Risk Mitigation Measures

Risk Mitigation Measures are the specific steps taken to eliminate hazards or reduce risks to an acceptable level following a formal Risk Assessment. For North American manufacturers, understanding the hierarchy of these measures is critical for CE compliance. It is not enough to simply warn users of danger; the EU requires a strict "three-step method" outlined in ISO 12100.

First, manufacturers must attempt inherently safe design changes to eliminate the hazard entirely. If that is not possible, the second step involves technical safeguards, such as light curtains or physical barriers. Only as a last resort should manufacturers rely on information for use, such as warning labels or PPE, to address residual risks.

This hierarchy is legally binding under the Machinery Directive and the incoming Machinery Regulation. Failing to prioritize design changes over warning labels is a common gap for US exporters. All selected measures and their effectiveness must be documented in the Technical File to prove that the Essential Health & Safety Requirements (EHSRs) have been met.