For the UK market, the Supply of Machinery (Safety) Regulations 2008 continues to be in alignment with the EU’s Machinery Directive, but with slight amendments specific to BREXIT derailed within Schedule 12 of The Product Safety and Metrology etc (Amendment etc.) (EU Exit) Regulations 2019. The regulations apply to both machinery and safety components which are manufactured or sold and operated in the UK on or after 29th December 2009 and the UKCA requirements after 31 December 2022.
Before machinery and other products in the Regulations’ scope, are placed on the market or put into service for the first time they must be designed and constructed to be safe. They must also have a technical file compiled and have appropriate conformity markings. Under the new regime, UKCA will be the marking applied under the regulation and CE will continue to be the marking applied under the Directive. Such equipment must also be supplied with comprehensive instructions or assembly instructions in the case of partly completed machinery in English. They must also be accompanied by a Declaration of Conformity, or in the case of party-completed machinery, a Declaration of Incorporation.
The following persons or companies are responsible for compliance with the Supply of Machinery (Safety) Regulations:
- Machine builders
- Assemblers of machine parts or installations
- Manufacturers of special-purpose tools, skids and rigs
- Machinery importers located in the UK
- Machinery distributors or dealers that buy from a UK-based manufacturer or importer are obligated to verify that the conformity assessment was performed and that the necessary documentation and information is available.
Relevant machinery under the regulations includes assemblies of machinery, components and interchangeable equipment:
- An assembly fitted with, or intended to be fitted with a drive system other than directly applied manual or animal effort, consisting of linked parts or
Components, at least one of which moves, and which are joined together for a specific application.
- Machinery referred to in 1 missing only the components to connect it on-site or to sources of energy and motion.
- Lifting apparatus whose only power source is directly applied manual effort.
- An assembly of machines and/or partly completed machinery which, in order to achieve the same end are arranged and controlled to function as an integral whole.
- Interchangeable equipment - a device which, after placing into service with machinery or tractor, is assembled with that machinery or tractor by the operator himself in order to change its function.
UK regulations define a responsible person as one who holds a position of sufficient responsibility to ensure machinery safety. However, they do not have to be an expert as they are allowed to seek appropriate advice. The responsible person must ensure that all the necessary research and tests are conducted so that machinery can be assembled and put into service safely. The responsible person must also ensure that the applicable Essential Health and Safety Requirements (EHSR) are satisfied. These are wide-ranging, taking into account potential dangers to operators and other persons who may be at risk. A typical example of an EHSR is the requirement to provide adequate warning labels where there are moving parts that might trap parts of the body of personnel using the machine. Another would be the requirement to provide safety guards for machine tools.
The responsible person must also ensure that the technical file is compiled and remains available for inspection by a competent national authority, such as the UK Health and Safety Executive, for a period of ten years after the last product was manufactured and placed on the market. However, it does not have to include detailed information such as the sub-assemblies of the machine, unless knowledge of them is essential for verification and compliance with the EHSRs.
The appropriate conformity assessment procedure must also be followed, these are dependent on the category of machinery and whether or not published designated standards are available, and if so, that they have been fully applied to cover all of the essential health and safety requirements of the machine:
- Regulation 10 – This regulation applies to machinery that does not fall within a category of machinery referred to in Part 4 of Schedule 2.In this case, the following conformity assessment procedure is applied:
- The responsible person shall follow the conformity assessment procedure with internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2 in respect of it.
- Regulation 11 – This regulation applies to machinery that falls within a category listed within Part 4 of Schedule 2 and that the machinery is manufactured fully in accordance with published designated standards, and that the published designated standards in accordance with which it is manufactured cover all the applicable essential health and safety requirements. In this case, one of the following conformity assessment procedures can be applied:
- the conformity assessment procedure with internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2; or
the type-examination procedure prescribed in Part 9 of Schedule 2 and the internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2, point 3; or the full quality assurance procedure prescribed in Part 10 of Schedule 2.
- Regulation 12 – This regulation applies to machinery that falls within a category listed within Part 4 of Schedule 2 where the machinery is not manufactured fully in accordance with published designated standards; or,
is only partly manufactured in accordance with the published designated standards which relate to it; or,
the published designated standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or, no designated standards exist for the machinery.
In this case, one of the following conformity assessment procedures can be applied, which in both instances require the intervention of an Approved
- the type-examination procedure prescribed in Part 9 of Schedule 2 and the internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2, point 3; or
the full quality assurance procedure prescribed in Part 10 of Schedule 2.
The responsible person must also ensure that appropriate instructions are made available to operate machinery safely; that a declaration of conformity is drawn up; and that the UKCA marking is affixed. In the UK, there has been an extension to the acceptance of CE marking until 1st January 2023, after which the UKCA marking requirements are mandatory and a legal requirement.
About TÜV SÜD www.tuvsud.com/uk
TÜV SÜD is one of the world’s leading experts in product testing and certification, with 150,000 product certificates in circulation globally. Its Product Service division analyses over 20,000 products each year in Europe, Asia-Pacific and the Americas, using its technical expertise to help customers optimise market access.
TÜV SÜD’s Machinery Safety Division is the UK market leader in machinery safety, providing a range of services on a worldwide basis. It is also the official partner of the Process and Packaging Machinery Association on regulatory affairs.
TÜV SÜD BABT is the world’s leading radio and telecommunications certification body with EU-based Notified Bodies and UK Conformity Assessment Body status. This enables TÜV SÜD to satisfy both CE and UKCA requirements for multiple EU Directives and UK Regulations, including those for radio equipment, machinery and electromagnetic compatibility, along with Wheel Mark and UK Conformity Mark requirements for marine equipment.