CE Marking: A Midterm Report

Is Europe’s new CE Marking system fulfilling the industry’s hopes of a reduction in third-party certification requirements? And is it really achieving its goal of replacing a multitude of national regulatory approval rules by a single pan-European system? The answers to these questions are emerging.

High Hopes

When CE Marking was introduced—the first directive was adopted in 1987—hopes were high for one clear, harmonized system to open up an 18-country market of more than 350 million people. Even if a given product needed more than one approval, such as EMC and mechanical product safety, at least each approval would be valid throughout the European Union (EU). This was a big step toward one-stop approval.

Even better, manufacturers were given increased powers to self-declare compliance with EU directives (Table 1). Mandatory independent conformity assessment in the EU was limited to special cases, such as weighing machines, and groups of high-risk or publicly sensitive products, such as medical devices and machinery presenting dangers of catastrophic injury. The expected results were cost savings, the disappearance of technical barriers and easier market access.

For the United States and other exporters to Europe, there was an additional incentive: the EU announced it would negotiate mutual recognition agreements (MRAs). An MRA is a binding arrangement with a given country under which the EU recognizes certificates from that country’s bodies as complying with EU regulations, and vice versa. In other words, even for those high-risk products requiring third-party involvement, the certification task would be simplified for U.S. exporters.

Today, the use of CE Marking is growing. The lone original directive has grown to 17, with even more in the pipeline (Table 2). In 1995 and 1996, two of the most wide-ranging directives, machinery and electromagnetic compatibility, became mandatory, complementing the old (1973) directive on low-voltage safety.

And what does the initial evidence show? The conclusions are tentative, but the evidence is strong. It suggests that the old system of separate national regulatory approvals for each kind of hazard is indeed disappearing, bringing one-stop regulatory approval a significant step closer. Customer interest in independent conformity assessment remains high. And U.S. exporters are still waiting for an MRA.

Regulatory Barriers Really Are Coming Down

Pessimists might point to signs that the EU has not yet reached the ultimate objective of a one-time approval process valid across all 18 countries—and they would be correct. For example:

National-Level Blocks—France refused to accept a European standard for short-circuit test requirements for electrical toys. Germany tried to ban a class of chemical dye used on clothing.

Lack of a Clear Basis for Pan-European Compliance—When the directive on personal protective equipment (PPE) came into force in 1995, suppliers received little guidance on how to classify a product into the right category for a range of mandatory conformity assessment operations. Today, almost every major directive has added some form of clarification.

Delays in Finalizing Harmonized European Standards—The EU has always emphasized the role of the harmonized European standards in facilitating compliance. But most observers accept that the EU is not even at the halfway point in producing enough Euro Norm (EN) standards to make the process flow smoothly. Meanwhile, suppliers often face complex technical reviews with authorized test houses, such as the competent bodies under the EU’s EMC Directive, or notified bodies under some safety directives.

The good news, however, far outweighs the bad. In only one major business sector, construction products, is one-stop approval still a distant dream. Everywhere else, evidence suggests that problems are either short-term or limited to minor subsectors. For the past three years, there have not been any physical or documentation checks on goods at EU internal frontiers. But even beyond this, the evidence is mounting.

National governments are finding it increasingly hard to enforce regulations which block one-stop, pan-European approval. A landmark court case in late 1995 in telecommunications condemned the French government for imposing its own independent certification rules.

Indeed, the courts are becoming a last resort. Procedures now exist for amicable review of attempts to deviate from harmonized approval, and most are settled long before court action becomes necessary. The EU has a complaints procedure that enables suppliers to force a review when one-stop approval is denied.

Compliance instructions are becoming clearer. In the PPE case quoted here, detailed guidelines were issued in February 1996. In another complex area, the marking of passive components for low-voltage electrical safety, guidelines are being developed.

The body of harmonized EN standards is growing. The total number of standards officially recognized so far is approaching 1,000, and far more are in the works.

Few manufacturers inside the EU report problems with free movement and one-stop approval. Survey evidence is now available to support this statement. One estimate from the British government puts the figure at less than 2% of all suppliers. The proportion of shipments affected would be even lower.

The EU earns high marks for good conduct in the World Trade Organization (WTO). After a full year of operation under the new WTO Technical Barriers to Trade code, which includes a prohibition on discriminatory certification requirements, only one complaint has been lodged against the EU.

Against the background of these successes, there is no question that one-stop regulatory certification for Europe is here to stay. The progress applies both to products eligible for self-declaration and to those requiring third-party approval. Where temporary problems remain, the past successes will lead regulators to fight even harder to solve them.

The Missing MRA

Although the EU hopes to complete its first MRAs with third countries during 1996, the latest indications suggest that the United States is not likely to be on the list. Explanations of the problems in the still-confidential political negotiations vary, with the EU blaming U.S. rigidity and perhaps vice versa. Meanwhile, U.S. exporters have no option but to continue to use European test houses for mandatory certification needs.

A Resurgence of Third-Party Certification?

The steady progress of one-stop approval in the EU has revealed a paradox. The EU’s directives rely heavily on self–declaration of compliance by suppliers, and yet there appears to be increasing interest in third-party certification. The reasons can be deduced from the evidence, which includes:

The European Consumers Association (BEUC), which groups all national consumers associations in the EU, repeatedly stresses that strong consumer protection must include recognized third-party conformity assessment schemes. The BEUC regards the self-declaration options of CE Marking as a bare regulatory minimum.

Suppliers are going to third-party test houses. Even if self-declaration is officially available for most products except large industrial machinery, suppliers are still flooding test houses with orders.

Why? Self-declaration includes specified requirements for test reports. One major European test house estimates that the minimum investment cost for the associated test equipment can often approach $500,000. Only the largest manufacturers can afford this.

Third-party certifiers are responding by strengthening the policing of their activity. There is a strong movement toward harmonized accreditation rules for certification bodies beyond the minimum required by EU regulations.

EAC, the main continental-level accreditation body in Europe, recently began its first multilateral accreditation scheme for certifiers, based on harmonized principles across Europe. The effort going into this program makes little sense unless accredited third-party certification is going to spread.

Taken together, the evidence of the operation of the CE Marking system is encouraging. The hard results are more important than the forecasts of future trends. The system is already making a substantial contribution toward achieving frontier-free trade among no less than 18 countries in Europe.

The frontiers and multiple documentary checks have been eliminated, and national regulations are fast losing the influence they had. The EU program represents one of the first multi-country, pan-regional and multi-sectoral efforts of its kind in the world, and its embryonic success offers encouraging signs for free trade throughout the world.

About the Authors

David Lohbeck has 20 years of engineering experience in industry, semiconductor machine design, plastics processing, computer design and international product safety and EMC. For the past nine years, he has worked in the field of European safety and EMC compliance with TUV Rheinland of North America. As manager of seminars and training for TUV Rheinland, Mr. Lohbeck has conducted many European compliance seminars. TUV Rheinland of North America, 4711 Golf Rd., Suite 711, Skokie, IL 60076, (847) 679-2888.

Raymond Schonfeld is Managing Director of Single Market Ventures, a company that provides literature and consulting projects to help exporters use the new European certification procedures. Single Market Ventures, 87 Rue Faider, B-1050, Brussels, Belgium, 011 322 537 2603.

Table 1.

For any given product, the EU uses this list of options to specify compliance requirements under its CE Marking directives. The combination of requirements may vary by product and, in rare cases, other requirements may be imposed.

Essential technical or performance requirements, linked to harmonized European (EN) standards but with exemptions from standards for unusual or novel products.

Action by the Supplier:

Technical file or other documentation on product specification, manufacturing process and quality assurance procedures.

Manufacturer’s declaration of conformity.

Affixing a product mark.

User instructions or other user information.

Use of independent third-party body.

Action by an approved independent body (required only for identified groups of high-risk products):

Type-approval, based on a sample.

Certificate of Conformity based on technical documentation and/or a sample.

Sampling or surveillance of products manufactured (product quality assurance, product verification or unit verification).

Analysis and/or monitoring of quality control, quality assurance and/or design procedures (production quality assurance or full quality assurance).

Affixing a product mark.