|European Conformity Assessment: Experiment or Model?
by JamesK. Walters
A soon-to-be-mandatory European Directive for pressure equipment
appears to some to be an example of problematic conformity assessment
policies in the European Union. James K. Walters, of the Air-Conditioning
and Refrigeration Institute, discusses some of the problems with
the Pressure Equipment Directive and European conformity assessment
Its useful to recall that Europe is the worlds newest economic
regional association committed to removing tariff and technical
barriers to trade in a dramatic and thorough fashion. Its also
useful to recall that the drive for a European Union is every
bit as logical and desirable as was the 18th century transformation
of the newly independent American colonies from a confederation
to a union under the Constitution. The question is whether Europeans
and others, but especially Europeans, will see this process as
just thatan evolving process rather than a solidification. The
question is important because it is arguable that some of Europes
practices would benefit from reformeven at this early stage.
One such process is conformity assessment. If not carried out
responsibly and thoughtfully, EC Directives, a predicate for the
conformity assessment mark, CE, can be a technical barrier to
trade and introduce anti-competitive costs to manufacturers.
The symbol for European conformity assessment is the CE mark.
Delaney and van de Zande call the mark the passport to Europe
for products.(1) It is not an option if the product manufactured
in or imported into Europe falls under certain European Directives
intended to harmonize the health, safety, and environmental requirements
of the European Unions member states.
Conformity assessment is simply defined as a process by which
compliance with essential requirements is determined. The process
can be carried out with or without the use of standards, although
in the United States, conformity assessment is often thought of,
along with standards, as one of the two pillars of corporate strategic
Requirements for the CE Mark typically flow from a European Directive
issued by the European Parliament and Council. One such directive
has the attention of the air-conditioning and refrigeration industry.
Its useful to review the situation as a case study and draw some
conclusions about the CE Mark process.
The Pressure Equipment Directive
The EU published the Pressure Equipment Directive (PED) on July
9, 1997, in the Official Journal of European Communities. The
PED entered into force for a three-year transitional period in
May 1999. It becomes mandatory in May 2002 within the EU. Between
1999 and 2002 manufacturers may comply with the PED or national
regulations. Beginning in May 2002 the testing of certain equipment
will be required to receive the CE Mark.
The PED is a Safety Directive and is intended for pressure vessels.
For over 50 years in the United States, air-conditioning and refrigeration
equipment have been treated differently than what one normally
thinks of as pressure vessels (e.g., tanks), because pressurized
and contained refrigerant is recognized as less of a hazard than
other, larger vessels containing other substances.
This PED however, inappropriately covers the air-conditioning
and refrigeration systems because its threshold of pressure is
too low. It applies to the design, manufacture, and conformity
assessment of pressure equipment and assemblies with a maximum
allowable pressure of 7.25 psi above atmospheric pressure. Depending
on the pressure of the vessel in question, the directive stipulates
various levels of testing requirements. In so doing the PED incorrectly
lumps parts of air-conditioning and refrigeration systems containing
a refrigerant under pressure into testing requirements for pressure
Tests to date on air-conditioning compressor housings show that
testing to the EU requirements cause the compressor housing to
deform or fracture. The PED will also apply to air-conditioning
and refrigeration piping, fittings, expansion joints, and housings
found in the industrys products.
The European Committee for Standardization (CEN) is drafting a
standard incorporating the requirements of the PED. When completed,
the standard (PrEN 378) will be cited as the implementing standard
against which conformity assessment tests for the EC Mark must
The concern for manufacturers is that complying with the test
requirements will require a second line of equipment for export
to Europe. The alternative is to make the line modified for Europe
the only line and incur additional manufacturing costs for other
There are a number of issues raised by this directive. Some would
argue that Europe either by design or default is using the directives
to export its safety, environmental and health philosophies. It
is, in effect, defining the worlds manufacturing processes by
creating a market that only accepts items constructed a certain
way. This happens all the time in the free market, but the emphasis
is on free. For example, U.S. buying habits cause exporters
to the United States to fashion products that are attractive to
the U.S. consumer because they are consistent with U.S. culture
and buying habits. It took the Japanese automobile industry 15
years to produce the correctly-sized, powered and outfitted car
that Americans would buy. Consumer markets set standards of production
and design. The size of the EU market combined with requirements
of the directives may result in supplier conformity. This is not
necessarily in consumers interests because suppliers to a regulated
market may have to pass on added costs and have less manufacturing
flexibility to meet different demands in other parts of the globe.
Europeans might respond that their system is market responsive
as well because the standards implementing the directives can
be amended, but this raises another issue. Because of the Vienna
Agreement between the European Committee for Standardization (CEN)
and the International Organization for Standardization (ISO),
a CEN draft can be simultaneously balloted in both CEN and ISO.
The effect is to give CEN an entrée to ISO not enjoyed by other
regional bodies. Further, as we see in the case of another directive
(on Low Frequency Emissions) the Europeans may be in a position
to outvote other countries in ISO or the IEC. In short, a standardization
process that is flexible in principle is not as responsive to
market changes as unfettered market adaptation.
The use of voluntary standards from CEN or ISO also raises a cost/
benefit issue. Despite European claims to the contrary (because
of a manufacturers ability to produce a Technical File) voluntary
standards adopted by CEN have a mandatory character if the European
Parliament and Council publishes them in the Official Journal.
Yet, there is no requirement for the standards to be assessed
from a cost/ benefit point of view. Admittedly this is the case
for U.S. standards, but in the case of Europe there is no mechanism
to successfully challenge the implementing standards to a directive
on its technical correctness or cost/benefit.
A Chilling Effect
The effect can be chilling and costly. Europeans might argue that
a directive that imposes the same requirement on domestic manufacturers
as well as importers is not a technical barrier to trade. Even
if that argument is granted, the directive may still be anti-competitive
in its effect. If that is so, the free market will adjust, but
the regulated marketthe conformity assessment marketmay not.
There are questions yet to be answered about how the European
Conformity Assessment process will play out in the market place.
There is no question about the value of conformity assessment
in general. But if Europe sees the CE Mark as a way to export
its social and cultural views of safety, health and environment,
this is not a model to follow. If it sees these efforts as an
experiment to be watched and modified in a free-market spirit,
its worth the effort. Either way, non-Europeans should be helpful
to their European conformity assessment colleagues by being as
watchful, constructively critical, and vocal as possible. //
(1) Helen Delaney, Rene van de Zande, A Guide to EU Standards
and Conformity Assessment, NIST Special Publication 951, National
Institute of Standards and Technology, Gaithersburg, MD 20899-2100.
Copyright 2000, ASTM