Statutory guidance

Supply of Machinery (Safety) Regulations 2008: Northern Ireland

Updated 7 November 2023

Guidance on the regulations as they apply to machinery being supplied in or into Northern Ireland.

November 2023

1. Introduction

This Guide is for businesses placing machinery on the market in Northern Ireland.

Under the terms of the Windsor Framework see footnote 1, Northern Ireland (“NI”) aligns with relevant EU rules (in Annex 2) relating to the placing on the market of manufactured goods. Machinery placed on the NI market must follow UK law as it applies to NI. The relevant law is the Supply of Machinery (Safety) Regulations 2008, which apply across the UK, but some of the provisions apply differently in NI so that they implement in Northern Ireland the Directive 2006/42/EC on machinery.

This Guide is designed to help you comply with the Supply of Machinery (Safety) Regulations 2008, as they apply in NI. References to “the 2008 Regulations” in this document are references to the Supply of Machinery (Safety) Regulations 2008, as they apply in NI.

The 2008 Regulations set out the requirements which must be met before machinery can be placed on the NI market or put into service. The purpose of the legislation is to ensure safe machinery is placed on the NI market or put into service by requiring manufacturers to show how their machinery meet the ‘essential health and safety requirements’.

Since 16 July 2021, the EU Regulation on Market Surveillance 2019/1020 (referred to as “MSC” in this document) has replaced the market surveillance provisions in the Regulation on Accreditation and Market Surveillance 765/2008. Under the terms of the Windsor Framework, EU rules on goods listed in Annex 2 apply in Northern Ireland, including MSC, which will be directly applicable in NI and applies in addition to the 2011 Regulations. MSC does not apply in Great Britain.

Article 4 of MSC requires that an economic operator responsible for compliance must be based in the EU (or NI) in order to lawfully place certain products on the market, including machinery. This responsible economic operator must fulfil certain compliance tasks. This Guide summarises key requirements of Article 4, but detailed guidance is available.

Read guidance on placing certain products on the Northern Ireland market

Machinery placed on the Great Britain (“GB”) market (GB comprises England, Scotland and Wales) must follow the separate rules for the GB market. If you are placing machinery on the market in Great Britain, you should read the relevant separate guidance.

Read guidance on the regulations in Great Britain

The government is committed to providing unfettered access for qualifying NI goods to the rest of the UK market. Machinery that can be placed on the market in NI in accordance with the 2016 Regulations, as they apply to NI, can be sold in the rest of the UK without any additional approvals. The arrangements here are explained in detail in the separate guidance for placing machinery on the market in GB.

2. Legislative Background

The Supply of Machinery (Safety) Regulations 2008 implement Directive 2006/42/EC on machinery.

The Directive continues to apply in respect of NI, under the terms of the Windsor Framework. However, the 2016 Regulations (as they apply in NI) also implement parts of the Windsor Framework which have particular provisions in them, recognising that the UK has left the EU.

There is therefore one set of UK 2008 Regulations, but some of the provisions apply differently in NI and GB. References to the 2008 Regulations in this guidance are references to those Regulations as they apply in NI.

The 2008 Regulations were amended by the Product Safety and Metrology etc. (Amendment) (Northern Ireland) (EU Exit) Regulations 2020 and the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 to give effect to the Windsor Framework as it relates to the placing on the NI market of machinery see footnote 2.

3. Scope

The Regulations apply to the following categories of products but only if they do not fall within any of the categories of products specified in Schedule 3 (which sets out the products to which the Regulations do not apply):

(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 (i) above, 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 (i), (ii) and (iii) above 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 NI 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 NI 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.

The Regulations do not apply to a product if or to the extent that other EU legislation that applies to Northern Ireland by virtue of the Windsor Framework makes more specific provisions that the Regulations do in connection with the hazards referred to in Annex I (Part 1 of Schedule 2).

4. Requirements

The 2008 Regulations

The 2008 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 product is safe; that the essential health and safety requirements (EHSRs) are satisfied; carrying out the necessary conformity assessment procedures; drawing up a EC declaration of conformity; and ensuring the machinery has the CE marking or both the CE and the UKNI see footnote 3 marking affixed.

MSC

Responsible economic operator

If machinery is offered for sale or supply to NI (or EU) consumers, it is considered to be placed on the EEA market. Article 4 requires that a responsible economic operator must be based in NI (or the EU) to carry out certain compliance tasks in respect of that machinery. This can be the manufacturer, an importer, a manufacturer’s authorised representative, or a fulfilment service. They must carry out the compliance tasks in Article 4 and their contact details must be indicated on the product or on its packaging, the parcel or an accompanying document.

Read guidance on placing certain products on the Northern Ireland market

5. Obligations of ‘responsible persons’

The 2008 Regulations

A ‘responsible person’ under the 2008 Regulations means the manufacturer (see definition of ‘manufacturer in the glossary (section 12)) of the machinery or the manufacturer’s authorised representative. see footnote 4

The obligations of responsible persons in relation to machinery under the 2008 Regulations are:

1. No responsible person shall place machinery on the NI 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 information necessary to operate it safely (i.e. instructions).
5. They must ensure that the relevant conformity assessment procedure is carried out.
6. They must draw up an EC Declaration of Conformity and make sure that a copy of this accompanies the machinery (and retain the original).
7. They must affix the CE marking to the machinery. When conformity assessment has been carried out by a UK notified body, the UKNI marking (also known as the (NI) indication) must be affixed as well as the CE marking. A product with both the CE and the UKNI markings cannot be placed on the European Economic Area (EEA) market. There is separate guidance on when and how to use the UKNI marking. Read guidance on UKNI marking
8. For partly completed machinery, the responsible person must ensure that the relevant technical documentation is prepared and made available; that assembly instructions are prepared, and a declaration of incorporation is drawn up and that both accompany the partly completed machinery until it is incorporated into machinery.

MSC

If machinery is offered for sale or supply to NI (or EU) consumers, it is considered to be placed on the EEA market. Article 4 requires that a responsible economic operator must be based in NI (or the EU) to carry out certain compliance tasks in respect of that machinery. This can be the manufacturer, the importer, a manufacturer’s authorised representative, or a fulfilment service. The responsible economic operator must:

1. Keep documentation: Verify that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keep the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for 10 years and ensure that the technical documentation can be made available to those authorities upon request.
2. Provide documentation: If a reasoned request is made by a market surveillance authority, provide them with all information and documentation necessary to demonstrate the conformity of the product.
3. Notify risk: If there is reason to believe a product presents a risk, inform the market surveillance authority.
4. Cooperate: Cooperate with market surveillance authorities, including requests to take appropriate corrective action. If that is not possible, mitigate the risks presented by the product when they believe the product presents a risk or are requested to do so by the market surveillance authorities.

The contact details of the responsible economic operator must be indicated on the product or on its packaging, the parcel or an accompanying document.

6. Obligations of authorised representatives

A manufacturer can appoint an authorised representative to perform certain tasks on their behalf.

An authorised representative appointed by a manufacturer to represent him in either the NI or EEA markets cannot be based in GB. No GB-based authorised representatives are recognised under NI law. This means that GB based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the NI or EEA markets.

An authorised representative must comply with all the duties, imposed on the manufacturer under the 2008 Regulations, that they are appointed for and mandated in writing by the manufacturer to perform.

7. Products placed on the market before 1 January 2021

If you placed an individual fully manufactured product on the EEA or the UK market (either in NI or GB) before 1 January 2021, you do not need to take any additional action. 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 took effect from 1 January 2021.

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:

• contracts of sale concerning goods which have already been manufactured and meet the legal requirements
• invoices
• documents concerning the shipping of goods for distribution

The relevant economic operator (whether manufacturer or authorised representative) bears the burden of proof for demonstrating that the good was placed on the market before 1 January 2021.

8. Conformity Marking

Where machinery is being placed on the NI market, and the manufacturer chooses to have it conformity assessed by an EU recognised body, the marking for the NI and EEA markets continues to be the CE marking.

The CE marking can continue to be used for the GB market see footnote 5, as long as all the other rules have been met.

Since 1 January 2021, where the manufacturer chooses to have the machinery conformity assessed by a UK notified body, the CE marking must be accompanied by the UKNI marking (also known as the UK(NI) indication). Products with the UKNI marking cannot be placed on the EEA market.

There is separate guidance on when and how to use the UKNI marking.

Read guidance on UKNI marking

9. Qualifying Northern Ireland Goods

The government is committed to providing unfettered access for qualifying NI goods to the rest of the UK market after. Machinery that can be placed on the market in NI in accordance with the 2008 Regulations can be sold in the rest of the UK without any additional approvals. The guide to placing machinery on the GB market has further details on these arrangements.

Read guidance on qualifying Northern Ireland goods

10. Notified Bodies

Notified Bodies are independent organisations notified to the European Commission to carry out the procedures for conformity assessment and certification set out in the 2016 Regulations.

From 1 January 2021, all active UK Notified Bodies have remained Notified Bodies for the purpose of products for the NI market. When these UK bodies are used for mandatory conformity assessment activity, then the manufacturer will need to affix both the CE and the UKNI markings. A product with both the CE and the UKNI markings cannot then be placed on the EEA market. There is separate guidance on when and how to use the UKNI marking.

Read guidance on UKNI marking.

A list of EU Notified Bodies can be found on the NANDO website. Economic operators are free to select any suitable Notified Body from any Member State. If a manufacturer uses a EU recognised Notified Body from this list, then they apply only the CE marking to their product (not the CE UKNI marking).

Access the list of UK Notified Bodies.

11. Enforcement

For products intended for workplace use, in NI enforcement is the duty of the Health and Safety Executive for Northern Ireland (HSENI).

In NI district councils have a duty to enforce the 2008 Regulations in relation to machinery not for use at work. In addition, the Secretary of State is able to enforce the 2008 Regulations.

Regulators’ Code

Enforcement 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

Penalties

A person committing an offence under the 2008 Regulations may be liable to a penalty. Penalties can include a fine or a prison sentence of not exceeding three months on summary conviction or of up to two years on indictment 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, and the economic operator is found to be in breach, it is at the discretion of the court to decide the penalties imposed on the offender.

12. Where to find guidance about Directive 2006/42/EC

Access guidance from the European Commission

The European Commission’s ‘Blue Guide’ aims to give a better understanding of EU product safety rules and to their application across different sectors and throughout the EU single market.

Access the Blue Guide from the European Commission

13. Glossary

• Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. An authorised representative can be based anywhere in the EEA or NI, but cannot be based in GB, in respect of products being supplied on the NI market.
• CE marking – the CE marking can be placed on products which are intended for the EU or NI markets and have either been conformity assessed by an EU Notified Body or, where the Regulations permit, have been demonstrated and declared by the manufacturer as meeting the essential health and safety requirements.

• EC Declaration of conformity – A document prepared by the manufacturer which must detail, amongst other things, the following:

  • the specific product to which the declaration is referring
  • the name and address of the manufacturer and, where applicable, their authorised representative

This must be kept by the manufacturer for a period of ten years from the date on which the product was placed on the NI market. This declaration must be made available to the enforcement authority upon request.

• Enforcement Authority – In NI, for products in the use in the workplace, the enforcing authority is the Health and Safety Executive for Northern Ireland (HSENI). For products for private use it is district councils.
• Fulfilment service – A natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved. This does not include postal, parcel or freight services. See footnote 6
• Manufacturer – A person who manufactures machinery with a view to its being placed on the market under that person’s own name or trademark or for that person’s own use in NI or an EEA state, or if there is no such person, the person who places that machinery or partly completed machinery on the market or puts it into service.
• Notified Body – A conformity assessment body based in the EEA or recognised for the purpose of carrying out the functions of a notified body under an agreement with between the EU and another country which has been designated and notified to carry out conformity assessment for placing products on the EU and NI markets; or a conformity assessment body that is based in the UK and have been approved and notified by the Secretary of State, including bodies which were notified bodies while the UK followed EU rules. If these UK based Notified Bodies are used, the CE marking must be accompanied by the UKNI marking and cannot be placed on the EEA market (just the NI market, or, where it is also a qualifying NI good, the GB market)
• Responsible person – the manufacturer (as defined, see above) or the manufacturer’s authorised representative (see above).
• UKCA marking – The UK Conformity Assessed UKCA) 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 the European Union. Products being placed on the NI market cannot be UKCA marked and must continue to be CE marked. There are special arrangements in place to ensure NI’s unfettered access to the rest of the UK.
• UKNI marking (also known as the UK(NI) indication) – The UKNI marking must be used along with the CE marking if manufacturers wish to use a UK Notified Body for conformity assessment. The UKNI marking allows the product to be placed on the NI market (and, under the Government’s unfettered access commitments, where the product is also a qualifying NI good, on the GB market), but not the EEA market.

Annex A

Machinery excluded from the 2008 Regulations

The 2008 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 Article 3(16) and (17) of Regulation 2018/858, c) vehicles covered by Regulation 168/2013, d) motor vehicles exclusively intended for competition, e) means of transport by air, on 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, insofar 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 2008 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.

The listing in Schedule 2, Part 1 of the 2008 Regulations 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 his machinery and in respect of which he 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.

14. Footnotes:

1: The “Windsor Framework” has the same meaning as set out in Joint Declaration No 01/2023 by the United Kingdom of Great Britain and Northern Ireland and the European Union in the Withdrawal Agreement Joint Committee on the Windsor Framework on 24 March 2023.

2: In 2019, the 2001 Regulations were amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 to fix any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and make specific provision for the UK market. The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were then 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 Windsor Framework.

3: Since 1 January 2021, where the manufacturer chooses to have the equipment conformity assessed by a UK notified body, the CE marking must be accompanied by the UKNI marking (also known as the UK(NI) indication). Products with the UKNI marking cannot be placed on the EEA market.

4: An authorised representative appointed by a manufacturer to represent him in either the NI or EEA markets cannot be based in GB. This means that GB based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the NI or EEA markets. An authorised representative based in NI can, under the 2001 Regulations as they apply in NI, carry out tasks on the manufacturer’s behalf for products placed on the NI or EEA markets.

5: 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 1 August 2023, the UK Government announced its intention to introduce legislation to extend recognition of goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. This will mean that certain goods that meet EU requirements can be placed on the GB market. These updates apply to the 18 regulations that fall under the Department for Business and Trade (DBT).

6: Fulfilment service is defined in Article 3 of MSC and for the purposes of MSC only is considered an economic operator. There are no specific obligations on fulfilment services under the 2008 Regulations.