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Commission describes the CE mark (an acronym for the French phrase
"Conformite Europeenne") as a "passport" that
allows manufacturers to circulate industrial products freely within
the internal market of the EU. The CE mark certifies that the products
have met EU health, safety and environmental requirements that ensure
consumer and workplace safety. All manufacturers in the EU and abroad
must affix the CE mark to those products covered by the "New
Approach" directives in order to market their products in Europe.
Once a product receives the CE mark, it can be marketed throughout
the EU without having to undergo further product modification.
The European Union (EU) developed "New Approach" Directives to streamline product approvals for a broad range of goods in order to facilitate trade within the EU single internal market. The "Old Approach" Directives contained a high degree of technical detail, and EU member states introduced national standards or regulations at a faster pace than the European Commission could finalize these "Old Approach" Directives. These national specifications often proved to be trade barriers.
New Approach Directives are limited to essential health and safety requirements for sectors such as machinery, electrical products, or medical devices. They do not cover specific products such as motor vehicles, cosmetics, or chemicals, which are still covered under the Old Approach Directives. The main difference between the New and Old Approach Directives is that under the New Approach, the technical details outlining the minimum requirements a product must meet are usually not found in the directive itself. The New Approach Directives are more general.
Technical details on how to meet these minimum health and safety requirements are left to the following three groups: 1) Manufacturers who self-certify products by meeting the requirements of the applicable directives, in some cases by using appropriate European standards; 2) the three regional European standards organizations (CEN, CENELEC and ETSI), which now make Europe-wide standards covering product sectors falling under the New Approach Directives; and, 3) government-appointed product certification bodies (called notified bodies), which provide testing and product approvals.
New Approach, the European Commission gives mandates to the standards
organizations to develop technical standards that meet the essential
health and safety requirements of CE Mark directives. The New Approach
Directives are designed to facilitate product certification, to maintain
a high level of consumer and workplace safety, and to expand intra-European
The New Approach Directives are listed on the website: . There are New Approach Directives for electronic and electrical products, machinery, medical devices, radio and telecommunications terminal equipment, recreational craft, pressure equipment, equipment for use in potentially explosive atmospheres, personal protective equipment, toys, simple pressure vessels, and others. New Approach Directives indicate a product has met certain health and safety requirements. A company affixes the CE mark to its product once it has met the requirements of the applicable New Approach Directive(s). These directives came about as a way of eliminating trade barriers and facilitating the EU Single Internal Market.
Not all products fall under the New Approach Directives. There are essentially three levels of regulatory control:
Old Approach - The Old Approach Directives apply to the foodstuff, motor vehicle, chemical, cosmetic, and pharmaceutical sectors. These regulations have technical specifications written into the annexes.
New Approach - These directives make references to harmonized standards and apply to broad product sectors such as machinery, electrical and electronic products, medical devices, and radio and telecommunications equipment. The directives usually set down general health and safety requirements, and the specifications for meeting these general requirements are found in the standards applicable to the manufacturer's product. Conformity assessment procedures (the system and responsibilities for testing and certification which should lie with the manufacturer and, where applicable, the notified bodies) are also contained in the these directives.
The General Product Safety Directive (GPSD) covers all products not specifically covered by the CE mark directives but which do require some level of safety regulation. These products may also be regulated at the national level by member states.
There is a vast body of European standards not mandated by the European Commission. These standards are not directed toward either the Old Approach or New Approach Directives. While the use of these standards is in theory voluntary, they can support claims of a product's quality either for marketing or legal purposes. These standards cover such products as furniture, household appliances (non-electrical), sports equipment, carpeting, footwear, and small hand-held tools. The standards define characteristics such as durability, appearance, quality, and even cultural preferences.
Most products covered by New Approach Directives can be self-certified by the manufacturer and do not require the intervention of an EU-authorized testing/certifying company called a notified body. To self-certify, the manufacturer must assess the conformity of the products to the applicable directives and standards. While the use of EU harmonized standards is voluntary in theory, in practice the use of European standards is the best way to meet the requirements of the CE mark directives, especially in the case of the Electromagnetic Compatibility (EMC) and Low Voltage Directives. (The word "harmonized" means that the standards have been approved by all 15 European Union countries). The standards offer specific guidelines and tests to meet safety requirements, while the directives are more general and do not, in most cases, offer detailed specifications on how to meet safety requirements. The Machine Directive, however, does offer more detailed information on how to meet safety requirements than most other CE mark directives. U.S. companies can self-certify to the CE mark requirements of the Machine Directive by meeting the provisions of the directive whether they use European, international or U.S. standards.
The manufacturer may affix the CE mark to his product once he's prepared a declaration of conformity, the certificate which shows the product conforms to the applicable requirements. He must maintain a technical file to prove conformity. The manufacturer or his authorized representative must be able to provide this certificate together with the technical file at any time, if requested by the appropriate member state authorities.
There is no specific form for the declaration of conformity but specific information is required. The declaration must include the following:
manufacturer's name and address;
While manufacturers can self-certify many products under the New Approach Directives, certain high-risk products cannot be self-certified. These dangerous products require an EC type-examination, which involves the inspection of a representative sample by a "notified body" within the European Economic Area (EEA). The EEA consists of the EU plus the European Free Trade Association countries of Iceland, Norway, and Liechtenstein, excluding Switzerland.
bodies are independent testing houses or laboratories authorized by
the EU member states to perform the conformity assessment tasks specified
in the directives. A notified body may use a subcontractor to perform
part(s) of a conformity assessment procedure. Many U.S. testing houses
act as subcontractors to the EU notified bodies. However, the notified
body is the ultimate authority, and a company must gain notified body
approval in order to claim CE mark compliance for its project. For
information on how to obtain a list of notified bodies or a list of
U.S. companies that subcontract to EU notified bodies, look at "Official
EU Website" shown below.
This directive shows how not only standards but directives can change as a result of the CE mark program. The R&TTE Directive (1999/5/EC) went into force on April 8, 2000 and replaces the previous directive on telecommunications terminal equipment (98/13/EC). The purpose of the new directive is to cover both radio and telecommunications terminal equipment.
The new R&TTE Directive allows manufacturers of telecommunications terminal equipment to self-certify, an option they didn't have in the past, by adhering to the appropriate European standards and getting a test result from a qualified laboratory, preferably an EU-affiliate lab. (There are EU-affiliate labs in the United States.) Types of equipment for which manufacturers can now self-certify include fax machines, phones, modems, and digital telecom equipment. Manufacturers of radio communications and wireless equipment will still need to get their product certified at an EU-affiliate lab authorized by a notified body.
Under the U.S.-EU Mutual Recognition Agreement (MRA) on telecom, there are now U.S. labs that are certified to do testing and certification for the R&TTE Directive. For a list of these labs, consult the website: http://ts.nist.gov/mra.
who have already complied with the old directive (1999/5/EC), and
whose product has been put in service will not need to re-certify
their products, but they will have to take off the old marking, put
on the CE mark, and be able to back up the CE mark with technical
documentation. Manufacturers who have products in inventory certified
under the old directive will have until April 2001 to sell their products.
After that, only products certified under the R&TTE Directive
will be allowed to enter the European market. For more information
on the R&TTE Directive, consult the website: http://europa.eu.int/comm/enterprise/rtte.
European national agencies, such as the Departments of Health, Industry and Labor, have been appointed to conduct market surveillance for CE marking. The purpose of this surveillance is to ensure that the provisions of the New Approach Directives have been met for products marketed within the European Union. In pursuit of this goal, surveillance authorities will:
commercial, industrial and storage premises on a regular basis;
The surveillance authority can ask for the manufacturer's declaration of conformity and technical file after making a random check. The manufacturer, his authorized representative or the importer must be able to provide the technical file within seven to10 days after the surveillance authority makes the request. If the product is found to be noncompliant, corrective action will depend on and be appropriate to the level of noncompliance.
authority will hold accountable the person responsible for affixing
the CE mark to the noncompliant product. Others responsible for the
noncompliance of the product will be held accountable as well. Penalties,
which may include imprisonment, are determined by national law.
No, a major challenge for U.S. firms that have CE-certified their products is to stay current on new standards coming on stream for their products. For example, the European standards bodies have developed some 900 standards for the Low Voltage Directive and around 185 standards for the Electromagnetic Compatibility Directive (EMC). Not only are new standards being issued, but these new standards in some cases have replaced standards that companies may have met earlier. European customs may look for reference numbers of widely-used standards on the Declaration of Conformity to assure compliance of products entering Europe. U.S. companies that use EMC or low voltage standards that have been replaced are considered to be noncompliant with CE mark requirements.
one of the stricter countries for enforcing CE mark requirements.
In a recent year the European Commission brought some 200 cases against
companies, many in Asia, for noncompliance with the Low Voltage Directive.
Some of these cases resulted in bans from the European market. U.S.
companies and test houses must keep up-to-date on these new standards
that will force changes in their testing and design plans.
ISO 9000 registration (or EN 29000 certification) is used widely in Europe on a voluntary basis as a condition of acceptance of a manufacturer's product or as a way of recognizing the manufacturer's credibility. While a quality system such as ISO 9000 indicates that a company has an efficient organization structure and has low failure costs, it does not always certify conformity with the CE mark directives. However, some directives require use of a quality management system as part of the conformity assessment.
the Machine Directive requires manufacturers to set up a quality control
system to make sure that future products coming off an assembly line
meet CE mark requirements. However, the quality control system does
not have to be ISO 9000, although ISO 9000 is a good choice, since
it is widely recognized. The Medical Device Directive does require
ISO 9000 (EN 13485) as part of the conformity assessment process.
Prior to the harmonization of standards under the New Approach, each European country developed its own standards through a national standards body. The new system provides for three standards bodies to create standards on a Europe-wide scale:
1) The European
Committee for Standardization (CEN) in Brussels, Belgium;
CENELEC activities are in the electrotechnical sector, while ETSI specializes in telecommunications. CEN covers all other sectors.
CEN and CENELEC's principal members are national standards bodies, while ETSI's membership incorporates a wider range of interested parties. These three are the only bodies that can develop a European standard (EN). When work on a European standard begins in one of these standards bodies, work on a corresponding national standard must stop. European standards, like European laws and European conformity assessment procedures, preempt and replace national (member state) standards.
The European standards (ENs) that play a role in New Approach Directives are known as "harmonized standards." These standards supporting European legislation: 1) are mandated by the European Commission; 2) have been developed by the European standards bodies listed above, and 3) address essential requirements of the New Approach Directives. These standards become officially recognized as harmonized standards when they are cited in the Official Journal of the European Communities.
that meet the applicable technical standards developed by the three
standards organizations are presumed to conform to the requirements
of EU directives and are allowed to circulate freely within the European
Union. Use of European standards is seen as a "fast track"
for gaining CE mark compliance for a product. For many products, though,
a manufacturer can choose not to comply with the CEN, CENELEC, or
ETSI standards, if the firm can demonstrate that its product satisfies
the essential safety and performance requirements of the directives.
International Copyright US Department of Commerce 2002: All Rights Reserved outside of the United States.