The Machinery Directive

The Machinery Directive applies to any machine marketed in the EU, and requires that all machines carry the CE mark. This requires the manufacturer to draw up a Declaration of Conformity, which states that the machine meets the Essential Requirements of the Machinery Directive. Placing the CE mark and making a declaration of conformity also implies that the machine fulfils all the Essential Requirements of any other Directives that may apply to it, such as the Low Voltage Directive (LVD), the Gaseous Appliances Directive (GAD and the Electromagnetic Compatibility Directive (EMC).

The Directive is primarily concerned with the safety of ‘non electrical’ machinery (machines in which the primary source of hazard is not electrical) in the following areas:

–Mechanical

–Electrical

–Stability

–Combustion (intended)

–Fire (unintended)

–High/low temperature

–Radiation

–Dust

–Noise

It covers manufacturers duties in

–Design

–Construction

–Handling

–Putting in service

–Operation

–Maintenance

–Servicing

–Signs/warnings

–Markings

–Instruction manuals

–Technical file

- Declaring conformity

How to declare conformity

There is a self-certification regime for the majority of machinery. This means that you are allowed to declare conformity without resorting to external certification. There are exceptions to this allowance, which apply to certain types of machines specified in Schedule 4 of the Directive. For these types of machines, examination of the Technical File, or submission of a sample of machinery for EC Type Examination is required before the declaration of conformity may be made and the CE Mark applied.

For all other machinery, the steps which a supplier must take are as follows. First, a risk assessment of the hazards posed by the machine should be made. Then check the list of Essential Safety Requirements in Schedule 3 of the regulations to see which apply and check that the machine complies with them. Next, make a Declaration of Conformity to confirm that your product meets the regulations.

How do I know if I meet the Essential Safety Requirements

The Essential Requirements given in the text of the Directive are general. However, there are many European Standards (EN’s) that are highly prescriptive in certain areas of machinery safety, design, construction and use. There are three basic types of European Standards, these are:

Type A - Fundamental safety principles for design and general aspects that can be allied to all machinery

e.g EN292:1991 Safety of Machinery - Basic Concepts, General Principles for Design

Type B - Group safety standards, dealing with one safety related device or measure that can be applied across a wide range of machinery

e.g. EN811:1996 Safety of Machinery - Safety Distances to Prevent Danger Zones being reach by the Lower Limbs

Type C - giving detailed safety requirements for a particular machine or group of machines

e.g. EN746:1997 Industrial Thermoprocessing Equipment

Applications of the guidance given in these standards will enable you to show that you are able to fulfil the Essential Requirements of the Directive.

Technical file

The machine supplier must also be able to assemble a Technical File on request and at short notice. This should demonstrate how the machine complies with the Essential Safety Requirements of the Directive. You do not need to hold a copy of the file on your premises, but you must be able to produce it, if asked to do so by the enforcement authorities. However, the development and maintenance of technical file is recommended as good manufacturing practice. The technical file should comprise:

–Overall drawing of the machine with drawings of control circuits.

–Detail design drawings.

–Calculations used in the design.

–Any relevant test results (noise, material strength tests etc)

–A list of the Essential Health and Safety Requirements

Any standards to which the machine has been designed/assessed/tested.

–Description of safety features

–Details of Quality Control procedures.

Machine Documentation

The regulations also state that the supplier must provide operating instructions in a European Union language which the operator can understand. You must also provide installation and maintenance instructions in a language, agreed with the purchaser, that the installer will understand.