Article 6 › 4

The Commission shall assess the seriousness of the inherent potential risk presented by a category of machinery or related product for the purpose of determining whether to add that category of machinery or related product to Annex I or to withdraw that category of machinery or related product from Annex I. That assessment shall be established based on the combination of the probability of occurrence of harm and the severity of that harm. In determining the probability and severity of harm, the following criteria shall, where relevant, be taken into account: (a) the nature of the hazard inherent to the function of the category of machinery or related product, taking into account the intended use and any reasonably foreseeable misuse; (b) the severity of harm which a person would suffer, including the degree of reversibility of that harm; (c) the number of persons potentially affected by the harm; (d) the frequency and the duration of the exposure to the hazard that a person would be exposed to in the course of the intended use or any reasonably foreseeable misuse of the category of machinery or related product; (e) the possibilities of avoiding or limiting harm; (f) in the case of safety components, the likelihood of serious consequences for the safety of the persons exposed to harm in the event of their failure.

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Source: EUR-Lex CELLAR · retrieved 2026-08-26