§4.1.2.4 Withdrawal, restriction or prevention of the presumption of conformity

Article 11(1) of Regulation (EU) No 1025/2012 contains a provision for a formal objection procedure according to which the publication of references of harmonised standards in the OJEU can be challenged (193) by Member States and the European Parliament. This situation might arise prior to the publication of the reference of the harmonised standard in the OJEU or in the case of a harmonised standard the reference of which has already been published in the OJEU. In both cases, where a Member State or the European Parliament (194) considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation, it has to inform the Commission thereof. After consulting the Member States (195), the Commission will adopt a decision: — to publish, not to publish or to publish with restrictions the reference to the harmonised standard concerned in the OJEU, or — to maintain, to maintain with restrictions or to withdraw the references to the harmonised standard concerned in or from the OJEU. Where a Member State has raised an action under a safeguard clause (196) against a product which complies with a harmonised standard and where such a safeguard action is considered justified, the Commission has a responsibility to initiate an objection against the relevant harmonised standard. The procedure to challenge a harmonised standard and its outcome does not affect its existence as a harmonised standard or as a European standard as only the ESOs can make decisions on the revision or withdrawal of their deliverables. In addition to the controls available to the Commission, only this objection procedure gives the European Parliament and the Member States a possibility to control the presumption of conformity i.e. the legal effect, which stems from the publication of the reference in the OJEU. Provided the formal objection is justified, it may only lead to the withdrawal, restriction or prevention of such a publication in the OJEU. In the first two cases, this means that the harmonised standard in question will no longer give presumption of conformity or presumption of conformity with the essential requirements is restricted. In the last case (prevention) it means that the standard does not give presumption of conformity at all. A harmonised standard can be challenged at any moment after its adoption by CEN, Cenelec or ETSI as a European standard. Furthermore, the reference may be removed from the OJEU by the Commission, without applying formal objection procedures, in certain exceptional cases where the relevant edition of a harmonised standard is not anymore reviewed or updated by the ESO itself and where the ESO itself does not regard it as a standard. Such cases include situations where the harmonised standard in question has been withdrawn by the relevant ESO without any intention to adopt a revised harmonised standard. The concept of essential requirements is based on the assumption that the harmonised standards reflect generally acknowledgeable state of the art and the ESO review harmonised standards regularly in accordance with the relevant standardisation request. When it is evident that a harmonised standard is not anymore recognised as a standard by the relevant ESO itself or where the standard is not anymore revised or available as a national standard such a document cannot be, as a rule, used anymore to provide presumption of conformity. The purpose of Article 11 of Regulation (EU) No 1025/2012 is to provide a procedure to challenge only valid harmonised standards, not withdrawn harmonised standards or draft harmonised standards which cannot be regarded as adopted European standards in the context of definitions given in Article 2 of Regulation (EU) No 1025/2012. Another specific situation where the Commission may need to remove references from the OJEU without formal objection relates to cases where publication in the OJEU is done by a mistake or where a reference of a document which cannot be regarded as a harmonised standard is published. The latter case may include cases where the standard is not covered by a standardisation request or where the standard does not cover any essential requirements or where the standard was not correctly adopted by respective ESO following the recognised standardisation principles. According to Regulation (EU) No 1025/2012 the Commission is obliged to inform stakeholders (197) on all pending formal objections against harmonised standards before formal decisions are taken.

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