• What is the CE Mark, and what is its purpose?
• What is the EU's New Approach to product certification?
• Which product groups are covered by the New Approach Directives?
• Can the foreign companies self-certify for the CE Mark?
• Under what conditions are the foreign companies unable to self-certify for the CE Mark?
• What have the Europeans done to enforce the CE Marking requirements and what are the penalties for non-compliance?
• Once a foreign company has certified its product with the CE Mark, is its work done?
• Is ISO 9000 required in order to get the CE Mark?
• How do European standards relate to the CE Mark?
• What is the advantage of using European Standards?
• What are the PECA Agreements With Central and Eastern Europe?

The European 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.

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WHAT IS THE EU's NEW APPROACH TO PRODUCT CERTIFICATION?

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.

Under the 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 trade.

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WHICH PRODUCT GROUPS ARE COVERED BY THE NEW APPROACH DIRECTIVES?

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.

Products meeting 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 company can demonstrate that its product satisfies the essential safety and performance requirements of the directives.

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CAN THE FOREIGN COMPANIES SELF-CERTIFY FOR THE CE MARK?

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:

–the manufacturer's name and address;
–the product description;
–the CE mark directives that apply to the product, e.g., the machine directive 98/37/EC or the low voltage directive 73/23/EEC;
–the European standards used, e.g. EN 50081-1:1993 for the EMC Directive or EN 60950-1: 2001 for the low voltage requirement for information technology; and,
–the signature of a company official for purposes of the company assuming liability for the safety of its product in the European market.

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UNDER WHAT CONDITIONS ARE THE FOREIGN COMPANIES UNABLE TO SELF-CERTIFY FOR THE CE MARK?

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.

Notified 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.

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WHAT HAVE THE EUROPEANS DONE TO ENFORCE THE CE MARKING REQUIREMENTS AND WHAT ARE THE PENALTIES FOR NON-COMPLIANCE?

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:

–visit commercial, industrial and storage premises on a regular basis;
–visit work places and other premises where products are put into service and used;
–organize random checks; and,
–take samples of products for examination and testing.

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.

The surveillance 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.

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ONCE A U.S. COMPANY HAS CERTIFIED ITS PRODUCT WITH THE CE MARK, IS ITS WORK DONE?

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.

Germany is 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.

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IS ISO 9000 REQUIRED IN ORDER TO GET THE CE MARK?

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.

For example, 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.

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HOW DO EUROPEAN STANDARDS RELATE TO THE CE MARK?

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;
2) the European Committee for Electrotechnical Standardization (CENELEC) in Brussels;
3) the European Telecommunications Standards Institute (ETSI) in Sophia Antipolis, France.

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.
There is a vast body of European standards that is not mandated by the European Commission. These standards are not directed towards either the Old Approach or the 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 (which are not covered by the Machinery Directive). They define characteristics such as durability, appearance, quality and even cultural preferences.

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WHAT IS THE ADVANTAGE OF USING EUROPEAN STANDARDS?