Mutual Recognition Agreements

It has been only a few months since the directives of the European Union (EU) have become mandatory. And as so many in the industry predicted, United States-based EMC laboratories are being penalized by the lack of recognition by the EU. These labs need a champion of the oppressed¾ which just may come in the form of mutual recognition agreements (MRAs) to balance the regulatory objectives and the needs of the marketplace.

Today, competent bodies referenced in the EMC Directive (89/336/EEC) may exist only in the EU. This situation is all the more unfair when you consider that there are many laboratories and consultants in the United States and throughout the world that are eminently qualified to assess and certify equipment under the provisions of Article 10 (2) of the EMC Directive for technical construction files.

This all started in the late 1980s, when the European Community, now the EU, began developing a group of new directives to eliminate barriers to trade. These directives eventually led to unified standards to replace a dozen different sets of national regulations.

Among these is the EMC Directive covering virtually all electrical and electronic equipment. Initiated in 1990, the directive impacts a wide range of U.S. exports. But unlike current commercial requirements such as radiated and conducted emissions, it also imposes immunity requirements that previously applied only to military equipment, certain automotive devices and other special applications.

The EU has also enacted product-specific directives with even more far-reaching implications. Suppose that your company manufactures electronic toys. Along with EMC, you now have to meet standards for toy safety and low voltage. If you make computers with built-in modems, they must meet additional requirements for telecommunications terminal equipment, low voltage and video display terminal (VDT) ergonomics.

Beginning in 1992, manufacturers could decide whether to meet the requirements of the directive or of the individual countries in which they were selling products. Many opted for the latter because they did not have immunity requirements. Effective Jan. 1, 1996, however, all electronic equipment destined for the EU must meet the more extensive requirements of the directive.

Enforcement is a nightmare. In the Netherlands, for example, all incoming equipment is inspected for the CE designation, without which it is not permitted to enter the country. Belgium, on the other hand, has no such provision, nor has it allocated funds to implement one.

Routes to Compliance

Today, there are three primary routes to compliance: self certification, technical construction files and MRAs.

Self Certification—usually the preferred method whereby a manufacturer or an authorized agent in the EU provides a declaration of conformity that the equipment in question meets all applicable standards.

Technical Construction File—used when there is any deviation from the standards, such as an MRI unit or CAT scanner that is too large to be tested under laboratory conditions and must be tested in situ. It also applies when there is an extensive family of products where testing each model would be prohibitive or when appropriate standards do not exist.

The technical construction file explains the provisions that have been taken to meet the essential requirements of the EMC Directive. Therefore, it must be approved by a competent body located within the EU. This arrangement poses a major obstacle to free trade between the United States and the EU.

Mutual Recognition Agreements—proposed in April 1994 by the U.S. Department of Commerce to reduce costs by permitting conformity assessment to be performed in the country of manufacture.

In the past two years, representatives of the United States and the EU have met five times to discuss MRAs. By most accounts, final adoption of the MRA approach is at least two years away.

One reason why negotiations have bogged down is the scope of the agreements. They cover not only EMC, but also telecommunications equipment, personal protective equipment, medical devices, pharmaceuticals, road safety equipment, recreational equipment and lawn equipment.

As such, the agreements involve multiple government agencies, among them the Department of Commerce, FDA, FCC, EPA, OSHA, FHWA and the USCG. Also party to the negotiations are private-sector representatives from the electrical, telecommunications, pressure equipment and other industries as well as associated testing and certification organizations. Under discussion are market access, legal issues, technical information exchange, self-certification, individual sector requirements, conformity assessment systems, joint enforcement, engineering judgment and equivalency of certifying bodies.

Concerning the latter, the Department of Commerce, through the National Institute of Standards and Technology, has introduced the National Voluntary Conformity Assessment System Evaluation (NVCASE) program at the midpoint of the negotiations. NVCASE will provide the U.S. government recognition to U.S.-based conformity assessment bodies that test or certify products for acceptance into regulated foreign markets. It will encompass quality system registration, laboratory testing and product certification.

In addressing these areas, the program will require quality system evaluation, on-site assessment, deficiency resolution and periodic surveillance. NVCASE will operate in product sectors where there is no responsible regulatory authority or when the responsible agency requests that NVCASE operate on its behalf. The FCC may become the U.S. competent authority for EMC compliance.

The evaluation process involves application, payment of an initial fee and agreement to pay subsequent fees comparable to those charged by the National Voluntary Laboratory Accreditation Program. The program has met the requirements for technical competence of the European Council of Ministers, clearing the way for the adoption of MRAs.

In the last round of negotiations, the Europeans were receptive for the first time to some staging of mutual recognition to allow time for the respective regulatory communities to gain confidence and understanding of each other’s evaluations and procedures, according to Dr. Charles M. Ludolph with the International Trade Administration of the U.S. Department of Commerce. This staging process calls for establishing standards for competency in conformity assessment, criteria for delegating product evaluations and approvals, and procedures for establishing equivalency of certifying bodies.

While the final agreement to adopt MRAs may take years, the process is going in the right direction. Retreat to nationalistic protectionism, in whatever form, is not viable in today’s global marketplace.

U.S. manufacturers and regulators need to place MRAs within the context of growing global economic pressures toward simplification, harmonization, confidence-building, budget reductions and cost pressures and competitiveness, concluded Dr. Ludolph. MRAs must support the needs of regulators, manufacturers and the conformity-assessment community. Anything less will not liberalize trade, but will cause the proliferation of international requirements which throttle the international economy.

About the Author

Gary L. Fenical is the Senior EMC Engineer at Instrument Specialties. He also serves as liaison between the U.S. EMC laboratory community and the EU’s Electromagnetic Compatibility Information Technology Committee. Instrument Specialties, P.O. Box A, Delaware Water Gap, PA 18327, (717) 424-8510.

Copyright 1996 Nelson Publishing Inc.

May 1996

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