On
commercial products
Commercial may refer to:
* a dose of advertising conveyed through media (such as - for example - radio or television)
** Radio advertisement
** Television advertisement
* (adjective for:) commerce, a system of voluntary exchange of products and s ...
, the letters CE (as the logo ) mean that the
manufacturer
Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of secondary sector of the economy. The term may refer to a ran ...
or
importer
An import is the receiving country in an export from the sending country. Importation and exportation are the defining financial transactions of international trade.
In international trade, the importation and exportation of goods are limited ...
affirms the good's conformity with European
health, safety, and environmental protection
standards Standard may refer to:
Symbols
* Colours, standards and guidons, kinds of military signs
* Standard (emblem), a type of a large symbol or emblem used for identification
Norms, conventions or requirements
* Standard (metrology), an object th ...
.
It is not a quality indicator or a
certification mark
A certification mark (or conformity mark) on a commercial product indicates the existence of an accepted product standard or regulation and a claim that the manufacturer has verified compliance with those standards or regulations. The specific ...
. The CE marking is required for goods sold in the
European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Ass ...
(EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards.
The
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the
notified body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These e ...
involved in the
conformity assessment
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specific ...
procedure. "CE" is the abbreviation of (
French
French (french: français(e), link=no) may refer to:
* Something of, from, or related to France
** French language, which originated in France, and its various dialects and accents
** French people, a nation and ethnic group identified with Franc ...
for "European conformity").
Meaning
The
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant
EU legislation
European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel Community following World War II, the EU has developed the aim to "promote peace, its valu ...
and the product may be sold anywhere in the
European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Ass ...
(EEA). It is a criminal offence to affix a
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark to a product that is not compliant or offer it for sale.
For example, most electrical products must comply with the
Low Voltage Directive
The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives adopted by the European Union before the "New" or "Global" Approach. The Directive provides common broad objectives for safety regulations, so that electri ...
and the
EMC Directive, among others; toys must comply with the
Toy Safety Directive. (The Low Voltage Directive is about electrical safety; EMC or
Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is the ability of electrical equipment and systems to function acceptably in their electromagnetic environment, by limiting the unintentional generation, propagation and reception of electromagnetic energy whic ...
means the device will work as intended without interfering with, or being affected by, the use or function of any other device.) The
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark indicates compliance with as many norms (
directives and
regulations
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...
) as apply at the time of the declaration of compliance (see below). In the case of electrical products, several later norms such as the
Restriction of Hazardous Substances Directive
The Restriction of Hazardous Substances Directive 2002/95/EC (RoHS 1), short for Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment, was adopted in February 2003 by the European Unio ...
(RoHS) and
Waste Electrical and Electronic Equipment Directive
The Waste Electrical and Electronic Equipment Directive (WEEE Directive) is the European Community Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) which, together with the RoHS Directive 2011/65/EU, became European Law ...
(WEEE) are relevant in addition to the Low Voltage Directive and EMC Directive. The exact significance of the
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark therefore depends on when it was applied to a specific unit.
![Broadcom WLL6230B-D99-4014](https://upload.wikimedia.org/wikipedia/commons/9/98/Broadcom_WLL6230B-D99-4014.jpg)
The marking does not indicate EEA manufacture or that the EU or another authority has approved a product as safe or conformant. The EU requirements may include safety, health, and environmental protection. If stipulated in any EU product legislation, assessment by a
Notified Body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These e ...
or manufacture according to a certified production quality system may be required. Where relevant, the
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark is followed by the registration number of the notified body involved in conformity assessment.
Not all products need CE marking to be traded in the EEA; only product categories subject to relevant directives or regulations 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 Within supply chain management and manufacturing, production control is the activity of monitoring and controlling any particular production or operation. Production control is often run from a specific control room or operations room. With invento ...
by the manufacturer (Module A; see
Self-certification, below), with no independent check of the conformity of the product with
EU legislation
European Union law is a system of rules operating within the member states of the European Union (EU). Since the founding of the European Coal and Steel Community following World War II, the EU has developed the aim to "promote peace, its valu ...
;
ANEC has cautioned that, amongst other things, CE marking cannot be considered a "safety mark" for consumers.
Countries requiring the CE marking
![UKCA filled](https://upload.wikimedia.org/wikipedia/commons/d/d7/UKCA_filled.svg)
CE marking is mandatory for certain product groups intended for sale within the European Union, the
European Free Trade Association
The European Free Trade Association (EFTA) is a regional trade organization and free trade area consisting of four List of sovereign states and dependent territories in Europe, European states: Iceland, Liechtenstein, Norway and Switzerlan ...
(EFTA), and
Turkey
Turkey ( tr, Türkiye ), officially the Republic of Türkiye ( tr, Türkiye Cumhuriyeti, links=no ), is a list of transcontinental countries, transcontinental country located mainly on the Anatolia, Anatolian Peninsula in Western Asia, with ...
. The manufacturers of products made within these countries, and the importers of goods made in other countries, affirm that CE-marked goods conform to EU standards. Following
Brexit
Brexit (; a portmanteau of "British exit") was the withdrawal of the United Kingdom (UK) from the European Union (EU) at 23:00 GMT on 31 January 2020 (00:00 1 February 2020 CET).The UK also left the European Atomic Energy Community (EAEC or ...
, the UK government introduced
UKCA marking
UK Conformity Assessed (UKCA) marking is a conformity mark that indicates conformity with the applicable requirements for products sold within Great Britain.
The UKCA marking became part of UK law at the end of the Brexit transition period, on ...
as its equivalent conformance indicator and this is required for relevant goods to be sold in
Great Britain
Great Britain is an island in the North Atlantic Ocean off the northwest coast of continental Europe. With an area of , it is the largest of the British Isles, the largest European island and the ninth-largest island in the world. It is ...
although goods with the
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark (only) can still be used until 31 December 2024.
As Northern Ireland has remained aligned to the
European Single Market under the
Northern Ireland Protocol
The Protocol on Ireland/Northern Ireland, commonly abbreviated to the Northern Ireland Protocol, is a protocol to the Brexit withdrawal agreement that governs the unique customs and immigration issues at the border on the island of Ireland betwe ...
, CE marking remains mandatory for products placed on the market there; although the UKCA mark may be used in addition it is not required.
Goods for sale anywhere in the United Kingdom may (and typically will) carry both marks.
, CE marking was not required by countries of the
Central European Free Trade Agreement
The Central European Free Trade Agreement (CEFTA) is an international trade agreement between countries mostly located in Southeastern Europe. Founded by representatives of Poland, Hungary and Czechoslovakia, CEFTA expanded to Albania, Bosnia and ...
(CEFTA), but members
Albania
Albania ( ; sq, Shqipëri or ), or , also or . officially the Republic of Albania ( sq, Republika e Shqipërisë), is a country in Southeastern Europe. It is located on the Adriatic and Ionian Seas within the Mediterranean Sea and shares ...
,
North Macedonia
North Macedonia, ; sq, Maqedonia e Veriut, (Macedonia before February 2019), officially the Republic of North Macedonia,, is a country in Southeast Europe. It gained independence in 1991 as one of the successor states of Socialist Feder ...
,
Serbia
Serbia (, ; Serbian language, Serbian: , , ), officially the Republic of Serbia (Serbian language, Serbian: , , ), is a landlocked country in Southeast Europe, Southeastern and Central Europe, situated at the crossroads of the Pannonian Bas ...
, and
Montenegro
)
, image_map = Europe-Montenegro.svg
, map_caption =
, image_map2 =
, capital = Podgorica
, coordinates =
, largest_city = capital
, official_languages = M ...
have applied for membership of the European Union, and are adopting many of its standards within their legislation (as had most Central European former member countries of CEFTA that joined the EU, before joining).
Rules underlying CE marking
The formal legal status of the
![Conformité Européenne (logo)](https://upload.wikimedia.org/wikipedia/commons/6/66/Conformit%C3%A9_Europ%C3%A9enne_%28logo%29.svg)
mark is set out in various
EU Directives
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before thei ...
and
Regulations
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...
.
The underlying principles are explained in the Commission's "Blue Guide".
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
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specific ...
, set up a
technical file
A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system.
All products that have a CE mark must have a technical file which must ...
, and sign a Declaration stipulated by the leading legislation for the product. 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
EU directives
A directive is a legal act of the European Union that requires member states to achieve a particular result without dictating the means of achieving that result. Directives first have to be enacted into national law by member states before thei ...
or
EU regulations
A regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into natio ...
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 legislation 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 regulations and if the conformity assessment procedure has been carried out accordingly.
* The manufacturer draws up an EU declaration of conformity or a declaration of performance (for Construction Products) and affixes the CE marking on the product.
* If stipulated in the directive(s) or regulation(s), an authorized third party (
Notified Body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These e ...
) must be involved in the conformity assessment procedure or in setting up a production quality system.
* 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.
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 the technical file to the EU declaration of conformity.
A guide to the implementation of directives and regulations based on the New Approach and the Global Approach (the "Blue Guide") was first published by the European Union in 2000. Updated versions were published on 28 February 2014 and 26 July 2016.
[Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C 272/01)](_blank)
/ref>
Self-certification
Depending on the level of risk
In simple terms, risk is the possibility of something bad happening. Risk involves uncertainty about the effects/implications of an activity with respect to something that humans value (such as health, well-being, wealth, property or the environme ...
of the product
Product may refer to:
Business
* Product (business), an item that serves as a solution to a specific consumer problem.
* Product (project management), a deliverable or set of deliverables that contribute to a business solution
Mathematics
* Produ ...
, the CE marking is affixed to a product by the manufacturer
Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of secondary sector of the economy. The term may refer to a ran ...
or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their own product. Self-certification exists only for products that have a minimal risk for their use, and this is clearly foreseen in the relevant directive and regulation according to the product "category". In order to certify, the manufacturer must do several things:
:1. Investigate whether the product needs to have a CE marking. The product must conform to all Directives and Regulations
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...
that apply to the product.
:2. Choose the conformity assessment
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specific ...
procedure from the modules called out by the directive or the regulation for the product according to each category (level of risk) involved. There are several modules available for the Conformity Assessment Procedures, but only a few of them involve self-certification. The most of these procedure require a "type Approval" and a Production conformity assessment by a Notified Body
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These e ...
. The common procedures (modules) of certification are as listed below. A product normally needs more than one procedure (Module) to be implemented:
::*Module A – Internal production control.
::* 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.
::* Module H1 – Full quality assurance and Design Examination.
The level of risk is defined by the "category" of each equipment. The higher the category, the higher the risk. After defining the category, the manufacturer, in order to obtain certification, shall then apply the relevant procedures for the specific category of the product or choose the relevant procedures for a higher-category product. The manufacturer, after insuring that the relevant modules for the product category have been applied, will affix the
mark and draw up a Declaration of Conformity. The Declaration of Conformity contains a description of the product, the directive(s) and regulation(s) applied, the product category for each directive or regulation, the module chosen, and the name and registration number of the notified body involved in certification procedures (models).
Notified bodies involved in certification procedures are organizations that have been nominated by a member state
A member state is a state that is a member of an international organization or of a federation or confederation.
Since the World Trade Organization (WTO) and the International Monetary Fund (IMF) include some members that are not sovereign states ...
(according to an accreditation
Accreditation is the independent, third-party evaluation of a conformity assessment body (such as certification body, inspection body or laboratory) against recognised standards, conveying formal demonstration of its impartiality and competence to ...
procedure) and have been notified by the European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
. These notified bodies act as Independent Inspection organizations and carry out the procedures as listed in the relevant Modules applied as stated by the relevant directives and regulations. A manufacturer can choose any notified body (notified for the certain directive or regulation and relevant Modules) in any Member State of the European Union.
In reality, the self-certification process consists of the following stages:
Stage 1: Identify the applicable norm(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 norms (directives and regulations) requiring CE marking. There are more than 20 sectoral product norms 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 norm(s) may be applicable, as there may be more than one, involves a simple exercise of reading the scope of each norm to establish which apply to the product (Such as the "Low Voltage Directive," 2014/35/EU). If the product does not fall within the scope of any of the sectoral norm, then the product does not need to bear CE marking (and, indeed, must not bear CE marking).
Stage 2: Identify the applicable requirements of the norm(s)
Each norm has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive or Regulation 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
The process is not always a self-declaration process, there are various 'attestation routes' to conformity depending on the Directive or Regulation and classification of the product. Many products (such as invasive medical devices, or fire alarm and extinguisher systems, Pressure Equipment, Lifts etc.) in most cases, have a mandatory requirement for the involvement of an authorised third party e.g. a "notified body".
There are various attestation routes which include:
*An assessment of the product by the manufacturer.
*An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by a third party.
*An assessment by a third party (e.g. EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party.
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 norm(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:
*Technical description
*Drawings, circuit diagrams and photos
*Bill of materials
*Specification and, where applicable, EU declaration of conformity for the critical components and materials used
*Details of any design calculations
*Test reports and/or assessments
*Instructions
*EU declaration of conformity
*Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).
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 norms, an EU declaration of conformity must be completed or, for partly completed machinery under the Machinery Directive, an ECU declaration of incorporation.
EU declaration of conformity
The EU declaration of conformity 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 norms ( directives and regulations
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...
) requiring CE marking affect the following product groups:
* Active implantable medical devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
(excludes surgical instruments)
* Appliances burning gaseous fuels
* Cableway
Cable transport is a broad class of transport modes that have cables. They transport passengers and goods, often in vehicles called cable cars. The cable may be driven or passive, and items may be moved by pulling, sliding, sailing, or by driv ...
installations designed to carry persons
* Construction products according to Regulation (EU) No. 305/2011 under specific rules
* Eco-design of energy related products
* Electromagnetic compatibility
Electromagnetic compatibility (EMC) is the ability of electrical equipment and systems to function acceptably in their electromagnetic environment, by limiting the unintentional generation, propagation and reception of electromagnetic energy whic ...
* Equipment and protective systems intended for use in potentially explosive
An explosive (or explosive material) is a reactive substance that contains a great amount of potential energy that can produce an explosion if released suddenly, usually accompanied by the production of light, heat, sound, and pressure. An expl ...
atmospheres
* Explosives
An explosive (or explosive material) is a reactive substance that contains a great amount of potential energy that can produce an explosion if released suddenly, usually accompanied by the production of light, heat, sound, and pressure. An expl ...
for civil uses
* Fertilizers
A fertilizer (American English) or fertiliser (British English; see spelling differences) is any material of natural or synthetic origin that is applied to soil or to plant tissues to supply plant nutrients. Fertilizers may be distinct from ...
Regulation (EU) No. 1009/2019
* Hot-water boilers
A boiler is a closed vessel in which fluid (generally water) is heated. The fluid does not necessarily boil. The heated or vaporized fluid exits the boiler for use in various processes or heating applications, including water heating, central h ...
* In vitro
''In vitro'' (meaning in glass, or ''in the glass'') studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called "test-tube experiments", these studies in biology an ...
diagnostic medical devices
* Lifts
* Low voltage In electrical engineering, low voltage is a relative term, the definition varying by context. Different definitions are used in electric power transmission and distribution, compared with electronics design. electrical safety codes define "low vo ...
* Machinery
A machine is a physical system using power to apply forces and control movement to perform an action. The term is commonly applied to artificial devices, such as those employing engines or motors, but also to natural biological macromolecule ...
* Measuring instruments
A measuring instrument is a device to measure a physical quantity. In the physical sciences, quality assurance, and engineering, measurement is the activity of obtaining and comparing physical quantities of real-world objects and events. Estab ...
* Medical devices
* Noise
Noise is unwanted sound considered unpleasant, loud or disruptive to hearing. From a physics standpoint, there is no distinction between noise and desired sound, as both are vibrations through a medium, such as air or water. The difference arise ...
emission in the environment
* Non-automatic weighing instruments
* Personal protective equipment
Personal protective equipment (PPE) is protective clothing, helmets, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection. The hazards addressed by protective equipment include physical, elec ...
* Pressure equipment
* Pyrotechnics
Pyrotechnics is the science and craft of creating such things as fireworks, safety matches, oxygen candles, explosive bolts and other fasteners, parts of automotive airbags, as well as gas-pressure blasting in mining, quarrying, and demolition. ...
* Radio Equipment
* Recreational craft
* Restriction of the use of certain hazardous substances
Dangerous goods, abbreviated DG, are substances that when transported are a risk to health, safety, property or the environment. Certain dangerous goods that pose risks even when not being transported are known as hazardous materials ( syllabi ...
in electrical and electronic equipment (RoHS
The Restriction of Hazardous Substances Directive 2002/95/EC (RoHS 1), short for Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment, was adopted in February 2003 by the European Unio ...
)
* Safety of toys
A toy or plaything is an object that is used primarily to provide entertainment. Simple examples include toy blocks, board games, and dolls. Toys are often designed for use by children, although many are designed specifically for adults and pet ...
* Simple pressure vessels
A pressure vessel is a container designed to hold gases or liquids at a pressure substantially different from the ambient pressure.
Construction methods and materials may be chosen to suit the pressure application, and will depend on the size o ...
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 US, Japan, Canada, Australia, New Zealand and Israel. Consequently, CE marking is now found on many products from these countries. Japan has its own marking known as the Conformity Mark.
Switzerland and Turkey (which are not members of the EEA) also require products to bear CE marking as an affirmation of conformity.
Characteristics of 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
* When a manufacturer puts the CE marking on a product it implies that it complies with all the Essential Health and safety requirements from all the directives and regulations that applies to its product.
** For example, for a machine, generally the Machinery directive applies, but often also:
*** Low voltage directive
The Low Voltage Directive (LVD) 2006/95/EC is one of the oldest Single Market Directives adopted by the European Union before the "New" or "Global" Approach. The Directive provides common broad objectives for safety regulations, so that electri ...
*** EMC directive
*** sometimes other directives or regulations, e.g. ATEX directive
The ATEX directives are two EU directives describing the minimum safety requirements for workplaces and equipment used in explosive atmospheres. The name is an initialization of the French term ''Appareils destinés à être utilisés en ATmos ...
*** and sometimes other legal requirements, e.g. for food contact materials
Food contact materials are materials that are intended to be in contact with food. These can be things that are quite obvious like a glass or a can for soft drinks as well as machinery in a food factory or a coffee machine.
Food contact materia ...
.
When the manufacturer of a machine puts the CE marking, it engages itself and guarantees, that it makes all the tests, assessments and evaluation on the product to conform to all the requirements of ''all'' the norms that apply to its product.
* CE marking has been introduced by the 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), 93/42/EEC (medical devices) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).
* 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 norm requires the involvement of a Notified Body in the conformity assessment procedure, depending on the legislation, an identification number may need to be put behind the CE logo. This is done under the responsibility of the Notified Body.
Misuse
The European Commission is aware that CE markings, like other certifications marks, are misused. CE marking is sometimes affixed to products that do not fulfill the legal requirements and conditions, or it is affixed to products for which it 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".[Buckinghamshire Trading Standards: What’s in your socket?, 2008.]
Detailed article on hazards found due to poor-quality AC adapters. "The good news for the consumer is that there appears to be a cheap charger for any make or model of mobile phone, toy or hand-held games consoles that you might require – the bad news is that it could kill you!" A test of 27 electrical chargers with UK sockets in 2008 found that all the eight legitimately branded ones 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.]
"China Export"
In 2008, a logo very similar to CE marking was alleged to exist and to stand for ''China Export'' because some Chinese manufacturers apply it to their products. However, the European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
says that this is a misconception. The matter was raised at the European Parliament
The European Parliament (EP) is one of the legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts ...
in 2008. The Commission responded that it was unaware of the existence of any "Chinese Export" mark and that, in its view, the misunderstanding had arisen because a producer had failed to respect the precise dimensions and proportions of the mark as prescribed in the legislation. The Commission was also aware of fraudulent misuse of the mark on products that did not comply with the standards, but that this is a separate issue. It had initiated the procedure to register CE marking as a Community collective trademark
A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from others ...
, and was in discussion with Chinese authorities to ensure compliance with European legislation. Chinese (and other non-EU) manufacturers are permitted to use the
mark provided that the goods have been manufactured in accordance with the relevant EU directives and regulations.
Nevertheless, and despite the Commission's assurance that it is without foundation, this urban myth
An urban legend (sometimes contemporary legend, modern legend, urban myth, or urban tale) is a genre of folklore comprising stories or fallacious claims circulated as true, especially as having happened to a "friend of a friend" or a family m ...
continues to be available on many websites.
Domestic plugs and sockets
Directive 2006/95/EC, the "Low Voltage" Directive, specifically excludes (amongst other things) ''plugs and socket outlets for domestic use'' which are not covered by any Union norm and therefore must not be CE marked. Throughout the EU, as in other jurisdictions, the control of ''plugs and socket outlets for domestic use'' is subject to national regulations. Despite this, the illegal use of CE marking can be found on domestic plugs and sockets, particularly so-called "universal sockets".
It is fairly common to see domestic sockets (and adaptors) that have an inbuilt 5 volt power supply. In the case of these sockets they must be CE marked, but the
mark applies to the 5 volt converter ''only'' and not the rest of the socket or adaptor. This is comparable to dedicated 5 volt power supplies.
Legal implications
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
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or if a product's safety is questioned.
In the UK, sale of any product that carries a
mark that is not so approved, or outside the scope of approval is a specific offence under Section 1 of the Trade Descriptions Act 1968
The Trade Descriptions Act 1968 is an Act of the Parliament of the United Kingdom which prevents manufacturers, retailers or service industry providers from misleading consumers as to what they are spending their money on.
This law empowers th ...
. The seller of such an article is as equally guilty as the manufacturer or importer. Ignorance as to the true status of the sold item is no defence against a prosecution (strict liability
In criminal and civil law, strict liability is a standard of liability under which a person is legally responsible for the consequences flowing from an activity even in the absence of fault or criminal intent on the part of the defendant.
...
). Under the Act, the misrepresentation is that the sold item conforms to a specification that it does not or that there is no such specification to which it can conform.
The procedures, measures and sanctions applying to counterfeiting of the CE marking vary according to the respective member state's national administrative and penal legislation. 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 with the applicable legislation before being forced to take the product off the market.
Use in computer systems
, the mark does not have a Unicode
Unicode, formally The Unicode Standard,The formal version reference is is an information technology Technical standard, standard for the consistent character encoding, encoding, representation, and handling of Character (computing), text expre ...
code point
In character encoding terminology, a code point, codepoint or code position is a numerical value that maps to a specific character. Code points usually represent a single grapheme—usually a letter, digit, punctuation mark, or whitespace—but ...
, nor is one in prospect. According to the Unicode principles, the mark is a font choice for the two ordinary upper-case letters, C and E, with a specific kerning
In typography, kerning is the process of adjusting the spacing between Character (symbol), characters in a Typeface#Proportion, proportional font, usually to achieve a visually pleasing result. Kerning adjusts the space between individual le ...
arrangement. The exact geometry that constitutes the mark is provided in the vector graphics
Vector graphics is a form of computer graphics in which visual images are created directly from geometric shapes defined on a Cartesian plane, such as points, lines, curves and polygons. The associated mechanisms may include vector display a ...
data of the .ai
.ai is the Internet country code top-level domain (ccTLD) for Anguilla, a British Overseas Territory in the Caribbean. It is administered by the government of Anguilla.
It is popular with companies in and projects related to the artificial int ...
and .eps files available from the European Commission.
See also
On motor vehicles
A motor vehicle, also known as motorized vehicle or automotive vehicle, is a self-propelled land vehicle, commonly wheeled, that does not operate on Track (rail transport), rails (such as trains or trams) and is used for the transportation of pe ...
and related parts, the United Nations Economic Commission for Europe
The United Nations Economic Commission for Europe (ECE or UNECE) is one of the five regional commissions under the jurisdiction of the United Nations Economic and Social Council. It was established in order to promote economic cooperation and i ...
's (UNECE) type approval can overrule some EU legislation, so the "emark" or "Emark", is often seen instead of the CE logo. Unlike the CE logo, the UNECE marks are not self-certified. This mark is not to be confused with the European Union's estimated sign
The estimated sign, , also referred to as the e-mark or () can be found on most prepacked products in the European Union (EU). Its use indicates that the prepackage fulfils EU Directive 76/211/EEC, which specifies the maximum permitted toleranc ...
, .
*
* (EAC) – The Eurasian Economic Union
The Eurasian Economic Union (EAEU or EEU)EAEU is the acronym used on thorganisation's website However, many media outlets use the acronym EEU. is an economic union of some post-Soviet states located in Eurasia. The Treaty on the Eurasian Econo ...
's version of the
mark
*
* (US)
* (US FDA)
* (GS)
*
* (TSE)
* - UK conformity mark
References
External links
How to reproduce the CE mark
(European Commission)
(European Commission's CE marking FAQ)
{{Authority control
European Economic Area
Consumer organizations
Certification marks
Symbols introduced in 1993
1993 establishments in the European Union