Purpose

The Machinery Directive 98/37/EC (formerly 89/392/EEC) 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.
 

Scope

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 military equipment and machines which are already covered by other, more specific, directives (e.g. lifts and medical equipment). However, there is also a general exclusion from the Machinery Directive for equipment which falls within the scope of the Low Voltage Directive and which presents hazards which are primarily of an electrical nature.

Secondhand machinery which was first used within the EEA prior to the date of the implementation of the directive (i.e. before 1 January 1995) is excluded from having to comply with the directive itself. 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, but may be subject to slightly lesser obligations with respect to marking and documentation.

Off-Road Vehicles

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 web page.
 

Directive history

The original Machinery Directive was numbered 89/392/EEC. The original 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. 98/37/EC supersedes and replaces the earlier directives and this is the reference number which should be referred to on declarations and as the citation for the Machinery Safety Directive.

Finally, in 2006, the Commission completed work on a replacement directive, 2006/42/EC, which contains several important changes and clarifications and will enter in to force (replacing all the previous directives) in 2010.
 

Enforcement

Directive 89/392/EEC has been implemented into United Kingdom law by Statutory Instrument (S.I.) 1992/3073: The Supply of Machinery (Safety) Regulations 1992. The amendments were implemented by S.I. 1994/2063; The Supply of Machinery (Safety) (Amending) Regulations 1994. No UK legislation was required to implement 98/37/EC since it makes no actual changes in the requirements of the Directive.

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.
 

Penalties

In the UK the maximum penalty for the supply of non-compliant machinery is three months imprisonment and/or a £5000 fine. 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.
 

Requirements

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 protection requirements of the Directive are properly completed, 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 protection requirements' and administrative provisions.

Essential protection requirements

The essential protection 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: indeed part 2 of EN ISO 12100 is essentially a reproduction of annex 1 of the Machinery Directive. 'Type B' standards deal with more specific issues: design of emergency stops (EN ISO 13850); prevention of unexpected start-up (EN 1037); pneumatic systems (EN 983); 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 manufacturers 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 machine was sold. 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 symbol 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 Low Voltage and EMC Directives.

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.
 

Annex IV machines

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 the case for annex IV machines.

Annex IV of the Directive contains a list of about 15 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. In either case, a copy of the technical file for the machinery must be lodged with a Notified Body before the CE mark is applied.

Declaration of Incorporation

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 and so 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 Low Voltage directives as well as being a machine) then the machinery must carry the CE mark for these directives even though it is not CE marked as a machine.

It has to be said that the Declaration of Incorporation is commonly used by manufacturers as an excuse for not performing the assessment and risk mitigation measures demanded by the Directive. This approach is incorrect, and is one of the key areas of confusion which is cleared up by the new Machinery Directive, 2006/423/EC, due to come into force in 2010.
 

Future developments

In December 2006, after a long gestation, the European Commission finally published a new Machinery Directive, 2006/42/EC. So far as the vast majority of manufacturers and users are concerned, the basic requirements of the Directive remain unaltered, and in particular the assessment and documentation requirements are basically the same. Annex IV is also untouched. In general terms, the key differences between the new and old directive are:

• Greater clarity and more explanations of the scope and certain definitions
• A narrowing of the scope of the exclusion which permits certain equipment also covered by the LVD to be excluded from the scope of the Machinery Directive
• Greater clarity in the requirements for partly completed machinery

Regulations implementing the new Directive are currently at draft stage in the UK, and are expected to be in-force by January 2010.

Other directives affecting machinery

Apart from the EMC and Low Voltage 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 equipment intended for use outdoors, 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 well apply to machines which also contain electrical equipment.

Useful links

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 and a list of the national implementing measures in each of the member states of the EU.

For details of draft standards, the New Approach web site is a good EU-funded resource.

The UK government's Department of Trade and Industry (DTI) 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.

Links to some bodies notified under the directive can be found on our Notified Bodies page.

Further advice

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. If you'd like us to prepare a no-obligation quote for assisting you with CE marking your products, please take a look at our page which gives details of the information required in order to be able to give you an accurate idea of the costs and procedures involved.

Exclusions

The following equipment is specifically excluded from the provisions of the Machinery Directive:

• Lifting equipment designed and constructed for raising and/or moving persons with or without loads, except for industrial trucks with elevating operator position.

• Machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads.

• Machinery for medical use used in direct contact with patients.

• Special equipment for use in fairgrounds and/or amusement parks.

• Steam boilers, tanks and pressure vessels.

• Machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity.

• Radioactive sources forming part of a machine.

• Firearms.

• Storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances.

• Means of transport, ie vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded.

• Seagoing vessels and mobile offshore units together equipment on board such vessels or units.

• Cableways for the public or private transport of persons.

• Agricultural and forestry tractors, as defined in Article 1(1) of Council Directive 74/150/EEC' of 4 March 1974 on the approximation of the laws of Member States relating to type-approval of wheeled agricultural or forestry tractors, as last amended by Directive 88/297/EEC2.

• Machines specially designed and constructed for military or police purposes.