Business and enterprise – guidance

Machinery manufacturers: legal responsibilities

The 'responsible person' for the machinery or assemblies produced, compliance with health and safety regulations, and duties to demonstrate compliance.

Introduction

Manufacturers and suppliers of machinery must comply with the Supply of Machinery (Safety) Regulations 2008, which implemented the Machinery Directive 2006/42/EC into UK law, and cover:

  • machinery
  • interchangeable equipment
  • safety components
  • lifting accessories
  • chains, ropes and webbing
  • removable mechanical transmission devices
  • partly completed machinery

With some exceptions machinery supplied in/into the UK must satisfy wide-ranging health and safety requirements on construction, moving parts, and stability, for example.

This guide explains which products are affected by the regulations and details a manufacturer’s legal responsibilities and how they can comply with the regulations.

Under the Supply of Machinery (Safety) Regulations 2008 machinery is defined as:

  • 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
  • an assembly as above, missing only the components to connect it on site or to sources of energy and motion
  • an assembly as either of the above, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure
  • assemblies of machinery or partly completed machinery as any of the above, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
  • an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort

Safety components are defined as components ‘supplied separately to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons’.

Exemptions from the regulations

Machinery and components that are exempt from the regulations include:

  • safety components which are intended to be used as spare parts to replace identical components and are supplied by the manufacturer of the original machinery
  • equipment specifically for use in fairgrounds and/or amusement parks
  • machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity
  • weapons, including firearms
  • the following means of transport, subject to paragraph 2 of these regulations:
    • agricultural and forestry tractors controlled under European Community (EC) type approval legislation
    • motor vehicles and trailers controlled under EC whole vehicle type approval legislation
    • two or three-wheeled motor vehicles controlled under EC type approval legislation
    • motor vehicles exclusively intended for competition
    • means of transport by air, on water and rail networks
  • seagoing vessels, mobile offshore units and machinery installed on board such vessels or units
  • machinery specially designed and constructed for military or police purposes
  • machinery specially designed and constructed for research purposes for temporary use in laboratories
  • mine winding gear
  • machinery intended to move performers during artistic performances
  • electrical and electronic products falling within the following areas insofar as they are designed for use within certain voltage limits:
    • household appliances intended for domestic use
    • audio and video equipment
    • information technology equipment
    • ordinary office machinery
    • low voltage switch and control gear
    • electric motors
    • switch gear and control gear, and transformers in respect of high-voltage electrical equipment
  • lifts controlled under the Lift Regulations 1997 as amended

The regulations do not apply to machinery first supplied in the European Economic Area before 29 December 2009. Such products are covered by EU Directive 98/37/EC.

The ‘responsible person’, (generally the manufacturer or their authorised representative) has to ensure that their product satisfies all the relevant essential health and safety requirements (EHSRs). In order to do so, they must ensure that:

  • a file containing technical information relating to the machine has been compiled
  • the appropriate conformity assessment procedure has been carried out
  • a EC Declaration of Conformity or Declaration of Incorporation has been issued
  • European Conformity (CE) marking has been properly affixed
  • the product is safe

Certain types of products are subject to more stringent checks and may involve assessments by a notified body before CE marking can be used.

Conformity assessment

The responsibility for demonstrating that machinery complies with the directive rests on the ‘responsible person’ applying all the relevant EHSRs as outlined in Schedule 2, Part 1 to the Supply of Machinery (Safety) Regulations 2008.

There are three methods of conformity assessment under the regulations. The method you use will depend on whether the machinery in question is included in Annex D of the machinery guidance notes from the Department for Business, Innovation & Skills (BIS). Download machinery regulations guidance notes (PDF, 424KB).

The 3 methods are:

  • Self assessment - for machinery not included in Annex D, or included in it but manufactured wholly in accordance with transposed harmonised standards, you should undertake your own risk assessment against essential health and safety requirements, produce a technical file and an EC Declaration of Conformity and affix the CE mark to the product.
  • EC type-examination - for machinery included in Annex D, but not manufactured wholly in conformity with transposed harmonised standards, you must have it assessed by a notified body. If compliant, the notified body will issue an EC type-examination certificate.
  • Full quality assurance - having manufactured a product using a full quality control system, you should have that system assessed by a notified body. The body will arrange the issue of the necessary documentation and CE marking.

If the machinery is intended for incorporation into other machinery covered by the regulations you should also draw up an EC Declaration of Incorporation.

Notified bodies

A notified body is a company that has been rigorously assessed against specific criteria. This is done on an individual directive basis by the national accreditation organisation of each member state of the EU and formally notified to the European Commission. A full list of such bodies can be viewed on the European Commission’s database, NANDO.

You can find a complete list of all notified bodies, including those appointed by the UK authorities, on the European Commission website.

CE marking

CE marking is a visible declaration by you or your authorised representative that the machinery satisfies all the provisions of all the relevant regulations. Machinery bearing the CE mark will be taken as meeting the requirements and thereby entitled to free circulation throughout the European Economic Area, provided that it does in fact satisfy those requirements. CE marking:

  • must be affixed in a distinct, visible, legible and indelible manner
  • should not be affixed to machinery for which a Declaration of Incorporation has been issued

For more information see the guide on CE marking.

Enforcement of the Supply of Machinery (Safety) Regulations

In Great Britain, the Health and Safety Executive (HSE) is primarily responsible for enforcing the Supply of Machinery (Safety) Regulations 2008 in relation to machinery for use at work. Local authority trading standards officers are responsible for machinery for private use.

In Northern Ireland, the HSE Northern Ireland is responsible for enforcing the regulations in relation to machinery for use at work, and district councils have responsibility for machinery used for private use.

The regulations make it an offence for the responsible person to supply machinery unless:

  • it is safe
  • it satisfies all the relevant essential health and safety requirements
  • a technical file is available
  • the conformity assessment procedures have been followed
  • a EC Declaration of Conformity/Incorporation has been issued
  • CE marking has been appropriately affixed

Where machinery bearing the CE marking is safe but there are breaches of other obligations, the responsible person will be given the opportunity to correct the breach before further enforcement action is taken.

Failure to comply with the regulations means that machinery cannot legally be placed on the market or put into service in the UK. Offenders could be prosecuted and, if convicted, be subject to a range of penalties which includes both fines and imprisonment.

Safeguard procedures

EU member states are required to withdraw from the market, or to restrict and prohibit the supply of, machinery bearing CE marking which does not comply with the safety requirements. They must immediately notify the European Commission and other member states of their action and give reasons. The commission will investigate and rule as to whether the action taken by a member state was justified, and such decisions (rulings) will be published.

Further information

Download guidance on the Supply of Machinery (Safety) Regulations 2008 (PDF, 424KB)

Complete list of notified bodies on the European Commission website