§168 リスク

Like the term ‘hazard’, the term ‘risk’ is used in the Machinery Directive with a more precise sense than in everyday use. The existence of a risk depends on the hazards generated by the machinery and also on the interface between the machinery and the operators and other exposed persons. A hazard may be present on machinery, but if no person is liable to be exposed to that hazard, there is no risk.

Risks may be characterised by reference to the hazard or hazardous situation concerned (such as, for example, a risk due to contact with moving parts, a risk due to contact with hot surfaces, a risk due to noise emissions or emissions of hazardous substances); risks may also be characterised by reference to their possible consequences (such as, for example, a crushing risk, a cutting risk, a risk of being burnt, a risk of loss of hearing).

The third step of the process of risk assessment is to estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence – see §158: comments on General Principle 1. The estimation of the risk is based on a combination of these two factors. The most serious risks involve a combination of a high probability of occurrence and the possibility of fatal or severe injury or damage to health. However, a low probability of occurrence may still result in a serious risk if fatal or severe injuries or damage to health may result. Risks must therefore be evaluated on a case-by-case basis, taking account of the fact that risks may be different in the phases of the lifetime of the machinery, depending on the operations concerned and the state of the machinery during each phase – see §173: comments on section 1.1.2 (a).

Market surveillance authorities (MSAs) should use risk assessment to determine the level of appropriate action to take to deal with the risk and to inform other MSAs of high risk machinery on the EU market using the Rapid Alert System (RAPEX). A risk assessment procedure has been developed to assist in this process as well as a guideline on how the system should be used. This system was developed for consumer products but it is also applicable to industrial machinery. However, at the moment it is under review mainly to expand its scope to deal with Directives and Regulations where the risk is not primarily with respect to health and safety of persons.