Manufacturers of machinery and plants, as well as manufacturers of electrical equipment, must determine the hazards and risks posed by their products. This is a legal requirement, e.g. under the Machinery Directive, the new Machinery Regulation or the Low Voltage Directive.
The international standard EN ISO 12100 explains the procedure for risk analysis and risk evaluation.
The risk assessment enables designers to identify risks posed by a product, machine or electrical device.
The aim is to identify potential hazards at an early stage and take appropriate protective measures to ensure the safety of people, the environment and other objects.
Is risk assessment voluntary or required by law?
Machinery Directive and Machinery Regulation
It is often assumed that performing a risk assessment is voluntary. However, both the Machinery Directive 2006/42/EC and the new Machinery Regulation (EU) 2023/1230 clearly state in Annex I and Annex III that risk assessment is a mandatory requirement:
The manufacturer (...) shall ensure that a risk assessment is carried out, in order to determine the essential health and safety requirements which apply to the machinery (...)
Low Voltage Directive
The Low Voltage Directive 2014/35/EU (LVD) imposes completely analogous obligations on manufacturers:
The manufacturer shall establish the technical documentation. (...) shall include an adequate analysis and assessment of the risk(s).
Risk assessment according to other directives
Numerous guidelines of the so-called New Legislative Framework require the performance of an appropriate risk analysis and assessment.
Details on the relevant legal provisions that require risk assessment or comparable requirements can be found in our technical article on the New Legislative Framework.
The most important steps in the risk assessment process are:
Excerpt from the iterative process for risk reduction, EN ISO 12100:2010, Figure 1
The risk reduction methods must be implemented by the designer in a specified order. This order is based on the so-called three-step iterative process for risk reduction from the EN ISO 12100 standard, which serves to systematically identify, evaluate and minimise hazards on a machine. The three steps in the iterative process are:
This legally prescribed sequence from EN ISO 12100 can be found in modified terminology in both the Machinery Directive and the Machinery Regulation. For products according to the Low Voltage Directive, CENELEC Guide 32 provides relevant information.
At IBF, we support you with our software solutions and seminars in the correct implementation of the risk assessment in mechanical and plant engineering (Machinery Directive and Machinery Regulation) and for electrical equipment (Low Voltage Directive).
Safexpert is our tried-and-tested software for CE marking and risk assessment in accordance with Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 as well as Low Voltage Directive 2014/35/EU. Thanks to their modular structure, our software solutions are suitable for companies of all sizes – from one-person businesses to medium-sized companies and international corporations.
The tool provides step-by-step guidance through the entire risk assessment process:
Depending on the scope of your projects, Safexpert offers special modules that provide you and your team with significant support in creating a standard-compliant risk assessment in accordance with EN ISO 12100.
We hold our in-person seminars at various locations in Germany, Austria, and Switzerland, while events in English and French take place online.
In addition to “traditional” practical seminars on risk assessment and CE marking, some events are also dedicated to specific technical topics or legal issues. These events are currently held exclusively in German.
We would be happy to offer you a training concept tailored to your needs, directly at your company, also in English and, of course, worldwide!
Tip: For help with Safexpert and our CE marking services, please contact our international partners!
WHAT needs to be done by WHOM and by WHEN in order to meet the legal requirements of the Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 as efficiently as possible. These are the key questions addressed in the eBook ‘Risk Assessment in Practice’. Where possible, legal details are not included.
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Risk assessments are performed by one person after the machine has been built, if at all. This procedure does not comply with legal requirements and usually costs a lot of money! Every person involved in the product development process is obliged to participate in the risk assessment as part of their work. Hazards are identified at an early stage and appropriate measures are determined immediately. Eliminating hazards during commissioning or during operation can be very expensive!
Everyone involved in the development processes relies on a possible CE representative or CE coordinator. This person can coordinate, organise or provide support, but should not be responsible for the operational implementation of risk assessments in projects!
Cost-saving inherently safe designs are not used. Instead, expensive safeguards are installed that would not be necessary in this form for the identified hazards and the assessed risk. A qualitative risk assessment can help to avoid unnecessary safety measures!
References to residual risks in the operating instructions are preferred to technical solutions. Numerous court rulings show that compliance with the legally required sequence is particularly important in order to avoid liability cases.
CE software for systematic and professional safety engineering
Practical seminars on aspects of risk assessment and ce marking
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