries of the European Free Trade Area (EFTA: Iceland, Liechtenstein, Norway, including Switzerland although it is not a member of the EEA), as well as within Turkey (as a result of the non-agricultural European Union-Turkey Customs Union).
It is still not required within the countries members of the Central European Free Trade Agreement (CEFTA), although some of them (Croatia, Serbia, Montenegro) are official candidates for membership to the European Union, and are already adopting many of its standards within their legislation (like the most of the former Central European countries that were members of CEFTA before joining the EU).
In some other European countries, the marking is not mandatory but it is almost always present (and in fact requested by customers that look for it) due to the proximity of markets and the existence of bilateral trade agreements or to the fact that a large part of the products are sold there for export to customers living in a country in the EES, or are imported from these countries (Monaco, Andorra, San Marino, Vatican, Jersey, Guernsey, Isle of Man) : for some classes of products, these countries may also have adopted the same standards, which can also be recognized by the CE marking. In these European countries the CE marking and the associated standards is protected (the manufacturers are declaring their conformance to a minimum list of standards). As many of the European standards are converging with international standards, the CE marking will be often present on products manufactured and sold outside of Europe (notably in Asia that exports lots of manufactured products to Europe).
[edit] New Approach
The " New Approach" procedure for CE Marking was adopted in 1985. It differs from the "old approach" in the sense that the Directives are just broad guidelines that give only the essential "Health and Safety Requirements (ESHRs)". The tests required to meet these ESHRs are given in the "Standards". The standards are harmonised to "EN". Manufacturers use "Self-Declaration" and demonstrate compliance with standards (references of which have been published in Official Journal of European Communities " (OJEC) which gives them “Presumption of Conformity” with directives. If a European Directive provides for CE marking it is known as a New Approach Directive (NAD). The New Approach is used for the regulation of highly technical sectors where the NAD sets out the essential characteristics (that mainly ensure safety) that a product must meet, and then voluntary European standards detail how a manufacturer can meet the required essential characteristics. There are three European Standards Orgainsations (CEN, CENELEC and ETSI) who draw up and update the standards that underpin the NADs. Although these standards are voluntary this does not weaken the directives as compliance with the essential requirements remains mandatory. The vast majority of manufacturers comply with the standards as it is the simplest way to demonstrate that their product meets the essential characteristics. If a manufacturer does not use the standards then they must demonstrate through alternative means how the product complies with the essential characteristics, which is normally more difficult and costly to do.
This 'New' Approach is now over 20 years old and the recent New Legislative Framework (NLF) [3], which comprises two Regulations and a Decision, updates the New Approach but also overhauls and improves the functioning of the internal market for all goods other that those regulated by NADs. The NLF doesn't fundamentally change the process outlined above; instead it increases the powers of market surveillence authorities, protects the CE mark from abuse, and seeks to clarify and harmonise terminology and common provisions in future legislation.
It is worth noting that if a product is within the scope of more than one NAD it must comply with all of them if it is to bear the CE mark.
The Construction Products Directive provides for CE marking, however, it functions very differently to other NADs as construction products are an intermediate product and so the CE marking does not have the same meaning. On a construction product the CE marking, in simple terms, means that performance values can be trusted and can be easily used to compare competing products.
[edit] The Global Approach
Also refers to the Modular Approach to conformity, the Global Approach specifies certain "Conformity Assessment Modules" which Directives refer to. This assures a uniform conformity procedure. There are eight conformity assessment modules Module A to H and are in the increasing order of risk or hazards of the product.The Directive (s) in question decide as to which module the manufacturer shall apply depending upon product classification.
[edit] CE Marking Procedure
The "New Approach" to conformity enables manufacturers to use what is called as "SELF DECLARATION" where the manufacturer himself declares conformity by signing the "Declaration of Conformity (DOC)" and then affixes the CE Mark on his product.
The following simple steps are involved
STEP 1: Identify Applicable "DIRECTIVES"
STEP2 : Identify Applicable "Conformity Assessment Module"
Although CE Marking follows the Self Declaration principle, depending upon product complexity and risk to human life, various conformity assesment module are prescribed:-
Module 'A' (Internal Production control).
Applicable for products falling under EMC and Low Voltage Directives. Manufacturer tests the product from third party. After compliance with the tests, his production process ensures continued conformance. He maintains "Technical Documentation" as a proof of compliance. There is No mandatory involvement of European Lab (i.e. Notified Body).
Module 'B' to 'H'
Mandatory involvement of European Lab is required which issues "Type Examination Certificate", certifies documentation (called "Techncal Construction File"(TCF) and carries out inspections.
STEP3 : Identify Applicable "Standard"
STEP4 : Test one sample of the productEither yourself or from test lab.
STEP5 : Compile "Technical Documentation"
STEP 6 : Sign the EC "Declaration of Conformity"
STEP 7 : Affix "CE Mark" on the product.
[edit] Declaration of Conformity
The CE marking is a mandatory European marking for certain product groups to indicate conformity with the essential requirements set out in European Directives. In order to use the CE mark on a product the manufacturer must draw up a Declaration of Conformity (DoC) in which the manufacturer attests conformity with all relevant NADs and takes sole legal responsibility. In some instances a NAD may require a Notified Body to issue a Certificate of Conformity in order to verify performance of the product or constancy of the production process (Factory Production Control) for example.
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.
[edit] 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 affirmations of conformity.
[edit] The e mark
The similar "e mark", rather than the CE logo, is used on motor vehicles and electronic components used in motor vehicles.[4]
(The "e mark" for motor vehicles is not to be confused with the estimated sign on food labels[5]).
[edit] Rumor about confusing CE marks
Some products are said to have a CE mark that stands for China Export, which is not conforming to European specifications. The two letters are close together, not spaced as in the European conformance mark. [6]
 European conformance CE mark |
 "China Export" CE mark |
However, the "China Export" mark doesn't exist. Some products may be conforming but not displaying the logotype correctly and others may illegally put the correct mark on a non-conforming item.[7]
[edit] References
- ^ "New Approach Standardisation in the Internal Market - Directives & Standards". CEN, CENELEC, ETSI, European Commission and EFTA.. http://www.newapproach.org/Directives/DirectiveList.asp. Retrieved on 2007-06-05.
- ^ "CE MARKING - Home". Export information site, by Department of Commerce (US Government). http://www.export.gov/cemark/index.asp. Retrieved on 2009-06-13.
- ^ http://ec.europa.eu/enterprise/newapproach/index_en.htm
- ^ Jarvis, Tim. ""e" is for Automobile Electronics". Compliance Engineering. http://www.ce-mag.com/archive/03/ARG/jarvis.html. Retrieved on 2008-12-28.
- ^ "estimated" sign for food weight/volume, information by the UK government.
- ^ [1]
- ^ http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=P-2007-5938&language=EN
