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:
How CE Marking affects exports to
Europe.
Which U.S. exports require CE
Marking.
How to select a notified body.
How to obtain CE Marking for exports.
CE Marking - What's In It For You
The good news - The most obvious benefit is
that the CE Marking on your product will gain you
access to the European Economic Area (EEA).
If the European product directives apply to your
products and you want to continue to export to
the European market (or introduce new
products), then CE Marking is mandatory and therefore 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 European Union (EU)
marketplace. The multiple and conflicting
national restrictions on regulated products will be
eliminated.
Additional benefits may include your product
being made safer for end-users and consumers as well as
reduced damage claims and liability premiums.
The not so good news - The new
product
directives may exceed the current national laws
and regulations. These increased or new essential
requirements may require a manufacturer to
change their design or production processes to
continue 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, undergoing constant change 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 the European Commissions 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. All other consumer products are subject to the requirements of the General Product Safety Directive 92/59/EC, which does not require the CE-mark.
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. 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 them
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 as to whether you may self-certify or not.
In case of third party certification the only opinion that matters is that of
the agencies that certify products for the
European Union. These agencies, independent and 'for profit' are called
"notified bodies", there are a couple hundred of
them and they are 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, only in cases where self-certification is not possible. 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
Once it is determined that you manufacture a product that is not subject to the self-certification route, 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.
Service - Many notified bodies do not
provide adequate service; usually
due to peakload situations, lengthy European vacations and some
simply disregard customer needs.
Consulting -
Some notified bodies will
(and some will not) offer advice in
addition to testing to accelerate the
process and simplify the process for you
(such as a desk audit of your technical
documentation prior to actual
submission).
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.
copyright 2007
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 can't find a Notified Body who will comply
with the items listed above, keep looking, they do
exist.
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
1/95 and covers new and used machinery with
moving parts (except manually
operated machines).
The Medical Device directive
was effective 06/98.
This directive requires an Authorized Representative be located in Europe.
The Electromagnetic Compatibility
directive was effective 1/96. 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 and was amended 1/97. This directive
applies to all electrical equipment designed for use with a voltage rating between 50 and 1000V AC and between 75 and 1500V DC.
copyright 2007 by qnet
Does Your Product Require CE Marking?
CE Marking is required if your customers are in located in certain countries and if they purchase
certain types of products from you.
1. Are your current or future customers in the following countries?
European Union (EU) member states - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and
United Kingdom.
European Free Trade Association (EFTA) members - Iceland, Liechtenstein and Norway.
2. Do you now, or will you in the future, ship to these customers the following types of products?
· Toys
· Construction Products
· Pressure Vessels
· Telecommunications
· Medical Devices
· Machinery
· Personal Protective Equipment
· Satellite Station Equipment
· Gas Appliances
· Pressure Equipment
· Appliances (other than gas)
· Non-automatic weighing instruments
· Recreational Craft
· Lift Machinery
· Equipment and Protective systems for explosive atmospheres
· Non-Automatic Weighing equipment
· Measuring Instruments
· In-Vitro Diagnostic Medical Devices
· Marine Equipment
· Electrical products
How Do You Acquire CE Marking?
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.
Determine if any directives apply to your
product. If more than one applies you will
have to comply with all of them.
Determine the extent to which your
product complies with the essential
requirements for design and
manufacturing in the applicable
directive(s).
Choose the conformity assessment
procedure from the options called out by
the directive for your product.
The directives often use a series of
questions about the nature of your
product to classify the level of risk and
refer to a chart called "Conformity
Assessment Procedures". The chart
includes all of the acceptable options
available to a manufacturer to certify their
product and affix the CE Marking.
Options for products with minimal risk
include self certification where the
manufacturer prepares a declaration of
conformity and affixes the CE
Marking to their own product.
Options for products with greater risks
can require tests, audits or additional
certificates from a notified body.
Select the applicable product standards
and test methods for your product and
select an independent lab If the product
testing is to be done externally.
Establish an authorized representative for regulatory affairs in
the European Union for your product. Some
directives require that a manufacturer
designate in Europe a
representative to produce
technical documentation in a timely
fashion when called upon to do so.
The directives require for many products
that a technical file be prepared by the
manufacturer. The technical file holds
information that verifies that the testing
was conducted properly and that the
product complies with applicable
standards.
Prepare a declaration of conformity that
includes a list of the directives and
standards that your product conforms to;
product identification, the manufacturer's
name, address and signature. The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.
Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.
Who's Going To Enforce The
Requirement For CE Marking?
Each member state of the European Union is
bound to adopt into their National Law, 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 penalties, criminal prosecution, etc. European Union legislation makes European importers liable for the products they import, including the machinery they provide to their employees for work under the PUWER Directive.
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"
- The Treaty of Rome, article 8a
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 states.
1983 The European Council requests the
European Commission to propose
revised legislation for health, safety and
environmental product restrictions.
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 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.
