The CE Mark - Are you ready?
By 2004, an
estimated one half of all U.S.
exports to the EU will require
the CE mark (Conformite
Europenne). The CE mark
indicates that a company has
met essential health and
safety requirements for a wide
range of products, including
machinery, electronics,
medical devices and
telecommunications equipment.
All companies selling products
within the EU must meet CE
mark requirements in order to
sell their product, CE mark
product certification is
crucial for U.S. companies
exporting to Europe. Below are
questions designed to help
U.S. exporters understand the
CE mark
What is the CE Mark and
what is it's purpose?
The CE mark
is an indication that a
company has met the essential
heath, safety and
environmental requirements
detailed in 22 European Union
directives covering an array
of products, including
electronics, machinery, simple
pressure vessels,
telecommunications, medical
devices, toys and others. Once
a company has met these
requirements, it can affix the
CE mark to its products and
sell them throughout the
European Union without having
to make separate product
modifications in each EU
country to which it is
selling.
The purpose
of rile CE mark is to
harmonize health, safety and
environmental regulations in
order to facilitate trade and
ensure a baseline level of
consumer safety among EU
member states. If a company
fails to meet CE mark
requirements, its product can
be held up by European customs
at the point of entry and
returned to the United Stores.
If the non-CE marked product
makes it through customs, CE
mark enforcement officials in
each member state could
discover the violation while
making routine checks at
manufacturing centers or in
stores. These enforcement
agents might also discover a
product in non-conformance
with the CE mark after
investigating an accident or
in acting on a competitor’s
complaint. Initial CE mark
violators are usually
penalized by fines. Repeated
violations can lead to a
product being banished from
the European market.
Which
product groups do the CE
Marking directives cover?
It is
estimated that about half of
all U.S. merchandise goods
exports to the EU will be
affected by these directives
when the CE mark program is
fully implemented.
The adopted
CE mark (or New Approach)
directives cover the following
product groups: Active
implantable medical devices,
electrical equipment for use
in explosive atmospheres,
cableway installations for
passengers, civil users of
explosives, construction
products, electromagnetic
compatibility, energy
efficiency for household
refrigerators and freezers,
energy labeling, gas
appliances, hot water boilers,
in-vitro diagnostic medical
devices, elevators, law
voltage, machinery safety,
medical devices, noise
emission of outdoor equipment,
personal protective equipment,
pressure equipment, radio and
telecommunications terminal
equipment, recreational craft,
satellite earth station
equipment, telecommunications
terminal equipment and toy
safety. New Approach
directives on packaging,
packaging waste and marine
equipment do not require the
CE mark
The one CE
mark directive not yet
approved by the EU, the
measuring instruments
directive, should be adopted
sometime in 2002.
Almost all
of the adopted CE mark
directives are mandatory,
meaning companies must meet
the directives in order to
sell their products in Europe.
Can US companies
self-certify for the CE Mark?
Most
products covered by the New
Approach directives can be
self-certified by the
manufacturer. To self certify,
the manufacturer must assess
the conformity of the products
to the applicable directives
and standards. Below is an
attempt to clarify the process
through five steps.
Step 1: Identify
the directives and standards
that app/y to your product. A
list of directives, standards
and harmonized standards
giving presumption of
conformity is maintained on
the New Approach web site, www.newapproach.org.
Step 2: Make
sure that your product is one
that can be self-certified.
While most products can be
self-certified, there are some
that cannot. Certain high risk
products may not be
self-certified. High-risk
products include dangerous
machines (as defined in Annex
4 of the Machine Directive),
simple pressure vessels, gas
appliances, and medical
devices. These products
require testing by an EU
affiliate lab in the U.S. that
is connected to a notified
body. Many U.S. testing houses
act as subcontractors for the
EU notified bodies. A list of
notified bodies (EU based test
labs) can be located on the EU
Europa web site The list of
notified bodies and the list
of test houses in the U.S.
that subcontract to EU
notified bodies call be
obtained through the Commerce
Department.
Step 3:
If your product cannot be
self-certified, obtain a test
result from a lab confirming
that the standards were met.
It is only necessary to use an
EU-affiliated lab within the
United States if your company
does not already abide by
European standards, if the
company uses European
standards, it can use any lab
that has the equipment to rest
to those standards, While the
use of European harmonized
standards is not required,
applying EU standards is the
best way to meet the
requirements of the CE Mark
directives,
Step 4: Establish
a technical file documenting
that your product conforms to
the CE Mark directive. The
main component of the
technical file is the lab
report showing that your
product conforms to the
European standard. Operating
instructions are also part of
the technical fi/e,
Step 5:
Create a Declaration of
Conformity. Once the company
has received the lab
certificate it is their
responsibility to fill out a
Declaration of Conformity
indicating that the product
has met CE mark requirements
for any applicable directives.
There is not a specific form
that must be used for the
Declaration of Conformity.
However, a declaration must
include the manufacturer's
name and address, the model
and serial number of the
product, the CE marking
directives that apply to the
product, the European
standards used and the
signature of a company
official showing that the
company assumes liability for
the safety of the product in
the European market. The
Department of Commerce's
Office of European Union
Affairs has sample conformity
declarations available upon
request.
After the
Declaration of Conformity has
been prepared, the
manufacturer must affix the CE
mark to the product, The
manufacturer or its authorized
representative must then be
able to provide the
Declaration of Conformity
together with the technical
file if requested by the
appropriate member-state
authorities.
A Follow-up
Step: Stay current on new
standards coming into play on
your products, A major
challenge for U.S. firms is to
stay current on new standards
in force for their products.
For example, the European
standards organizations have
developed some 750 standards
for the low voltage directive
and 175 standards for the
electromagnetic compatibility
directive (EMC). Not only are
new standards being issued,
hut also these new standards,
in some cases, have replaced
standards that companies may
have met earlier. U.S.
companies that use EMC or low
voltage standards that have
been replaced are considered
to be non-compliant with CE
mark requirements. U.S.
companies can keep abreast of
any changes by consulting the
New Approach and European
Union websites listed at the
end of the article.
What is the US Department
of Commerce doing to help US
companies get the CE Mark?
The
Commerce Department has
information packages for each
CE mark directive available to
U.S. companies, These CE mark
packages contain the
applicable CE mark directive,
the updated list of standards,
instructions on how to meet CE
mark requirements, a list of
labs in the U.S, (some EU
affiliate labs and some non-EU
labs), a sample declaration of
conformity; guides explaining
the directives and other
information, such as what goes
into a technical file and a CE
mark overview with the
complete list of CE mark
directives. To request an
information package, contact
thc Commerce Department's
Office of European Union
Affairs, whose address and
telephone number appear at the
end of the article.
Where can
I find more information on the
CE Mark?
The
following web sites provide
information on CE marking:
http://www.newapproach.org
(CE mark directives and the
updated list of standards)
http://www.europa.eu.int/comm/enterprise/newapproach/standardization
(Principal EU website).
http://www.eurunion.org/legislat/index.htm
(Delegation of the European
Commission to the United
States. Choose the
"standards" option.
http://europa.eu.int/ISPO/infosoc/legreg/docs/91263.html
(Information about notified
bodies, that is, the EU-based
test labs).
http://www.trade.gov/td/tic/
(Select Europe for general
information on exporting to
Western Europe).
http://www.buyusa.gov/europeanunion/
(US Liaison Office to EEC)
http://www.ita.doc.gov/td/tic/ce_mark/ceindex1.htm
- US Department of Commerce's
Trade Information Center CE
Mark page.
In addition, the following
contacts within the Department
of Commerce are valuable
sources of information:
Trade Information Center,
Phil Combs or JoAnn Queen;
Tel: (800) USA-TRAD(E), Email:
TIC@ita.doc.gov
Office of
the European Union and
Regional Affairs, Bob Straetz,
CE mark specialist; Tel: (202)
482-4496; Fax: (202) 482-2897.
U.S,
Mission to the European Union,
Suzanne Seen & Sylvia
Mohair; Tel: (32 2) 513-2674
or 2675; Fax: (32 2)
513-1228.11
Local
Michigan firms can also get
excellent guidance from:
Dr. Val Liepa
U of M College of
Engineering
Electrical Engineering &
Computer Science
3242 EECS
Ann Arbor, MI 48109
Phone: 734 647-1792
EMail Address: liepa@umich.edu
Date Updated: March 27, 2007
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