Statutory guidance

Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016: Great Britain

Updated 18 December 2024

Guidance on the regulations as they apply to equipment or systems being supplied in or into Great Britain.

This guidance has been amended to reflect the announcements on 1 August 2023 and 24 January 2024 that the Government is extending recognition of certain goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. The Product Safety and Metrology etc. (Amendment) Regulations 2024 give effect to this and came into force on 1 October 2024.

December 2024

1. Introduction

This Guide is for businesses placing equipment and protective systems intended for use in potentially explosive atmospheres on the market in Great Britain (“GB”).

Read guidance on the regulations in Northern Ireland (“NI”).

This Guide is designed to help you comply with The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016, as they apply in GB (referred to in this document as the “2016 Regulations”). The 2016 Regulations set out the requirements that must be met before products can be placed on the GB market. The purpose of the legislation is to ensure safe products are placed on the GB market by requiring manufacturers to show how their products meet the ‘essential health and safety requirements’.

2. Legislative Background

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 implemented Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres.

The EU Withdrawal Act 2018 preserved the Regulations and enabled them to be amended so as to continue to function effectively now that the UK has left the EU. Accordingly, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 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 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 GB only, and not to NI, in support of implementing The Protocol of Ireland and Northern Ireland (“The Northern Ireland Protocol”) and now the Windsor Framework.
• 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 NI 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) gave effect to this.
• On 20 June 2022, the Government announced the provisions for UKCA labelling and importer 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.
• On 1 August 2023 and 24 January 2024, the UK Government announced it would extend recognition of goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. This means that certain goods that meet EU requirements can be placed on the GB market beyond 31 December 2024. The Product Safety and Metrology etc. (Amendment) Regulations 2024 give effect to this and came into force on 1 October 2024. The legislation also provides for a ‘Fast-Track’ UKCA scheme, whereby steps taken towards CE marking will count towards UKCA marking, while UK product safety regulations remain aligned with EU product safety law.

3. Scope

The 2016 Regulations apply to equipment and protective systems intended for use in potentially explosive atmospheres as defined in regulation 3.

Specifically, the 2016 Regulations relate to:

• equipment intended for use in potentially explosive atmospheres, defined as machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy or the processing of material and which are capable of causing an explosion through their own potential sources of ignition
• protective systems intended for use in potentially explosive atmospheres, defined as devices which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems
• safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but which are required for or contribute to the safe functioning of equipment and protective systems, with respect to the risks of explosion
• components defined as any item essential to the safe functioning of equipment and protective systems but with no autonomous function

The 2016 Regulations do not apply to products listed in regulation 3(3).

4. Obligations of manufacturers

A manufacturer is a person who manufactures products, or has products designed or manufactured, and markets those products under their name or trademark.

Obligations of manufacturers of products:

1) Before placing a product on the GB market, the manufacturer must:

a) ensure that the product has been designed and manufactured in accordance with the essential health and safety requirements and that they have had the relevant conformity assessment procedure carried out and technical documentation drawn up

b) decide which conformity assessment marking (UKCA, CE, or CE + UKNI) (see section 8 (or section 9 for Qualifying NI Goods)) and the specific marking of explosion protection followed by the symbol of the equipment group and category to the product they intend the product to have when placed on the GB market

c) draw up technical documentation

d) ensure that the relevant conformity assessment procedure is carried out

e) draw up a declaration of conformity (UK DoC if UKCA marked, EU DoC if CE marked) or a written attestation of conformity (for components of products)

f) affix the relevant conformity assessment marking (see section 8 (or section 9 for Qualifying NI Goods)) to the product except where it is not possible or warranted to affix the marking to the product, in which case it must be affixed to the packaging and the accompanying documents

2) The manufacturer must keep the declaration of conformity up to date and keep it, along with the technical documentation, for 10 years after the equipment has been placed on the GB market.

3) The manufacturer must label their products with their name, registered trade name or registered trade mark, a postal address, and the type batch or serial number (or other identification). Where the size and nature of the product does not provide sufficient space to include the type, batch or serial number (or other identification) and/or it is not possible to include the manufacturer’s name, registered trade name or registered trade mark or a postal address on the product, the manufacturer must ensure the information is provided on the packaging or in a document accompanying the product.

4) Save where the product is a component, the manufacturer must also ensure it bears the specific marking of explosion protection referred to in paragraph 5(1)(f) of Schedule 1 to the 2016 Regulations, and, where applicable, bears the other markings and information referred to in paragraph 5 of Schedule 1.

5) The manufacturer must ensure that their products are accompanied by relevant instructions and safety information in easily understandable English.

6) Manufacturers must ensure that procedures are in place for series production to remain in conformity with Part 2 of the 2017 Regulations. In doing so, they must take account of any changes in design or characteristics, and any change in a designated standard or in another technical specification by reference to which the UK Declaration of Conformity or attestation of conformity was drawn up.

7) The manufacturer must, when appropriate with regard to any risk posed to end-users, carry out sample testing of products they have placed on the GB market, investigate any complaints that the products are not in conformity with the 2016 Regulations, and keep distributors informed of any actions taken as a result. The manufacturer must also keep a register of these complaints, of products found not to be in conformity, and of product recalls.

8) Manufacturers must take action where they have reason to believe that the products they have placed on the GB market are not in conformity with the 2016 Regulations, by bringing the product into conformity, withdrawing the product or recalling the product. Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority (MSA), giving details of how the product is not in conformity and any corrective measures taken. Read more information on how to notify the MSA.

9) The manufacturer must also cooperate with and provide information to enforcing authorities following any requests.

Manufacturers wishing to place goods on the NI market should follow the Regulation as it applies to NI. Qualifying NI goods can be placed on the GB market without any additional approvals, although additional information as to the UK based importer may be required, if the goods have an importer based in the EU/EEA. See further detail in Section 9 on Qualifying NI Goods.

Technical documentation

Until 31 December 2020, the regulations explicitly required the manufacturer to supply a Notified Body with relevant technical documentation and the Notified Body to acknowledge receipt of the documentation provided by the manufacturer and retain the information so that it was available to MSAs.

Unfortunately, the requirement for the manufacturer to supply a Notified Body with relevant technical documentation was inadvertently deleted from the regulations as they apply from 1 January 2021 to Class I – category M2 and Class II – category 2 equipment which is neither electrical or powered by internal combustion engine, and which has been conformity assessed by the manufacturer on the basis of Module A – Internal Production Control. Nevertheless, the policy and intention of the regulations remains the same, and the omitted explicit obligation will be restored as soon as a legislative opportunity arises.

In the meantime, manufacturers should continue to supply the technical files to an Approved Body so that they in turn can meet their requirements in the regulations to retain the information for MSAs to review.

5. Obligations of authorised representatives

Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf.

Mandated authorised representatives for the GB market can be based in GB or NI but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK under the 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 products being placed on the NI or EEA markets. Therefore, a GB manufacturer selling products to the EEA or into NI, who wishes to appoint an authorised representative to carry out tasks for them in respect of those products, must appoint an authorised representative based in NI or the EEA.

An authorised representative must comply with all the duties imposed on the manufacturer under the 2016 Regulations that they are appointed by the manufacturer to perform. There are some duties that a manufacturer cannot mandate an authorised representative to perform (e.g. conformity assessment) and some that must form part of the authorised representatives mandate (e.g. retention of technical documentation).

The manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.

Any references in the 2016 Regulations to the manufacturer are to be taken to include a reference to the authorised representative including in relation to penalties for failure to comply with those duties.

6. Obligations of importers

An importer is a person or business based in the UK who places equipment and protective systems on the GB market from a country outside the UK. This means that a UK business which used to act as a ‘distributor’ before 1 January 2021 is now legally an ‘importer’ if they place products from an EEA country or Switzerland on the GB market and therefore must comply with the importer duties under GB legislation.

This includes equipment and protective systems that are supplied to NI businesses from the EEA and then placed on the GB market. In this instance the NI business will take on importer obligations for EEA-supplied goods that are placed on the GB market (see also section 9 on Qualifying NI Goods).

Importers have additional legal obligations that go beyond those of distributors, such as checking that manufacturers have carried out the required conformity assessment procedures and including their (the importer’s) name, registered trade name or mark and a postal address on the product or, where this is not possible, on its packaging or in accompanying documentation.

To assist with the transition, the UK is applying a transitional period ending 31 December 2027 ^{[footnote 1]} to allow those UK operators who import goods from the EEA or Switzerland (who from 1 January 2021 are importers) into the GB market to provide their details on the accompanying documentation or packaging as an alternative to placing them on the product itself (even where it would be otherwise possible to include it on the product). This applies to goods that are not qualifying NI goods. For further detail on qualifying NI goods, please see section 9 on Qualifying NI Goods.

Can you be contacted easily if there is a problem?

A key principle underpinning product safety, for the benefit of consumers and regulators, is traceability of a product back to its source.

In recognition that under the new regulatory regime you may have the new status of an importer when placing products from an EEA or Switzerland state on the GB market, you are temporarily permitted when placing such products on the market (until 31 December 2027) to indicate your name, registered trade name or registered trade mark and postal address on the product’s packaging or in a document accompanying the product, instead of on the product itself. As set out above, this is usually only permitted where it is not possible to provide the specified information on the product itself. This additional temporary easement is permitted until 31 December 2027. ^{[footnote 2]}

We understand that there may be a period of adjustment to the new arrangements for importer documentation for the GB market, and it may be difficult to provide your details on documentation accompanying each and every individual product.

You may therefore use an alternative method where, for example, your contact information is on a document accompanying a batch of products. This document would then follow each batch of products through the distribution chain. Your contact details must follow each product through the distribution chain, but not necessarily by one document per product. Ultimately, the end user, each distributor (and a regulator) must be able to access the information.

Methods which enable traceability of the product after the initial batch has been broken up could include:

• The importer address is present in shipping documents.
• The importer address is present on the invoice to the GB customer.
• The importer address is present on the label that is on the outer packaging (“shipper”) in which a number of finished goods is packed (normally customers will receive shippers unless the order is very small so that the shipper has to be opened and split).
• The importer address is included on the EU Declaration of Conformity and/or UK Declaration of Conformity (whichever is relevant for the product in question).

You should work with your distributors to ensure physical documentation does accompany batches of product as far as possible, and in all cases that there are measures in place to ensure end users are able to identify the UK importer.

Alongside that, but not as an alternative, you can use your company website to provide more information, access to product details and contact points for retailers, consumers and enforcement bodies.

These options are for a time limited period only and may not be used after 31 December 2027. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address where required ahead of this date.

The EU does not have any such transitional provision. In the absence of this, equipment and protective systems being sold from GB to NI or the EEA must be labelled with the NI or EU-based importer’s address.

The obligations of importers in the UK include:

1) Before placing a product on the GB market the importer must ensure that:

a) the product is in conformity with the essential health and safety requirements

b) the relevant conformity assessment has been carried out by the manufacturer

c) the manufacturer has drawn up technical documentation

d) the product has the relevant conformity assessment marking (see section 8 (or section 9 for Qualifying NI Goods) and is accompanied by the declaration of conformity or attestation of conformity (as applicable) as well as required labelling including the specific marking of explosion protection followed by the symbol of the equipment group and category to the product and manufacturer’s identification

2) The importer must keep a copy of the declaration of conformity or attestation of conformity (as applicable) and technical documentation for a period of 10 years after the product has been placed on the GB market.

3) The importer must not place products on the GB market unless they conform with the essential health and safety requirements.

4) The importer must provide their name, registered trade name or registered trade mark and a postal address at which they can be contacted on the product or, where it is not possible to provide this on the product, or where the importer has imported the product from an EEA state or Switzerland and places it on the GB market before 31 December 2027, on its packaging or in an accompanying document.

5) The importer must ensure that when placing a product on the GB market, it is accompanied by instructions which can be easily understood by the end user.

6) The importer must, when appropriate, with regard to any risk posed to end-users, investigate any complaints that the products are not in conformity with the 2016 Regulations, and keep distributors informed of any actions taken as a result. The manufacturer must also keep a register of these complaints, of products found not to be in conformity, and of product recalls.

7) The importer must take action where they have reason to believe that the products they have placed on the GB market are not in conformity with the 2016 Regulations, by bringing the product into conformity, withdrawing the product or recalling the product. Where the product presents a risk, the importer must immediately inform the MSA, giving details of how the product is not in conformity and any corrective measures taken. Read more information on how to notify the MSA.

8) The importer must ensure that while products are under their responsibility, their storage and transport conditions do not jeopardise their conformity with the essential health and safety requirements.

9) The importer must also cooperate with and provide information to enforcing authorities following any requests.

Qualifying NI goods complying with the legislation as it applies in NI, including affixing the CE marking, may also be placed on the GB market. See further detail in section 9 on Qualifying NI Goods.

7. Obligations of distributors

UK businesses which were distributors of goods within the EU single market should now consider whether they are importers from the EU single market and therefore what additional requirements they need to comply with – see section 6 above, when placing products on the GB market. The same applies to distributors of goods from the EEA and Switzerland.

A distributor is any person, other than the manufacturer or importer, who makes products available on the GB market.

The obligations of distributors include:

1) When making a product available on the GB market the distributor must act with due care to ensure that it is in conformity with Part 2 of the 2016 Regulations, which means the product must be in conformity with the essential health and safety requirements.

2) Before placing a product on the GB market, the distributor must verify that:

a) the product bears the relevant conformity assessment marking (see section 8 (or section 9 for Qualifying NI goods))

b) the product is accompanied by the declaration of conformity or the attestation of conformity

c) the product is accompanied by instructions and safety information

d) the importer and manufacturer have complied with their obligations as to required labelling including the specific marking of explosion protection followed by the symbol of the equipment-group and category to the product and their identification

3) Where the distributor considers that a product is not in conformity with the health and safety requirements, the distributor must not make that product available on the GB market. Where the product presents a risk, the distributor must inform the manufacturer or the importer, and the MSA. Read more information on how to notify the MSA.

4) The distributor must ensure that while products are under their responsibility, their storage and transport conditions do not jeopardise their conformity with the essential health and safety requirements.

5) The distributor must also cooperate with and provide information to enforcing authorities following any requests.

8. Conformity assessment and marking before placing equipment on the GB market

As set out in section 4 above, before placing equipment on the GB market or using it for their own purposes, the manufacturer must:

a) design and manufacture the equipment in accordance with the essential safety requirements

b) determine the conformity procedure that applies, carry out the relevant conformity assessment procedure, (or have it carried out by an independent third party, depending on the category the product falls into), and draw up the relevant technical documentation

The product should then be marked with the applicable conformity assessment marking, provided it meets the essential requirements, and the relevant conformity assessment procedure has been carried out and/or a certificate has been issued by the relevant body.

What conformity assessment marking should the product have and when?

In line with the Government’s announcements on 1 August 2023 and 24 January 2024 about extended recognition of CE marking for products intended for the GB market, the Product Safety and Metrology etc. (Amendment) Regulations 2024 were made on 23 May 2024, and came into force on 1 October 2024.

These regulations extend recognition of CE marking indefinitely in GB. This allows businesses to use either CE or UKCA markings when placing goods on the GB market beyond 31 December 2024.

However, if GB based businesses wish to place products on the EEA market, they will continue to require a CE marking before the product is placed on the EEA market, including NI.

Self-declaration

Manufacturers placing equipment and protective systems on the GB market on the basis of self-declaration of conformity (where the Regulations permit) can affix either the UKCA marking or the CE marking before placing equipment on the GB market.

It is possible to affix both the UKCA marking and the CE marking to the same equipment, where conformity procedures are based on self-declaration, as long as the EU and GB requirements remain the same. When selling to the EU or supplying to NI, the CE marking remains mandatory.

Where independent third-party conformity assessment is required

Placing on the market in GB	Conditions to be met	Timeframe
Can be CE marked	If the product was conformity assessed by an EU Notified Body (but not a UK Approved Body), and meets all the essential safety requirements	Since 31/12/20
Must be UKCA marked	If the product has been conformity assessed by a UK Approved Body, and meets all the essential safety requirements	Since 31/12/20
Can be UKCA marked, but not CE marked	If the product is intended for placing on the GB market after 1 October 2024, and conformity assessment steps have been begun by an EU Notified Body and completed by a UK Approved Body, and has met all the essential safety requirements	New, since 1 October 2024

Placing on the market in NI	Conditions to be met	Timeframe
Must be CE marked	If the product was conformity assessed by an EU Notified Body and meets all the essential safety requirements	Since 31/12/20
Must be CE + UKNI marked	If the product has been conformity assessed by a UK Approved Body, and meets all the essential safety requirements	Since 31/12/20

Placing on the market in EEA	Conditions to be met	Timeframe
Must be CE marked	If the product was conformity assessed by an EU Notified Body (but not a UK Approved Body), and meets all the essential safety requirements	Since 31/12/20

Can a product be dual marked CE and UKCA?

Yes, but only, and before placing on market:

a) where an EU Notified Body has completed conformity assessment procedures for CE marking, and

b) where a UK Approved Body has completed conformity assessment procedures for UKCA marking, and it meets all the essential safety requirements

OR from 1 October 2024:

c) where an EU Notified Body has completed conformity assessment procedures for CE marking and it meets all the essential safety requirements, the product can also be UKCA marked, or

d) where an EU Notified Body has begun conformity assessment procedures for CE marking, and these have then been completed by a UK Approved Body for UKCA marking and it meets all the essential safety requirements, the product can be UKCA marked

Can a CE marked product already on the market, subsequently be UKCA marked?

A product already on the market, marked with a CE marking, cannot subsequently be UKCA marked, unless it has undergone full conformity assessment by a UK Approved Body and meets all the essential requirements.

Any queries about CE marking or UKCA marking policy should be directed to Goods.Regulation@businessandtrade.gov.uk.

Where do I affix the conformity assessment marking?

The conformity assessment marking should be affixed visibly, legibly and indelibly to the equipment. Where it is not possible or not warranted on account of the nature of the equipment to affix the conformity assessment marking directly on the equipment (or its data plate), then it can be affixed to the packaging and accompanying documents.

Until 31 December 2027, the UKCA marking may be affixed to a label affixed to the equipment or a document accompanying the equipment, rather than being affixed to the equipment itself (even where it is otherwise possible to affix it to the equipment itself). ^{[footnote 2]}

Placing on the market

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

Products imported for further manufacture and components

When products are imported into GB for further manufacture or processing, they are not considered placed on the market. Only fully manufactured products can be considered placed on the market. Under these circumstances, the GB manufacturer of the finished product has the sole and ultimate responsibility for ensuring it is compliant before they place it on the GB market.

A finished product must be compliant with all applicable legislation when placed on the GB market. Components may be placed on the market separately and can constitute a fully manufactured product in its own right. This may include a requirement for the components of the product to be individually conformity assessed and marked. However, for many products, a single marking covering the overall product is sufficient.

Spares

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).

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 MSAs.

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 the relevant legislative requirements at the time the product is first placed on the market or put into service.

9. Qualifying Northern Ireland Goods

The Government committed to providing unfettered access for qualifying NI goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in NI in accordance with the legislation, as it applies to NI, can be sold in the rest of the UK without any additional approvals.

This means that products that are qualifying NI 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 apply in NI under the terms of the Windsor Framework 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 equipment 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 NI goods.

10. Approved Bodies

The UK established a new framework for UK based bodies to assess products against GB rules. Existing UK notified bodies were granted new UK ‘approved body’ status and are listed on a new UK database.

Approved bodies are UK based 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 2016 Regulations.

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 health and safety requirements (which are, as yet, substantially 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 equipment which falls within the scope of the 2016 Regulations to assess the adequacy of the technical design.

Where an approved body finds that essential safety requirements have not been met by a manufacturer, they must not issue a certificate of conformity and they must require the manufacturer to take corrective measures.

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.

11. Enforcement and penalties

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

The Office of Nuclear Regulation is responsible for enforcement in relation to products intended to be used on nuclear sites in GB.

The 2016 Regulations provide powers to the Secretary of State or a person appointed to act on their behalf to enforce the Regulations and RAMS (Regulation EC 765/2008, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which sets out requirements for market surveillance of products.

Note: ATEX has separate Regulations for NI not covered by this guidance. The Health and Safety Executive for Northern Ireland (HSENI) is responsible for enforcement in NI.

The 2016 Regulations also provide powers to MSAs to take action against economic operators for products that present a risk or are not in conformity with the Regulations, as set out in regulation 55 to 60. Economic operators are also required to co-operate with the enforcement authority and on request, must provide information and take action as appropriate.

The UK MSAs (HSE, ONR) will take all appropriate measures to withdraw from the GB market or to prohibit and restrict the supply of products which may endanger the health and safety of persons, property or the environment.

Regulators’ Code

MSAs must continue to 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 Regulations may be liable to a penalty. Penalties can include:

• a fine or prison sentence of up to three months, or both, on summary conviction, or
• a fine or prison sentence of up to two years, or both, on conviction or indictment

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.

12. Glossary

• Approved Body – A conformity assessment body which 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. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.
• CE marking – The conformity assessment marking used by the European Union. Certain goods (including equipment for use in potentially explosive atmospheres) can be placed on the GB market bearing the CE marking. Where third party conformity assessment is required before the CE marking can be affixed, the assessment must be carried out by a Notified Body, not a UK Approved Body.

• Declaration of conformity – A document prepared by the manufacturer which must detail 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 product was placed on the GB market. This declaration must be made available to the enforcing authority upon request.

• Distributor – Any person in the GB supply chain, other than the manufacturer or the importer, who makes a product available on the GB market.
• Market Surveillance Authority – This is the Health and Safety Executive or the Office for Nuclear Regulation (when the product is used on a nuclear site).
• Importer – A person established in the UK who places a product from a country outside of the UK on the GB market. This includes a person based in NI who has been supplied with the product from an EEA country, who would, under NI law, be a distributor. A person who before 1 January 2021 (under EU Rules) distributed products within the EU (including the UK, and including Switzerland) is now an importer if they are bringing products into GB from another country (including EU Member States, the EEA or Switzerland).
• Manufacturer – A person who manufactures a product, or has a product designed or manufactured, and markets that product under their name or trademark.
• UKCA marking – The UK Conformity Assessed (UKCA) marking is the new UK conformity marking used for certain goods being placed on the GB market.
• 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 NI 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 NI goods.

13. Footnotes

1. On 20 June 2022, the Government announced the provisions for importer labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the provisions for 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. ↩ ↩²