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The Role of Standards in European Conformity Assessment

by Rene van de Zande

Rene van de Zande describes the role of standards in getting your product to market in the European conformity assessment environment.

European-wide product legislation and CE Marking directly affect industry both within and outside the European Economic Area (EEA).(1) They have become a fact of life when conducting trade in Europe. Manufacturers and exporters are confronted by harmonized health and safety requirements for their products, addressed in the so-called New Approach Directives. They must comply with mandatory European regulations, carry out associated procedures, and develop a system for complying with health and safety requirements and for documentation.

The New Approach Directives are supported by harmonized standards which play a significant role in ensuring their application. This article addresses the significance of European Standards (EN) and other standards in the European conformity assessment process.

New Approach to Technical Harmonization

One of the objectives of the European Union (EU) was and 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 Mark offer manufacturers and exporters great advantages by eliminating differing national product regulations among members of the EU and the signatory states of the EEA.

The CE Mark is required as an indicator of conformity to the New Approach Directives. It is mandatory to affix the CE Mark to products that are within the scope of one or more Directives. The mark may indicate conformity to the directives relating to toys, medical devices, personal protective equipment, machinery, electrical safety, household gas appliances and other product families. Over 65 percent of U.S. export to Europe is within the scope of one or more New Approach Directives. The CE Mark is a sign to national inspection authorities, such as customs, that the product is permitted to be sold for use in the countries that make up the EEA.

The New Approach 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 (the European Commission for Standardization (CEN), the European Commission for Electrotechnical Standardization (CENELEC), the European Telecommunications Standards Institute (ETSI)), and government-appointed product certification bodies (so-called Notified Bodies).

The Role of the EN

Most products that are within the scope of European product legislation can be self-certified by the manufacturer and exporter. Certain products may not be self-certified and must be subjected to the testing by a Notified Body within the EEA. Notified Bodies are independent testing houses or laboratories authorized by the EU member states to perform the conformity assessment tasks specified in directives.

The European Standards (ENs) are drafted by one of three European Standards organizations (CEN, CENELEC, ETSI). Certain EN standards are specifically directed towards the essential requirements of New Approach Directives. There are, however, other EN standards that are not necessarily directed toward essential requirements. These standards may or may not address health or safety aspects of products. They may define other characteristics, such as durability, appearance, quality levels, or even cultural preferences. They may be test methods or measurement guides. Their use is also voluntary. Certain ASTM standards in this category could provide a competitive edge for exporters when applied to products for export.

Products that meet the essential technical standards developed by CEN, CENELEC, and ETSI are presumed to conform to the requirements of New Approach Directives and allowed to circulate freely within the EU. This presumption of conformity is one of the advantages a manufacturer has if he applies an EN standard. The exporter also needs to consider the Notified Body and its familiarity with the EN standard when third party intervention is required. The Notified Body often is led by the specifications set in EN standards. Although a product may differ from an EN standard, the difference does not necessarily make the difference between “safe” and “unsafe.” A Notified Body, however, will sometimes stick to the only specification it knows—either the product meets the specification called for, or it does not.

In addition, insurers, lending institutions and consumers do not always recognize a standard that does not emanate from one of the European Standards bodies. In this case, the marketplace may not accept the product, particularly when an EN already exists for the same product.

Despite the advantages, a manufacturer is under no legal requirement to declare conformity to European standards. The legal fact is that virtually all EN standards are voluntary—although if an injury results that would have been prevented by adherence to an available European standard, the producing company will have a very hard time defending the difference.

Other Standards May Do the Job as Well

Should a manufacturer be concerned if he is shipping his product to Europe for the first time and has, therefore, not applied any European standard in his design? Depending on the product, in most cases there should be no such concern. The EN standards do not contain “surprises” for the most part—that is, they reflect commonly known engineering principles.

If a manufacturer does not apply EN standards to prove conformity to the health and safety requirements of the law, he must then demonstrate that the product meets the essential safety and performance requirements of the directives.

The application of an ASTM, American National Standards Institute (ANSI), American Society of Mechanical Engineers (ASME), the U.S. Occupational Safety and Health Administration (OSHA), the National Fire Protection Association (NFPA) or other relevant U.S.-based standard will almost certainly result in conformity to the essential requirements of a European Directive. Depending on the standard, there could be a reasonably close correspondence between a standard(s) commonly used in the United States and its European counterpart(s). For example, the OSHA standards relating to machinery safe guard openings and distances are based on the same ergonomic principles as is EN 294 (Safety distances to prevent danger zones from being reached by upper limbs).

In the area of electrical safety for machinery, NFPA 79 and EN 60204-1 are very close, and effort is being made to harmonize them completely. There are some differences. For example, NFPA 79 requires that wire insulation be marked every 24 inches with the wire size, insulation rating, and manufacturer identifier. European wire is typically not so-marked, and there are differences in typical insulation thickness and other parameters, between European and U.S. wires. From a standpoint of engineering principle, there are differences of opinion about which type of wire is “better,” but in practice, both are very safe.

European design, however, differs from U.S. design in some significant aspects, for example, preferring the use of pictograms instead of words to indicate the function of control devices. Some standards cannot be made equivalent, e.g., inch vs. metric thread and variety made to account for differences in local utilities such as 110 vs. 240 volt mains.

Where the design approach or performance level is different between two standards, there is usually a good technical reason for the difference. Take the matter of permitted point-of-use conducted emission (drawing of harmonic power) for example. The scheme of power distribution in the United States is such that industrial users (who may have significant harmonic power draw) are almost certain to be on a separate substation from residential power users. The substation damps out the harmonic power signal from the industry so the residential consumer never sees it. Therefore, in the United States, point-of-use limiting of conducted emissions is usually an unnecessary expense. Contrast this with the European power distribution scheme, which does not separate industrial and residential power consumers. In Europe therefore, it is necessary to control conducted emissions at the point-of-use.

Product Liability

The legal concept of product liability is the same in the EU as it is in the United States, although the scale of award in the United States is considerably higher. New Approach Directives do not always provide guidance on how to implement, nor do they provide interpretations of the law. Legal critiques of design(s) are conducted in hindsight at trials, where the issue may be whether or not the manufacturer was negligent, and whether or not the designer produced a reasonably safe design. When these are the issues, a national European court will inquire as to how the manufacturer of the product applied (or didn’t apply) good safety engineering practices.

A review of the law will show that some designs are deemed “not reasonably safe” and that some manufacturers have judgments rendered against them for failing to exercise reasonable engineering practices. The legal obligation to use good engineering practices in safety matters is not embedded in Directives, but exists independently of them.

This does not make design decisions straightforward for the manufacturer, but it does place the manufacturer in a unique position. A manufacturer, or more precisely the designer, is the only one who can evaluate and change the design of a product before it is put on the market. It follows, then, that in the event of a breach of safety, the manufacturer and/or the designer will be the responsible parties required to defend the design decisions related to the product.

What Really Should Be Applied: A Risk Assessment

Most New Approach Directives require a risk evaluation of the products they govern. A good designer examines all possible risks related to a design, and does everything possible to remove them. A designer must be able to (legally) defend the safety aspects of his design decisions for a period of time. A systematic risk assessment on the one hand, and good documentation of the design decisions concerning safety on the other, are the heart of CE Marking. The strongest defense against liability is the combination of the use of standards where reasonable, and a documented design review that shows how the manufacturer effectively minimized risk.

Some manufacturers are reluctant to prepare written design reviews. They reason that such reviews could be used against them in a products liability lawsuit. Not recognizing or effectively dealing with a hazard, however, is not a winning argument. A more powerful defense is available when the manufacturer can show awareness of hazards, and can also show how risks to the user were minimized through the thoughtful application of design, guarding, and instructions.

In the event of a lawsuit, the court might use the concept of “reasonableness” in deciding whether or not the manufacturer or the injured user is at fault. In other words, the court might have to decide which of the two behaved more reasonably. The design hierarchy, “design out, then guard against, and warn as a last resort,” is applied in New Approach Directives, and by the common law in the United States.

Be Wary of Applying “Double Standards” in a Design

A manufacturer should not consider making a product “safer” for one market than for another. When a product is made in two slightly different versions, the burden falls to the manufacturer to understand how the difference in design affects the risk of injury. Assume for example a manufacturer that makes a household fan with 3-millimetre-wide grille openings for sale in the United States (conforming to UL standards, ostensibly because some U.S. jurisdictions favor UL marking), also makes an identical fan, except with 2.5-millimetre-wide grille openings (conforming to EN standards, ostensibly to satisfy European preferences). If there is an injury involving a fan having 3-millimetre grille openings, that would not have occurred on the fan having 2.5-millimetre fan openings, the injured party will correctly point out that the manufacturer makes a safer fan for the Europeans, and will assert that people operating fans in the United States are entitled to the same degree of safety that European fan users have. It may be that the difference between 2.5- and 3-millimetre-wide openings results in an insignificant difference in safety, and that this size of grille opening is reasonably safe, but a manufacturer incurs a heightened risk of legal liability when two different designs are produced. “Conformity to standards” is a weak justification for producing different designs; a structured risk assessment based on engineering fundamentals provides a superior method to justify any differences in marketed designs.

An injured party might claim that the warnings on the equipment were inadequate. The test of warning label adequacy involves considerations of label placement (labels are to be placed so they are likely to be viewed by the operator, before encountering the hazard) and label content. The legal requirements for adequacy are different between the United States and Europe. The accepted (albeit not preferred) European approach of providing a warning label with only a pictogram representation of the hazard, in conjunction with descriptive text in the operation manual, is deemed inadequate in the United States. The U.S. legal system will refer to ANSI Z535, which describes label designs having at least text, and preferably a pictogram in addition.

Conclusion

The role of European standards in European conformity assessment of products is significant. Be reminded that many EN standards have specifically been developed to provide manufacturers the specifications, which, if applied, provides the presumption of conformity of their product to the applicable mandatory health and safety requirements addressed in the New Approach Directives.

The role of standards in this process is the same in the United States and Europe. Standards are, for the most part, informative but not mandatory. Deviation from a standard does not automatically result in legal liability, but the manufacturer will probably face a challenge in a court of law if the cause of the injury is attributable to the difference between the manufactured product and the relevant standard.

Adherence to any standard, however, does not guarantee protection against liability. Standards are useful to guide an engineering decision, but they are not the final answer. When deciding on a design, a company is served better by a written record of a reasoned discussion that comprehends all of the hazards and failure modes, their probabilities, and the magnitude of the resulting harms than it would be by checklist-demonstrated compliance with the relevant standard(s). In other words, conduct a thorough risk assessment. //

Note

(1) 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 rejected the EEA Agreement.

Copyright 2000, ASTM

Rene van de Zande is president and CEO of Emergo Group, Inc., a consulting firm for manufacturers and exporters, specializing in all aspects of European and North American conformity of their products, and the implementation of business management and efficiency systems in accordance with international standards.

The author would like to acknowledge Mr. Charles Seyboldt for his outstanding knowledge of U.S. and EU product safety regulations.