CE Marking and Exports to Europe
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CE Marking is currently required for many
products sold in Europe, yet many U.S. exporters are still unsure
or unaware of what affect this has on their business. In this
article we will try to clarify the following:
CE Marking - What's In It For You?
First, the good news: - The most obvious benefit
is that the CE Marking on your product will gain you access to
the EEA (European Economic Area). If the new product directives
apply to your products and you want to continue to export to the
European market (or introduce new products), then CE Marking will
be crucial to your success.
There will be only one set of laws and regulations
to comply with in designing and manufacturing your product for
the entire marketplace. The multiple and conflicting national
restrictions on regulated products will be eliminated. Additional
benefits may include your product being made safer for consumers
as well as reduced damage claims and liability premiums.
Now, the not so good news: The new product
directives may exceed the current national laws and regulations.
These increased or new requirements may require that a manufacturer
change their design or production processes to continue in, or
enter into this market. You will incur costs in obtaining the
product certification and any required testing. Also, the new
directives and their implementation is confusing, constantly changing
and subject to interpretation.
What is CE marking?
The European Commission refers to the CE Marking
of products as a "passport" which can allow a manufacturer
to freely circulate their products within the European marketplace.
The marking applies only to products regulated by European health,
safety and environmental protection legislation (product directives)
but this is estimated to include more than 50% of the goods currently
exported from the U.S. to Europe.
The actual CE Marking is the letters "CE"
which a manufacturer affixes to certain products for access to
the European market (consisting of 18 countries and also referred
to as the European Economic Area or EEA).
The letters "CE" are an abbreviation
of a French phrase "Conformite Europeene". The marking
indicates that the manufacturer has conformed with all the obligations
required by the legislation .
Note: Initially, the phrase was "CE
Mark"; however, "CE Marking" was legislated as
its replacement in 1993.
What Can A Notified Body Do For You?
Most companies need a guide to take then through
the CE Marking maze. There are many expert sources of information
available to you (conferences, consultants, Department of Commerce,
the Internet, hot lines, etc.) all of which are more than willing
to sell or give you their best opinion.
However, the only opinion that matters is
that of the agencies that certify products for the European Union.
These agencies are called "Notified Bodies." There
are a couple hundred of these agencies, all located in Europe
(some have satellites outside the EU that perform tests and submit
results back to Europe for final approval). Notified Bodies are
authorized by European countries to serve as independent test
labs and perform the steps called out by product directives. They
must have the necessary qualifications to meet the testing requirements
set forth in the directives. Notified Bodies may be a private
sector organization or a government agency. Manufacturers may
choose a notified body in any member state of the European Union.
Lists of Notified Bodies are published by the European Commission
in the Official Journal of the European Communities.
What To Look For In A Notified Body
The best way to proceed is to contact a notified
body whose qualifications match up with your product, and whose
credentials and affiliations match up with your and your target
markets. After that there are a number of variables to consider.
Price - Obtain quotes from at least
a few Notified Bodies; pricing can vary dramatically from one
notified body to the next.
Service - Many Notified Bodies do not provide adequate service; usually due to peak load situations and some simply
disregard customer needs.
Consulting - Some Notified Bodies
will offer advice in addition to testing to accelerate the process
an simplify the process for you. This may include a desk audit
of your technical documentation prior to actual submission. Some
ISO 9000 and Product Certification
- Very convenient and economical
(when both are required) if a notified body
can provide both services.
Documentation - Find a notified body
that will accept documents in English.
Mutual Recognition - Look for a notified body that will accept ISO 9000 registration from a U.S. registrar to avoid duplicate costs; also , find a notified body that will consider using qualified U.S. based subcontractors for audits to reduce travel related expenses.
If you need help in selecting the appropriate
notified body, contact UNZ & CO. We are prepared to assist
Which Directives Are Most Likely To Apply?
There are four directives which are quite
inclusive. In addition, when more than one directive applies
to a product, the product must comply with all applicable directives
The Machinery directive became effective
January 1, 1995, and covers any machine with moving parts (except
manually operated machines).
The Telecommunications Terminal Equipment
directive became effective November 1, 1992. However, it
was recently reported that the supporting technical standards
under development now interpret computer and network hardware
to fall under this directive.
The Electromagnetic Compatibility directive
became effective January 1, 1996. This directive applies to most
electronic equipment and concerns itself with electromagnetic
emissions and immunity.
The Low Voltage directive has been
in place since 1973. Recently added to it is a requirement for
CE Marking which will be come effective January 1, 1997. This
directive applies to all electrically operated products.
Does My Product Require CE Marking?
CE Marking is required if your customers are
located in certain countries and if they purchase certain types
of products from you.
European Free Trade Association (EFTA) members
- Iceland, Liechtenstein and Norway.
Invited to join by January 2000 - Bulgaria,
Hungary, Poland, Romania, Czech and Slovak Republics.
There are a series of steps outlined below.
Depending upon your product and the nature of the risks it presents,
there are several alternatives also noted that may apply to your
situation. A notified body would be the best resource for identifying
the steps and alternatives that would apply to your specific product(s).
Regulated Exports Versus Non-Regulated
In the European market, regulated products
are those which represent a potential threat to the general public
and are identified by the regulated product directives. These
directives (about 40 in total including proposed and adopted)
are intended to assure that only products that conform to the
safety requirements gain entry to the European market. Only those
regulated products with a CE Marking can gain entry to the European
market after the enforcement date for the product directive.
In the European market, non-regulated products
are any products not identified by the product directives. These
products do not require CE Marking but may need to comply with
national standards of the country receiving the goods. Once a
product enters one country, that same product gains entry to all
member states of the EEA by means of mutual recognition.
Who Enforces The Requirement For CE Marking?
Each member state of the European Union is
bound by the General Product Safety directive to adopt laws, regulations
and administrative provisions to ensure that products placed on
the market are safe. Each country has its own way of handling
enforcement. Many have added staff specifically to conduct spot
checks against implemented directives and respond to complaints.
Countries have also set in place a combination of return-to-origin
procedures, financial and prison term penalties. Most of the
countries would prefer to monitor and educate manufacturers and
distributors than initiate legal action.
In many cases this education is being provided to the manufacturer by their own customers. European Union legislation makes European importers liable for the products they import, including the machinery they provide to their employees for work. U.S. exporters are finding that no matter how interested a prospective European customer may be in their product, they will not risk importing non-conforming products when accidents will generate legal action against them.
What 's Europe Trying To Pull With This CE Marking?
Since the signing of the Treaty of Rome in
1946, the European community has continued to pursue the plans
for economic development laid out in that document.
"The community shall adopt measures with the aim of progressively establishing the internal market ...The internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured"
CE Marking is just one measure that the European
Union has adopted to establish a single market and foster economic
development for the member states. Listed below are some key
events leading up to the free movement of goods throughout Europe:
1975 The European Court of Justice via "the
rule of reason" permits European Union (then called European
Community) members to set national rules so long as trade between
member states is not restricted. However, product restrictions
were permitted for health, safety or environmental reasons.
1979 The European Court of Justice upholds
"mutual recognition" permitting products manufactured
(or imported) by a member state which do not present a health,
safety or environmental threat, to travel freely among other
1983 The European Council requests the European
Commission to propose revised legislation for health, safety and
environmental product restrictions.
1985 The European Council approves "New
Approach" legislation, eliminating national regulations that
restrict trade and establishing community-wide standards, testing
and certification procedures.
1992 The Vice President of the Commission
of Brussels along with ministers from the EU and the EFTA sign
an agreement organizing the free movement of goods, persons, services
and capital within the European Economic Area (EEA).
What's New About the New Approach?
The implementation of the New Approach policy
resulted in the changes outlined below:
Product Directive Content - directives
will be limited to the "essential requirements" or
performance levels to which the product must conform. Previously,
the directives included detailed technical specifications which
took forever to prepare since it involved the wrong level of
bureaucracy and expertise.
Harmonized Standards - the technical
specifications required of products to comply with the directive
will be established by several European standards agencies (CEN,
CENELEC, ETSI and EOTA).
Compliance Procedures - the directives
are linked to a series of compliance modules based on 4 factors
including the nature of risk involved. There is a concerted
effort to provide a range of choices to the manufacturer.
CE Marking - common rules established
for the affixing of the CE Marking to products.
About the Author. . . Phil Gardiol
Phil Gardiol is one of the founders of
QNET, a consulting and training firm specializing in both quality
and international business. Phil has 20+ years experience consulting
and training and has several books published on ISO 9000. Since
1990, Mr. Gardiol has helped 100+ companies achieve registration
and shown many registered companies how to minimize documentation..
Phil's ISO training materials are distributed by QNET to many
educational institutions and training firms throughout the U.S.
Phil also publishes the QNET TIMES a monthly
newsletter on ISO 9000. Write:
Copyright 1996 Unz & Co, Inc. All Rights