European Community law on the supply of new products
A number of European Directives and Regulations have been adopted by the EU to set common minimum objectives for the harmonisation of technical rules for new products. Most of these affect the health and safety of new products by design and construction.
All businesses wishing to place goods on the single European market must meet all the relevant European product law applicable to the particular product, which in most cases includes the requirement for CE marking in the prescribed form:
Relevant European legislation
Here are details of some key European legislation concerned with the design, construction and supply of products when placed on the European Economic Area market.
Where products are not covered by EU legislation (eg fairground machinery) businesses should seek advice on the national rules that may apply in any particular member state from the relevant authorities in that country.
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). The exceptions are listed at Annex 1 of the Directive (eg certain electrical equipment), or where other EU legislation covers the machinery in question. These include:
- the Lifts Directive for most goods and passenger lifts
- the Cableways Regulation for cableway installations designed to carry people
- the Medical Devices Regulation, which includes those essential health and safety requirements from the Machinery Directive relevant to machinery that is a medical device
- the Personal Protective Equipment (PPE) Regulation for machinery which is also PPE in the scope of the PPE Directive
- the Toys Safety Directive for machinery intended to be used as toys
The scope of the Machinery Directive includes ‘machinery’ in the strict sense and other products which are treated in the same way for conformity assessment as machinery. That means they must be CE marked, and accompanied by a Declaration of Conformity and Instructions when first placed on the market (or first put into service if not placed on the market). These other products (as defined by Article 2 of the directive) are:
- interchangeable equipment
- safety components
- lifting accessories
- chains, ropes and webbing
- removable transmission devices
‘Partly complete machinery’ (PCM), as defined by Article 2g, are also in scope of the Machinery Directive but are subject to a different conformity assessment procedure – PCM must not be CE marked under the Machinery Directive (although may be under other applicable Directives) and must be accompanied by a Declaration of Incorporation and Assembly Instructions.
Some products which are machinery (in both the strict and general sense as explained above) may also be covered by other product legislation in addition to the Machinery Directive, including:
- electrically powered/controlled machinery where the Electromagnetic Compatibility Directive (EMC) also applies
- machinery incorporating radio equipment where the Radio Equipment Directive also applies
- machinery incorporating pressure vessels where the Pressure Equipment and/or Simple Pressure Vessels Directives may also apply
- construction products subject to the Construction Products Regulation which are machinery for permanent incorporation 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
- Noise emissions by equipment for use outdoors where the Outdoor Noise Directive also applies
A fuller explanation of the interfaces and overlaps between the machinery and other Directives is given in the European Commission guide to the application of the Machinery Directive.
The Low Voltage Directive 2014/35/EU (LVD) applies to most electrical equipment designed for use with a voltage rating of between 50 and 1000 volts for alternating current and between 75 and 1500 volts for direct current. This excludes the equipment and situations listed in its Annex II, largely because they are covered by other Directives and international agreements. The excluded items and situations are:
- electrical equipment for use in an explosive atmosphere
- electrical equipment for radiology and medical purposes
- electrical parts for goods and passenger lifts
- electricity meters
- plugs and socket outlets for domestic use
- electric fence controllers
- radio-electrical interference
- specialised electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the member states participate
- custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes
The safety objectives listed in Annex I of the LVD cover electrical hazards and information requirements, and include the protection of people, domestic animals and property from non-electrical dangers caused by electrical equipment (the LVD is a total safety directive). Although the LVD does not apply to most machinery, its safety objectives are covered by EHSR 1.5.1 of the Machinery Directive.
CE marking of electrical equipment in scope is required, although it may exceptionally be attached to the packaging or included with the other information accompanying the product (eg where it may not be possible to legibly mark very small components). Although a Declaration of Conformity must be drawn up and kept by the manufacturer with the technical documentation, there is no requirement for it to be provided with the product.
The LVD imposes detailed and explicit obligations on all economic operators:
- manufacturers (and their authorised representatives)
- importers placing goods on the market from a third country
- distributors (who may be deemed manufacturers where rebranding goods made by another)
Equipment for use in explosive atmospheres
Directive 2014/34/EU (ATEX) concerns equipment and protective systems intended for use in potentially explosive atmospheres. It also covers:
- safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for, or contributing to, the safe functioning of equipment
- protective systems with respect to the risks of explosion
Equipment in scope may be electrical and/or mechanical.
ATEX may apply in addition to other directives, such as the Low Voltage and Machinery Directives (eg controlling devices under ATEX may also be electrical equipment, and a machine may include a protective system within scope of ATEX).
Certain equipment is excluded from the scope of ATEX, including:
- medical devices intended for use in a medical environment
- equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances
- equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas
- personal protective equipment covered by Regulation EU/2016/425 (previously Directive 89/686/EEC)
- seagoing vessels and mobile offshore units, together with equipment on board such vessels or units
- means of transport, ie vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport that are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere are not excluded
In addition to CE marking, ATEX requires the specific explosion protection mark on products within scope.
The Lifts Directive 2014/33/EU applies to most goods and passenger lifts, but some products which lift people and goods are not covered (eg constructions hoists, escalators and mechanical walkways where the Machinery Directive applies, and cableway installations designed to carry people where the Cableways Installations Regulation applies).
The Lifts Directive does not apply to:
- lifting appliances whose speed is not greater than 0.15 m/s
- construction site hoists
- cableways, including funicular railways
- lifts specially designed and constructed for military or police purposes
- lifting appliances from which work can be carried out
- mine winding gear
- lifting appliances intended for lifting performers during artistic performances
- lifting appliances fitted in means of transport
- lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery
- rack and pinion trains
- escalators and mechanical walkways
Where a relevant hazard exists on products in scope which is not covered by the essential health and safety requirements (EHSRs) of the Lifts Directive, the EHSRs of the Machinery Directive are included – see the Preliminary Remarks at 1.1 of Annex I of Directive 2014/33/EU .
Pressure equipment and vessels
Directives 2014/68/EU and 2014/29/EU cover pressure equipment in general and also simple pressure vessels. They are primarily concerned with the hazards from energy stored in the equipment within scope. Machinery and other equipment may incorporate pressure equipment within scope of these Directives, in which case these and their provisions may apply alongside other Directives relevant to the product (eg the Machinery Directive).
Regulation EU/2016/426 concerns appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 °C.
Forced draught burners and heating bodies equipped with such burners are also considered as appliances in scope, as too are safety devices, controlling devices or regulating devices and subassemblies. However, appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from this Regulation’s scope.
Regulation EU/2016/424 relates to cableway installations designed to carry people and covers:
- funicular railways and other installations with vehicles on wheels or on other suspension devices where traction is provided by one or more cable(s)
- cable cars where the cabins are lifted and/or displaced by one or more carrier cables (including gondolas and chair lifts)
- drag lifts, where users with appropriate equipment are dragged by means of a cable
It also applies to subsystems and safety components of such installations.
This Regulation does not apply to:
- lifts within the meaning of the Lifts Directive 2014/33/EU
- cable-operated tramways of traditional construction
- installations used for agricultural purposes
- on-site or mobile equipment for use in fairgrounds and/or amusement parks which are designed for leisure purposes and not as a means of transporting people
- mining installations or on-site installations used for industrial purposes
- cable-operated ferries
- chain-driven installations
Explosives and pyrotechnic articles
Directives 2014/28/EU and 2013/29/EU concern certain explosives and pyrotechnic articles.
The Electromagnetic Compatibility Directive 2014/30/EU (EMC) will apply to much equipment with an electrical aspect, mainly to prevent interference with, and from, other electrical equipment.
It applies alongside other Directives (eg Machinery and Low Voltage), although in some cases the Radio Equipment Directive (RED) applies instead of EMC.
Medical devices in scope of the Medical Devices Regulation EU/2017/745 are covered by this legislation. Where a medical device is also a machine the relevant machinery essential health and safety requirements from Annex I of 2006/42/EC are called into scope.
Personal protective equipment
Regulation 2016/425/EU is concerned with the basic safety requirements which personal protective equipment (PPE) must satisfy in order to ensure the health protection and safety of users. There are some exclusions including:
- PPE specifically for use by the armed forces
- for self-defence
- for private use protecting against adverse weather conditions
- helmets/visors for two- and three-wheeled motor vehicles
Regulation 305/2011/EU, harmonises the conditions for the marketing of construction products in scope. It requires reliable information to be available on construction products in relation to their performance, and CE marking.
Construction products within scope are essentially any product or kit which:
- is produced and placed on the market for permanent incorporation in construction works (or parts of those works) and
- has an effect on the performance of the basic requirements of the construction works
Some construction products (eg powered doors and windows within the scope of EN 13241:2003+A2:2016, the current product standard for Industrial, commercial and garage doors and gates) may also be machinery within scope of the Machinery Directive 2006/42/EC.
Directive 2014/53/EU concerns radio equipment. Where electrical equipment in scope of the Low Voltage and/or Electromagnetic Compatibility Directives incorporates radio equipment as defined by Directive 2014/53/EU, the provisions of the Low Voltage and Electromagnetic Compatibility Directives do not apply separately to that equipment, but are covered by the Radio Equipment Directive, which (unlike the Low Voltage Directive), has no voltage limitations.
Noise emissions by equipment for use outdoors
Directive 2000/14/EC is concerned with noise emission by equipment used outdoors (which may include machinery subject to the Machinery Directive).
Emission of gaseous and particulate pollutants by non-road mobile machinery
Regulation 2016/1628/EU/ is concerned with the emission of gaseous and particulate pollutants by non-road mobile machinery (which may include machinery subject to the Machinery Directive).
Restriction of the use of certain hazardous substances in electrical and electronic equipment
Directive 2017/2102/EU is concerned with the use of certain hazardous substances (lead, cadmium etc) in electrical and electronic equipment.
Ecodesign for energy related products
Directive 2009/125/EC is concerned with the performance of any products that have an impact on energy consumption during use (excluding means of transport for people and goods).
Directive 2009/48/EC concerns the safety of toys. Where a toy is a machine, the Toy Safety Directive applies instead of the Machinery Directive. If a toy incorporates radio equipment, the Radio Equipment Directive (which also covers electrical safety and electromagnetic compatibility) will also apply.
General product safety
The General Products Safety Directive (GPSD) 2001/95/EC covers all products intended for or likely to be used by consumers, where there are no other specific provisions in Community Law with the same objectives for safety.