The CE marking: separating fact from fiction
David Lohbeck, TUV Rheinland of NA Inc
The CE (European Conformity) marking is a symbol that manufacturers affix to products or machines to indicate that a product conforms to all relevant European directives and standards (Figure 1a). The CE marking is generally based on compliance with European standards, some of which have been in place for decades. Various directives and standards contain the requirements for this marking, including the Low-Voltage Directive (73/23/EEC), the Machinery Directive (89/392/EEC), and the Electromagnetic Compatibility (EMC) Directive (89/336/EEC). These directives, along with the appropriate European standards, cover all safety, EMC, health, and environmental concerns. CE marking of machinery became effective in January 1995, EMC conformity has been a requirement since January 1, 1996, and electrical products must bear the CE marking as of January 1, 1997 (Reference 1).
Clear up the confusionUnfortunately, confusion still surrounds the CE marking in countries outside the EU, especially in the United States. Furthermore, the value of the CE marking for selling products has been overstated, and the associated risks of nonconformity are generally not well-understood.
The purpose of the CE marking is to allow manufacturers to place products on the market and ensure the free movement of goods. The CE marking is primarily for market control by customs inspectors and enforcement authorities. The EU did not intend the CE marking to be a sales or marketing tool.
The CE marking simply indicates that the product conforms to the relevant directives' safety and EMC requirements and that the manufacturer has performed all the necessary evaluation procedures. The "CE" symbol is not a registered trademark and is, in principle, the manufacturer's responsibility. Except for some high-risk products, most manufacturers can perform a self-assessment of their products to meet the essential requirements of the directives. In doing so, the manufacturer has a choice of meeting the minimum legal requirements or meeting the market expectations as well. In Europe, expectations vary considerably among countries.
You should not confuse CE marking with another mark, certificate, or approval issued by an accredited certification body, as listed in the Official Journal of the European Communities (OJEC). Regardless of the presence of a CE marking, and to achieve a higher level of quality and ensure safety/EMC compliance, customers can also demand an approval mark, certification, or test report from a European third party (a testing laboratory referred to as a "notified body" for safety or a "competent body" for EMC) (Figure 1b).
The following list clearly states what the CE marking is and is not:
- The CE marking is a declaration for customs inspectors and allows the product to be placed on the market;
- It is not for sales, marketing, or promotion, and it cannot guarantee sales;
- It is not a quality marking;
- It is not a mark of certification or approval;
- And it is not for components (with a few exceptions).
Follow steps to assess conformityFigure 2 lists the steps necessary to affix the CE marking. An important step is "conformity assessment." The objective of the conformity-assessment procedures in the 93/465/EEC directive is to enable the authorities to ensure that products placed on the market conform to the directive's requirements and that products meet the high level of safety for a given product or product sector. There are seven procedures, or modules, in 93/465/EEC, but the applicable generic or product-specific directive sets the range of conformity choices as follows (Figure 3):
- Self-declaration: The self-declaration route is available for products or machines that don't require a mandatory examination, which is the case for most products and machines. The manufacturer takes complete responsibility for the assessment, testing, documentation, declaration of conformity, and application of the CE marking. A technical file must be available on demand for national enforcement authorities. Keep in mind that this process is an internal self-assessment that results in issuance of the manufacturer's own declaration of conformity and the CE marking. The buyer may demand proof of safety/EMC compliance from a European notified/competent body in the form of a mark, certificate, or test report.
- Voluntary certification: Manufacturers often have a European body, such as a notified/competent body, assess the product and apply a mark and certification for marketing purposes and as a defense of due diligence, in case there is a challenge to the product's conformity. This certification route provides confirmation of the testing accuracy and documentation to help support the manufacturer's declaration of conformity and CE marking.
- Mandatory certification: The EU does not require most products and machines to undergo mandatory certification. However, some high-risk machinery requires type examination by a European notified body. After successful testing, the EU body issues a "type-examination certificate" for machine safety or a "certificate of conformity" for EMC. The manufacturer then affixes the CE marking to the product and issues a declaration of conformity.
A product's technical file consists of the documentation necessary to demonstrate the product's conformity to the essential requirements of the directives. The file must cover the design, manufacture, and operation of the product. The file is for market-surveillance purposes and must be at the disposal of national enforcement authorities for inspection and control. The file must be readily available and can be in English or another EU language.
The necessary contents of the file depend on the applicable directive but in general consist of the following: declaration of conformity, name and address of the manufacturer, general description and identification of the product, list of the applied harmonized standards, solutions adopted to satisfy essential requirements and rationales, examination results and design calculations, test reports, designs and drawings, parts lists, operation manual, and measures adopted to ensure ongoing compliance.
The declaration of conformity is the procedure that the manufacturer or authorized representative uses to ensure and declare that the products satisfy the requirements of the applicable directives. The declaration of conformity contains the following: name and address of manufacturer or representative, description of the product, directives declared, list of applied harmonized standards, additional standards and specifications where appropriate, place and date of issue, and name and signature of authorized person.
When harmonized standards do not exist or are applied only in part, the EMC Directive sometimes mandates the use of a competent body for mandatory certification and a special file called the "technical construction file" (TCF). The TCF is common for large machines or for products that have numerous variations. The manufacturer generates the TCF in conjunction with a competent body. This process is commonly called the "TCF route" and is a certification process that requires the competent body to issue a certificate of conformity. Under the TCF route, the manufacturer may place the CE marking on the product only after satisfactory testing, completion of the TCF, and receipt of the certificate from the competent body.
STEPS TO THE CE MARKING
Limiting liabilityBy signing the declaration of conformity, the manufacturer or authorized representative in Europe is responsible for all aspects of the assessment, testing, documentation, declaration, and CE marking. In all cases, the manufacturer or representative assumes the responsibility and liability even when using the services of a consultant or test lab. The liability is not transferable to the consultant, outside test lab, or notified body.
Notified bodies can subcontract certain testing activities to private laboratories. The rules concerning subcontracting of work by notified bodies to outside laboratories are strictly limited to specific tasks and stipulate that the notified body itself must perform the assessment, appraisal, and certification. Notified bodies can subcontract testing to audited laboratories, but the notified body must directly supervise the procedures and tests. Only the European body certificate and validated test report have the support of the notified or competent body. Some test labs improperly issue so-called EC "certificates." In Europe, this right is exclusively reserved for European accredited certification bodies.
A view from the European Commission
|The European Parliament posed written questions concerning the CE marking to the European Commission. Martin Bangemann, vice president of the European Commission, published answers in the Official Journal of the European Communities (OJEC; 95/C 326/50). A summary of the first four questions and answers are as follows: Question: Does the CE mark on a product guarantee free access to the whole internal market for the product concerned?|
Risks of nonconformityThe objective of the Product Liability Directive (85/374/EEC) is to protect consumers from defective products. This directive states that all producers involved in production are liable, insofar as the finished product, component, or any raw material they supply is defective. The liability extends to importers and persons who present themselves as producers by affixing their name. The directive does not set any financial ceiling on the producer's liability.
The primary directives clearly state that a member state can restrict a product's market access for any of the following reasons: The product fails to conform to standards, the manufacturer faultily applies the standards, the product fails to comply with good engineering practice, the product is likely to endanger a person's safety, the product does not comply with the protection requirements (EMC), or the manufacturer unduly affixed the CE marking.
The General Product Safety Directive (92/59/EEC) gives member states the authority to control nonconforming products and take appropriate measures. The severity of the action depends on the situation and the nonconformity of the product. When a member state ascertains that a product does not comply with the requirements, the manufacturer must do one or more of the following with the product: restrict or prohibit its sale, make it comply, withdraw it from the market, or destroy it. The member state must inform the commission, which in turn informs the other member states. These states can also take appropriate action and may impose financial penalties.
Under the old approach, a manufacturer was required to show only that it took reasonable measures to ensure a safe product. The new approach in directive 85/374/EEC changes the emphasis to strict liability: Consumers can initiate civil actions themselves and don't need to prove negligence. Also, the consumer can take simultaneous action against all parties involved in the supply chain.
"Due diligence" reduces riskManufacturers can use certification and inspection bodies and testing laboratories to reduce the risks and hence the likelihood of damages. The EU and member states sanction notified and competent bodies to interpret directives and standards and issue test reports and certificates on conformity. Various member states, such as Germany, provide accreditation for their own bodies at the national level, which then are accredited at the European level.
Be clear on one thing: Such testing and reporting doesn't change or reduce the manufacturer's liability. However, a mark, certificate, or test report from a notified body can reduce the risk and ensure a defense of "due diligence" in the event of challenge. Due diligence means taking all reasonable steps to ensure conformity. Using testing and certification, the role of the notified body is to accurately interpret directives and standards and thereby ensure conformity.
David Lohbeck was a manager at TUV Rheinland of NA Inc, where he worked for 11 years. He has conducted seminars and training on European Union safety and EMC standards and published the CE Marking Handbook (available at www.bh.com). He holds a BS from Arizona State University and an MA from the University of Phoenix. He is currently a regulatory manager at Dell Computer Corporation.