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WHAT IS THE CE MARKING, AND WHAT IS ITS PURPOSE?
The European Commission describes the CE marking (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 marking 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 marking to
those products covered by the "New Approach" directives in order
to market their products in Europe. Once a product receives the
CE marking, it can be marketed throughout the EU without having
to undergo further product modification.
WHAT IS THE EU's NEW APPROACH TO PRODUCT CERTIFICATION?
The 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. 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.
New 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.
Technical 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 develop 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 product
approvals.
Under the New Approach, the European Commission gives
mandates to the European standards organizations to develop
technical standards that meet the essential health and
safety requirements of CE Marking 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.
WHICH PRODUCT GROUPS ARE COVERED BY THE NEW APPROACH
DIRECTIVES?
The New Approach Directives are listed on the website:
www.newapproach.org . There 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. A
company affixes CE marking to its product once the essential
health and safety requirements of the applicable New
Approach Directive(s) have been met. These directives came
about as a way of eliminating trade barriers and
facilitating the EU Single Internal Market.
Not all products fall under the New Approach Directives.
There are essentially three levels of regulatory control:
Old Approach - The Old Approach Directives apply to the
foodstuff, motor vehicle, chemical, cosmetic, detergents,
biocides, and pharmaceutical sectors. These regulations have
technical specifications written into the annexes.
New 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, accredited test laboratories) are also
contained in these directives.
The General Product Safety Directive (GPSD) covers all
products not specifically covered by CE marking directives
but which do require some level of safety regulation. These
products may also be regulated at the national level by
member states.
The role of standards in New Approach, Old Approach and GPSD:
There is a vast body of European standards. Voluntary
industry standards are known as European harmonized
standards whenever they are linked to European new approach
legislation. European harmonized standards are developed by
one of three European standards organizations based on a
mandate from the European Commission. Products meeting the
applicable technical standards developed by the European
standards organizations are presumed to conform to the
requirements of EU new approach directives and are allowed
to circulate freely within the European Union. Use of the
European harmonized standards is seen as a "fast track" for
gaining CE marking 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 directives.
Old approach legislation may refer to existing standards in
the text or annexes, thus becoming mandatory. Technical
annexes often are standards in their own right.
As for the general product safety directive, safety of
products can be demonstrated by using existing standards
which have been referenced in the Official Journal, the EU
equivalent of the U.S. Federal Register. These standards
cover products such as furniture, household appliances
(non-electrical), sports equipment, childcare articles, and
small hand-held tools. The standards define characteristics
such as durability, appearance, and quality.
UNDER WHAT CONDITIONS ARE U.S. COMPANIES UNABLE TO
SELF-CERTIFY FOR THE CE MARKING?
While manufacturers can self-certify many products under the
New Approach Directives, certain high-risk products cannot
be self-certified. These higher risk products require the
services of 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 Switzerland.
Notified 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 marking compliance for its project. For information on
how to obtain a list of notified bodies, look at
http://ec.europa.eu/enterprise/newapproach/nando.
For a list of U.S. companies that subcontract to EU notified
bodies, go to “Testing/Certifying Labs” on this website.
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