CE marking The CE mark, or formerly EC mark, is a mandatory
conformity marking for certain products sold within the European Economic Area since 1985.
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).
Meaning Existing in its present form since 1995, 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 usman 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.
Countries requiring the CE marking 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 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).
Rules underlying CE marking 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:
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.
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.
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:
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.
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: 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 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: Technical description
Drawings, circuit diagrams and photos Bill of materials
Specification and, where applicable, Declarations of Conformity for the critical components
and materials used Details of any design calculations
Test reports and/or assessments Instructions
EC 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 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:
Name and address of the manufacturer Details of the product (model, description
and the serial number where applicable) List of applicable sectoral Directives and
standards that have been applied A statement declaring that the product complies
with all of the relevant requirements Signature, name and position of the responsible
person The date that the Declaration was signed
Details of the authorised representative within the EEA (where applicable)
Additional Directive/standard specific requirements In all cases, except for the PPE Directive,
all of the Directives can be declared on one Declaration.
Once a Declaration of Conformity has been completed, the final step is to affix the
CE marking to the product. When this has been done, the CE marking requirements have been
met for the product to be placed legally on the EEA market.
Purpose for safety issues. 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 directives requiring CE marking 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 Restriction of the use of certain hazardous
substances RoHS 2 For a complete listing, see the New Approach
website established by the European Commission and EFTA with the European Standardisation
Organisations. 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, CE marking is now found on many products from these countries. Japan
has its own marking known as the Technical 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 products this implies that he complies to
all the Essential Health and safety requirements from all the directives that applies to its
product. When the manufacturer of a machine puts the
CE marking, it engage himself and guarantee, that he makes all the tests, assessments and
evaluation on the product to conform all the requirements of ALL the directives that applies
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) 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 directive requires the involvement of
a Notified Body in the conformity assessment procedure, its identification number has to
be put behind the CE logo. This is done under the responsibility of the Notified Body.
The e mark 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. Misuse
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. China Export
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.
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. 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.