Revision of EN ISO 12100 and Its Role in the New Machinery Regulation
As Europe prepares for the implementation of the new Machinery Regulation (EU) 2023/1230, a closely linked development is unfolding: the revision of the foundational machinery safety standard EN ISO 12100. This update is more than a routine revision—it is a strategic realignment, designed to bring the standard in step with the new regulatory framework and to address modern safety challenges faced by machinery manufacturers and integrators.
EN ISO 12100 is the harmonized Type-A standard that underpins risk assessment and risk reduction in machinery safety. Its forthcoming revision responds directly to changes introduced by the new Machinery Regulation, which enters into force in January 2027. The updated standard is expected to be harmonized under the Regulation, once listed in the Official Journal of the European Union. From that point forward, a transition period of approximately 2.5 years will allow both the old and new editions to be used for presumption of conformity. At the CEN/CENELEC level, the “date of withdrawal” (DoW) mechanism typically allows for a two- to three-year window before conflicting national standards must be withdrawn.
For manufacturers operating in or exporting to the European Union, early awareness and preparation for these changes is critical. The revised EN ISO 12100 will serve as a blueprint not only for safer machinery but also for streamlined compliance under the new Regulation.
Key Changes in the Revised EN ISO 12100
- The revised standard introduces a series of substantial updates that reflect both technological advancement and evolving regulatory expectations. Among the most notable changes is the expansion of terminology. New definitions include “tolerable risk” (3.19), described as a risk level accepted within the context of societal values, and “cybersecurity” (3.41), which refers to protection measures against unauthorized access or attacks on machine control systems. These additions recognize the growing importance of software-based controls and digital threats in modern machinery.
- A new Figure 1 has been added to Section 4, offering a clearer depiction of the overall iterative process of risk assessment and risk reduction. The earlier schematic remains as Figure 2, preserving continuity for users familiar with the 2010 edition. This visual enhancement improves usability and supports a more structured approach to safety planning.
- Section 5 brings perhaps the most future-looking addition: a reference to unintended, self-developing behavior from AI. Specifically, sub-clause 5.4(b) includes this risk under the category of possible machine operating states. For further technical understanding, users are referred to CEN ISO/TR 22100-5, which details how AI and machine learning can introduce new safety concerns and how these can be addressed within a traditional risk assessment framework.
- The topic of cybersecurity receives its own dedicated subsection: 6.3.5.15, titled Cyber security and protection against corruption. This section outlines basic but essential protective measures such as preventing unauthorized access to hardware and software, avoiding unintended changes to configuration data, using physical port locks, air-gapping, and controlling remote access. Though high-level, this content lays the groundwork for the forthcoming Type-B standard prEN 50742, which will offer more detailed implementation requirements.
- Other updates include a revised approach to emissions. Section 6.3.4 now offers general guidance only, rather than detailing specific types of emissions such as noise or vibration. This streamlining encourages manufacturers to tailor their strategies to the relevant risks for their specific machine types.
- Section 6.4, covering information for use, has been adapted to support electronic documentation. In particular, it notes that future operating instructions must meet the requirements of EN ISO 20607, a standard that is also currently under revision and expected to be published in parallel with the new ISO 12100. A further addition clarifies the importance of explaining the significance and purpose of signals and warning devices in user instructions—a step toward improving operator understanding and safety behavior.
- Several annexes also see meaningful change. While Annex B largely retains its existing structure, Table B.1 has been expanded to include the hazard of electromagnetic processes, especially those linked to permanent magnets. In Table B.3, the term verification is being progressively replaced with validation, reflecting evolving practices in functional safety. Additionally, Table B.4 updates its language around control system-related hazards, making terminology more consistent.
- Annex C is a new addition derived from ISO/TR 22100-1. It offers practical guidance on how to apply the hierarchy of standards—Type A, B, and C—to achieve an acceptable level of risk. It emphasizes the role of Type-C standards, which provide detailed safety requirements and verification methods for specific machine types, even when these requirements diverge from Type-B standards.
- Annex D mirrors the content of ISO/TR 22100-2 and focuses on the relationship between EN ISO 12100 and ISO 13849-1, the key standard for the design and validation of safety-related control systems. It explains how ISO 13849-1 should be applied within the broader risk assessment framework defined by EN ISO 12100 and offers illustrative examples to guide users through practical implementation.
Together, these updates signal a clear message: EN ISO 12100 is evolving not only to reflect current technology but also to act as a strategic enabler for compliance under the new Machinery Regulation. The revised standard provides a coherent, forward-looking structure that supports manufacturers in designing safer, more compliant, and more resilient machinery.
For companies aiming to place products on the EU market after 2027, the new EN ISO 12100 will be indispensable. Certification Company remains at the forefront of these developments and offers expert guidance to ensure your machinery is aligned with the latest safety expectations.