The CE Marking Authority Compliance Management System defines the regulatory requirements, rules, and standards that apply to your product. Then executes the program which, generates the compliance report, producing detailed clause-by-clause assessments against the standards and reviewing supplier documentation.

We offer you flexible solutions for your business needs by supplying you with a test plan which can be conducted by you in-house, saving time and expense. Then we review the data or we can conduct the testing for you. Then finally, we supply you with a complete technical file that demonstrates compliance with the applicable legislation.

As part of the Compliance Management System, we monitor all the applicable regulations and standards and inform you when they are updated enabling you to manage your technical file effectively and giving you peace of mind.

This Guide is for businesses placing machinery on the market in Great Britain after BREXIT.

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 the 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 meets the ‘essential health and safety requirements’.

Legislative Background

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 provisions 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.

Scope

The Regulations apply to:

a) machinery, described as:
(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 subparagraph (i), missing only the components to connect it on-site or to sources of energy and motion

(iii) an assembly as referred to in subparagraph (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

b) interchangeable equipment, described as:

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

c) safety components, described as components:

(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

d) lifting accessories, described as components or equipment that:

(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

e) chains, ropes and webbing, described as being:

designed and constructed for lifting purposes as part of lifting machinery or lifting accessories

f) removable mechanical transmission devices, described as:

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).

g) partly completed machinery, described as:

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

Requirements

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 2024 the CE marking) affixed.

Obligations of ‘responsible persons’

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:

1. No responsible person shall place machinery on the GB market or put it into service unless it is safe.
2. They must ensure that the essential health and safety requirements are satisfied in respect of it.
3. They must ensure that the technical file is compiled and made available on request.
4. They must provide the information necessary to operate it safely.
5. They must ensure that the relevant conformity assessment procedure is carried out.
6. They must draw up a declaration of conformity and make sure that a copy of this accompanies the
machinery.
7. They must affix the relevant conformity marking to the machinery.
8. For partly completed machinery, the responsible person must also ensure that assembly instructions are
prepared, a declaration of incorporation is drawn up, and that both accompany the partly completed
machinery until it is incorporated into machinery.

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.

Obligations of authorised representatives

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.

Conformity assessment and marking – products placed on the GB market before 11 pm 31 December 2024

Products placed on the market before 11 pm 31 December 2024

If you place an individual fully manufactured product on the EEA or the UK market (either in Northern Ireland or Great Britain) before 11 pm 31 December 2024, 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 11 pm 31 December 2024.

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 the 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:

1. contracts of sale concerning goods that have already been manufactured and meet the legal
requirements
2. invoices
3. documents concerning the shipping of goods for distribution

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 11 pm 31 December 2024.

Spares

Products that 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 a ‘new’ product. Therefore, the modified product must comply with GB regulatory requirements, including the requirement for UKCA marking from 11 pm 31 December 2024.

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.

Conformity assessment and marking – products placed on the GB market from 11 pm 31 December 2024

Assessment through third-party organisations

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 11 pm 31 December 2024. 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 2027, 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).

Self-declaration

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 11 pm 31 December 2024, 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.

Reducing re-certification/re-testing costs for UKCA marking
The Government has introduced legislation to allow conformity assessment activities undertaken by EU-recognised Conformity Assessment Bodies (CABs), for CE certification before 11 pm 31 December 2024, to be used by manufacturers, and other relevant persons, to declare existing product types as compliant with UKCA requirements. Products must still bear the UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate or after 31 December 2027, whichever is sooner. For ongoing production, they will need to undergo conformity assessment with a UK Approved Body once any of the relevant CE certifications have expired, or after 31 December 2027, whichever is sooner.

Before 11 pm 31 December 2024, if an EU-recognised CAB has completed the relevant conformity assessment activities applying to a product, this would allow manufacturers to apply the UKCA mark without the need for any UK Approved Body involvement. They could continue to place their goods on the market on the basis of their existing CE certification following the end of this year, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).

Where manufacturers are using conformity assessment under existing CE certification before 11 pm 31 December 2024 as the basis to demonstrate compliance with UKCA requirements for their products, it is recommended they 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-recognised CAB (or CAB recognised under an EU Mutual Recognition Agreement with a third country) which carried out the conformity assessment procedures.

This measure applies across all relevant module types.

Qualifying Northern Ireland Goods

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:

the CE marking is lawfully applied to the good on the basis of self-declaration
any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement) and a CE marking is affixed
the certificate of conformity previously held by a UK-approved body has been transferred to an EU-recognised notified body and a CE marking has been affixed
any mandatory third-party conformity assessment was carried out by a UK-based body, and the good is therefore marked with the CE marking and with the new UKNI marking
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.

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).

Approved Bodies

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 that 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 the 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.

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.

Enforcement

For products intended for workplace use, the Health and Safety Executive (HSE) has a duty to enforce 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.

Regulators’ Code

Enforcing authorities must have regard for 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.

Penalties

A person committing an offence under the Regulations may be liable for a penalty. Penalties can include a fine or a prison sentence of up to two years for the most serious offences. It is a 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.

Glossary

Approved Body – A conformity assessment body that has been approved by the Secretary of State.
Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. Authorised representatives for the GB market must be based in the UK.
Declaration of conformity – A document prepared by the manufacturer that must detail, among other things, the following:
the business name and full address of the manufacturer and, where appropriate, the manufacturer’s authorised representative
a description and identification of the machinery, including generic denomination, function, model, type, serial number, and commercial name
Designated standard – A technical specification that is adopted by a recognised standardisation body or which is designated by the Secretary of State.
Enforcement Authority – In Great Britain, for machinery in use in the workplace, this is the Health and Safety Executive. For products for consumer use, this is local trading standards authorities or the Secretary of State. In Great Britain, in relation to machinery for use on railways, it is the duty of the Office of Rail Regulation to enforce these Regulations.
Manufacturer – A person who designs or manufactures machinery or partly completed machinery, with a view to its being placed on the GB market under their own name or trademark or for their own use in the UK; or where there is no such person, the person who places the machinery or partly completed machinery on the GB market or puts it into service.
Putting into service/Placing on the market – References to placing machinery or partly completed machinery on the market are references to making it available in GB for the first time with a view to distribution and whether for reward or free of charge. References to putting any machinery or partly completed machinery into service are references to the first time that it is used for its intended purpose in GB.
Responsible Person – The manufacturer or their authorised representative, or the person placing the product on the GB market or putting the product into service in GB.
Safe – Machinery that, when properly installed and maintained, and used for the purposes for which it is intended, or under conditions which can be reasonably foreseen does not endanger the health of, or result in death or injury to, any person or domestic animal or endanger property.
UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods being placed on the GB market, in place of the CE marking which is the conformity marking used in Northern Ireland and the European Union.
UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods.

Annex A

Machinery excluded from the Regulations
The Regulations do not apply to:

1. safety components which are: a) intended to be used as spare parts to replace identical components and
b) supplied by the manufacturer of the original machinery
2. equipment specifically for use in fairgrounds and/or amusement parks
3. machinery specially designed or put into service for nuclear purposes which, in the event of failure, may
result in an emission of radioactivity
4. weapons, including firearms
5. subject to paragraph 2 of Schedule 3, the following means of transport: a) agricultural and forestry
tractors, in respect of the risks covered by Regulation 167/2013, b) motor vehicles as defined in regulation
4(1) of the Road Vehicles (Approvals) Regulations 2009, c) vehicles covered by Regulation 168/2013, d)
motor vehicles exclusively intended for competition, and e) means of transport by air, water, and on rail
networks
6. seagoing vessels, mobile offshore units, and machinery installed on board such vessels or units
7. machinery specially designed and constructed for military or police purposes
8. machinery specially designed and constructed for research purposes for temporary use in laboratories
9. mine winding gear
10. machinery intended to move performers during artistic performances
11. electrical and electronic products falling within the following areas, in so far as they are covered by the
Electrical Equipment (Safety) Regulations 2016: a) household appliances intended for domestic use, b)
audio and video equipment, c) information technology equipment, d) ordinary office machinery, e) low-
voltage switchgear and control gear, and f) electric motors
12. the following types of high voltage electrical equipment: a) switch gear and control gear, and b)
transformers

Annex B

Essential Health and Safety Requirements relating to the design and construction of machinery
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) that 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.

General Principles

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:

1. Determine the limits of the machinery, which include the intended use and any reasonably foreseeable
misuse thereof
2. Identify the hazards that can be generated by the machinery and the associated hazardous situations
3. Estimate the risks, taking into account the severity of the possible injury or damage to health and the
probability of its occurrence
4. Evaluate the risks, with a view to determining whether risk reduction is required; and
5. Eliminate the hazards or reduce the risks associated with these hazards by application of protective
measures, in the order of priority established in section 1.1.2(b) of Annex I to Directive 2006/42/EC as set
out in Schedule 2 to the 2008 Regulations.

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.

Footnotes:

1: The following legislative amendments and Government announcements apply:

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 14 November 2022, the Government announced it would be extending this until 31 December 2024. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.
On 20 June 2022, the Government announced the provisions for UKCA labelling would be extended until 31 December 2025. On 14 November 2022, the Government announced it would be extending the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) 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 labelling would be extended until 31 December 2025. On 14 November 2022, the Government announced it would be extending the transition period for UKCA marking until 31 December 2024 and the provisions for UKCA labelling and importer labelling until 31 December 2027. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this.