CE MARKING FREQUENTLY ASKED QUESTIONS
European Commission describes the CE mark (an acronym for
the French phrase "Conformite Europeenne") as a
"passport" that allows manufacturers to
circulate industrial products freely within the internal
market of the EU. The CE mark certifies that the products
have met EU health, safety and environmental requirements
that ensure consumer and workplace safety. All
manufacturers in the EU and abroad must affix the CE mark
to those products covered by the "New Approach"
directives in order to market their products in Europe.
Once a product receives the CE mark, it can be marketed
throughout the EU without having to undergo further
IS THE EU's NEW APPROACH TO PRODUCT CERTIFICATION?
European Union (EU) developed "New
Approach" Directives to streamline product
approvals for a broad range of goods in order to
facilitate trade within the EU single internal market. The
"Old Approach" Directives contained a high
degree of technical detail, and EU member states
introduced national standards or regulations at a faster
pace than the European Commission could finalize these
"Old Approach" Directives. These national
specifications often proved to be trade barriers.
Approach Directives are limited to essential health and
safety requirements for sectors such as machinery,
electrical products, or medical devices. They do not cover
specific products such as motor vehicles, cosmetics, or
chemicals, which are still covered under the Old Approach
Directives. The main difference between the New and Old
Approach Directives is that under the New Approach, the
technical details outlining the minimum requirements a
product must meet are usually not found in the directive
itself. The New Approach Directives are more general.
details on how to meet these minimum health and safety
requirements are left to the following three groups: 1)
Manufacturers who self-certify products by meeting the
requirements of the applicable directives, in some cases
by using appropriate European standards; 2) the three
regional European standards organizations (CEN, CENELEC
and ETSI), which now make Europe-wide standards covering
product sectors falling under the New Approach Directives;
and, 3) government-appointed product certification bodies
(called notified bodies), which provide testing and
the New Approach, the European Commission gives mandates
to the standards organizations to develop technical
standards that meet the essential health and safety
requirements of CE Mark directives. The New Approach
Directives are designed to facilitate product
certification, to maintain a high level of consumer and
workplace safety, and to expand intra-European trade.
PRODUCT GROUPS ARE COVERED BY THE NEW APPROACH DIRECTIVES?
are New Approach Directives for electronic and electrical
products, machinery, medical devices, radio and
telecommunications terminal equipment, recreational craft,
pressure equipment, equipment for use in potentially
explosive atmospheres, personal protective equipment,
toys, simple pressure vessels, and others. New Approach
Directives indicate a product has met certain health and
safety requirements. A company affixes the CE mark to its
product once it has met the requirements of the applicable
New Approach Directive(s). These directives came about as
a way of eliminating trade barriers and facilitating the
EU Single Internal Market.
all products fall under the New Approach Directives. There
are essentially three levels of regulatory control:
Approach - The Old Approach Directives apply to the
foodstuff, motor vehicle, chemical, cosmetic, and
pharmaceutical sectors. These regulations have technical
specifications written into the annexes.
Approach - These directives make references to harmonized
standards and apply to broad product sectors such as
machinery, electrical and electronic products, medical
devices, and radio and telecommunications equipment. The
directives usually set down general health and safety
requirements, and the specifications for meeting these
general requirements are found in the standards applicable
to the manufacturer's product. Conformity assessment
procedures (the system and responsibilities for testing
and certification which should lie with the manufacturer
and, where applicable, the notified bodies) are also
contained in the these directives.
General Product Safety Directive (GPSD) covers all
products not specifically covered by the CE mark
directives but which do require some level of safety
regulation. These products may also be regulated at the
national level by member states.
is a vast body of European standards not mandated by the
European Commission. These standards are not directed
toward either the Old Approach or New Approach Directives.
While the use of these standards is in theory voluntary,
they can support claims of a product's quality either for
marketing or legal purposes. These standards cover such
products as furniture, household appliances
(non-electrical), sports equipment, carpeting, footwear,
and small hand-held tools. The standards define
characteristics such as durability, appearance, quality,
and even cultural preferences.
Products meeting the applicable technical standards
developed by the three standards organizations are
presumed to conform to the requirements of EU directives
and are allowed to circulate freely within the European
Union. Use of European standards is seen as a "fast
track" for gaining CE mark compliance for a product.
For many products, though, a manufacturer can choose not
to comply with the CEN, CENELEC, or ETSI standards, if the
company can demonstrate that its product satisfies the
essential safety and performance requirements of the
THE FOREIGN COMPANIES SELF-CERTIFY FOR THE CE MARK?
products covered by New Approach Directives can be
self-certified by the manufacturer and do not require the
intervention of an EU-authorized testing/certifying
company called a notified body. To self-certify, the
manufacturer must assess the conformity of the products to
the applicable directives and standards. While the use of
EU harmonized standards is voluntary in theory, in
practice the use of European standards is the best way to
meet the requirements of the CE mark directives,
especially in the case of the Electromagnetic
Compatibility (EMC) and Low Voltage Directives. (The word
"harmonized" means that the standards have been
approved by all 15 European Union countries). The
standards offer specific guidelines and tests to meet
safety requirements, while the directives are more general
and do not, in most cases, offer detailed specifications
on how to meet safety requirements. The Machine Directive,
however, does offer more detailed information on how to
meet safety requirements than most other CE mark
directives. U.S. companies can self-certify to the CE mark
requirements of the Machine Directive by meeting the
provisions of the directive whether they use European,
international or U.S. standards.
manufacturer may affix the CE mark to his product once
he's prepared a declaration of conformity, the certificate
which shows the product conforms to the applicable
requirements. He must maintain a technical file to prove
conformity. The manufacturer or his authorized
representative must be able to provide this certificate
together with the technical file at any time, if requested
by the appropriate member state authorities.
is no specific form for the declaration of conformity but
specific information is required. The declaration must
include the following:
manufacturer's name and address;
–the product description;
–the CE mark directives that apply to the product, e.g.,
the machine directive 98/37/EC or the low voltage
–the European standards used, e.g. EN 50081-1:1993 for
the EMC Directive or EN 60950-1: 2001 for the low voltage
requirement for information technology; and,
–the signature of a company official for purposes of the
company assuming liability for the safety of its product
in the European market.
WHAT CONDITIONS ARE THE FOREIGN COMPANIES UNABLE TO
SELF-CERTIFY FOR THE CE MARK?
manufacturers can self-certify many products under the New
Approach Directives, certain high-risk products cannot be
self-certified. These dangerous products require an EC
type-examination, which involves the inspection of a
representative sample by a "notified body"
within the European Economic Area (EEA). The EEA consists
of the EU plus the European Free Trade Association countries
of Iceland, Norway, and Liechtenstein, excluding
bodies are independent testing houses or laboratories
authorized by the EU member states to perform the
conformity assessment tasks specified in the directives. A
notified body may use a subcontractor to perform part(s)
of a conformity assessment procedure. Many U.S. testing
houses act as subcontractors to the EU notified bodies.
However, the notified body is the ultimate authority, and
a company must gain notified body approval in order to
claim CE mark compliance for its project. For information
on how to obtain a list of notified bodies or a list of
U.S. companies that subcontract to EU notified bodies,
look at "Official EU Website" shown below.
HAVE THE EUROPEANS DONE TO ENFORCE THE CE MARKING
REQUIREMENTS AND WHAT ARE THE PENALTIES FOR
national agencies, such as the Departments of Health,
Industry and Labor, have been appointed to conduct market
surveillance for CE marking. The purpose of this
surveillance is to ensure that the provisions of the New
Approach Directives have been met for products marketed
within the European Union. In pursuit of this goal,
surveillance authorities will:
commercial, industrial and storage premises on a regular
–visit work places and other premises where products are
put into service and used;
–organize random checks; and,
–take samples of products for examination and testing.
surveillance authority can ask for the manufacturer's
declaration of conformity and technical file after making
a random check. The manufacturer, his authorized
representative or the importer must be able to provide the
technical file within seven to10 days after the
surveillance authority makes the request. If the product
is found to be noncompliant, corrective action will depend
on and be appropriate to the level of noncompliance.
surveillance authority will hold accountable the person
responsible for affixing the CE mark to the noncompliant
product. Others responsible for the noncompliance of the
product will be held accountable as well. Penalties, which
may include imprisonment, are determined by national law.
A U.S. COMPANY HAS CERTIFIED ITS PRODUCT WITH THE CE MARK,
IS ITS WORK DONE?
a major challenge for U.S. firms that have CE-certified
their products is to stay current on new standards coming
on stream for their products. For example, the European
standards bodies have developed some 900 standards for the
Low Voltage Directive and around 185 standards for the
Electromagnetic Compatibility Directive (EMC). Not only
are new standards being issued, but these new standards in
some cases have replaced standards that companies may have
met earlier. European customs may look for reference
numbers of widely-used standards on the Declaration of
Conformity to assure compliance of products entering
Europe. U.S. companies that use EMC or low voltage
standards that have been replaced are considered to be
noncompliant with CE mark requirements.
is one of the stricter countries for enforcing CE mark
requirements. In a recent year the European Commission
brought some 200 cases against companies, many in Asia,
for noncompliance with the Low Voltage Directive. Some of
these cases resulted in bans from the European market.
U.S. companies and test houses must keep up-to-date on
these new standards that will force changes in their
testing and design plans.
ISO 9000 REQUIRED IN ORDER TO GET THE CE MARK?
9000 registration (or EN 29000 certification) is used
widely in Europe on a voluntary basis as a condition of
acceptance of a manufacturer's product or as a way of
recognizing the manufacturer's credibility. While a
quality system such as ISO 9000 indicates that a company
has an efficient organization structure and has low
failure costs, it does not always certify conformity with
the CE mark directives. However, some directives require
use of a quality management system as part of the
example, the Machine Directive requires manufacturers to
set up a quality control system to make sure that future
products coming off an assembly line meet CE mark
requirements. However, the quality control system does not
have to be ISO 9000, although ISO 9000 is a good choice,
since it is widely recognized. The Medical Device
Directive does require ISO 9000 (EN 13485) as part of the
conformity assessment process.
DO EUROPEAN STANDARDS RELATE TO THE CE MARK?
to the harmonization of standards under the New Approach,
each European country developed its own standards through
a national standards body. The new system provides for
three standards bodies to create standards on a
The European Committee for Standardization (CEN) in
2) the European Committee for Electrotechnical
Standardization (CENELEC) in Brussels;
3) the European Telecommunications Standards Institute (ETSI)
in Sophia Antipolis, France.
activities are in the electrotechnical sector, while ETSI
specializes in telecommunications. CEN covers all other
and CENELEC's principal members are national standards
bodies, while ETSI's membership incorporates a wider range
of interested parties. These three are the only bodies
that can develop a European standard (EN). When work on a
European standard begins in one of these standards bodies,
work on a corresponding national standard must stop.
European standards, like European laws and European
conformity assessment procedures, preempt and replace
national (member state) standards.
European standards (ENs) that play a role in New Approach
Directives are known as "harmonized standards."
These standards supporting European legislation: 1) are
mandated by the European Commission; 2) have been
developed by the European standards bodies listed above,
and 3) address essential requirements of the New Approach
Directives. These standards become officially recognized
as harmonized standards when they are cited in the
Official Journal of the European Communities.
There is a vast body of European standards that is not
mandated by the European Commission. These standards are
not directed towards either the Old Approach or the New
Approach Directives. While the use of these standards is
in theory voluntary, they can support claims of a
product's quality either for marketing or legal purposes.
These standards cover such products as furniture,
household appliances (non-electrical), sports equipment,
carpeting, footwear and small hand-held tools (which are
not covered by the Machinery Directive). They define
characteristics such as durability, appearance, quality
and even cultural preferences.
IS THE ADVANTAGE OF USING EUROPEAN STANDARDS?
that meet the applicable technical standards developed by
the three standards organizations are presumed to conform
to the requirements of EU directives and are allowed to
circulate freely within the European Union. Use of
European standards is seen as a "fast track" for
gaining CE mark compliance for a product. For many
products, though, a manufacturer can choose not to comply
with the CEN, CENELEC, or ETSI standards, if the firm can
demonstrate that its product satisfies the essential
safety and performance requirements of the directives.