sec_4_1_2_2__para__6

Harmonised standards never replace legally binding essential requirements. A technical specification given in a harmonised standard is not an alternative to a relevant essential or other legal requirement but only a possible technical means to comply with it. In risk related harmonisation legislation this means in particular that manufacturers always, even when using harmonised standards the references of which are published in the OJEU, remain fully responsible for assessing all the risks of their product in order to determine which essential (or other) requirements are relevant. After this assessment a manufacturer may then choose to apply technical specifications given in harmonised standards the references of which are published in the OJEU to implement ‘risk reduction measures’ (189) which are specified by harmonised standards. In risk related harmonisation legislation harmonised standards the references of which are published in the OJEU most commonly provide certain means to reduce or remove risks while manufacturers remain fully responsible for risk assessment to identify relevant risks and to identify relevant essential requirements in order to select suitable harmonised standards the references of which are published in the OJEU or other specifications.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.