FEATURE Machine safety
REDEFINING ROBOTICS SOFTWARE
From freeze to flow: the new EU regulation redefines robotics software qualification says Sjoerd van der Zwaan, Chief Product Officer, Solid Sands
T
he new EU Regulation 2023/1230 is set to enter force on 20 January 2027, replacing the long-standing Machinery Directive 2006/42/EC. The implications for machinery manufacturers are profound because the regulation extends the scope of machine safety to include software-driven, autonomous, and AI-enabled systems. As a result, the need to qualify machine software and its toolchain as part of a continuous, lifecycle-based process comes into sharp regulatory focus.
EU Regulation 2023/1230 extends mandatory
safety requirements to digital machine components that were previously addressed only indirectly. Embedded software and AI functionality for industrial robots and cobots (collaborative robots), and autonomous mobile machinery now fall clearly within the regulation’s scope. For machine builders, it signals a fundamental shift. Software is no longer an implicit contributor to safety; it is formally recognised as an explicit safety component, with direct impact on qualification processes and ongoing compliance. When launching a machine into the
commercial marketplace, the manufacturer is responsible for ensuring that its design and build meet safety requirements. The company must undertake appropriate risk assessments and qualification activities, with high-risk machinery subject to third-party review. The regulation now makes clear that software- defined safety elements require dedicated compliance scrutiny, reinforcing the need to qualify not only the application software but also the software toolchain used to create it. Regulation 2023/1230 is closely aligned
16 June 2026 | Automation
with the EU’s AI Act and Cyber Resilience Act, forming part of a broader shift toward a horizontal, lifecycle-based regulatory approach focused on sustained compliance. Together, these frameworks place software and its toolchain at the centre of machine safety and compliance. Qualification is no longer a one-time certification milestone; it must be demonstrated and maintained throughout the operational life of the machine. Historically, compliance followed
a predictable model: manufacturers qualified their software toolchain once, froze it, certified the product, and avoided changes wherever possible. This approach is increasingly incompatible with modern machinery. Cybersecurity threats require ongoing patches and updates, and compilers and standard libraries change through bug fixes, performance improvements, and language evolution. Locking these elements down indefinitely conflicts with regulatory expectations that emphasize sustained safety assurance.
In parallel with the AI Act and Cyber Resilience Act, Regulation 2023/1230 reflects this reality. Software is treated as a dynamic element of the safety case; cybersecurity is
elevated to a safety objective; and autonomous systems interacting with human operators are now subject to more stringent conformity procedures.
Under this new regulatory environment, authorities expect evidence that the entire software development process is controlled, auditable, and trustworthy. Compliance now depends on demonstrating how safety is maintained as systems evolve. Rather than freezing toolchains, manufacturers must implement assurance practices that scale with change, supported by continuous verification. This shift elevates the importance of
software toolchain qualification. Compilers and libraries directly influence functional correctness, determinism, and traceability in safety-related control systems. Optimisation mechanisms, while essential for performance and real-time constraints, may introduce subtle risks – for example by altering numerical behaviour or execution paths in ways not visible at application level. Library defects can also propagate through issues such as inconsistent data handling across formats. The distinction between assuming a
software tool works and proving that it works becomes critical. Under the regulation, software is a traceable and assessable part of the machinery safety case, requiring demonstrable qualification. Evidence must extend from system-level integration testing down to the application software, libraries, and compiler. Effective assurance therefore relies on structured, repeatable testing of the toolchain against defined specifications. Toolchain qualification that delivers confidence across domains such as automotive and industrial is grounded in three real-life use cases: the continuous qualification of compiler and standard library toolchains to maintain
automationmagazine.co.uk
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