Only safe, flawless, and quality goods
should be available on the European market – at least, that’s the objective of
the CE mark. The seal proves that the product in question conforms to EU health
and safety standards, whether it's toys or construction machines. Our experts
conduct an audit on your products based on the appropriate EU regulations, such
as the low-voltage or electromagnetic compatibility directive. A CE declaration
of conformity means your product now has right of way onto the European market.
Benefits
at a Glance
CE mark helps you:
·
Stick to current EU guidelines
·
Reduce liability for your
company with documented safety standards
·
Improve the quality and safety
of your products
·
Take advantage of short audit
times and our extensive experience
Four
Steps to Your Product’s CE Mark
Step
1:
Our employees determine which directive are applicable to your
product.
Step 2:
We carry out the conformity evaluation procedure and all required
audits on your behalf. With a declaration of conformity, you demonstrate that
your product complies with all valid regulations, such as health and safety
product regulation or medical product regulations.
Step 3:
Some products or machines rated as dangerous need to have been initialized by
an authorized body
Step 4:
You can now label your product as CE mark approved.
CE
Directive and the CE Mark
The 'CE' abbreviation
stands for 'Communauté Européenne,' French for 'European Union.' It also stands
for EU-wide standards, which simplify the traffic of European goods.
The CE marking as it has been legally called since
1993 (per directive 93/68/EEC)(Decision 93/465/EEC), or formerly EC mark is a mandatory conformity marking for
products placed on the market in the European
Economic Area (EEA). With the CE
marking on a product, the manufacturer declares that the product conforms to
the essential requirements of the applicable EC directives.
The actual meaning of
"CE" has been disputed. It is often taken to be an abbreviation of French: Conformité Européenne, meaning
"European Conformity". However,
"CE" originally stood for "Communauté Européenne",
"Comunidad Europea", "Comunidade Europeia" and
"Comunità Europea", meaning "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
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
and Liechtenstein. It is also obligatory for all such 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
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 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 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.
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.
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
·
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
Dimensions
The CE logo must be at
least 5 mm high (except on small-scale equipment/machinery such as
spectacles). Where it cannot be placed on the product itself (e.g. contact lens
solution), it must be placed on the packaging.
The letters "CE"
are not enough. The logo must not be modified.
CE Marking is
the symbol 
as
shown on the top of this page. The letters "CE" are the
abbreviation of French phrase "Conformité Européene"
which literally means "European Conformity". The term initially used
was "EC Mark" and it was officially replaced by "CE
Marking" in the Directive
93/68/EEC in 1993. "CE
Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For
instance, in the Directive 2007/47/ec, of 5 September 2007, amending the
directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page
document.
- CE
Marking on a product is a manufacturer's declaration that the product
complies with the essential
requirements of the
relevant European health, safety and environmental protection legislation,
in practice by many of the so-called Product
Directives.*
*Product
Directives contains
the "essential requirements" and/or "performance levels"
and "Harmonized Standards" to which the products must conform.
Harmonized Standards are the technical specifications (European Standards or
Harmonization Documents) which are established by several European standards
agencies (CEN, CENELEC, etc).
CEN stands
for European Committee for Standardization.
CENELEC stands for
European Committee for Electrotechnical Standardization.
- CE
Marking on a product indicates to governmental officials that the product
may be legally placed on
the market in their
country.
- CE
Marking on a product ensures the free
movement of the product within
the EFTA & European Union (EU) single market (total 28 countries), and
- CE
Marking on a product permits the withdrawal
of the non-conforming products by
customs and enforcement/vigilance authorities.
General principles of the CE marking
- The
CE marking shall be affixed only by the manufacturer or his authorised
representative.
- The
CE marking shall be affixed only to products to which its affixing is
provided for by specific Community harmonisation legislation, and shall
not be affixed to any other product.
- By
affixing or having affixed the CE marking, the manufacturer indicates that
he takes responsibility for the conformity of the product with all
applicable requirements set out in the relevant Community harmonisation
legislation providing for its affixing.
- The
CE marking shall be the only marking which attests the conformity of the product
with the applicable requirements of the relevant Community harmonisation
legislation providing for its affixing.
- The
affixing to a product of markings, signs or inscriptions which are likely
to mislead third parties regarding the meaning or form of the CE marking
shall be prohibited. Any other marking may be affixed to the product
provided that the visibility, legibility and meaning of the CE marking is
not thereby impaired.
- Member
States shall ensure the correct implementation of the regime governing the
CE marking and take appropriate action in the event of improper use of the
marking. Member States shall also provide for penalties for infringements,
which may include criminal sanctions for serious infringements. Those
penalties shall be proportionate to the seriousness of the offence and
constitute an effective deterrent against improper use.
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 his 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 (EEA, the 27 Member States of the EU and
EFTA countries Iceland, Norway, Liechtenstein), as well as Turkey. This also
applies to products made in third countries which are sold in the EEA and
Turkey. 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.
There are more than 20 directives setting out the product categories
requiring CE marking. The essential requirements that products have to fulfil
(e.g. safety) are harmonised at EU level and are set out in general terms in these
directives. Harmonised European standards are issued with reference to the
applied directives and express in detailed technical terms the essential
requirements. It is up to you to ensure that your product complies with the
essential requirements of the relevant EU legislation. Full compliance of a
product to the harmonised standards gives a product the “presumption of
conformity” with the relevant essential requirements. The use of harmonised
standards remains voluntary. You may decide to choose other ways to fulfil
these essential requirements. Testing the product and checking its conformity
to the EU legislation (Conformity Assessment Procedure) is the responsibility
of the manufacturer. One part of the procedure is, as a general rule, a risk
assessment. By applying the relevant harmonised European standards, you will be
able to fulfill the essential legislative requirements of the directives. The
manufacturer has to establish the technical documentation required by the
directive(s) for the assessment of the product’s conformity to the relevant
requirements, and for the risk assessment.
Together with the EC declaration of conformity, the technical documentation
must be presented on request to the relevant national authorities. Each
directive covering your product specifies whether an authorised third party
(Notified Body) must be involved in the conformity assessment procedure
necessary for CE marking. This is not obligatory for all products, so it is important
to check whether the involvement of a Notified Body is indeed required. These
Bodies are authorised by national authorities and officially “notified” to the
Commission and listed in the NANDO (New Approach Notified and Designated
Organisations) database.
