New Machinery Regulation: Status of harmonised standards

There are currently more than 800 harmonised standards listed in the Official Journal of the European Union in accordance with the Machinery Directive 2006/42/EC. These technical standards ensure a high level of safety and protection for the users of machinery and other persons exposed to the machinery.

By being listed as a harmonised standard, these standards carry a presumption of conformity. This means that users of these documents can assume that the solutions and measures described in the standards are suitable for fulfilling the legal requirements of the directive, for which they were developed by the European standardisation organisations CEN/CENELEC on behalf of the EU Commission.

The need for harmonised standards was also substantiated by the new publication of the Machinery Regulation in June 2023. This is the subject of this briefing note.
 

Changed requirements as part of the Machinery Regulation

Most of the legal requirements of the Machinery Directive can also be found in the new Machinery Regulation (EU) 2023/1230. However, the revision has also resulted in amended or completely new essential health and safety requirements (EHSRs for short), such as "Protection against corrosion" (Annex III, 1.1.9) or "Risk of contact with live overhead lines" (Annex II, 3.5.4.), so that harmonised standards must at least be reviewed and, if necessary, adapted to the new requirements of the regulation. You can find an overview of the most important changes to the new Machinery Regulation 2023/1230 in our technical article on the new Machinery Regulation

The topic of harmonised standards was already communicated in the first draft of the new Machinery Regulation 2021, which was published for public comment. In a position paper, CEN/CENELEC pointed out the difficulty of adapting all harmonised standards to the new requirements within the deadline set by the EU Commission until they come into force (30 months). At that time, an extension of the deadline from 30 to 36 months was proposed, but this was not taken into account when the regulation was finally published in June 2023.

Presumption of conformity under the Machinery Directive = presumption of conformity under the Machinery Regulation?

This planned adaptation of the harmonised standards has now taken a new turn at the end of 2023: As things stand, the EU Commission will also fully certify the presumption of conformity under the Machinery Regulation for all standards currently listed in the EU Official Journal under the Machinery Directive - provided they cover the same EHSRs communicated in both pieces of legislation. ¹ Of course, these documents cannot fulfil newly added requirements without revision, which is why the listing of these documents in the EU Official Journal with restrictions is being discussed as an interim solution.² This form of publication has already proven its worth in the past, for example when individual sections of standards are exempted from the presumption of conformity.

According to the publisher CEN/CENELEC, the review will take place over the year 2024 as part of a so-called "gap analysis". The individual technical committees tasked with drawing up harmonised standards in accordance with the Machinery Regulation are to review the changes in the EHSRs for their standards and introduce them within a time frame set by the Commission.³
The review of all standards currently published in the Official Journal of the EU in accordance with the Machinery Directive is to be completed by the end of 2026 at the latest, so that an implementing decision with a complete list of harmonised standards in accordance with the Machinery Regulation is available shortly before the deadline of 20 January 2027. The "gaps" identified by the committees could then appear as restrictions in the Official Journal as part of the decision.

In addition to the review mandate, the standardisation mandate also includes the scheduled revision of existing standards. As part of this revision, the technical committees are to take into account the requirements of the Machinery Regulation in addition to the EHSRs under the Machinery Directive. The standardisation mandate also includes the creation of new harmonised standards specifically for the newly added requirements of the Machinery Ordinance, such as cybersecurity, AI or additive manufacturing.

New publications of European standards that appear before the deadline of 20 January 2027 must then (still) cover the requirements of both sets of regulations. In addition to the existing Annex ZA (reference of a European standard to the EHSRs to be covered by Directive 2006/42/EC), these documents will probably also contain an Annex ZB for Machinery Regulation (EU) 2023/1230. This double annex is likely to be familiar to standard users from the last revision of the Machinery Directive 98/37/EC.