Understanding EN ISO 12100: Enhancing Machinery Legislation Compliance Through Risk Assessment

In the realm of machinery and product safety, adherence to established standards and regulations is paramount. One such standard, EN ISO 12100, plays a crucial role in ensuring the safety of machinery used across industries. In this blog post, we’ll explore what EN ISO 12100 is and delve into the process of conducting a risk assessment in line with its principles.

EN ISO 12100: The Pillar of Machinery Legislation Compliance

It’s essential to highlight that EN ISO 12100 is no ordinary standard; as well is being an essential document that helps manufacturers, engineers, and stakeholders in ensuring machinery safety and regulatory compliance, it serves as the foundational pillar that underpins all harmonized standards in the field of machinery safety compliance. This standard is unique, being the only ‘type-A’ standard, which means that it provides fundamental principles for machinery risk assessment and risk reduction that are universally recognised.

The principles outlined in EN ISO 12100 are the bedrock upon which ‘type-B’ and ‘type-C’ harmonized standards are built. These harmonized standards, specific to machinery types or processes, are intricately linked to EN ISO 12100, offering detailed guidance on how to achieve safety and compliance within particular contexts. Understanding and applying this not only ensures adherence to essential principles but also paves the way for seamless integration with other harmonized standards, streamlining the path to machinery legislation compliance and product safety.

The Importance of Risk Assessment

A risk assessment, as defined by EN ISO 12100, is a structured and comprehensive process aimed at identifying and evaluating potential hazards associated with machinery. It serves several crucial purposes:

Safety Enhancement. Identifying and mitigating potential hazards significantly reduces the risk of accidents and injuries related to machinery operation.

Regulatory Compliance. A thorough risk assessment ensures that machinery meets the safety requirements outlined in various regulations and directives, such as the Machinery Directive in the European Union.

Product Quality. By addressing safety concerns at an early stage, manufacturers can enhance product quality and longevity.

Liability Mitigation. Conducting a risk assessment demonstrates a commitment to safety, which can be a vital factor in liability cases.

Conducting a Risk Assessment According to EN ISO 12100

This directive provides a structured methodology for risk assessment:

Identification of Hazards. Begin by identifying potential hazards related to the machinery. This includes mechanical, electrical, chemical, and ergonomic hazards, among others.

Risk Estimation. Evaluate the risks associated with each identified hazard, considering the likelihood and severity of harm.

Risk Evaluation. Determine if the risk is acceptable or requires further risk reduction measures.

Risk Reduction. If risks are deemed unacceptable, implement risk reduction measures. This may involve design modifications, protective measures, or changes in operating procedures.

Verification. Verify the effectiveness of the risk reduction measures to ensure that the machinery complies with safety requirements.

Documentation. Maintain comprehensive documentation of the risk assessment, risk reduction measures, and verification activities.

How We Can Support Manufacturers with Compliance

Manufacturers and businesses navigating the complex landscape of machinery legislation compliance can benefit from guidance and support. We offer expertise and resources to ensure your machinery meets safety standards, including those defined by EN ISO 12100. Whether you require in-depth risk assessment guidance, compliance consultancy, or tailored solutions, we are here to assist you.


EN ISO 12100, with its risk assessment principles, serves as a cornerstone of machinery safety and regulatory compliance. By understanding and applying these standards, manufacturers can achieve not only compliance with legal requirements but also a higher level of safety for their machinery and equipment. Remember, we are here to support you in your compliance journey and ensure that your machinery operations meet the highest safety standards. Here is a helpful link to further information from CEN/CENELEC.

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