European Community law on the supply of new products
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
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 links to the Directives and relevant guidance.
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.
- Electrical equipment
- Equipment for use in explosive atmospheres
- Pressure equipment and vessels
- Gas appliances
- Explosives and pyrotechnic articles
- Electromagnetic compatibility
- Medical devices
- Personal protective equipment
- Construction products
- Radio equipment
- Noise emissions from equipment for use outdoors
- Emission of gaseous and particulate pollutants by non-road mobile machinery
- Restriction on use of certain hazardous substances in electrical equipment
- Ecodesign for energy-related products
- General product safety
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.
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, other than the equipment and phenomena listed in its Annex II, largely because they are covered by other Directives and international agreements. The excluded items and phenomena 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
The safety objectives listed in Annex I of the LVD cover electrical hazards and information requirements, and include the protection of persons, domestic animals and property from non-electrical dangers caused by electrical equipment. Although the LVD does not apply to machinery, the safety objectives of the LVD are called up by EHSR 1.5.1 of the Machinery Directive.
CE marking of electrical equipment in scope is required, although it may be attached to the packaging or included with the other information accompanying the product (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 Low Voltage Directive is implemented by the Electrical Equipment (Safety) Regulations.
Equipment for use in explosive atmospheres
Directive 2014/34/EU (ATEX) concerns equipment and protective systems intended for use in potentially explosive atmospheres. 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 and protective systems with respect to the risks of explosion are also covered by this Directive. Equipment in scope may be of electrical and / or mechanical nature. The ATEX Directive has been implemented by the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations .
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 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 Directive 89/686/EEC
- seagoing vessels and mobile offshore units together with equipment on board such vessels or units
- means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means 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 escalators and mechanical walkways, cableway installations designed to carry people). This Directive has been implemented by the Lifts Regulations.
Clarification of which products are in scope of the Lifts Directive was given in 2009 by an amendment made by Article 24 of the Machinery Directive 2006/42/EC. Some products which were previously in scope of the Lifts Directive are no longer (eg constructions hoists, these now in scope of the Machinery Directive).
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 called up by the Preliminary Remarks at 1.1 of Annex I of 95/16/EC.
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. These Directives have been implemented by the Pressure Equipment and Simple Pressure Vessels (Safety) Regulations. Further information on these is available from the section on pressure systems. Machinery and other equipment may incorporate pressure equipment within scope of these Directives in which case these Directives and their provisions may apply alongside other Directives relevant to the product (eg the Machinery Directive).
Directive 2009/142/EC 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 scope. This Directive has been implemented by the Gas Appliances (Safety) Regulations. It is due to be replaced by 2016/426/EU in 2018.
Directive 2000/9/EC relates to cableway installations designed to carry persons and covers funicular railways and other installations with vehicles on wheels or on other suspension devices where traction is provided by one or more cables, cable cars where the cabins are lifted and / or displaced by one or more carrier cables (including gondolas and chair lifts), and 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. It has been implemented by the Cableway Installations Regulations 2004.
This Directive does not apply to:
- lifts within the meaning of the Lifts Directive 95/16/EC
- 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 persons
- mining installations or on-site installations used for industrial purposes
- cable-operated ferries
- chain-driven installations
It is due to be replaced by 2016/424/EU in 2018.
Explosives and pyrotechnic articles
Directives 2014/28/EU and 2013/29/EU concern certain explosives and pyrotechnic articles and are implemented by The Explosives Regulations 2014 (Amendment) Regulations 2016 and Pyrotechnic Articles (Safety) Regulations 2015.
The Electromagnetic Compatibility Directive 2014/30/EU (EMC) will apply to much other equipment with an electrical aspect, primarily to prevent interference with other electrical equipment and its own immunity from such disturbance. It applies alongside other Directives (eg Machinery and Low Voltage). It has been implemented by the Electromagnetic Compatibility Regulations.
Medical devices as defined by Article 1 of the Medical Devices Directive 93/42/EC (as amended by 2007/47/EC) are covered by these Directives. Where a medical device is also a machine the relevant machinery essential health and safety requirements (EHSRs) are called up into scope by 2007/47/EC. These have been implemented by the Medical Devices Regulations.
Personal protective equipment
Directive 89/686/EEC (as amended) 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, and helmets / visors for two- and three-wheeled motor vehicles. This Directive has been implemented by the Personal Protective Equipment (EC Directive) Regulations. It is due to be replaced by 2016/425/EU in 2018.
Direct acting EU Regulation No. 305/2011  , which repealed the earlier Construction Products Directive, and took full effect from 1 July 2013, 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 incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works. Some construction products (eg powered doors and windows within the scope of EN 13241-1, the product standard for Industrial, commercial and garage doors and gates) may also be machinery within scope of the Machinery Directive 2006/42/EC. This EU regulation is enforced by Trading Standards through the Construction Products Regulations 2013.
Directive 2014/53/EU concerns radio equipment and telecommunications terminal equipment and is enforced by Trading Standards.
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). It has been implemented by the Noise Emission in the Environment by Equipment for use Outdoors Regulations.
Emission of gaseous and particulate pollutants by non-road mobile machinery
Directive 97/68/EC is concerned with the emission of gaseous and particulate pollutants by non-road mobile machinery (which may include machinery subject to the Machinery Directive). It has been implemented by the Non-Road Mobile Machinery (Emission of Gaseous and Particulate Pollutants) Regulations.
Restriction of the use of certain hazardous substances in electrical and electronic equipment
Directive 2002/95/EC is concerned with the use of certain hazardous substances (lead, cadmium, etc) in electrical and electronic equipment and has been implemented by the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations.
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). It has been implemented by the Ecodesign for Energy-Related Products Regulations.
Directive 2009/48/EC concerns the safety of toys and is implemented by the Toy (Safety) Regulations.
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. It has been implemented by the General Products Safety Regulations.