§4.1.2.5 Revision of harmonised standards

Harmonised standards translate the essential requirements or other legislative requirements into detailed technical specifications, methods of measurement to assess and/or declare the compliance with the essential requirements and, in some cases, numerical values to allow compliance with the essential requirements. Like any technical document, they are subject to change, or in other words to a revision. The formal decision to revise a harmonised standard is taken by the ESOs. This takes place on the basis of their own initiative (198), or following a standardisation request from the Commission directly or, indirectly, based on a Commission decision after a formal objection. The need for revision can result from the changes of the scope of the Union harmonisation act (such as an extension of the scope to other products or a modification of the essential requirements), from the fact that the Commission or a Member State challenges the contents of the harmonised standard, indicating that it could no longer give presumption of conformity with the essential requirements, as a result of technological development or due to market demand. When a harmonised standard is revised, the revision must be covered by a standardisation request to maintain the possibility of giving presumption of conformity. Unless the contrary can be deduced, the terms and conditions of the original standardisation request apply also for the revision of the harmonised standard. This does not exclude the possibility of a new or revised standardisation request, in particular where the revision is related to shortcomings with respect to the essential requirements. To give presumption of conformity, the revised harmonised standard must satisfy the general conditions according to the Union harmonisation legislation: the harmonised standard is based on a standardisation request, it is presented by the relevant ESO to the Commission and its reference is published by the Commission in the OJEU. It is under the exclusive competence of the Commission to decide on dates when the references of the superseded harmonised standards are withdrawn from the OJEU. In most common cases a withdrawal date set by the Commission and published in the OJEU allows for a ‘transitional or coexistence period’ during which both the withdrawn (superseded) harmonised standard and the revised (superseding) harmonised standard give a presumption of conformity simultaneously. The ‘transitional or coexistence period’ points to the time period between the date of publication of a reference of a revised harmonised standard in the OJEU and the date of withdrawal from the OJEU of the reference of the superseded harmonised standards. It is the responsibility of the Commission to ensure that such transitional periods are of sufficient length but at the same time not disproportionately long. After a transitional period, only the revised (superseding) harmonised standard gives a presumption of conformity. The Commission may consider that, for safety or other reasons, the superseded version of the harmonised standard must cease to give a presumption of conformity after a relatively short transitional period or even immediately. If circumstances allow, the Commission may consult the Member States and the ESOs prior to taking a decision to reduce the period during which both versions of the standard give a presumption of conformity. If necessary, the initially set transitional period might also be extended by the Commission. Unless decided otherwise on the basis of a proposal by the Commission, the removal of the reference of a harmonised standard from the OJEU after its revision does not automatically invalidate existing certificates issued by notified bodies; it only concerns the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced according to the old certificate may still benefit from the continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies. However, manufacturers must keep themselves appraised of changes in the state of the art, assess the extent of the changes to the superseded version of the standard and, if necessary, take appropriate action. The kind of action to be taken by the manufacturer depends on the nature of the changes in the harmonised standards, in particular whether these changes are material with regard to the coverage of the essential requirements and whether they concern the product in question. In addition, the notified body shall also keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the relevant requirements, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The reference of the revised harmonised standard, together with the information concerning the superseded version of the harmonised standard, and the date when the presumption of conformity of the superseded version of the standard ceases are published in the OJEU. It is in the interest of manufacturers to check every publication of the list of harmonised standards in the OJEU and to verify within it the validity of the harmonised standards they have applied in order to assess the conformity of their product. This is particularly essential in cases where manufacturers declare conformity themselves (in case of internal production control) and where manufacturer want to ensure continuous presumption of conformity for the products placed on the market. In the context of guidelines (199) agreed between the Commission and the ESOs there is an expectation that all revised harmonised standards should contain specific information indicating significant changes to a revised or amended harmonised standards and this information should be made publicly available (free of charge) by the ESOs.

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