Machinery Directive

The Machinery Directive 2006/42/EC (formerly 98/37/EC) is one of a series of measures introduced under Article 100a of the Treaty of Rome. Article 100a directives all have the primary objective of creating a single European market in goods and services with the objective of providing producers and consumers with the benefits of economies of scale that this offers.

The effect of the Directive has been to introduce identical requirements for machinery safety in every country within the European Economic Area (EEA).

The Directive provides for a widely applicable framework for safety assessment and even when it is not strictly applicable, it can provide a good basis for risk assessment and documentation in order to demonstrate due diligence on the part of a manufacturer or supplier.

The Directive applies to all machinery and to safety components. A machine is defined as “an assembly...of linked parts or components, at least one of which moves...”. Clearly this definition encompasses a very large range of machines, from simple hand-held power tools through to complete automated industrial production lines.

There are some exclusions from the Directive - for example motor vehicles used on public roads, weapons and machines which are already covered by other, more specific, directives (e.g. Lift Safety Directive and Toy Safety Directive). It is also possible for the Machinery Directive to apply alongside other directives when there are hazards which the more specific directive does not fully cover, for example the lifting function of medical devices used to move patients. Certain specific types of equipment which fit the definition of machinery but are also within the scope of the Low Voltage Directive are also excluded from the Machinery Directive on the grounds that the risks they present are mainly electrical in nature.

These include “ordinary office machinery” and “household appliances for domestic use”.

Secondhand machinery which was first used within the EEA prior to the date of the implementation of the old directive (i.e. before 1 January 1995) is excluded from having to comply with new Directive. However, if that machinery is refurbished or upgraded so that its original specification is changed, it will have to be made to comply with the full requirements of the Directive.

Any machinery which was manufactured before 1 January 1995 must be made to comply with the directive if it subsequently brought into Europe from outside just as would any newer machinery manufactured outside the EU.

Equipment manufactured for the manufacturer's own use is not excluded from the requirements.

A contentious area of application of the Machinery Directive is that of off-road vehicles, including dirt bikes, quad bikes, snowmobiles etc. This is an area of regulation where technically the Machinery Directive applies but the “state of the art” of industry and various national on-road vehicle regulations cloud the issue significantly. The situation is also not helped by the lack of published standards for construction of some types of off-road machinery. A detailed overview of the situation can be found on our off-road machinery page.

The original Machinery Directive was numbered 89/392/EEC. This directive was modified in 1991 by Directive 91/368/EEC which removed the original exclusions for mobile machines and for machines intended for lifting loads. A further amending Directive, 93/44/EEC, was introduced in 1993 which was intended to bring passenger lifting equipment not already within the scope of the Lift Safety Directive into the scope of the Machinery Directive. Finally, Directive 93/68/EEC which affected all the CE marking directives by introducing a consistent approach to the requirements marking, documentation and enforcement was introduced.

Since the combination of these different amendments resulted in a complex interrelationship which made it difficult to determine a single comprehensive set of requirements, in 1998 the EC introduced Directive 98/37/EC which is a consolidation of the previous directives into one document although it makes no changes whatsoever in the actual requirements.

Finally, in 2006, the Commission completed work on a replacement directive, 2006/42/EC, which contained several important changes and clarifications and entered in to force (replacing all the previous directives) on 29 December 2009.

There was no transition period between the old and new Directives so equipment sold around the end of 2009 would either have to be declared compliant with both directives, or the documentation should have been changed over the 2009/2010 year end period.

The Commission amended the Directive to a new requirement for environmental protection for equipment used for the application of pesticides and herbicides, which came into force November 2009.

Directive 89/392/EEC has been implemented into United Kingdom law by the Supply of Machinery (Safety) Regulations 2008 (Statutory Instrument 2008:1597).

The Regulations are enforced in the United Kingdom by the Health and Safety Executive for machinery used in the workplace, and the Trading Standards Service for machinery used at home.

In the UK the maximum penalty for the supply of non-compliant machinery is two years imprisonment and/or fines running to many thousand GBP. More importantly, the Regulations also give the authorities the power to force manufacturers to recall or replace faulty product - potentially a far more onerous penalty.

It should also be remembered that any incident which involves injury or damage will fall within the scope of other legislation, for example the The Health and Safety at Work Act 1974 and The Consumer Protection Act 1987. These laws provide for greatly increased penalties than those available under the Machinery Safety Regulations.

The vast majority of machinery may be self-certified by the manufacturer (or their authorised representative within the EU). What this means is that so long as the administrative and safety requirements of the Directive are properly satisfied, the manufacturer can perform all of the assessment and documentation procedures in-house and does not need to submit to any form of external test or approval.

The requirements of the Directive can essentially be split into two sections - the essential health and safety requirements (EHSRs) and administrative provisions.

EHSRs

• The essential health and safety requirements demand that machine manufacturers identify the hazards which their products contain and then assess the risks which these hazards present to users. Any risks thus identified must be reduced to as low a level as is reasonably practicable.
• Annex I of the Directive gives a comprehensive list of the potential hazards which may arise from the design and operation of machinery, and gives general instructions on what hazards must be avoided. Detailed requirements are laid out in a series of safety standards.
• The standards are drafted by multi-national committees of industry experts and reflect design requirements for particular pieces of machinery much more closely than could ever be achieved by specific legislation. Once a standard has been accepted by the European Commission (the process of 'harmonisation'), it is given the 'EN' prefix. This means conformity with the requirements of the standard gives a 'presumption of conformity' with the requirements of the Directive.
• Because so many standards are required to cover the full range of machines within the scope of the Directive, the European standards bodies devised a hierarchy which can be applied in every situation. The most basic standards, known as 'Type A' standards set out requirements for the safety of machines only in the most general terms. 'Type B' standards deal with more specific issues: design of emergency stops (EN ISO 13850); prevention of unexpected start-up (EN ISO 14118); pneumatic systems (EN ISO 4414); temperature of touchable surfaces (EN ISO 13732-1) and many others. Finally, 'Type C' standards deal with specific types of machine: for example, EN 1012 deals with safety of compressors and vacuum pumps; EN 792 deals with pneumatic hand tools and EN 201 deals with injection moulding machines for rubber or plastic.

Administrative Provisions

• The administrative provisions of the Directive (at least so far as manufacturers are concerned) are primarily aimed at forcing manufactures to provide documentary evidence that the machinery complies with the Directive. This is done via the creation of a 'Technical File'. The general form and content of the Technical File is dictated in the Directive and manufacturers must be able to make this information available for inspection by the authorities (the HSE in the UK) for up to 10 years after the date on which the last machine was placed on the market. However, except for Annex IV machines (see below), there is no obligation to produce a copy of the file unless demanded to do so by the enforcement authority, and only the enforcement authority has a right to see it. The manufacturer does not have to provide a copy to the customer unless they choose to.
• Machinery meeting the requirements of the Directive is required to have the CE logo clearly affixed to indicate compliance. It must also show the year of manufacture, some form of serial number, and other ratings as required by the relevant standards. An item of equipment may only display the CE mark when the equipment satisfies all relevant directives; for instance machines with electrical controls must also comply with the requirements of the EMC Directive.
• Where volume production is envisaged, the Directive requires that control measures must be implemented to ensure that all of the machines manufactured will conform to the provisions of the Directive.
• Finally, the manufacturer must prepare and sign an 'EC Declaration of Conformity'. This is basically a statement which confirms the identity of the manufacturer and the machinery for which they are claiming compliance, and is signed to confirm that the correct procedures have been followed. If the manufacturer is based outside the European Community, this Declaration must also contain the address of someone within the EU from whom the authorities can obtain the technical documentation.

The Machinery Directive is mutually exclusive with the Low Voltage Directive, so that either one or the other will apply but never both. Annex 1 of the Machinery Directive contains requirements for electrical safety which precisely mirror those of the Low Voltage Directive Annex 1, so the safety requirements of the two directives are identical, but the Declaration of Conformity will cite the Machinery Directive and not the Low Voltage Directive (LVD).

As mentioned in the previous section, the vast majority of machinery may be self-certified by the manufacturer (or their authorised representative within the EU). However, this is not necessarily the case for Annex IV machines.

Annex IV of the Directive contains a list of about 25 types of machine which are subject to special procedures. Machines in this list must either be made fully in accordance with the provision of the relevant type C standard, or they must be subject to a type examination by a Notified Body.

Safety components are equipment which are independently placed on the market and whose failure might endanger the safety of persons. The Directive includes an indicative list (Annex V). Items on this list include:

• Guards for PTO shafts
• PLC’s used to control safety related functions
• Monitored hydraulic valves
• Load monitoring devices for lifting machinery
• Emergency stop controllers and two hand control relays
• Safety equipment intended to fit on machinery for lifting people

It's notable that many of these items do not fit the traditional definition of machinery and might more normally be considered as electrical equipment. However, because they have a safety function for machinery they are covered by the Machinery Directive and hence excluded from the LVD.

The application of the CE mark under the Machinery Directive is in effect a statement which confirms that the machinery fully complies with the requirements of the Directive and is safe to use. Clearly, this is not appropriate for partly completed machines which are intended to be incorporated into another machine or which cannot function unless they are built into a complete production line. For these circumstances, instead of signing a Declaration of Conformity, the manufacturer does what they can to assess the machine they have built and to mitigate any risks to the user, and then signs a document called a 'Declaration of Incorporation'. This basically states that the machinery is incomplete and must be made to fully conform with the requirements of the Directive before it is brought into service. The manufacturer must provide information on the residual risks which the machine contains and on the assessment work which they have completed.

The Declaration of Incorporation is a concept which exists only in the Machinery Directive. If other CE marking directives apply (e.g. a check-weigher which is intended for incorporation into a packaging line, and which is covered by the EMC and ATEX directives as well as being a machine) then the equipment must be provided with a Declaration of Conformity to these directives (a single document should be drawn up covering the requirements for both Conformity and Incorporation). The CE mark cannot be applied in this case, because the requirements of all applicable Directives cannot be fully complied with.

Apart from the Electromagnetic Compatability Directive - EMC and Low Voltage Directive Annex 1 directives already mentioned, other directives which are likely to have an effect on equipment within the scope of the Machinery Directive are Directive 2000/14/EC on the Noise Emission of Outdoor Equipment, and Directive 2002/44/EC on human body exposure to vibration ('the Physical Agents Directive'). The latter directive sets limits for the maximum exposure of workers to hand-arm and whole body vibration in the workplace and so goes much further than the basic essential requirements of the Machinery Directive. It is entirely conceivable that some machinery can be legitimately CE marked under the Machinery Directive but for it to be basically useless in the work place because it exposes the user to excessive vibration levels when in use.

For machinery intended for use in a flammable atmosphere, the ATEX Directive will apply, and engine driven machinery is likely to be subject to the Non-road mobile Engine Exhaust Emissions Directive. Additionally, the RoHS and WEEE directives may apply to machines which also contain electrical equipment.

The European Commission have a special section on machinery with a great deal of useful information on their EUROPA server. This includes the full text of the directive, lists of the current harmonised standards as well as guidance and interpretative documents.

For details of draft standards, the CEN web site is a good resource.

The UK government's Department for Business, Energy & Industrial Strategy publish a number of useful guides on the Directive and these are available for download.

Useful information may also be found on the Health and Safety Executive web site.

Information about bodies notified under the Directive can be found on our Notified Bodies page and from the European Commission's NANDO database.

As with all CE marking directives, the actual requirements for any piece of equipment under the directive are complex and dependent on not only the design but also the type of user, the intended use and sometimes even what is claimed in the instructions or sales literature.

For further advice specific to your products, please contact us at Conformance and we will be pleased to discuss your needs.