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What Australian manufacturers and exporters need to
know about European Product legislation and CE marking when producing
or exporting their products to the European Union
By Kim
Niemans, Consultants Europe
What is CE Marking?
15 EU members and candidate states
What are the implications for industry?
What are the administrative procedures?
- Declaration of Conformity
- Technical Construction File (TCF)
- CE User Manual
Which product groups must be marked?
Which product Directives have been adopted?
What are Harmonized European Standards?
Who is liable for a product?
Authorized representation
Is there a relation between CE Marking and ISO 9000?
Consultants Europe - What can we do for you?
Useful Resources
What is CE Marking?
The CE marking is a European proof of conformity and is also known as
"Trade Passport to Europe" that allows manufacturers and exporters
to circulate products freely within the 15 European Union (EU) members.
The letters, "CE" -- French for "Conformité Européne,"
indicate that the manufacturer has satisfied all assessment procedures
specified by law for its product to be sold on the European market.
Although consumers may perceive the CE marking as a quality
mark, it is not. The CE mark stands for the minimum safety requirements.
The CE marking addresses itself primarily to the national surveillance
authorities of the member states, and its use simplifies their task. Just
looking at the CE marking will not tell surveillance authorities to which
directive a given product complies. Rather, it is the declaration of conformity
that contains the details of the directive(s) to which the product complies
and the standards that were relied upon in assuring compliance.
The CE marking must be affixed to the product, to its data
plate or, where this is not possible or not warranted on the 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 marking must be affixed visibly, legibly and indelibly.
Where special provisions do not impose specific dimensions, the CE Marking
must have a height of at least 5 millimetres.
15 EU members and candidate states
- Austria (1995),
- Belgium (Founder Member
in 1957),
- Denmark (1973),
- Finland (1995),
- France (FM 1957),
- Germany (FM 1957),
- Greece (1981),
- Ireland (1973),
- Italy (FM 1957),
- Luxemburg (FM 1957),
- The Netherlands (FM 1957),
- Portugal (1986),
- Spain (1986),
- Sweden (1995) and
- United Kingdom (Great
Britain)(1973).
Candidate States
Estonia (applied for membership in 1995),
Latvia (1995), Lithuania
(1995), Poland (1994), Czech
Republic (1996), Slovakia (1995),
Hungary (1994), Slovenia
(1996), Romania (1995), Bulgaria
(1995), Malta (1990), Cyprus
(1990) and Turkey (1987).
EU is Growing
Already in discussion for two years, in the hope to be allowed into the
EU during the next two or three years, are: Poland, Hungary, Slovenia,
The Czech Republic, Cyprus and Estonia. As for Romania, Bulgaria, Slovakia,
Latvia, Lithuania and Malta, it is their objective to become member states
around 2004.
What are the implications for industry?
One of the objectives of the EU is the realization of an internal (single)
market: a market in which products can be traded freely without any trade
restrictions. The adoption of harmonized European product legislation
and the CE Marking offer manufacturers and exporters great advantages
by eliminating differing national product regulations among members of
the EU and the signatory states of the European Economic Area Agreement.
This new European legislation has far-reaching consequences
for industry both within and outside the EEA. Manufacturers and exporters
are now confronted by new health and safety requirements for their products.
They must comply with mandatory EU regulations, carry out associated procedures,
and develop a system for complying with health and safety requirements
and for documentation.
Products that do not carry the CE marking 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.
What are the administrative procedures?
Before the CE marking can be affixed to the product, the manufacturer
must follow certain procedures. These procedures may differ for each directive
and each product. The following procedures may be applicable: declaration
of conformity; compiling a technical construction file: applying for and
filing an EC Type-examination certificate; compiling a user manual; and
affixing the CE marking.
1. Declaration of Conformity
The declaration of conformity must contain the following information:
- Product identification;
- The EU directives complied with;
- Standards used to verify compliance with the directives;
- Name of notified body if required by the directive;
- Be signed by or on behalf of the manufacturer or the
authorized representative and identify that signatory;
- The manufacturer's name and address.
2. Technical Construction File (TCF)
Most directives impose an obligation for the manufacturer or the authorized
representative to provide a technical file that demonstrates the technical
basis for conformity of the product to the requirements of the directive.
The manufacturer must implement internal measures to ensure that the product
remains in conformity. The file is intended essentially for national surveillance
authorities.
The TCF must be kept at the disposal of national surveillance authorities
for inspection and control purposes, and be available for at least ten
years, starting from the production date of the final product.
The main elements comprising a TCF are the following:
- 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 case of series production, the internal conditions
that have been observed to safe-guard compliance with the directive;
- CE user manual.
3. CE User Manual
The directives usually have a direct relation to user safety. Information
provided to a user plays an essential role in avoiding or reducing safety
risks. Thus, a user manual is often an essential safety requirement. If
not available in-house, it is advisable to seek technical and legal assistance
in compiling the CE user manual. A user manual must contain all the information
required for the correct and safe use of a product, including:
- Information on risks;
- Identification and discouragement of hazardous applications;
- Instructions on how the product can be put to safe use;
- Set out who is authorized to perform certain actions;
- Identification of appropriate safety precautions have
to be taken.
- The CE user manual must be drawn up in the language
of the country or countries in the EEA into which the product is imported
and in the language of the country or countries in the EEA where the
product is to be used.
Which product groups must be marked?
There are 23 product groups for witch CE marking is required:
- Air traffic management equipment & systems,
- Appliances burning gaseous fuels,
- Cableway installations to carry persons,
- Construction products,
- Electrical equipment,
- Equipment and protective systems for explosive atmospheres,
- Explosives for civil uses,
- Hot water boilers,
- Household refrigerators & freezers,
- Lifts,
- Machinery,
- Marine equipment,
- Measuring instruments,
- Medical devices,
- Active implantable medical devices,
- In vitro diagnostic medical devices,
- Non-automatic weighing equipment,
- Personal protective equipment,
- Pressure equipment,
- Simple pressure vessels,
- Recreational craft,
- Radio equipment & telecommunications terminal equipment,
- Toys and
- Trans-European conventional rail system
Which product Directives have been
adopted?
The new EU product directives deal with large families of products or
horizontal risks such as those addressed in the Electromagnetic Compatibility
Directive. The manufacturer and exporter are responsible for ensuring
the product meets the requirements for all applicable directives. The
following directives (with the reference between brackets) have been adopted:
- Low Voltage (73/23/EEC)
- Simple Pressure Vessels (87/404/EEC)
- Safety of Toys (87/378/EEC)
- Construction Products (89/106/EEC)
- Electromagnetic Compatibility (EMC) (89/336/EEC)
- Machine Safety (98/392/EEC)
- Personal Protection Equipment (89/686/EEC)
- New Hot-water Boilers (92/42/EEC)
- Gas Appliances (90/396/EEC)
- Explosives for Civil Uses (93/15/EEC)
- Recreational Craft (94/25/EC)
- Non-automatic Weighing machines (90/384/EEC)
- Active Implantable Medical Devices (90/385/EEC)
- Equipment for Explosive Atmospheres (94/9/EEC)
- Telecommunications Terminal Equipment (91/263/EEC)
- General Product Safety Directive (2001/95/EC)
Most of the above-mentioned directives are amended by Directive
93/68/EEC, "Rules for the Affixing and Use of the CE Conformity Marking."
What are Harmonized European Standards?
EU product directives are limited to essential safety, health or other
performance requirements in the general public interest. The technical
details of how to meet these requirements are left to manufacturers who
self-certify products, the three regional European standards organizations,
CEN, CENELEC, ETSI, and government appointed product certification bodies.
Products that meet the essential technical standards developed
by CEN, CENELEC and ETSI are presumed to conform to the requirements of
EU directives and allowed to circulate freely within the European Union.
For many products, however, a manufacturer can choose not
to comply with CEN, CENELEC, ETSI standards, but must then demonstrate
that the product meets the essential safety and performance requirements
of the directives.
Who is liable for a product?
Since the introduction of European product legislation and CE marking,
product liability has become a very important factor for the manufacturer,
exporter or importer in conducting trade in Europe. The central element
of European product legislation is user safety.
If damage or injury is sustained from a particular product,
the user may hold the manufacturer, authorized representative, agent or
importer responsible. European legislation in the area of product liability
allows users of products to claim damages as the result of an injury.
All manufacturers, exporters and importers have a responsibility to ensure
that the products they place on the market are safe. European product
liability legislation provides instruments and enforcement for users who
want to claim damages.
It is therefore necessary for parties involved in the placing
of products on the European market to reach contractual agreements in
order to cover liability issues.
Liability aspects should be covered not only in the
CE marking administrative requirements such as the declaration of conformity,
Technical Construction File and user manual, but also in the sales contract.
Authorized representation
One of the most important aspects of the CE marking regulation is that
producers and exporters from Non-European countries need an European Authorized
representative when they want to sell their products within the European
Union. Only when a product conforms to the essential European requirements
and there is an official European Authorized Representative, the product
may be sold in the European Union.
The Authorized representative of a non-European product
is responsible for the CE marking and safety of the product.
The Authorized representative is legally obliged to have
a Technical Construction File, for inspection by the official notified
authorities. In this File all technical specifications of the product
have to be available.
Is there a relation between CE Marking
and ISO 9000?
Companies that have in their possession a quality management certificate
demonstrate with this that they have an efficient organizational form
and that they have low failure costs. Failure costs are the costs incurred
due to organizational shortcomings within the company. The quality system
makes no reference to the quality of the product. The quality certificate
is only a recommendation for customers that their order will be processed
correctly and on time. In contrast to the quality system, the CE marking
only indicates that the product complies with the essential requirements
relating to safety, health, environment and consumer protection of the
user.
Some directives explicitly make use of a quality management
system (ISO 9000) as part of the conformity assessment. Only in specific
cases this is a requirement to comply with CE marking directives.
If a company wishes to provide the customer with assurance
about the functional quality of the product, the company needs to obtain
a voluntary quality inspection mark. The inspection mark guarantees that
products will conform to safety and functional requirements over the long
term. It is sometimes also the case that these products meet the essential
requirements of European Directives. In such cases, little extra effort
is required to meet CE marking requirements.
Consultants Europe - What can we
do for you?
Consultants Europe provides technical
and legal services worldwide for European Product Legislation and CE marking
certification. For more information consult our free 24 hours CE marking
helpdesk at www.ce-marking.nl
Consultants Europe is an international orientated technical
and legal organisation with expertise in the certification and testing
of products sold or traded on the European market. We carry out the entire
CE marking certification process for designers, manufacturers, exporters
and importers. We ensure that their products meet all requirements needed
for compliance with European directives.
The expertise of Consultants Europe is based on a combination
of practical and theoretical knowledge in product safety, engineering,
quality assurance, technical documentation and the use of all facilities
of test laboratories. Our experts identify hazards, asses risks and determine
the appropriate safety measures. If required our technical engineers have
the possibility to modify products in our own test laboratories to ensure
compliance with the essential European requirements. Our legal department
covers all aspects of product liability and the legal consequences that
arise from the European product legislation.
Consultants Europe's unique resources and expertise has
allowed it to develop an efficient and cost-effective certification program
for all small, medium and large enterprises (SME). Consultants Europe
has developed structured methods for companies to assess and improve the
level of product compliance in accordance with each of the European directives.
Consultants Europe offers a complete range of technical
and legal services that can be used by a company in the process of product
certification. Our experts offer full support on all the directives such
as compliance testing of products, compiling of user's manuals, risk analysis,
technical files and legal advice.
Each service is carried out by our technical specialists
and verified by our legal department. Consultants Europe is a continuing
reference for distributors, agents, customer, insurance companies, surveillance
authorities, etc. in Europe. Organisations worldwide can rely on our proven
technical and legal support.
Consultants Europe will officially register your
products. This will ensure optimal protection of your products against
unauthorised imitation, counterfeit, or forgery of your product.
Consultants Europe offers the following services:
- Identification of applicable EU Directives for products
- Certification requirements for products to be sold or
traded in or outside the European market
- Determining applicable European or international standards
for products
- Supplying documentation on harmonised European Standards
- Single European Market legislation documentation
- Quality systems for CE Marking
- Product compliance testing
- Verification of tests conducted by an organisation or
third party
- On-site consultations
- Audits regarding compliance testing
- Risk assessment
- Compiling of safety requirements and instructions
- Health and safety requirements
- Verification, drafting and translation of user manuals
- Verification and compiling of Technical Construction
Files
- Drafting of Declaration of Conformity
- Product liability assessment and support
- Technical and legal support in case of disputes
- Modifications of the product.
- Conferences, seminars and training in theory and practise
- Practical guide books and software for CE certification
of products
- Authorised representation in Europe
- Identifying Hazards, Risks and determining safety measures
- Product registration
Authorised Representation
One of the most important aspects of the CE marking regulation
is that producers and Exporters from Non-European countries need to appoint
an authorised representative when they want to sell their products within
the European Union. This is applicable by law.
Consultants Europe acts as authorised representative for
many organisations outside the EU. Consultants Europe Authorised Representation
Services include:
- Verification of the classification of products
and carrying out of a CE end-control. This CE end-control includes an
investigation of the device and technical documentation (technical file),
labelling and packaging;
- Use of Consultants Europe's name and registered
address in Europe (label requirement); office, phone, fax, mail handling,
etc.;
- Notification to the Competent Authorities of the
CE Declaration of Conformity, with description of the concerned device
and names and addresses of distributors established in the Community.
- Notification of the Competent Authorities of any
changes in the product;
- Administration of the technical file; presentation
of the file or parts of it to Competent Authorities, when approved by
client;
- Technical and legal representation, assistance,
and reporting in case of incidents reported by users, distributors,
or National Competent Authorities.
- Organisation and carrying out, with the Manufacturer,
the Incident Reporting.
- Carrying out of assessment and determination of
the severity of incidents;
- Representation before the European Commission
and national Competent Authorities, in case of recall or risk of product
or withdrawal from the market.
- 24/7 "Product Information Desk" regarding
all inquiries.
Useful Resources
New Approach to
Standardization
This site provides access to the New Approach directives (unofficial versions),
references to the relevant technical standards, information about and
contact points for the European standards bodies and explanations of the
underlying concepts of the New Approach.
Guide
to the Implementation of Directives Based on New Approach and Global Approach
The Guide is intended to contribute to better understanding of directives
based on the New Approach and the Global Approach and to their more uniform
and coherent application across different sectors and throughout the Single
Market.
New
Approach directives
These sites contain several links, among which are lists of Notified
Bodies designated by the Member States and the EFTA countries (EEA
Members) under the New Approach and Global Approach Directives.
New
Approach Directives - List of directives and references of harmonised
standards
A list of directive numbers and titles follows the latter. Clicking on
the directive number (for example, "73/23" for the Low Voltage
Directive) automatically links to the text of the directive as published
in the Directory
of Community legislation in force.
EUR-Lex
The portal to EU law containing the full versions of legislation.
What's
New
The site contains an excellent overview of the New Approach documents
available on the web.
European
Free Trade Association (EFTA)
Sources
for Standards
Lists the principal governmental and commercial sources for standards.
Legislative
summaries of each New Approach directive may be accessed through SCADPlus.
Product areas covered are:
- Electrical and electronic equipment and gas appliances
About the Author:
Kim Niemans is a technical and legal specialist
in European Product Legislation. Kim works closely with the European Commission
with regard to all the new developments in European Product legislation.
Kim’s specialty is supporting organizations with information regarding
European Product Legislation outside of Europe.
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