EUROPEAN PRODUCT REQUIREMENTS IN EUROPE - CE MARKING

摘要

There are substantial differences in the U.S. and European approaches towards regulating the safety of new technologies. The U.S. has adopted a prescriptive, standards-based strategy that places the responsibility for safety almost solely in the hands of employers, the users of the technology. OSHA standards represent a set of minimum requirements that employers are mandated only to meet. Even if technological advances and best practices in an industry have totally eclipsed OSHA standards, employers are under no regulatory obligation to adopt the more protective measures. While the OSHA machinery standards remain practically unchanged since the seventies, the Europeans have adopted a risk-based approach. In the U.S., purchase orders for new machinery routinely specify compliance with OSHA standards but OSHA does not regulate the designer or fabricator of new machines, OSHA regulates the user. (1) Since 1995, machine tool suppliers who want to sell their products in the European Union (EU) have been required to incorporate risk assessment into their design and demonstrate the safety of their products. (2) This formal review entitles them to carry the CE Mark (Conformite Europeene) without which their products cannot be legally sold. The conformity procedure requires the supplier to assemble records that describe the approach to ensuring that the machine satisfies regulatory requirements. These records are referred to as the Technical File. They do not have to be provided to government agencies unless there is an incident with a piece of equipment, at which time the government has a right to evaluate the Technical File for sufficiency. Affixing the CE Mark without compiling an acceptable Technical File can lead to fines and imprisonment. The CE Marking has had a significant impact in Europe and can serve as a policy model for U.S. governmental organizations that fund the development of innovative environmental cleanup technologies.