Understanding Significant Modification of Machinery: Key Insights and Implications

The term “significant modification of machinery” has long been present in the industrial sector, yet it lacked a formal definition in legal terms until recently. The new Regulation (EU) 2023/1230 by the European Parliament and Council provides a clear framework, defining significant modification as any change in machinery that necessitates substantial protective measures and impacts compliance with essential health and safety requirements. Consequently, every significant modification requires a new conformity assessment before the machinery can be reintroduced to the market or put back into use.

Definition of Significant Modification of Machinery

According to Regulation (EU) 2023/1230, a significant modification is defined as:

“A significant modification means a physical or digital change to machinery or a related product after it has been placed on the market or put into service, which was not foreseen or planned by the manufacturer and affects the safety of the machinery or related product, creating a new hazard or increasing existing risk, requiring:

a) the addition of guards or protective devices to the machinery or related product, necessitating modification of the existing safety-related system; or

b) the application of additional protective measures to ensure the stability or mechanical strength of the machinery or related product;“

Thus, any change that requires the implementation of new protective measures or affects the risk assessment qualifies as a significant modification, necessitating a new conformity assessment.

Examples of Significant Modification of Machinery

• Adding new control systems that impact safety.
• Changing protective mechanisms, such as guards, that require modifications to the existing safety system.
• Introducing autonomous elements to a previously manually operated machine.
• Switching the control system from pneumatic to electric, necessitating appropriate protective measures.
• Modernizing mechanical components, such as introducing a new type of drive, affecting the risk assessment.

Examples of Non-Significant Modifications

• Replacing standard guards with newer models that do not affect the existing safety level.
• Adding a cooling system that does not impact the machine’s safety functionality.
• Changing the control panel to a more intuitive one without affecting the machine’s safety function.
• Improving lighting in the machine’s workspace, enhancing work comfort without affecting the risk assessment.
• Replacing mechanical components with newer ones of the same technical parameters, without changing the machine’s functionality.

Each of these changes may require a conformity assessment to ensure user safety and compliance with Regulation (EU) 2023/1230.

Proper Procedures for Significant Modifications

• Introducing a New Sensor System: If you add a new safety sensor system to the machine requiring integration with the existing control system, a full assessment is necessary to ensure that this addition does not affect the reliability and operation of other protective components.
• Adapting the Machine for a New Product: If the machine is modified to handle a new product, such as one with different physical properties (e.g., heavier or requiring a different operating speed), there is a risk that this change could impact operator safety or machine integrity. Such changes must be analyzed for safety, including machine stability.
• Changing the Drive Type: Converting the drive from pneumatic to electric may introduce new risks related to electric shock. In such cases, appropriate protective measures, such as additional insulation or anti-shock protections, are necessary.

Roles of Users and Manufacturers in Modifications

The responsibilities for conducting significant modifications lie with both manufacturers and users of machinery. The manufacturer is responsible for designing and providing solutions that minimize risk during production, while the user is responsible for ongoing maintenance and monitoring of the machine’s safety status. The decision to modify a machine should be made jointly, taking into account the manufacturer’s technical knowledge and the user’s experience from operating in real-world conditions.