What is this article about?
Under the Machinery Directive 2006/42/EC, the “significant change” of a machine is of central importance for manufacturers , operators and users of machines. Such changes can have serious consequences for the safety and legal status of the machine, as they may result in the machine having to undergo the conformity assessment procedures again. But what exactly is meant by a “significant change”? What criteria and consequences are associated with it? This article explains the term “significant change” and its meaning in the Machinery Directive.
The legal basis of the Machinery Directive 2006/42/EC
The Machinery Directive 2006/42/EC regulates the essential health and safety requirements that machines must meet when placed on the market or put into service in the European Union. It also specifies which machines may be marked with a CE marking and which conformity procedures must be followed. A machine that complies with the Machinery Directive must
can be operated safely without posing a risk to people or the environment.
The concept of “significant change” is defined in the Machinery Directive
not explicitly defined,
However, it has been clarified through various interpretations and guidelines. It refers to a change that affects the safety requirements of a machine to such an extent that the original declaration of conformity is no longer valid and new tests and measures are required.
What is a significant change to a machine?
A machine is considered to be significantly modified if a modification to the machine changes the original safety design or the risk profile of the machine to such an extent that the existing EC declaration of conformity and the CE marking are no longer valid. Such a change can be made by the machine manufacturer, the operator or a third party.
Typical examples of significant changes are:
- Modifications or extensions that significantly change the functionality or capacity of the machine.
- Changes to the machine’s control system, such as replacing the machine control with another technology or making significant changes to the safety software.
- Installation of new components that do not comply with the original safety requirements of the machine or that significantly affect the operation of the machine.
Modifications to the protective devices or the removal of safety-relevant components that reduce the level of protection of the machine.
Criteria for a significant change to a machine
In practice, there are a few key criteria that are used to determine whether there has been a significant change to the machine:
- change in the risk profile
A significant change occurs when the modification increases the risks posed by the machine or creates new hazards. For example, increasing the speed or pressure of a machine could create new hazards that were not taken into account in the original risk analysis.
- interference with the safety functions
If the safety functions of the machine are interfered with by removing or modifying protective devices, this is usually a significant change. This also applies if new safety functions are added that change the entire safety concept of the machine.
- change in operating mode
If the conversion changes the way the machine is operated, this can be a significant change. This could be the case, for example, if a semi-automatic machine becomes a fully automatic machine as a result of the conversion, as the operation and interaction with the machine changes significantly.
- Repair vs. Remodeling
It is important to distinguish between a mere repair and an actual conversion. A repair or maintenance job in which worn parts or defective components are replaced with equivalent or similar parts is not generally considered a significant change. On the other hand, a conversion in which new technologies or non-original components are used can very well represent a significant change.
recommendation of the BAMS
The Federal Ministry of Labor and Social Affairs ( BMAS ) in Germany deals with various legal regulations and regulations to ensure the safety and health protection of employees in various work environments. An important aspect in this area is the Machinery Directive, which sets out requirements for the safe operation and use of machines. Under the Machinery Directive, it is crucial to consider changes to machinery carefully, particularly when significant changes are involved.
If changes exceed the established limits, the modification is considered material. The effect of this is that the entire machine is considered new and the person making the change becomes, in practice, the manufacturer. The assessment of whether the change made should be classified as significant is the responsibility of the person carrying out the modification.
Whether the safety level (including all formalities) of a comparable CE machine must be achieved during the conversion depends crucially on whether conversion measures give rise to new risks that are no longer covered by the existing protective measures, see Figure 1.
Only the honestly conducted risk assessment can provide information about this. So anyone who makes changes as an operator,
a risk assessment must be carried out
carry out.
Consequences of a significant change to a machine
If a significant change has been made, this has legal and safety consequences:
- New Conformity Assessment
In this case, the person who made the significant change takes on the role of the new manufacturer. This means that he must treat the machine as if it were a new machine. The machine must then go through the full conformity assessment procedure according to the Machinery Directive. This includes a new risk analysis, the preparation of technical documentation, the preparation of a new EC declaration of conformity and the affixing of a new CE marking.
- safety requirements
After the modification, the machine must continue to comply with the essential health and safety requirements of the Machinery Directive. If the modification makes the machine unsafe or creates new risks that have not been sufficiently minimised, the machine cannot be placed on the market or operated.
- Liability
The responsibility for the safety of the machine passes to the person who made the significant modification. This person is then responsible for any future accidents or damage that may arise from the unsafe use of the modified machine.
Practical examples of significant changes to a machine
To better understand what constitutes a significant change, here are some short practical examples:
- Increasing machine power: Increasing the power of a motor or the capacity of a press could lead to an increase in kinetic energy and therefore a higher risk.
- Replacing the control system: Replacing an old mechanical control system with a modern electronic control system can change the way safety functions are monitored and performed.
Modification of protective devices: If an operator removes a protective cover to gain easier access, this constitutes a significant modification as it compromises the safety of the machine.
borderline cases and gray areas
In practice, there are often grey areas where it is not clear whether a change is to be classified as significant or not.
internal experts or external consultants can help make an informed decision
to meet.
Conclusion: Be careful when making changes to machines
The term “significant change” is a key point when dealing with machinery, as it determines whether a machine continues to meet safety requirements or must be considered a new machine. Any change that affects the risk profile or safety functions of the machine can have far-reaching consequences. It is therefore essential to carefully check whether any planned modification constitutes a significant change and to act accordingly.