KANBrief 3/23

The new Machinery Regulation and what it means for harmonized standards

In probably no other industrial sector are standards as important as in mechanical engineering. The new EU Machinery Regulation presents the standards committees with the major task of reviewing the standards for their conformity with the new statutory basis and, if necessary, taking measures to bring them into line with it.

The importance of the safety of machinery users and the wide diversity of machine types has led over the years to over 800 harmonized standards being created under the European Machinery Directive, an astonishingly large number. Users of these standards can assume that the solutions and measures described in them enable the legal requirements of the regulations or directives for which they were developed to be satisfied. Among these standards are some 100 "type B" standards, which address specific safety aspects or protective devices affecting a large number of machines. Over 700 standards describe requirements and technical solutions for specific machine types (type C standards). Over the years, the symbiosis between the Machinery Directive and harmonized standards has created a proven system that ensures a high level of safety, recognized worldwide, for machinery products.

Standardization now faces a mammoth task

With publication of the new Regulation (EU) 2023/1230 on machinery in the Official Journal of the EU on 29 June 2023, the European Commission has now opened a new legal chapter. The Machinery Regulation will replace the current Machinery Directive 2006/42/EC on the cut-off date of 20 January 2027, i.e. without a transition period. In addition to numerous formal and conceptual amendments to the legal text, significant changes have been made to Annex I of the Machinery Directive, which describes the essential health and safety requirements (EHSRs). The EHSRs are found in the new Annex III of the Machinery Regulation. Fulfilment of these safety requirements is the main purpose of the harmonized standards. The amendments inevitably raise the following questions:

What immediate consequences do the new and amended EHSRs have for the content of current harmonized standards? Can the standards harmonized under the Machinery Directive continue to be used under the Machinery Regulation, and do they still give rise to a presumption of conformity?

The answer to the first question is not trivial, because practical/normative implementation in detail of the new EHSRs of "Protection against corruption", "Supervisory function" (on autonomous mobile machinery) and "Risk of contact with live overhead power lines" is still the subject of intense discussion.

However, a broad overview of the standards' scope shows that hardly any category of machinery is likely to remain completely unaffected by the new or strongly amended EHSRs. All harmonized standards will therefore need to be reviewed for their relevance to the new EHSRs, and should they be affected, amended in both form and content in accordance with the procedural rules of the European Commission (table in Annex ZA, dated references). Theoretically, this would entail revision of almost all of the approximately 800 standards, including extensive assessments by the HAS Consultants in each case. Completion of this task in the three and a half years that are left before application of the Machinery Regulation becomes mandatory is in no way realistic.

A possible interim solution: conditional listing

For this reason, the European Commission is planning – as at August 2023 – the following exceptional step: all European standards (both EN and EN ISO) that are harmonized under the Machinery Directive at an as-yet unspecified point in time in the first half of 2026 are to be transferred en bloc as harmonized standards under the new Machinery Regulation. The only limitation will be that, obviously, these standards can ensure harmonization only for the EHSRs that they already address under the Machinery Directive. In order to make this clear to standards users when the standards are listed in the Official Journal, it will be essential for each responsible Technical Committee (TC) to subject its entire portfolio of standards to a review (NOT necessarily a revision) in order to identify the gaps with respect to the new Machinery Regulation. At the same time, work will begin at CEN and CENELECto produce normative solutions to the new or significantly modified EHSRs to enable the gaps identified to be addressed in normative provisions.

With the support of the coordinating CEN/CENELEC "Machinery" Sector Forum, a guidance document is currently being prepared to assist the TCs in this very ambitious task. The guidance document is to be made available by the end of 2023 at the latest.

It is of course already possible – and advisable – to make conformity with the new Machinery Regulation an objective during new projects or pending revisions of existing standards. It is therefore to be hoped that by the beginning of 2027, a part of the standards will already have been brought into line with the new Machinery Regulation. For the majority of harmonized standards, however, this will not be possible until application of the Machinery Regulation has already become mandatory.

A more precise timeframe on future standards revisions is anticipated with the European Commission's new standardization mandate for the Machinery Regulation, which is expected to be available in the coming year. Unlike previous mandates, the term of this standardization mandate will be limited (probably to between 5 and 10 years). It forms the legal basis by which harmonized standards may be developed under the new Machinery Regulation. The first draft of the standardization mandate was published at the end of June. Comments from stakeholders are expected to be discussed in the autumn in the relevant Commission committees.

Finally, as a further measure, transition of harmonized standards from the Machinery Directive to the Machinery Regulation is to be made easier for users of standards. For standards published between 2024 and the first half of 2026, two Annexes ZA are to be created: one for the Machinery Directive, the other for the Machinery Regulation, showing which sections of the standard cover which parts of the legislation. The affected standard TCs will also be provided with relevant information in due course.

The measures described all contribute to the transition of harmonized standards from the Machinery Directive to the new Machinery Regulation progressing as smoothly as possible.

Dr Frank Wohnsland
VDMA (German mechanical engineering association)
Chair of the CEN/CENELEC "Machinery" Sector Forum