Machine Builder Regulations – The Machinery Directive (98/37/EC)

The Machinery Directive covers the supply of new machinery in the European Economic Arena (EEA). Any machine supplied within the EEA must comply with this directive.

In order to comply, suppliers of machinery must satisfy a wide range of Essential Health and Safety Requirements (EHSR’s) which are listed within the directive.

Conformity to the Machinery Directive is by self declaration. A “Declaration of Conformity” document should be supplied with new machinery and a CE Mark affixed to the machine to show compliance.

Facts about the Machinery Directive:

• Essential Health and Safety Requirements (EHSR’s)
• Provision and Use of Work Equipment Regulations
• CE Marking
• Technical File
• Machinery Safety Standards

The Directive gives a list of Essential Health & Safety Requirements (referred to as EHSRs) to which machinery must comply where relevant. The purpose of this list is to ensure that the machinery is safe and is designed and constructed so that it can be used, adjusted and maintained throughout all phases of its life without putting persons at risk.

The Directive also provides a hierarchy of measures for eliminating the risk:

(1) Inherently Safe Design -Where possible the design itself will prevent any hazards.
Where this is not possible (2) Additional Protection Devices e.g., Guards with interlocked access points, non-material barriers such as light curtains, sensing mats etc., should be used.
Any residual risk which cannot be dealt with by the above methods must be contained by (3) Personal Protective Equipment and/or Training. The machine supplier must specify what is appropriate.

Suitable materials should be used for construction and operation. Adequate lighting and handling facilities should be provided. Controls and control systems must be safe and reliable. Machines must not be capable of starting up unexpectedly and should have one or more emergency stop devices fitted. Consideration must be given to complex installations where processes upstream or downstream can affect the safety of a machine. Failure of a power supply or control circuit must not lead to a dangerous situation. Machines must be stable and capable of withstanding foreseeable stresses. They must have no exposed edges or surfaces likely to cause injury.
Guards or protection devices must be used to protect risks such as moving parts.These must be of robust construction and difficult to bypass. Fixed guards must be mounted by methods that can only be removed with tools. Movable guards should be interlocked. Adjustable guards should be readily adjustable without the use of tools.
Electrical and other energy supply hazards must be prevented. There must be minimal risk of injury from temperature, explosion, noise, vibration, dust, gases or radiation. There must be proper provisions for maintenance and servicing. Sufficient indication and warning devices must be provided. Machinery shall be provided with instructions for safe installation, use, adjustment etc.

The responsible person must draw up an EC Declaration of Conformity and affix the CE mark to all machines supplied. The machines should also be supplied with the EC Declaration of Conformity.

Note: Safety components should have an EC Declaration of Conformity but not a CE mark with respect to the Machinery Directive (although they may be CE marked to indicate conformity to other directives such as the EMC and/or Low Voltage Directives).

The CE mark indicates that the machine conforms to all applicable European Directives and that the appropriate conformity assessment procedures have been completed. It is an offense to apply the CE mark for the Machinery Directive unless the machine satisfies the EHSRs for all applicable directives and it is, in fact, safe. It is also an offense to apply any mark that may be confused with the CE mark.

Where the equipment is supplied for assembly with other items to form a complete machine at a later date, the responsible person may issue a DECLARATION OF INCORPORATION with it (instead of a declaration of conformity). The CE mark should NOT be applied. The declaration should state that the equipment must not be put into service until the machine into which it has been incorporated has been declared in conformity.
This option is not available for equipment which can function independently or which modifies the function of a machine.

The person responsible for a declaration of conformity must ensure that the following documentation will be available on the premises for inspection purposes.
A technical file including:

1. Overall drawings of the equipment including control circuit drawings.
2. Detailed drawings, calculation notes, etc. required for checking the conformity of the machinery with the EHSRs.
3. A list of:
   • The EHSRs relevant to the equipment.
   • Applicable Harmonized European Standards.
   • Other applicable standards.
   • Technical design specifications.
4. A description of methods adopted to eliminate hazards presented by the machinery.
5. If desired, any technical report or certificate obtained from an approved body (test house) or laboratory.
6. If conformity is declared with a Harmonized European Standard, any technical report giving test results for it.
7. A copy of the instructions for the machinery.

For series manufacture, details of internal measures (quality systems, for example) to ensure that all machinery produced remains in conformity:

• The manufacturer must carry out necessary research or tests on components, fittings or the completed machinery to determine whether by its design and construction it is capable of being erected and put into service safely.
• The technical file need not exist as a permanent single file, but it must be possible to assemble it to make it available in a reasonable time. It must be available for ten years following production of the last unit. Failure to make it available in response to a substantiated request by an enforcement authority may constitute grounds for doubting the conformity.
  The technical file does not need to include detailed plans or any other specific information regarding sub-assemblies used for the manufacture of the machinery, unless they are essential to verify conformity with the EHSRs.