Principles, Standards and Implementation

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Regulations

EU Directives and Legislation The EU Machinery Directive Essential Health and Safety Requirements The Machinery Directive—Conformity Assessment and Standards Technical File Conformity Assessment Notified Bodies
EC Declaration of Conformity Procedure EC Declaration of Incorporation for Partly Completed Machinery Machinery Supplied from Outside the EU—
Authorized Representatives		 The EU Use of Work Equipment Directive (U.W.E. Directive) U.S. Regulations Occupational Safety and Health Administration Canada Regulations
The Machinery Directive—Conformity Assessment and Standards

A harmonized European (EN) Standard that is listed in the Official Journal of the European Union (OJ) under the Machinery Directive, and whose date of cessation of presumption of conformity has not expired, confers a presumption of conformity with certain of the EHSRs. (Many recent standards listed in the OJ include a cross-reference identifying the EHSRs that is covered by the standard).

Therefore, where equipment complies with such current harmonized European standards, the task of demonstrating conformity with the EHSRs is greatly simplified, and the manufacturer also benefits from the increased legal certainty. These standards are not legally required, however, their use is strongly recommended since proving conformity by alternative methods can be an extremely complex issue. These standards support the Machinery Directive and are produced by CEN (the European Committee for Standardization) in cooperation with ISO, and CENELEC (the European Committee for Electrotechnical Standardization) in cooperation with IEC.

A thorough, documented risk assessment must be conducted to ensure that all potential machine hazards are addressed. It is the responsibility of the machine manufacturer to ensure that all EHSRs are satisfied, even those that are not addressed by harmonized EN Standards.