|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
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 knowseither 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 voluntaryalthough 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 partthat 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.
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 didnt apply) good safety engineering
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
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
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.
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
(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