Did you know that the introduction of new regulations concerning machine safety could revolutionize the way industrial equipment is designed and constructed? Regulation 2023/1230/EU, which replaces the previous Directive 2006/42/EC, brings forth a series of changes aimed at enhancing machine safety across the European Union. Particularly hazardous machines, those whose improper design or use could pose significant threats to the health and safety of users and those nearby, receive special attention under this new regulation.
In today’s article, we will explore the changes introduced by the new regulation and how it affects the responsibilities of manufacturers, industrial automation integrators, and other business entities involved in the design, production, and operation of machines. Could these new regulations impact your company or the production processes you implement? Let’s consider the challenges and opportunities that arise in light of these changes.
Understanding the new requirements and preparing for their implementation can be key to minimizing risks and ensuring that every machine introduced to the market meets the highest safety standards. What requirements must particularly hazardous machines meet? What conformity assessment procedures will now be required? Answers to these questions can be found in the following sections of the article.
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Particularly Hazardous Machines in Directive 2006/42/EC
In previous years, Directive 2006/42/EC served as the legal foundation for machine safety within the European Union. It outlined essential health and safety requirements that all machines introduced to the market had to meet. A significant emphasis was placed on particularly hazardous machines, which required more stringent conformity assessment procedures and additional technical safeguards. The directive mandated a thorough risk analysis for each machine and the implementation of measures to eliminate or minimize risks during the design phase. Machines listed in Annex IV of the directive, if not designed in accordance with harmonized standards, required the involvement of a notified body in the conformity assessment process. For these machines, self-declaration of conformity by the manufacturer without the involvement of a notified body was not possible. The notified body had to conduct an EC type examination or approve the manufacturer’s quality management system to ensure compliance with the directive’s requirements. This requirement applied only to selected types of machines, which, due to their nature and associated risks, were considered particularly hazardous. These machines included:
- Circular saws (single and multi-blade) for working with wood and similar materials, as well as for meat processing,
- Surface planers for woodworking with manual feed,
- Presses for cold metal working,
- Injection or compression molding machines for plastics and rubber,
- Devices for lifting persons or persons and goods,
- Manually loaded waste collection vehicles equipped with a compression mechanism,
- Protective devices designed to detect the presence of persons,
- Logic units ensuring safety functions,
- and other machines listed in Annex IV of the directive.
According to the directive, the manufacturer had to prepare a declaration of conformity, confirming that the machine met all essential requirements specified in the directive. The applicable regulations also clearly stated that such machines should be equipped with appropriate safety elements, such as emergency stop systems, guards for moving parts, and other technical measures aimed at protecting users. All these actions aimed to ensure that particularly hazardous machines were designed and operated in a way that minimized risks to people. However, experiences gained during the application of Directive 2006/42/EC indicated the need for more precise and up-to-date regulations, ultimately leading to the development and adoption of Regulation 2023/1230/EU.
Particularly Hazardous Machines in Regulation 2023/1230/EU
The new Regulation 2023/1230/EU introduces detailed changes concerning particularly hazardous machines, focusing on expanding the list of machines requiring conformity assessment by a notified body and introducing new categories of machines. Among the new categories listed in the regulation are:
- Machines with machine learning-based components – particularly those with safety elements exhibiting variable behavior, utilizing machine learning algorithms. Such safety systems must be certified by a notified body to ensure that their variability does not negatively impact user safety.
- Autonomous machines – machines operating autonomously, without direct human supervision, including collaborative robots in shared workspaces with humans. In such cases, the notified body must conduct a type examination to ensure that autonomous systems operate safely.
- Next-generation industrial robots – especially those equipped with advanced perception systems (e.g., image recognition) and human interaction capabilities. An assessment by a notified body is required to ensure that these systems do not pose new, uncontrolled hazards.
Regulation 2023/1230/EU introduces more stringent requirements for risk analysis and precise testing, which must be conducted by notified bodies. As in Directive 2006/42/EC, each machine requires a detailed risk analysis, but now the technical documentation must include more detailed information on the use of advanced technologies, such as artificial intelligence and machine learning systems.
Additionally, the regulation expands the scope of mandatory quality management system audits, aimed at confirming that all serially produced machines meet the requirements specified by notified bodies. Manufacturers must ensure that the quality management system is regularly verified and updated in line with new technologies and requirements.
In summary, Regulation 2023/1230/EU expands the range of machines requiring certification by a notified body for CE marking, introducing new categories related to the development of autonomous and machine learning technologies. These changes aim to better adapt to contemporary technological challenges and ensure an even higher level of safety in production environments, both for operators and bystanders.
FAQ
The list of machines requiring certification has been expanded, new categories such as autonomous machines and those with machine learning have been added, and risk analysis and technical documentation requirements have been tightened.
No, only particularly hazardous machines listed in the regulation. A detailed conformity assessment is required.
Autonomous machines, those with machine learning components, and next-generation robots with advanced perception systems.
Documentation must include a full risk analysis, detailed descriptions of safeguards, and test reports. It must also be updated according to new requirements.
Manufacturers must conduct a full risk analysis, commission certification from notified bodies for certain machines, create and update technical documentation, and implement a quality management system that will be regularly audited.