§4.1.2.2 Role of harmonised standards

Harmonised standards are developed and adopted like other European standards following the internal rules of ESOs. According to these rules, all European standards must be transposed at national level by the national standardisation bodies. This transposition means that the European standards in question must be made available as national standards in an identical way, and that all conflicting national standards must be withdrawn in a given period. Harmonised standards are European standards to which Regulation (EU) 1025/2012 and sectoral Union harmonisation legislation give a special meaning. However, it is important to note that the definition of a harmonised standard does not contain any reference to the publication of its reference in the OJEU. As long as a reference of a harmonised standard is not published in the OJEU the harmonised standard, or parts thereof, does not give presumption of conformity with the essential or other requirements it aims to cover. The ESOs are formally requested to draft harmonised standards via a standardisation request issued by the Commission. The role and preparation of the Commission’s standardisation request to the ESOs is detailed in the ‘Vademecum on European standardisation’ (185). In order to provide presumption of conformity, a harmonised standard must match the relevant essential or other legal requirements of the relevant piece of legislation in line with the relevant standardisation request and be referenced in the OJEU. A harmonised standard may contain specifications relating not only to essential requirements but dealing with other non-regulated issues. In such a case, these specifications are to be clearly distinguished from those covering the essential requirements. A harmonised standard does not necessarily have to cover all essential requirements but it must be always clear which requirements are ‘aimed to be covered’ (186) as otherwise a manufacturer complying with a harmonised standard, referenced in the OJEU, does not know against which requirements a ‘presumption of conformity’ will apply and public authorities and notified bodies do not know against which essential requirements they must accept a presumption of conformity. The relevant essential or other legal requirements aimed to be covered are usually indicated in a separate informative annex (187) to a harmonised standard. When essential requirements are covered only partially, it should be clearly indicated in the standard. In some cases the scope of a harmonised standard may also indicate the relevant requirements with sufficient clarity (e.g. when there is a clear reference to covered safety related risks). This information on the ‘aimed coverage of essential or other requirements’ given in a harmonised standard thereby determines the scope and the limits of the so-called ‘presumption of conformity with legal requirements’. A clear distinction must be made between ‘conformity with a standard’ and ‘presumption of conformity (when applying (188) a harmonised standard)’. ‘Conformity with a standard’ usually makes a reference to a situation where a standard is ‘fully applied’. This is for instance the case of voluntary certification against a standard. For the purposes of ‘presumption of conformity’ it is sufficient to apply only those provisions relating to the essential or other legal requirements aimed to be covered. 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. Flowchart 1 The role of harmonised standards in complying with relevant essential requirements identified by a manufacturer - a generic philosophy for cases where a manufacturer needs to identify relevant essential requirements Where harmonised standards fail to indicate clearly the essential requirements aimed to be covered such standards may become less useful for manufacturers and market surveillance authorities as there is less legal certainty on the real ‘scope of presumption of conformity’. An unclear or incorrect indication of the essential requirements aimed to be covered may also lead, in some cases, to formal objections against harmonised standards (see point 4.1.2.5). Where a harmonised standard covers only part of the essential requirements identified as relevant by manufacturers or only certain aspects thereof, they additionally have to use other relevant technical specifications or develop solutions in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature in order to meet the essential requirements of the legislation in question. In a similar way when manufacturers choose not to apply all the provisions given in a harmonised standard, and which normally would provide presumption of conformity, they need, on the basis of their own risk assessment, to indicate in their technical documentation how the compliance is reached or that relevant essential requirements are not relevant for the product. Occasionally standards may contain errors or offer different possible readings. If manufacturers find such an error or uncertainty, they should first make contact with the national standardisation body to seek for clarification.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07