The Machinery Directive 2006/42/EC

How Does the Machinery Directive 2006/42/EC Relate to Me?

That depends on who you are. Take a look at the more detailed explanation of the different roles in the machinery directive and how you might knowingly, or unknowingly, be taking these duties on.

The Manufacturer Perspective

As the manufacturer you are responsible for completing the conformity assessment procedure for CE marking the machine to the Machinery Directive 2006/42/EC.

If you supply (or make available) for use in to the EEA for the first time a machine that:

• You made
• You designed and commission to be made (without contractually committing the machine builder to meet your obligations under the appropriate directives)
• You Imported from outside the EEA (and hadn’t been previously certified – CE marked)
• You modified (substantially so that it is considered a new machine)
• You integrated in to a line (see guidance on Assemblies of Machines)

…Then you are the manufacturer. Now who are you?

The User Perspective

The CE mark should have been applied by the manufacturer at the point of supply or putting in to service. If you are satisfied that this was done correctly (see PUWER Regulation 10) then no further action is needed.

The Modifier Perspective

The modification or adaption of machines is always a hot topic and is the quickest way to take on duties under the Machinery Directive, effectively, as the manufacturer of the changes you have made. The best option is always to seek to maintain the existing CE mark. This can be achieved in the following manner:

1. Request permission. If you receive an acknowledgement from the person or company whom last CE marked the machine that your modification is acceptable then this is written evidence that your proposed/actual changes have been approved (and evidenced by the CE manufacturer) and the CE mark is still valid.
2. Complete a conformity assessment procedure limited to the changes, and their affects. Hold this in the form of a Technical Construction File for the modification to evidence that the original CE mark is still valid. This may be done in-house or by a competent provider of CE Marking Machinery services such as Spiers.

However, where your changes take the use of the machine outside of its intended use and limits by substantial modifications e.g. increase in load bearing capacity, increased through-put, a change in safety concept or a change in the environment of use then this is likely to require a conformity assessment in full for the purposes of CE Marking the Machine afresh.

What is the definition of a Machine in the Directive?

It is important to know the definitions of machinery in the directive since these dictate where the requirements are and what requirements shall be met. There are several definitions of what qualifies as a machine and in some cases this affects the nature and the output of the conformity assessment procedure.

The primary and most basic definition of a machine in the directive is given in article 2 (a) as:

(a) ‘machinery’ means:

“an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application…”

For example, an electric motor in itself is not a ‘machine’ in these terms. However, an electric motor assembled with a gearbox or pump would be.

Who wrote it?

The European Commission were the authors but it was approved for use by the European Parliament and the Council.

Who does it apply to?

The Machinery Directive applies to machines, however, in the supply or manufacture of machines certain people take on roles and legal duties (enforced by local laws implementing the Directive). These roles are:

1. The manufacturer
2. The person responsible for compiling the technical construction file
3. The authorised representative

Who is ultimately responsible for a machine being safe?

The ‘manufacturer’ is primarily responsible for the safe design and condition of the machine at the point of supply. Once the machine is put in to use in the workplace (assuming that it is not for domestic use) there are legal duties under PUWER in the UK that also put responsibility on to the user/employer.

However, where the manufacturer gives a written mandate to an authorised representative then the responsibility for the safety of the machine can be shared with the authorised representative.

How does it relate to other UK safety law?

The Supply of Machinery (Safety) Regulations 2008 is the UK implementation of the Machinery Directive 2006/42/EC. It is very nearly an exact copy and paste with a few adjustments around citations. A notable difference is the UK requirement to identify a ‘responsible person’.

The responsibility for demonstrating that machinery complies with the Directive rests on the ‘responsible person’. The responsible person In relation to machinery or partly completed machinery is either:

1. the manufacturer (see above) of that machinery or partly completed machinery
2. the manufacturer’s authorised representative (see above)

Who enforces the Machinery Directive in the UK and what is the enforcement history?

It is a well-known fact that in the UK it is more likely that enforcement will occur under PUWER as opposed to the UK law that implements the Machinery Directive i.e. the Supply of Machinery (Safety) Regulations 2008, as amended by the Supply of Machinery (Safety) (Amendment) Regulations 2011.

The enforcement of the Machinery Directive in the UK is awkward since it is primarily trade law under the European Communities Act and is therefore aligned to Trading Standards primarily. However, Trading Standards has a remit to support consumers only and this does not include legal entities such as private limited companies. Therefore, an issue in the workplace where a machine is not correctly CE marked will be enforced by the HSE and not trading standards. The only time this issue comes to light is normally post accident, by which time the user/employer has already most likely breached PUWER and the HSE are faced with the comparatively low hanging fruit of prosecuting the user/employer for this breach as opposed to pursuing the now very distant manufacturer who may not even be within the UK borders.

A quick check of HSE prosecutions area against the Supply of Machinery (Safety) Regulations 2008 for the CE Marking of Machines shows that only two prosecutions have been brought about and neither of them resulted in a fine (as of 23/05/2016). Looking further, we can see that prosecutions under the Health and Safety At Work Act 1974, Section 6, (which cover the responsibilities of the manufacturer and designer of articles including machines) show that there have been 3 attempted prosecutions and on one of those being successful.

In conclusion, enforcement of the safe design and supply of industrial machinery is very thin. However, it is law all the same.

How can I CE mark my machine?

The responsible person can complete their own CE conformity assessment procedure in the following basic manner:

1. Demonstrate conformity against the EHSRs referencing the appropriate standards where used and linking the evidence
2. Complete a risk assessment where non-conformities and non compliances are identified. (See BS EN 12100 2010)
3. Compile the technical construction file that includes the evidence linked to the EHSRs
4. Produce the Declaration of Conformity or incorporation as appropriate

This CE conformity assessment procedure for CE marking machines should be woven in the to cycle of the machine in order that risk can be identified early and designed out by inherent safe design where feasible i.e. Design Risk Assessment (DRA).

The failure to consider risk reduction by design and complete proper DRAs may lead to further costs later on in the conformity assessment procedure.

What help is there available?

To be clear, in the vast majority of cases you, the manufacturer, can CE mark your machine with no third party involvement. However, if you feel that you need support or perhaps you simply need to an independent expert to complete your due diligence for you then services, such as those supplied by Spiers, can used for this purpose.

Our services include:

1. Design Risk Assessment Support
2. Functional safety specification, verification and validation to BS EN 13849-1/2
3. Design Reviews
4. CE Audits ( a due diligence check)
5. CE Marking (a procedure implemented by us that results in a CE marked machine where suitable evidence is provided

There are a number of courses that touch on CE marking machines but Spiers provide the only accredited qualification in CE marking machines that addresses each and every EHSR in order that you are left in no doubt of the requirements of evidence for a safe machine.