Bookmark and Share
Standardization News Search
In My Opinion
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 policies.

It’s useful to recall that Europe is the world’s newest economic regional association committed to removing tariff and technical barriers to trade in a dramatic and thorough fashion. It’s 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 that—an evolving process rather than a solidification. The question is important because it is arguable that some of Europe’s practices would benefit from reform—even 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 Union’s 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 standardization.

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. It’s 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 vessels.

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 industry’s 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 be conducted.

Exporting Philosophy?

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 global markets.

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 world’s 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 manufacturer’s 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 market—the conformity assessment market—may 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, it’s 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

Jim Walters is director, International Standards, at the Air-Conditioning and Refrigeration Institute (ARI), Arlington, Va. ARI administers the secretariat of several ISO committees. Walters is a member of the boards of directors of the Standards Engineering Society and The Center for Global Standards Analysis, and is a member of ASTM.