Machinery Regulation 2023/1230/EU:
A new piece of legislation, concerning the supply of machinery onto the European Market, was adopted in July 2023 and becomes mandatory from the 20th January 2027. Up until now, like many of the safety directives, the legislation covering machinery safety was imposed through a European Directive. The migration from Directive to Regulation for European members now requires the legislation to be implemented directly into their legal system, leaving very little ‘wiggle room’ for member states. In the UK, the Supply of Machinery (Safety) Regulations 2008 (SI. 2008/1597) implemented the European Directive EU Machinery Directive 2006/42/EC, verbatim through the establishment of this Statutory Instrument (SI. 2008/1597). This, however, was not the case for all member states.
What aspects of the Machinery Directive have been amended?
‘In comparison with the 2006 Directive, the Regulation clarifies some complex issues such as ‘incomplete machinery’ and ‘substantial modifications’. The Machinery Regulation also intends to better cover new technologies such as autonomous mobile machinery (robots), internet of things with connected equipment, or artificial intelligence (AI), where specific modules of AI using learning techniques ensure safety functions.’ Regulation 2023/1230/EU – Machinery
The main changes that manufacturers will now need to consider include the following:
Machines (Or related products) to which special Procedures apply
Equipment that was considered ‘high risk’ and warranted additional evaluation, commonly referred to as Annex 4 machines, are still referenced in the new Regulations but are split into two groups and listed as Annex 1. The new Regulation effectively divides the old Annex 4 equipment into two parts. Part A consists of machines that require mandatory third-party conformity assessment, while Part B allows for self-assessment, provided certain conditions are met. Substantial Modifications The new Regulations give more details on what constitutes a ‘substantial modification’ to machinery
and what needs to be done if such a modification takes place.
Safety Components – Software
The definition of safety components now includes not only physical components but also digital components, including software.
New Digital Technologies
The Machinery Regulations also aim to address the safety and liability implications stemming from new digital technologies such as Artificial Intelligence, the Internet of Things and Robotics.
Protection Against Corruption
This is a new section under the new Machinery Regulations which contains requirements to prevent intentional or accidental corruption of software/hardware.
Digital Instructions
Instructions may now be provided in a digital format, subject to some format/access requirements. However, when a paper format is requested at the time of purchase, the manufacturer shall provide,
within one month, the instructions in paper format.
How do I ensure that I stay compliant?
What impact the transition from the Machinery Directive 2006/42/EC to the Machinery Regulation (EU) 2023/1230 shall have will vary from product to product. At the very minimum it may be necessary to update Technical Documentation, including Declarations of Conformity, to reference the new Machinery Regulation. However, in some cases products may need to re-evaluated or even redesigned to address updated Essential Health and Safety Requirements contained in the new Regulation and with new considerations for AI-based safety systems.