Supplier of European
Standards, British Standards, American Standards, ISO and J1
visas
Home, Standard Bodies, Common Standards, How To Order, Supplier of., Quote form
The
CE Mark
The British American
Chamber receives numerous telephone calls from manufacturers and exporters who
have had their product seized by customs officials in the European Union at the
worst or returned to them because they did not have the CE mark affixed to them.
To assist manufacturers/exporters considering exporting their product to Europe,
the following explanation of the CE mark is given.
The CE
(Conformité Europeenne) mark appears on products that
meet safety standards that apply to all countries of the European Union (EU). It
was created under the Single European Act and introduced to facilitate the free
movement of goods (and services) within the European
Union.
The CE mark must be
affixed to the product, to its data plate or, where this is not possible or not
warranted on account of the nature of the product, to its packaging, if any, and
to the accompanying documents by the manufacturer, the authorized representative
in the community or, in exceptional cases, by those responsible for placing the
product on the market. The CE Mark must be affixed visibly, legibly and
indelibly. Where special provisions do not impose specific dimensions, the CE
Mark must have a height of at least 5 millimeters.
Products, which do not
carry the CE Mark and are not in compliance with the directives, may be
restricted, prohibited from sale or forced to withdraw from the European
market.
Manufacturers and
authorized representatives or anyone responsible for placing products on the
European market can be held personally liable for damages or
injury.
Each country is
responsible for enforcing the law and inspecting the product to ensure it meets
the required specifications. Companies and its employees can be prosecuted where
discrepancies are found.
Products bearing the CE
mark indicating that the manufacturer has conformed to all the requirements
under the legislation can be traded freely throughout the EU without further
modification or testing.
The EU members
as at January 2001 were:
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
Sweden
United Kingdom
Note: In addition to the
15 EU member states, the provisions of European product legislation also apply
to signatory states of the European Economic Area (EEA), Iceland, Liechtenstein
and Norway. Switzerland declined to participate.
New Approach
Directives:
The problem of creating
uniformity in the European Union was addressed by the creation of “New Approach
Directives”.
Each of these directives
covers a range of products and sets out the essential safety requirements that
products -- including imports – must satisfy before they may be sold anywhere in
the EU. Products covered by one or more directives (see list) must meet the
requirements set out in the directive(s). They bear the CE mark, which is
affixed by the manufacturer or exporter as proof of their
compliance.
The following
directives have been issued as at 1st January
2001:
-
Low voltage
(73/23/EEC)
-
Industrial Trucks (74/150
EEC)
-
Motor Vehicles trailers
(70/50/56 EEC)
-
Products labeling
directive (83/374 EEC)
-
Simple
Pressure Vessels (87/404/EEC)
-
Safety of Toys
(87/378/EEC)
-
Construction Products
(89/106/EEC)
-
Electromagnetic
Compatibility (89/336/EEC)
-
Machinery Safety
(89/392/EC)
-
Personal Protective
Equipment (89/686/EEC)
-
Non-automatic Weighing
Instruments (90/384/EEC)
-
Active Implantable Medical
Devices (90/385/EEC)
-
Gas Appliances
(90/396/EEC)
-
Telecommunications
Terminal Equipment (91/263/EEC)
-
Mobile Machinery (91/368
EEC)
-
Hot Water Boilers
(92/42/EEC)
-
Medical Devices
(93/42/EEC)
-
Lift Machinery (93/44
EEC)
-
Explosive for Civil Uses
Directive (93/5)
-
Satellite Earth Station
Equipment (94/9/EEC)
-
Recreational Craft
(94/25/EEC)
-
Packaging & packaging
waste (94/62EEC)
-
Lift Safety (95/16
EEC)
-
Energy Labeling (97/75
EEC)
-
Pressure Equipment
(97/23/EEC)
The directives that we receive the greatest number of
enquiries about are:
-
Low voltage directive
(73/23/EEC)
-
Electromagnetic
compatibility directive (89/336/EEC)
-
Machinery Safety Directive
(89/336/EEC)
-
Active implantable medical
devices directive (90/385/EEC)
-
Medical devices directive
(93/42/EEC)
Procedure
for affixing the CE mark to a product –
manufacturing:
The procedures to be
followed can be no more complicated than the specification requirements that a
manufacturer has to meet laid down by purchasers of their
product.
THERE IS NO REASON FOR
MANUFACTURERS TO INCUR THE EXPENSE OF CONSULTANTS EXCEPT in the case of a
complicated piece of machinery, which has to conform to more than one directive
and numerous standards or in cases where a notified*body has to be
employed.
*Notified bodies are independent testing
houses or laboratories authorized by the EU member states and located in them to
perform the conformity assessment tasks specified in directives, these have to
be employed in the case of active implantable medical devices and one or two
other products of which woodworking machinery is one of the main
ones.
Manufacturers and
exporters may choose a notified body located in any EU member
state.
Procedure
for affixing the CE mark to a product –
administrative:
An important part of the
procedure is the compilation of a Technical Construction File
(TCF), which must be compiled before the CE mark can be affixed, and the
product is sold in the EU.
The TCF must be produced
in one of the official languages of the European Union and be made available to
the responsible authorities in any EU country.
The
technical construction file’s main elements are:
§
Declaration of
Conformity
§
A general description of
the product
§
Design and production
drawing and diagrams
§
Detailed technical data
for essential aspects of the product
§
List of standards and/or
solutions applied
§
Report of calculations and
tests that have been carried out
§
Certificate and inspection
reports
§
In the case of series
production, the internal conditions that have been observed to safeguard
compliance with the directive
§
CE user
manual
The
declaration of conformity must be produced in the
language of each country in which the product is sold with a copy of the
declaration at the disposal of the national authorities. They may also request a
copy for their files. It should contain the following:
§
Name and address of the
manufacturer or his authorized representative established within the
Community
§
A description of the
product
§
Reference to the
harmonized standards
§
Where appropriate,
reference to the specifications on which conformity is
declared
§
Identification of the
signatory who has been empowered to enter into commitments on behalf of the
manufacturer or his authorized representative established within the
community
§
The last two digits of the
year in which the CE marking was affixed (for the first
time)
§
The declaration of
Conformity must be drawn up at least in one of the official languages of the
community.
The CE
user manual:
The EEC directive usually
lists very specifically what the operating manual must contain, amongst items
will be the following:
§
Putting into service and
use
§
Assembly, dismantling and
adjusting
§
Maintaining service and
repair
§
Where necessary training
instruction
British Standards have
issued an excellent series of handbooks written by their experts who are
employed to help manufacturers to comply with the CE Mark
rules.
Apart from setting out how
one can conform to the requirements of the directive applicable to them, they
include a copy of the directive and a list of all standards issued in terms of
it to date of publication.
We recommend these
handbooks to manufacturers contemplating exporting to Europe as they can save
them many hours in researching how to prepare their product for the European
market, as well as saving the costs of consultants.
They may also after
studying the requirements for the CE mark come to the conclusion that their
potential sales do not justify the cost of their meeting the required standards
laid down.
The following are the
handbooks issued to date covering the directives in force, which we can supply
as an authorized distributor of British Standards:
Technical Handbook
#
Directives #
TH 42056: Electromagnetic
Electromagnetic Compatibility
Compatibility
Europe
(89/336 EEC)
TH 42072: Personal
Protective
Directive 89/686/EEC
Equipment
TH 42073: CE Marking
for
Machinery Safety (89/686/EEC)
Machinery
TH 42075: CE Marking for
Electrical
Directive for Safety of Electrical
Equipment
Equipment designed for certain
Voltage
limits (73/23/EEC)
TH 42076: CE Marking of
Medical
Medical Devices Directive Medical Devices
(93/42/EEC)
TH 42087: Packaging and
packaging
Packaging and packaging waste
Waste
– Europe
(94/62 EEC)
TH 42091: CE Marking for
pressure
The pressure equipment Directive
equipment
(97/23 EEC)
TH 42097: CE Marking of
the
Construction products
Construction Products
Directive
(89/106 EEC)
TH 42098: Radio and
Telecommunication Terminal
Telecommunications
Terminal
Equipment (91/263/EEC)
Equipment (R&TTE)
Guide. On CD Rom
All of these handbooks can
be supplied by the British American Chamber at a price of $200 each except for
TH 42098, which is $375.
Home, Standard Bodies, Common Standards, How To Order, Supplier of, Quote form
![]()
British-American Chamber of Commerce
41 Sutter Street,
Suite 303
San Francisco, CA
94104
Tel: 415-296-8645
Fax: 415-296-9649
info@baccsf.org