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Updated 26 July 2022
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Guidance on the regulations as they apply to machinery being supplied in or into Great Britain.
July 2022
This Guide is for businesses placing machinery on the market in Great Britain.
Read guidance on the regulations in Northern Ireland
This Guide is designed to help you understand The Supply of Machinery (Safety) Regulations 2008 as they apply in Great Britain (referred to in this document as the “2008 Regulations”). The 2008 Regulations set out the requirements that must be met before machinery can be placed on the GB market or put into service. The purpose of the legislation is to ensure safe machinery is placed on the market or put into service by requiring manufacturers to show how their machinery meet the ‘essential health and safety requirements’.
The Supply of Machinery (Safety) Regulations 2008 implemented Directive 2006/42/EC on machinery. The EU Withdrawal Act 2018 preserved the Regulations and enabled them to be amended so as to continue to function effectively now the UK has left the EU. Accordingly, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 see footnote 1 fixed any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and made specific provision for the GB market.
The 2008 Regulations replaced the Supply of Machinery (Safety) Regulations 1995 and were amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 to apply solely to the GB market.
There is therefore one set of UK 2008 Regulations, but some of the provisions apply differently in NI for as long as the Northern Ireland Protocol is in force. References to the 2008 Regulations in this guidance are references to those Regulations as they apply in Great Britain.
Read guidance on the regulations in Northern Ireland
The Regulations apply to:
(i) an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application
(ii) an assembly as referred to in sub-paragraph (i), missing only the components to connect it on site or to sources of energy and motion
(iii) an assembly as referred to in sub-paragraph (i) or (ii), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure
(iv) assemblies of machinery as referred to in sub-paragraphs (i), (ii) and (iii) or partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
(v) an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort
devices which, after the putting into service of machinery or of a tractor, are assembled with that machinery or tractor by operators themselves in order to change its function or attribute a new function, in so far as they are not tools
(i) which serve to fulfil a safety function
(ii) which are independently placed on the market
(iii) the failure or malfunction of which endangers the safety of persons, and
(iv) which are not necessary in order for the machinery to function, or for which other components which do not fall within the previous sub-paragraphs may be substituted in order for the machinery to function
(i) are not attached to lifting machinery
(ii) allow a load to be held
(iii) are placed between the machinery and the load or on the load itself, or are intended to constitute an integral part of the load, and
(iv) are independently placed on the market
designed and constructed for lifting purposes as part of lifting machinery or lifting accessories
removable components for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing (when such components are placed on the market with a guard the components and the guard together shall be regarded as one product).
drive systems and other assemblies which:
(a) are almost machinery
(b) cannot in themselves perform a specific application, and
(c) are only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery
The Regulations make it an offence for a ‘responsible person’ to supply machinery, partly completed machinery or safety components unless they comply with the 2008 Regulations.
Compliance with the 2008 Regulations includes ensuring that the essential health and safety requirements (EHSRs) are satisfied; carrying out the necessary conformity assessment procedures; drawing up a declaration of conformity; and ensuring the machinery has the UKCA or (alternatively until 11pm 31 December 2022 the CE marking) affixed.
A ‘responsible person’ under the Regulations means the manufacturer (see definition of ‘manufacturer’ in the glossary section 12) of the machinery or the manufacturer’s authorised representative.
The obligations of responsible persons under the Regulations are:
Manufacturers based in Northern Ireland can follow the legislation as it applies to Northern Ireland and place qualifying Northern Ireland goods on the GB market without any additional approvals. See further detail in Section 9 on Qualifying Northern Ireland Goods.
Manufacturers are able by written mandate to appoint authorised representatives to perform all or part of the obligations and formalities imposed on manufacturers (either as manufacturers or responsible persons) by the Regulations.
Mandated authorised representatives for the GB market can be based in GB or Northern Ireland but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the 2008 Regulations as they apply in GB.
No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry out tasks on the manufacturer’s behalf for machinery being placed on the Northern Ireland or EEA markets. Therefore, a GB manufacturer selling machinery to the EEA or placing on the NI market, who wishes to appoint an authorised representative to carry out tasks for them in respect of that machinery, must appoint an authorised representative based in Northern Ireland or the EEA.
If you place an individual fully manufactured product on the EEA or the UK market (either in Northern Ireland or Great Britain) before 11pm 31 December 2022, you do not need to do anything new. These individual goods can continue to circulate on either market until they reach their end user and do not need to comply with the changes that take effect from 11pm 31 December 2022.
A fully manufactured good is ‘placed on the market’ when there is a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other rights in the product. This does not require physical transfer of the good.
You can usually provide proof of placing on the market on the basis of any relevant document ordinarily used in business transactions, including:
The relevant responsible person (manufacturer, authorised representative or person placing on the market or putting into service) bears the burden of proof for demonstrating that the good was placed on the EEA or UK market before 11pm 31 December 2022.
The UK will allow CE marked machinery that has been either self-declared as compliant (where permissible) or where compliance must and has been demonstrated through assessment by an EU-recognised conformity assessment body (notified body) to be placed on the GB market until 11pm 31 December 2022.
Machinery lawfully placed on the market with a CE marking by 11pm 31 December 2022 can continue to circulate on the GB market after this date. There is no requirement to re-test or re-mark such machinery.
Products which are repaired, refurbished or exchanged without changing their original performance, purpose, or type, are not considered ‘new’ and therefore do not need to be recertified and remarked.
This includes if the product is temporarily exported for repair (as the product is not being placed on the GB market for the first time when re-imported).
If the product has been subject to important changes, substantially changing its original performance, purpose, or type, it will be considered as a ‘new’ product. Therefore, the modified product must comply with GB regulatory requirements, including the requirement for UKCA marking from 1 January 2023.
Repair, replacement and maintenance operations are often carried out using other products which are spare parts. Spare parts are considered to have been placed on the market at the time at which the original product or system they are ultimately intended to repair, replace or maintain was placed on the market.
This means that spare parts can comply with the same conformity assessment requirements that were in place at the time the original product or system they are ultimately intended to repair, replace or maintain was placed on the market.
The definition of a spare part will vary depending on the commercial context, but it is broadly determined by a product’s ultimate intended usage. Whether a product is ultimately intended to be used as a spare part should be evidenced by any document demonstrating this intended use, which should be produced when requested by market surveillance authorities.
From 1 January 2021, machinery intended for the GB market should be conformity assessed by a UK approved body and UKCA marked, not CE marked. See footnote 2
Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may be placed on the GB market after 31 December 2022. See further detail in Section 11 on Qualifying Northern Ireland Goods.
Rules around physically affixing the new UKCA marking mirror those which currently apply for the application of the CE marking although, until 31 December 2025, the UKCA marking may be affixed to a label affixed to the machinery or a document accompanying the machinery, rather than being affixed to the machinery itself (even where it is otherwise possible to affix it to the equipment itself).
Where self-declaration of conformity is permitted in the Regulations, manufacturers placing machinery on the GB market, can affix the UKCA marking on the machinery before placing it on the GB market. Alternatively, until 31 December 2025, before placing it on the GB market, manufacturers can affix CE marking based on self-declaration of conformity with the EU requirements, where permitted.
It is possible to affix both the UKCA marking and the CE marking to the same machinery on the basis of self-declaration, where permitted, as long as the EU and GB requirements remain the same. When selling to the EU or placing on the NI market, the CE marking remains mandatory.
On 20 June 2022, the Government announced it intends to introduce legislation which will allow completed conformity assessment activities carried out under EU requirements (including existing testing, certification, and contractual arrangements relating to the quality control or auditing of existing certificates) undertaken by non-UK conformity assessment bodies (CABs) (accredited by their national accreditation body) for CE certification before 1 January 2023 to be used by manufacturers to declare existing product types as compliant with UKCA. Products must still bear UKCA marking. For ongoing production, they will need to undergo conformity assessment with a UK Approved Body once any of the relevant CE certification has expired, or after 5 years (31 December 2027), whichever is sooner.
This will allow manufacturers to apply the UKCA mark without the need for any UK-recognised CAB involvement and continue to place their goods on the GB market, on the basis of an existing CE type examination completed before 31 December 2022, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).
Where manufacturers are using existing CE certification completed before 1 January 2023 as the basis to demonstrate compliance with UKCA for their products, they should include in the UK Declaration of Conformity the list of relevant UK designated standards and equivalent EU harmonised standards that apply to their product, as well as details of the EU CAB (or CAB recognised under an EU Mutual Recognition Agreement) which carried out the conformity assessment procedures.
If conformity assessment procedures have not been completed and a supporting CE certificate issued before 1 January 2023, these products are considered ‘new’ products. This also includes where goods are subject to important changes, overhauling its original performance, purpose, or type requiring new certification. Any ‘new’ good must comply with GB regulatory requirements, including the requirement for conformity assessment by a UK approved body from 1 January 2023.
This measure applies across all module types.
Read guidance on UKCA marking
The government committed to providing unfettered access for qualifying Northern Ireland goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in Northern Ireland in accordance with the legislation, as it applies to Northern Ireland, can be sold in the rest of the UK without any additional approvals.
This means that products that are qualifying Northern Ireland goods can be sold in the rest of the UK if any of the following apply:
This will be the case even if there are changes between the EU rules that the Northern Ireland Protocol applies to NI and the GB rules.
Read guidance on UKNI marking
NI businesses that are importing products from the EEA and placing them on the GB market must ensure that the relevant conformity assessment procedure has been carried out, that the technical documentation has been drawn up and that the machinery bears the CE marking. They will also have to comply with the importer labelling duties (see Section 6 on obligations of importers).
Read guidance on qualifying Northern Ireland goods
The UK has established a new framework for UK based bodies to assess machinery against GB rules. Existing UK notified bodies have been granted new UK ‘approved body’ status and are listed on a new UK database.
UK approved bodies are conformity assessment bodies which have been approved by the Secretary of State to carry out the procedures for conformity assessment and certification for the GB market as set out in the 2008 Regulations as amended.
These approved bodies retain their 4-digit identification number. New approved bodies will be assigned a number by the Office for Product Safety and Standards on behalf of the Secretary of State.
Approved bodies can assess products for the GB market against GB essential requirements (which are, as yet, the same as EU essential requirements).
UK approved bodies must be established in the UK and be independent of the manufacturer. Approved bodies must examine the technical documentation and supporting evidence in respect of machinery or partly completed machinery to assess the adequacy of the technical design.
Where, having issued a certificate or approval, an approved body finds that applicable requirements of the Regulations have not been met by a manufacturer, they must require the manufacturer to take corrective measures and/or suspend or withdraw the certificate or approval.
View the register of UK Approved Bodies
The register also contains details of bodies in other countries such as Australia, New Zealand, Canada, Japan, and the United States of America, which the UK is designating as Approved Bodies through Mutual Recognition Agreements.
For products intended for workplace use, the Health and Safety Executive (HSE) has a duty to enforce of the Regulations in Great Britain.
In Great Britain, local trading standards authorities have a duty to enforce the Regulations in relation to consumer goods.
Alternatively, the Office for Product Safety and Standards on behalf of the Secretary of State is able to enforce the Regulations. The Office of Rail Regulation is responsible for the enforcement of these Regulations in Great Britain where the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006 make it the enforcing authority, within the meaning of section 18(7) of the 1974 Act, in relation to machinery or partly completed machinery for use in the operation of a railway, tramway or any other system of guided transport, as defined in those Regulations.
Enforcing authorities must have regard to the Regulators’ Code when developing the policies and operational procedures that guide their regulatory activities in this area. They should carry out their activities in a way that supports those they regulate to comply and grow, including choosing proportionate approaches that reflect risk.
In responding to non-compliance that they identify, regulators should clearly explain what the non-compliant item or activity is, the advice being given, actions required, or decisions taken, and the reasons for these. Unless immediate action is needed to prevent a serious breach, regulators should provide an opportunity for dialogue in relation to the advice, requirements or decisions, with a view to ensuring that they are acting in a way that is proportionate and consistent. The Secretary of State takes account of the provisions of both the Regulators’ Code and the Growth Duty in exercising their regulatory functions.
Read the Regulators’ Code
A person committing an offence under the Regulations may be liable to a penalty. Penalties can include a fine or a prison sentence of up to two years for the most serious offences. It is matter for the enforcement authority to decide what action is appropriate in each case taking into account the circumstances of the case and the enforcement authorities’ own policies, operational procedures and practices in line with the Regulators Code. Should a prosecution take place, it is at the discretion of the court to decide the penalties imposed on the offender.
Declaration of conformity – A document prepared by the manufacturer which must detail, among other things, the following:
The Regulations do not apply to:
For the purposes of this Annex, the term ‘machinery’ incorporates machinery; interchangeable equipment; safety components; chains, ropes, and webbing; lifting accessories; and removable transmission devices.
To comply with the Regulations, machinery must satisfy the essential health and safety requirements (EHSRs) which apply to it. The full list of EHSRs is laid out in Schedule 2, Part 1 of the 2008 Regulations as amended by the Product Safety and Metrology etc. (Amendment etc) (EU Exit) Regulations 2019.
The listing in Schedule 2, Part 1 of the 2008 Regulations, as amended, begins with a crucially important statement of ‘General Principles’, reproduced in full below. This, in turn, explicitly requires the carrying out of a risk assessment, meaning that the responsible person should determine which are the EHSRs applicable to their machinery and in respect of which they must take measures.
The responsible person must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.
By the iterative process of risk assessment and risk reduction referred to above, the responsible person shall:
The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the responsible person or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 of Annex I to Directive 2006/42/EC as set out in Schedule 2 to the 2008 Regulations and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 of Annex I to Directive 2006/42/EC as set out in Schedule 2 to the 2008 Regulations apply.
The essential health and safety requirements are mandatory. However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.
The list of essential requirements is organised into several sections. The first section has a general scope and is applicable to all kinds of machinery. The other sections refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of the list in order to be sure of meeting all the applicable essential requirements. When machinery is being designed, the requirements of the general section and the requirements of one or more of the other sections shall be taken into account, depending on the results of the risk assessment carried out in accordance with the opening paragraph of these General Principles.
1: The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were amended by the Product Safety and Metrology etc. (Amendment to Extent and Meaning of Market) (EU Exit) Regulations 2020 to apply to Great Britain only, and not to Northern Ireland, in support of implementing The Protocol of Ireland and Northern Ireland (“The Northern Ireland Protocol”). The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were further amended by the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to provide for a 24 month transition period for importer labelling (for goods from the EEA), UKCA marking, to amend the definition of “authorised representative” as well as introducing an end (in 12 months from the end of the Transition Period) to the recognition of goods meeting EU requirements, as well as introducing provisions for qualifying Northern Ireland goods. On 24 August 2021 the Government announced the transition period for UKCA marking would be extended until 31 December 2022. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 20 June 2022, the Government announced the provisions for UKCA marking and labelling would be extended until 31 December 2025. Legislation will be placed before Parliament in the autumn 2022 to give effect to this.
2: On 24 August 2021 the Government announced the transition periods for UKCA marking and UKCA labelling would each be extended until 31 December 2022 and 31 December 2023 respectively. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 20 June 2022, the Government announced the provisions for UKCA marking and labelling would be extended until 31 December 2025. Legislation will be placed before Parliament in the autumn 2022 to give effect to this
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