Machinery

Machinery in Europe

European Community law on the supply of new products

In order to facilitate a single European market for goods some 20 years ago the European Union began what is described as the ‘New Approach’. A number of Directives were adopted with the aim of setting objectives for the harmonisation of technical rules, primarily but not exclusively, affecting the health and safety of new products by design and construction.

The principal aim of the ‘New Approach’ was to remove barriers to trade by requiring all products to meet common minimum health and safety objectives, which would be supported by agreed standards at the product level. This framework was intended to be applied equally and consistently throughout the EU and the other trade partners of the EEA. All EU member states are required to implement these European product supply Directives into national law and provide for their enforcement. In recent years, following a review, this system has been strengthened by an EU Decision and new EU Regulations on the market surveillance of products covered by these Directives.

Brief details of the key European Directives concerned with the design, construction and supply of products when placed on the EEA market are provided, together with information on Directives.

A number of NLF (New Legislative Framework) alignment Directives have recently come into force which replace the existing Directives, as described below, for these topic areas (LVD, PED, SPVD, ATEX, Lifts & Explosives). Products manufactured under the old Directives and already available for sale may continue to be made available on the market until the existing stocks run out. However, new products within scope of these NLF alignment Directives should now comply with the provisions of these new Directives when placed on the single market.

Machinery

Most new machinery is covered by the Machinery Directive 2006/42/EC (as amended in relation to machinery for applying pesticides by 2009/127/EC). These Directives are implemented by the Supply of Machinery (Safety) Regulations. The exceptions are listed at Annex 1 of the Directive (eg certain electrical equipment, etc), or where other Directives cover the machinery in question instead of the Machinery Directive. These other Directives include:

  • the Lifts Directive for most goods and passenger lifts (Article 24 of 2006/42/EC amends the Lifts Directive and clarifies the borderline between these Directives)
  • the Cableways Directive for cableway installations designed to carry persons
  • the Medical Devices Directive (which calls up the essential health and safety requirements of the Machinery Directive) for machinery which is a medical device
  • the Personal Protective Equipment (PPE) Directive for machinery which is also PPE in the scope of the PPE Directive
  • the Toys Directive for machinery intended to be used as toys

Some products which are machinery may also be covered by other Directives in addition to the Machinery Directive, including:

  • electrically powered / controlled machinery where the Electromagnetic Compatibility Directive (EMC) applies
  • construction products subject to the Construction Products Directive which are machinery for incorporation in a permanent manner in construction works (buildings), such as powered gates, doors, windows, shutters and blinds, ventilation and air conditioning systems
  • non-road mobile machinery with combustion engines, where the gaseous and particulate emissions are covered by the Non-road Mobile Machinery Directive

A fuller explanation of the interfaces and overlaps between the machinery and other Directives is given at paragraphs 89-92 of the European Commission guide to the Machinery Directive.

Non-Road Mobile Machinery (NRMM) Emissions Regulations

Directive 97/68/EC (emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery) was adopted in 1997.

The Directive requires that, in order to be first placed on the EU market, engines for use in non-road mobile machinery must be approved to demonstrate compliance with pollutant emission limits. The measures arose from an EC policy to harmonise the national arrangements of Member States, thus removing potential barriers to trade. Directive 97/68/EC has been subsequently amended by 2001/63/EC, 2002/88/EC, 2004/26/EC, 2006/105/EC, 2011/88/EU and the last amendment Directive 2012/46/EU.

The Directive was implemented into UK law by the “Non-Road Mobile Machinery (Emission of Gaseous and Particulate Pollutants) Regulations 1999” (Statutory Instrument No. 1999/1053). The Regulations apply to new engines to be installed in non-road mobile machinery, intended and suited to move, or to be moved on the ground, either on or off the road.

(see the consolidated European Directive for 97/68/EC).

What counts as non-road mobile machinery?

Non-road mobile machinery (NRMM) is defined as any mobile machine, item of transportable industrial equipment, or vehicle – with or without bodywork – that is:

  • not intended for carrying passengers or goods on the road,
  • installed with a combustion engine – either an internal spark ignition (SI) petrol engine, or a compression ignition diesel engine

Examples of non-road mobile machinery include, but are not limited to:

  • garden equipment, such as hedge trimmers and hand-held chainsaws,
  • generators,
  • bulldozers,
  • pumps,
  • construction machinery,
  • industrial trucks,
  • fork lifts, and
  • mobile cranes.

If you manufacture engines for non-road mobile machinery

If your business manufactures engines for use in non-road mobile machinery (NRMM) that will be sold in European Union (EU) member states, you will need to have them type-approved.

Engine marking requirements

Approved engines must bear the following markings:

  • trade mark or trade name of the engine manufacturer,
  • the engine type, engine family (if applicable) and a unique ID number, and
  • the EC type approval number.

The mark must be:

  • durable for the useful life of the engine, and
  • secured to an engine part necessary for normal engine operation and not normally requiring replacement during engine life.

The engine must be supplied with a supplementary movable plate that can be positioned, if necessary, to make the marks visible when the engine is installed in a machine.

The engine must bear all the relevant markings before it leaves the production line.

If you want to sell non-road mobile machinery

If you intend to sell non-road mobile machinery (NRMM) in a European Union (EU) member state, the equipment must only use engines that have been type approved by an accredited body in an EU member state.

The responsibility for obtaining type approval rests with the engine manufacturer, and not the manufacturer of the NRMM itself or the retailer. However, when an engine is manufactured outside the EU, the manufacturer of the NRMM needs to ensure that it has an appropriate type approval certificate from an accredited body in an EU member state. This can be done either by direct arrangement with the approval authority, or in collaboration with the engine manufacturer’s local representative.

Machinery Directive

In the European Union, all new machinery in scope of the Machinery Directive has to be designed and constructed to meet common minimum European requirements for safety. The outward signs of compliance are CE marking on the equipment and a document (Declaration of Conformity) issued by the Responsible Person (normally the manufacturer) declaring the product’s conformity. To achieve compliance the Responsible Person must undertake a conformity assessment process to meet the Directive’s obligations.

Manufacturers of new machinery (and other products in scope) to be placed onto the European-wide market of the European Economic Area (EEA) must design, construct and supply safe products that comply with the Machinery Directive 2006/42/EC. In particular, they must be designed and built to meet the relevant essential health and safety requirements listed in Annex 1 of this Directive. This requirement applies to the manufacturers of machinery, even where it is for their own use. It also applies to those who modify existing machinery to such an extent it must be considered a new machine, and to those who bring existing non-CE marked machinery onto the EEA market, or into service, for the first time.

Importers, distributors and suppliers should ensure that only safe and compliant machinery (CE marked and accompanied by a Declaration of Conformity and instructions in the language of the end user) is placed onto the EEA market.

Users of new machinery should ensure that they only selected and put into service new machinery which is safe and complaint, keeping it safe and compliant in use.

The Machinery Directive is one of a number of “New Approach” Directives concerned with the implementation of a common European market for free trade between EU member states. The principal effect is to remove barriers to trade by requiring common standards for the health and safety of new products. It is intended to be applied equally and consistently throughout the EU and the other trade partners of the EEA, to facilitate a free open common market for products within scope (most new machinery and some other related equipment).

The current Machinery Directive (2006/42/EC) came into full effect from 29 December 2009 and is implemented in the UK by the Supply of Machinery (Safety) Regulations 2008 link to external website. This Directive updated and replaced the earlier Machinery Directive 98/37/EC link to external website, which in turn replaced the first Machinery Directive 89/392/EEC. This was originally implemented in the UK by the Supply of Machinery (Safety) Regulations 1992, later amended in 1994 and 2005, but these were repealed and replaced in full at the end of 2009 by the current regulations. Where possible the Member State regulations implement the European Directive by copying the text unaltered, in particular the Annexes, such as Annex 1 detailing the essential health and safety requirements (EHSRs) for machinery and other products in scope.

The basic requirements of the Machinery Directive (compliance with EHSRs, compiling a technical file, CE marking, Declaration of Conformity, provision of user instructions) have not changed since it was first implemented throughout the EU in the 1990s. Also unchanged are the fundamental principles for the health and safety of machinery by design and construction. The wording and order of the EHSRs have evolved a little, mostly to clarify what was meant, and to add some new requirements as the Directive’s scope expanded (eg the inclusion of safety components placed independently on the market).

Amendment of the Machinery Directive: machinery applying pesticides

A further amendment to the Directive (2009/127/EC) was published in 2009. This relates principally to environmental protection aspects of machinery for applying pesticides (so should not affect the majority of products within scope of the Machinery Directive). All EU member states must apply these new provisions from 15 December 2011.

New amending regulations, the Supply of Machinery (Safety) (Amendment) Regulations 2011) will implement this change from 15 December 2011. It is not expected that this small change will profoundly affect product manufacturers of machinery for applying pesticides as many of these aspects should have already been considered and designed for by the current manufacturers of these products. However, manufacturers of machinery for applying pesticides will need to re-visit their conformity assessment process, checking it takes the new EHSRs fully into account, and ensure that technical files and other documentation is updated accordingly.

The main requirements of the Machinery Directive

In common with most other New Approach product Directives, the Machinery Directive requires products in scope (including almost all new machinery) by design and construction to:

  • undergo conformity assessment as required by the Directive,
  • meet all of the relevant essential health and safety requirements for the product, to the state of the art,
  • be CE marked, and
  • accompanied by a Declaration of Conformity and user instructions in the language of the end user (user instructions essential for health and safety should be provided in printed form),
  • and that a technical file is compiled to demonstrate compliance with the above processes and requirements. This must be kept securely for at least 10 years from the last dates of manufacture and be made available on request to market surveillance authorities.

Who has responsibilities under the Machinery Directive

The manufacturer, or the manufacturer’s authorised (in writing) representative in Europe (in the UK they are known as the Responsible Person), carry the full responsibility for the safety and conformity of the product. This duty must be met before the product is placed on the market or put into service.

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