Most new products come within the scope of one or more of these product safety regulations and Directives, and all have a common requirement for CE marking. However, some work equipment that is not powered or used to lift - such as hand tools, racking and ladders - does not come within the scope of these regulations and must not be CE marked. Instead these products must meet section 6 of the Health and Safety at Work etc Act 1974.
Section 6 of the Health and Safety at Work etc Act 1974 (HSW Act)
Section 6 of the HSW Act applies to articles and substances for use at work where other more specific product safety law does not apply (see list below, and, for substances, REACH). In particular, section 6 applies to:
- intermediate suppliers of machinery and other products for use at work
- products for use at work, first placed on the European market before the relevant Product Safety Directive came into effect
- the second-hand supply of products, previously used in the EEA for use at work (unless so substantially refurbished as to be considered 'new')
- fairground equipment
Section 6(1) of the HSW Act places a general health and safety obligation on anyone in the supply chain, so far as reasonably practicable, for when articles for use at work are being used, set, cleaned or maintained. This obligation includes providing information and instructions on safe use, including any subsequent revisions to that information. Enforcement of section 6 of the HSW Act is undertaken by HSE.
Supply of Machinery (Safety) Regulations
The Supply of Machinery (Safety) Regulations 2008 and the Supply of Machinery (Safety) (Amendment) Regulations 2011 implement Directives 2006/42/EC and 2009/127/EC on Machinery. Their scope extends to other products such as safety components, lifting tackle and partly completed machinery, but excludes such items as domestic electrical machines and fairground equipment.
The Regulations require that all machinery:
- is designed and constructed to be safe, meeting the essential health and safety requirements listed in the Regulations (these are supported by many harmonised standards)
- is CE marked
- is supplied with instructions in English
- has a Declaration of Conformity (or, in the case of partly completed machinery, a Declaration of Incorporation)
These Regulations apply to manufacturers or their authorised representatives. In some cases, they apply to others - such as importers of non-CE-marked equipment from outside the EU, and those who design and construct machinery for their own use. However, the Regulations do not usually apply to intermediate suppliers of CE-marked machinery, which is covered by section 6 of the HSW Act. (The non-application of the Regulations to intermediate suppliers may change in the next few years, when the Machinery Directive is brought into line with other EU legislation.) Both HSE and local trading standards enforce the provisions of these Regulations, depending on the field of use of the equipment (HSE leads where machinery is for use at work).
Electrical Equipment (Safety) Regulations
The Electrical Equipment (Safety) Regulations 2016 implement Directive 2014/35/EU (and replace the previous Electrical Equipment (Safety) Regulations 1994 which implemented Directive 2006/95/EC) on low-voltage equipment (most electrical equipment operating between 50-1000 volts alternating current and 75-1500 volts direct current). Machinery subject to Directive 2006/42/EC is excluded, although the essential requirements and standards made under these Regulations apply to electrically powered machinery by virtue of the Supply of Machinery (Safety) Regulations 2008 (Schedule 2, part 1, paragraph 1.5.1).
The Electrical Equipment (Safety) Regulations are supported by many standards and require that electrical equipment be CE marked, constructed to good engineering practice and safe. These Regulations apply to manufacturers or their authorised representatives, importers and distributors. Both HSE and local trading standards enforce the provisions of these Regulations, depending on the field of use of the equipment (HSE leads where the equipment is for use at work).
- Electrical Equipment (Safety) Regulations 2016, implementing Council Directive 2014/35/EU (PDF document) - legislation.gov.uk
The Lifts Regulations 2016 implement Directive 2014/33/EU (and replace the previous Lifts Regulations 1997 which implemented Directive 96/16/EC, as amended by 2006/42/EC. HSE enforces the provisions of these Regulations. Certain types of lift are excluded because they are subject to the Supply of Machinery (Safety) Regulations 2008. These exclusions include:
- construction hoists
- those travelling at an angle of less than 15" to the horizontal
- those which operate very slowly (less than 0.15 metres per second)
- those used for access to work stations on machinery
Lifts placed on the market or brought into use must be safe (meeting essential health and safety requirements), be CE marked and certified by a Declaration of Conformity. Information about the lift, its safe installation, use and maintenance, and other test documentation, must be provided both by and to those installing the lift.
Pressure Equipment Regulations and Simple Pressure Vessels (Safety) Regulations
The Pressure Equipment (Safety) Regulations 2016 and The Simple Pressure Vessels (Safety) Regulations 2016 implement Directives 2014/68/EU and 2014/29/EU (and replace the previous Pressure Equipment Regulations 1999 and Simple Pressure Vessels (Safety) Regulations 1991 (as amended in 1994) which implemented Directives 97/23/EC PED and 2009/105/EC (SPVD). These Regulations provide for the safety, by design and construction, of most pressure equipment and assemblies at a pressure of more than 0.5 bar. HSE enforces the provisions of these Regulations for equipment for use at work.
Duties for safety are placed on the manufacturer or their authorised representative, importers and distributors. Machinery may include pressure systems which come within scope of these Regulations. In such cases, the requirements of these Regulations apply to the pressure parts of the machine, alongside those requirements under the Supply of Machinery (Safety) Regulations for the machine.
- Pressure systems - HSE (GB)
- The Pressure Equipment (Safety) Regulations 2016 - legislation.gov.uk
- The Simple Pressure Vessels (Safety) Regulations 2016 - legislation.gov.uk
Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations
The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 implement Directive 2014/34/EU (and replace the previous Regulations 1996, as amended in 2001 & 2005, which implemented Directive 94/9/EC as amended), and are usually known as ATEX, for equipment and protective systems intended for use in explosive atmospheres. Safety, controlling and regulating devices intended for use outside potentially explosive atmospheres - but still contributing to the safe functioning of equipment / protective systems against explosion - also come within scope of the Regulations. In addition to CE marking, ATEX equipment must bear the specific explosion protection mark - Fig 1. HSE enforces the provisions of these Regulations.
Manufacturers or their authorised representative, importers and distributors must meet the requirements for safety. ATEX components (eg a rotary valve) may be incorporated within other products (e.g. dust extraction machinery). In such cases, the machine may be supplied with an additional Declaration of Conformity, relating specifically to the ATEX component.
- The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 - legislation.gov.uk
- The Dangerous Substances and Explosive Atmospheres Regulations 2002 - legislation.gov.uk
Gas Appliances (Safety) Regulations
The Gas Appliances (Safety) Regulations 1995 implement Directive 90/396/EEC concerning appliances burning gaseous fuels, excluding industrial appliances. Local trading standards services enforce the provisions of these Regulations if the gas appliance is designed for domestic use, otherwise HSE is the enforcing authority. The regulations apply to gas appliances and fittings which must undergo type examination by a notified body before they can be CE marked and supplied. There may be new regulations in 2018 when Directive 2016/426/EU comes into effect.
Cableway Installations Regulations
The Cableway Installations Regulations 2004 implement Directive 2000/9/EC concerning cableways designed to carry people, and their subsystems or safety components. However, they do not cover cableway installations used:
- in mining for industrial purposes
- wholly or mainly for agriculture
- in fairgrounds and amusement parks, where designed for leisure purposes and not as a means of transportation
Some other similar equipment is also excluded, such as cable ferries, rack railways and tramways. HSE enforces the provisions of these Regulations. Prior authorisation from the Secretary of State for Transport for a new or modified cableway is required, and 'stage 2' authorisation is required before the cableway can be put into service. There may be new regulations in 2018 when Directive 2016/424/EU comes into effect replacing 2000/9/EC.
The Explosives Regulations 2014 (Amendment) Regulations 2016
The Explosives Regulations 2014 (Amendment) Regulations 2016 implement Directive 2014/28/EU and are concerned with safety requirements for explosives, and the security controls on their transfer. These Regulations are enforced by HSE. Ammunition, explosives intended for military or police use, and pyrotechnic articles (including fireworks) are generally excluded. They replace the earlier Placing on the Market and Supervision of Transfers of Explosives Regulations 1993.
Pyrotechnic Articles (Safety) Regulations 2015
The Pyrotechnic Articles (Safety) Regulations 2015 implement Directive 2007/23/EC on the placing on the market of pyrotechnic articles and deal with the harmonisation of standards for, and safety of, pyrotechnic articles. Products covered include:
- theatrical pyrotechnics
- other pyrotechnic articles, including car air-bag detonators, shroud cutters and a wide variety of specialist articles
The Regulations do not apply to pyrotechnic articles intended for military or civil authority use, explosives or marine equipment (which are covered by other legislation). The Department for Business, Energy and Industrial Strategy (BEIS) has the policy lead for these Regulations and trading standards services have the enforcement role.
Personal Protective Equipment (EC Directive) Regulations
The Personal Protective Equipment (EC Directive) Regulations 1992 (as amended in 1993, 1994 & 1996) implement Directive 89/686/EC, as amended, concerning the basic safety requirements of most personal protective equipment (PPE) whether for use at work or elsewhere. These have been replaced by the Personal Protective Equipment (Enforcement) Regulations 2018 and Regulation EU 2016/425 of the European Parliament and of the Council. HSE are the enforcing authority for these Regulations where the PPE is being used at work. Trading Standards authorities enforce the Regulations for PPE supplied to consumers..
- The Personal Protective Equipment (EC Directive) Regulations 1992 - legislation.gov.uk
- Personal Protective Equipment (Enforcement) Regulations 2018 - legislation.gov.uk
- BIS - Personal Protective Equipment (PPE) Directive (Directive 89/686/EEC) - GOV.UK
Electromagnetic Compatibility Regulations
Electromagnetic Compatibility Regulations 2016 which implement Directive 2014/30/EU (and replace the Electromagnetic Compatibility Regulations 2006, as amended 2006 regulation amendment, which implemented Directive 2004/108/EC) concern the avoidance of undue electromagnetic disturbance generated by electrical equipment, and the sufficient immunity of electrical equipment against electromagnetic disturbance. As most machinery is electrically powered, it will have to meet these requirements in addition to those under the Machinery Directive 2006/42/EC. HSE does not have a role in respect of these Regulations, even for industrial equipment, and most enforcement falls to the relevant local trading standards service.
- Electromagnetic Compatibility Regulations 2016 - legislation.gov.uk
- BEIS - Electromagnetic Compatibility - GOV.UK
Construction Products Regulations
The Construction Products Regulations 2013, The Construction Products Regulations 1991 and The Construction Products (Amendment) Regulations 1994 concerning products produced for permanent incorporation in building and civil engineering works enforce the provisions of the direct acting EU Regulation 305/2011. Where such products are also machinery (eg powered roller shutter doors), they will also have to meet the Machinery Directive 2006/42/EC and the Electromagnetic Compatibility Directive 2014/30/EU (if electrically powered).
HSE does not have a role in respect of the Construction Products Regulations, even for industrial products enforcement falls to the relevant Trading Standards authority.
- The Construction Products Regulations 2013 - legislation.gov.uk
- The Construction Products Regulations 1991 - legislation.gov.uk
- The Construction Products (Amendment) Regulations 1994 - legislation.gov.uk
- DCLG Portal
Medical Devices Regulations
The Medical Devices Regulations 2002, as amended 2003 Medical Devices Regulations amendment, 2005 Medical Devices Regulations amendment, 2007 Medical Devices Regulations amendment and 2008 Medical Devices Regulations amendment, implement Directive 93/42/EC (as amended by 2007/47/EC) concerning medical devices used for diagnostic or therapeutic purposes. Where a medical device is also a machine it is excluded from the scope of the Machinery Directive 2006/42/EC, although it must still meet the relevant essential health and safety requirements of that Directive, as these are called up by these Regulations. HSE does not have a role in respect of these Regulations, even for workplace equipment, and enforcement falls to the Medicines and Healthcare products Regulatory Agency.
- The Medical Devices Regulations 2002 - legislation.gov.uk
- Medicines and Healthcare products Regulatory Agencywebsite
Noise Emission in the Environment by Equipment for use Outdoors Regulations
The Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001, as amended 2001 and 2005, implement Directive 2000/14/EC (as amended). These are environmental protection Regulations concerning noise emissions from equipment for use outdoors. Much of the equipment within the scope of this Directive may also be machinery and so will have to meet requirements under the Machinery Directive 2006/42/EC, concerning noise exposure to the operator and other workers. Enforcement of these Regulations falls to Regulatory Delivery.
- The Noise Emission in the Environment by Equipment for use outdoors Regulations 2001 - legislation.gov.uk
Non-Road Mobile Machinery (Emission of Gaseous and Particulate Pollutants) Regulations
The Non-Road Mobile Machinery (Emission of Gaseous and Particulate Pollutants) Regulations 1999, as amended 2002, 2004, 2006 and 2008, are environmental protection Regulations which implement Directive 97/68/EC, as amended, concerning gaseous and particulate emissions from non-road mobile machinery. In addition to these Regulations, mobile construction plant powered by internal combustion engines also come within scope of the Machinery Directive. Enforcement of these Regulations falls to the Vehicle Certification Authority.
Radio Equipment and Telecommunications Terminal Equipment Regulations
The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000, as amended in 2003 Regulations amendment and 2003 second Regulations amendment, implement Directive 1999/5/EC concerning safety and interference with other radio equipment. Enforcement of these Regulations falls to the relevant local trading standards service, or OFCOM in the case of the protection and management of the radio spectrum.
General Product Safety Regulations
The General Product Safety Regulations 2005 implement Directive 2001/95/EC concerning consumer products which are not covered by any other Directive. Enforcement of these Regulations falls to the relevant local trading standards service. These Regulations also provide trading standards authorities with their main enforcement powers to undertake market surveillance.
Toys (Safety) Regulations
The Toys (Safety) Regulations 2011 implement Directive 2009/48/EC concerning the safety of toys, and replace the 1995 Toys (Safety) Regulations. Where a toy is also a machine, powered by an electric motor or other source of non-manual power - and so potentially falling within the scope of the Machinery Directive - only the Toy Directive applies. Enforcement of these Regulations falls to the relevant local trading standards authority.
- The Toys (Safety) Regulations 2011 - legislation.gov.uk
- BEIS - Other Product Safety Directives - GOV.UK
Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008, as amended 2009, implement Directive 2002/95/EC and restrict the use of certain hazardous materials (lead, cadmium, mercury, etc) in the manufacture of various types of electronic and electrical equipment. The National Measurement Office enforces the provisions of these Regulations.
- The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008 - legislation.gov.uk
- The National Measurement Office - GOV.UK
- BEIS - Restrictions on Hazardous Substances in Electrical Equipment - GOV.UK
Ecodesign for Energy-Related Products Regulations
The Ecodesign for Energy-Related Products Regulations 2010 replace the 2007 and 2008 Regulations of the same name and implement Directive 2009/125/EC, which aims to improve the environmental performance of products throughout their life-cycle, starting at a very early stage in their design. Enforcement of these Regulations falls to the National Measurement Office.