The EU Commission published the Machinery Regulation (2023/1230) in June 2023. The Regulation entered into force on 19 July 2023, but will apply from 20 January 2027, replacing the Machinery Directive 2006/42/EC. As this is an EU Regulation, it does not require separate implementation in Member States, but applies directly.
In many respects, the Machinery Regulation is similar to the Machinery Directive. In terms of safety requirements, the most important and effective reforms relate to digitalisation and machine control systems. This text does not cover all the reforms provided for in the Regulation, but focuses on changes relating to standards.
The Machinery Regulation has been aligned with other New Approach Directives. This mainly concerns market surveillance activities. The Machinery Regulation defines the concept of a ‘substantial change’ that may affect the modernisation of equipment in use. The Regulation allows for the provision of information on use in digital form under certain conditions. The Machinery Regulation authorises the Commission to develop technical specifications if there is no harmonised standard or if a standardisation organisation is unwilling or unable to develop one (see requests for standardisation).
The annexes to the Machinery Regulation have been reorganised so that the essential health and safety requirements have been moved to Annex III. Many changes have been made to Annex III, but the most significant ones are:
1.1.9 Protection against data damage (cybersecurity)
Hardware components related to safety and connected to a data transmission network must be protected against (including intentional) damage.
The software version must be easily identifiable.
The machine must collect information about interference with the control system (i.e. a log file).
1.2.1 Self-developing behaviour (artificial intelligence) must not cause hazards, and monitoring data must be left at the development stage.
3.2.4 Monitoring function for autonomous mobile machinery
3.5.4 Contact with overhead lines.
The new requirements must be translated into harmonised standards. This work is only just beginning. The reform will take a long time and will be carried out in stages. The Commission sent a request for standardisation to CEN in August 2023. Its publication is scheduled for the end of 2024 (at the time of writing in April 2024, the request was still under consideration).
In the first phase, CEN plans to update the safety standards for type A and B machinery. After that, type C standards can be updated by referring to the new or updated type A and B standards. The CENELEC/TC 44X committee is currently developing a new type B standard for cybersecurity.
Due to the large number of harmonised standards, efforts are being made to align them with the Machinery Regulation by creating a new Annex Z. The European Committee for Standardisation (CEN) is currently conducting a gap analysis to determine which standards currently comply with the requirements of the Machinery Regulation, which standards need to be revised and the scope of these changes. It is possible that Annex Z, which refers to the Machinery Regulation, will have to exclude some new safety requirements from its scope in order to keep the standard harmonised during the transition period. Missing safety solutions may be added later, when the necessary type B standards are published and can be referenced in the new version of the standard.
