§4.1.2.3 The Presumption of conformity

Union harmonisation legislation may set out that Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the OJEU (190). European standards, including harmonised standards, may be based fully or partially on international ISO or IEC standards. However, the presumption of conformity is possible only when applying the European version published by reference in the Official Journal, because of possible technical modifications introduced in it to ensure adequate compliance with the legal requirements. Additionally ISO and IEC versions do not contain information about which provision of the standard is relevant for which essential requirement, as this information is only included in their European version. The objective of publishing the reference in the OJEU is to set the date from which the presumption of conformity takes effect. Publication of references of harmonised standards is managed by means of Commission Implementing Decisions. Publication in the OJEU is the ultimate goal for a harmonised standard and the end of the process which started when the relevant Commission standardisation request was issued. Publication of references is not an automatic action and the Commission must perform certain checks and assessments before publication takes place. The Commission may thus refuse to publish the references or, where appropriate, may set certain restrictions which are published together with the references. In a situation where a formal objection procedure has been already initiated prior to the publication of a reference in the OJEU, there is a doubt whether a harmonised standard entirely satisfies the requirements it aims to cover within the meaning of Article 11(1) of Regulation (EU) No 1025/2012. Because of this doubt, the Commission cannot publish the reference according to Article 10(6) of Regulation (EU) No 1025/2012 and a Commission Implementing Decision within the meaning of Article 11(1) must be taken. The recourse to harmonised standards referenced in the OJEU and which give a presumption of conformity remains voluntary (191). Manufacturers can choose whether or not to apply such harmonised standards or parts thereof. However, if manufacturers choose not to apply a harmonised standard, they must demonstrate that the products are in conformity with essential requirements by the use of other means of their own choice (for example by means of any existing technical specifications including all other available standards). If the manufacturer applies only a part of a harmonised standard or the harmonised standard does not cover entirely all relevant essential requirements, the presumption of conformity exists only to the extent the harmonised standard corresponds to the essential requirements. For that reason it is necessary that each harmonised standard contains clear and correct information on legal (essential) requirements covered. Compliance with harmonised standards is, according to certain Union harmonisation acts, an option having effect on the applicable conformity assessment procedure, and sometimes opens the possibility for conformity assessment without the intervention of a third party or for a larger choice of procedures (192).

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