Navigate through the new EU Machinery Regulation with Pilz

The new EU Machinery Regulation 2023/1230 marks a significant shift in the regulatory landscape for machinery within the European Union. Replacing the longstanding Machinery Directive 2006/42/EC, which has been in force for over a decade, the new machinery regulation brings a host of changes and implications for manufacturers, importers and distributors.

The Machinery Directive 2006/42/EC stands as a cornerstone in ensuring the safety and wellbeing of individuals interacting with machinery within the European Union. Its application has been mandatory in the EU since 2009. This vital piece of legislation sets forth standardised health and safety requirements, aiming to harmonise essential safety measures for the seamless interaction between humans and machines.

By outlining clear guidelines and regulations, the Machinery Directive plays a crucial role in promoting workplace safety, reducing accidents, and enhancing overall operational efficiency. It underscores the significance of prioritising human-machine interactions to prevent potential hazards and ensure a secure working environment.

Why do we have the new Machinery Regulation?

The European Commission’s decision to revise the Machinery Directive stems from the realisation of inadequacies and inconsistencies in the current Directive 2006/42/EC. One key aspect of the new regulation is its focus on addressing emerging technologies and innovations in machinery design and production. With advancements such as automation, robotics, and artificial intelligence becoming more prevalent in industrial settings, the new EU Machinery Regulation 2023/1230 aims to provide clear guidelines and requirements to ensure the safe integration of these technologies into modern machinery.

The official title of the Machinery Regulation is Regulation (EU) 2023/1230 of the European Parliament and of the Council on Machinery.

Overview of the most important changes

• Machines subject to inspection
   

In the future, six machine categories will be subject to inspection; the use of a harmonised standard does not relieve the inspection responsibility. This is owing to current advances in artificial intelligence. Machine makers can no longer self-certify compliance with a harmonised standard for the six mentioned product classes, as they previously could. Instead, a specific accreditation body must be involved.

• Substantial modification
   

The regulation has been expanded to include a description of a significant modification of machinery as well as the legal ramifications of such a change. A conformity assessment procedure is required for machinery safety when a machine is significantly modified or when changes are made that influence the machine’s compliance with the legislative provisions for CE marking. If a significant modification occurs, the operator becomes the manufacturer, with all of the responsibilities that are involved.

• Safety components
   

Safety components are now defined to include software in addition to physical, digital, and/or mixed-type components.

• Cybersecurity
   

The Machinery Regulation now includes standards for the cybersecurity of machinery in a new section named “Protection against corruption”. Cybersecurity threats must not be permitted to undermine the machine’s safety features. Manufacturers must reconsider their current safety concepts in this area.

• Digital Instructions
   

Manufacturers will be able to provide instructions in digital format. If the consumer requests it, the manufacturer must provide instructions in print format. The EU Declaration of Conformity can also be submitted in digital format. Partially built machinery can be given with both digital assembly instructions and a digital Declaration of Incorporation.

In summary

As technology advances and industries evolve, it is crucial for regulations to keep pace to ensure safety, efficiency, and effectiveness in machinery operations. The new EU Machinery Regulation aims to address these shortcomings by refining product coverage criteria and streamlining conformity assessment processes.

It is still unclear how the process will work with the existing harmonised standards under the Machinery Directive. As it currently stands, these will have to be relisted. With over 750 directly listed standards, this will be a significant effort over many years. With a 42-month transition period, the standards committees will have a lot of work ahead of them. It will be fascinating to see if the relevant standards will be available as harmonised standards by the time the EU Machinery Regulation goes into effect on January 20, 2027. This leaves the door open for authorities to impose special transitory provisions.

Manufacturers must adapt their processes to meet the new regulatory standards outlined in this legislation. From risk assessments to technical documentation requirements, compliance with the EU Machinery Regulation 2023/1230 will be essential for accessing markets within the European Union.

How Pilz can help

While change can bring uncertainty, embracing the opportunities presented by the EU Machinery Regulation 2023/1230 can lead to enhanced safety standards, improved market access, and continued innovation within Europe’s machinery sector. Staying informed about the implications of this new regulation will be crucial for businesses to navigate these changes. By understanding how it impacts their operations and product offerings, companies can proactively address any compliance challenges that may arise.

For years, Pilz has been a machine manufacturer’s partner providing a comprehensive suite of machinery safety services ranging from safety analysis to validation and CE marking. Pilz experts will advise you if you need to make significant changes to your plant and machinery to meet the Machinery Regulation standards. Pilz is also looking at the new normative security requirements because Industrial Security maintains the integrity of machine safety. This is why Pilz has expanded its service offerings to include appropriate Industrial Security training and services.

How will you carry out CE marking in the future? Which processes need to be adapted? How do you ensure that you comply with all the specifications and requirements? These are just a few questions you will need to tackle during the 3-year transition period. As safety experts, Pilz can help manufacturers navigate through the new EU Machinery Regulation with ease.