Statutory guidance

Pressure Equipment (Safety) Regulations 2016: Great Britain

Updated 4 December 2024

Guidance on the regulations as they apply to equipment 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 pressure equipment or assemblies on the market in Great Britain (GB). ^{[footnote 1]}

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

This Guide is designed to help you understand the Pressure Equipment (Safety) Regulations 2016, (referred to in this document as “the PE(S)R”), as they apply to GB. The PE(S)R set out the requirements that must be met before pressure equipment or assemblies can be placed on the GB market. The purpose of the legislation is to protect consumers and other end users from unsafe products by requiring manufacturers to show how their pressure equipment or assemblies meet the ‘essential safety requirements’.

The Regulations regulate the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.

2. Legislative Background

The PE(S)R implemented Directive 2014/68/EU on pressure equipment and assemblies. The EU Withdrawal Act 2018 preserved the PE(S)R and enabled them to be amended so as to continue to function effectively once the UK 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.

There is therefore one set of UK PE(S)R, but some of the provisions apply differently in NI in line with the terms of the Windsor Framework. References to the PE(S)R in this guidance are references to those Regulations as they apply in GB.

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.

Read guidance on the regulations in NI.

3. Scope

The PE(S)R apply to pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar, although there are a number of exclusions, which are set out in regulation 4 and Schedule 1 to the Regulations. “Pressure equipment” means vessels, piping, safety accessories and pressure accessories and, where applicable, elements attached. “Assembly” means several pieces of pressure equipment assembled to form an integrated and functional whole. For full details of ‘permanent joints’, ‘piping’, ‘pressure accessories’, ‘safety accessories’ and other definitions see Regulation 2.

4. Product classification

In order to know how the PE(S)R apply to specific items of pressure equipment, the manufacturer will need to know:

1. the type of equipment concerned, i.e. vessel, steam generator or piping
2. the state of the intended fluid contents – gas or liquid and
3. the fluid group of the intended contents – Group 1 or Group 2.

Group 1 comprises those substances and mixtures: ^{[footnote 2]}

• unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5
• flammable gases, category 1 and 2
• oxidising gases, category 1
• flammable liquids, category 1 and 2
• flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint
• flammable solids, category 1 and 2
• self-reactive substances and mixtures, type A to F
• pyrophoric liquids, category 1
• pyrophoric solids, category 1
• substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3
• oxidising liquids, category 1, 2 and 3
• oxidising solids, category 1, 2 and 3
• organic peroxides types A to F
• acute oral toxicity, category 1 and 2
• acute dermal toxicity, category 1 and 2
• acute inhalation toxicity, category 1, 2 and 3
• specific target organ toxicity – single exposure, category 1

Assistance with identifying the hazard classes of substances can be found on the Health and Safety Executive (HSE) website.

Group 1 also comprises substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid.

Group 2 comprises substances and mixtures not referred to under group 1, within the definition of a fluid, including steam.

With this information the manufacturer can identify the relevant conformity assessment table in Schedule 1B to the PE(S)R ^{[footnote 3]} and determine the correct classification of the equipment by plotting the maximum allowable pressure and, in the case of vessels, the volume in litres or, for piping, the nominal size (DN).

Equipment and assemblies which are below or equal to the limits set out in regulations 6(a)-(c) or 7 of the PE(S)R must be designed and manufactured in accordance with sound engineering practice in order to ensure safe use and must be accompanied by adequate instructions for use. Unless required by other applicable legislation, this second category of equipment and assembly must not bear a conformity assessment marking (e.g. the UKCA or CE marking (see section 9)). This is set out in regulation 8 of the PE(S)R.

In the paragraphs below, unless indicated otherwise, the references to pressure equipment or assemblies does not include those under the limits referred to in regulation 8.

5. Obligations of manufacturers

A manufacturer is a person who manufactures pressure equipment and/or assemblies, or has pressure equipment and/or assemblies designed or manufactured, and either markets that pressure equipment under their name or trademark or uses it for their own purposes.

The obligations of manufacturers of pressure equipment include:

1) Before placing pressure equipment on the GB market or using it for their own purposes, the manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements; or, in the case of equipment falling within regulation 8, that it meets the requirements of that regulation.

2) The manufacturer then must:

a) classify the equipment or assembly into the appropriate category

b) decide which conformity assessment marking (UKCA, CE, or CE + UKNI) they intend the equipment to have when placed on the GB market (see section 9)

c) determine the conformity procedure that applies, draw up the relevant technical documentation

d) 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)

Where can the independent third party/ certifying body be based?

Where the independent third party can be based is determined by the final marking of the product. UK approved bodies can only conformity assess equipment for UKCA marking. Their activities are not recognised by the European Commission for the purposes of CE marking. EU Notified Bodies can only conformity assess for CE marking, but their activities can count towards UKCA marking, though they themselves cannot UKCA mark pressure equipment.

Slightly different rules apply to the certifying of personnel and materials for pressure equipment. Part 3 of Schedule 2 to the Regulations, as amended by the Pressure Equipment (Safety) (Amendment) Regulations 2024 (SI 2024/490), includes in the essential safety requirements, the use of:

a) Suitably qualified personnel for permanent joining activities for pressure equipment in Categories II, III and IV.

a. For pressure equipment intended for UKCA marking and placing on the GB market, permanent joining personnel must be approved by a competent approved body, Notified Body or Recognised Third-Party Organisation (“RTPO”), based either in the UK or in the European Economic Area (EEA).

b. For pressure equipment intended for CE marking and placing on the GB market, permanent joining personnel must be approved by a competent Notified Body or RTPO, based in the EEA.

b) Suitably qualified personnel for non-destructive testing activities for pressure equipment in Categories III and IV.

a. For pressure equipment intended for UKCA marking and placing on the GB market, non-destructive testing personnel must be approved by an RTPO based either in the UK or in the EEA.

b. For pressure equipment intended for CE marking and placing on the GB market, non-destructive testing personnel must be approved by an RTPO based in the EEA.

Part 4 of Schedule 2 to the Regulations includes in the essential safety requirements, the use of suitable materials:

a) For pressure equipment in Categories III and IV intended for UKCA marking and placing on the GB market, material appraisals can be carried out by a UK approved body or an EU Notified Body.

b) For pressure equipment in Categories III and IV intended for CE marking and placing on the GB market, material appraisals can be carried out by an EU Notified Body.

c) For pressure equipment intended for the GB market, either for UKCA or CE marking, a material manufacturer’s quality assurance system can be certified by a competent body based either in the UK or in the EEA.

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.

A list of EU Notified Bodies can be found on the NANDO website.

3) Once the relevant conformity assessment procedure has been done, but before placing the product on the market, the manufacturer must:

a) Draw up a declaration of conformity (UK DoC if UKCA marked, EU DoC if CE marked (see section 9 for information on CE/ UKCA conformity assessment)).

b) Affix the applicable conformity assessment marking (see section 9) ^{[footnote 4]} visibly, legibly and indelibly to the equipment. Where it is not possible or not warranted on account of the nature of the equipment or assembly to affix the conformity assessment marking directly on the pressure equipment or assembly (or its data plate), then it can be affixed to the packaging and accompanying documents. ^{[footnote 5]}

4) Where applicable, the manufacturer must ensure that the identification number of the relevant conformity assessment body is affixed to the equipment or assembly.

5) The manufacturer must keep the declaration of conformity (UK DoC if UKCA marked, EU DoC if CE marked) up to date and keep it and the relevant technical documentation for 10 years.

6) The manufacturer must label the product with their name, registered trade name or registered trademark and address, and with the type, batch or serial number (or other identification). The name and address must be clear, legible and in easily understandable English. This applies to all products (including those to which regulation 8 refers). Where it is not possible to put this information on the pressure equipment or assembly, the manufacturer must ensure it is given on its packaging or a document accompanying the equipment or assembly.

7) When placing pressure equipment or an assembly on the GB market, the manufacturer must ensure that it is accompanied by instructions and safety information in clear, legible and in easily understandable English. This applies to all products (including those to which regulation 8 applies).

8) The manufacturer must ensure that procedures are in place for series production to remain in conformity with Part 2 of the PE(S)R. In doing so, they must take account of any changes in pressure equipment or assembly design or characteristics, and any change in a harmonised standard or in another technical specification by reference to which the declaration of conformity was drawn up.

9) When appropriate, with regard to the risks to the health and safety of consumers and other users, the manufacturer must carry out sample testing and they must investigate any complaints that the pressure equipment or assemblies they have placed on the GB market are not in conformity with the 2016 Regulations, and keep records of these complaints, of products found not to be in conformity, and of product recalls.

10) The manufacturer must take action where they have reason to believe that any product is not in conformity with the PE(S)R. Where pressure equipment or an assembly presents a risk, the manufacturer must immediately inform the market surveillance authority (MSA) of the risk, giving details of (a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and (b) any corrective measures taken.

Read more information on how to notify the MSA.

Manufacturers wishing to place goods on the NI market should follow the legislation 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 10 on Qualifying NI Goods.

6. Obligations of authorised representatives

Manufacturers are able by written mandate 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 PE(S)R as they apply in GB.

No GB-based authorised representatives are recognised under EU 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. Therefore, a GB manufacturer selling pressure equipment or assemblies to the EEA or into NI, who wishes to appoint an authorised representative to carry out tasks for them in respect of the product, 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 PE(S)R 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 PE(S)R 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.

7. Obligations of importers

An importer is a person established in the UK who places pressure equipment from a country outside of the UK on the GB market. This means that a UK business which acted 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 pressure equipment and assemblies 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 10 on Qualifying NI Goods).

Importers have additional legal obligations which 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 equipment or, where this is not possible, on the packaging or in accompanying documentation.

To assist with the transition, the UK is applying a transitional period ending on 31 December 2027 ^{[footnote 6]} to allow UK suppliers of goods from the EEA or Switzerland (who from 1 January 2021 became importers into the GB market) to provide their details on the accompanying documentation as an alternative to placing them on the product itself. This applies to goods that are not qualifying NI goods. For further detail on qualifying NI goods, please see Section 10 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 arrangements you may have the new status of an importer when placing pressure equipment or an assembly from an EEA state or Switzerland on the GB market, you are temporarily permitted when placing such equipment or assemblies on the market (until 31 December 2027) to indicate your name, registered trade name or registered trade mark and a postal address on the equipment or assembly’s packaging or in a document accompanying the equipment or assembly, instead of on the equipment or assembly itself. As set out above, this is usually only permitted where it is not possible to provide the specified information on the equipment or assembly itself. This additional temporary easement is permitted until 31 December 2027.

We understand that 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, pressure equipment and assemblies being sold from GB to NI or the EEA must be labelled with the NI or EU-based importer’s address.

Read guidance on the regulations in NI.

The obligations of importers include:

1) The importer must ensure that where relevant:

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

b) the manufacturer has drawn up technical documentation

c) the pressure equipment or assembly has the relevant conformity assessment marking (see section 9 (or 10 for Qualifying NI goods)), when relevant, and is accompanied by the required documents

d) the manufacturer has complied with the labelling requirements with regard to contact details and conformity assessment body number (see section 5)

2) Where it is not possible or warranted on account of the nature of the equipment or assembly to affix the conformity assessment marking on the pressure equipment or assembly (or its data plate), then it can be affixed to packaging and accompanying documents. ^{[footnote 4]}

3) The importer must keep a copy of the declaration of conformity (UK DoC if UKCA marked, EU DoC if CE marked) and technical documentation for a period of 10 years after the pressure equipment or assembly has been placed on the GB market and must co-operate with and provide information to the enforcing authorities when requested.

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 pressure equipment or assembly, or where this is not possible, or where the importer has imported the equipment from an EEA state or Switzerland and places it on the GB market before 31 December 2027, on its packaging or in its accompanying documentation. ^{[footnote 5]}

5) The importer must ensure that when placing pressure equipment or assembly on the GB market, it is accompanied by instructions in clear, legible and easily understandable English.

6) Having regard to the risks to the health and safety of consumers and other users, the importer, when appropriate, must carry out sample testing of the pressure equipment or assembly they have placed on the GB market and must investigate complaints about pressure equipment or assemblies that are not in conformity with the PE(S)R and keep a register of those complaints.

7) When an importer has reason to believe that pressure equipment or an assembly is not in conformity with the essential safety requirements, the importer must not place the pressure equipment or assembly on the GB market.

8) The importer must take action where they have reason to believe that any product is not in conformity with the PE(S)R. Where pressure equipment or an assembly presents a risk, the importer must immediately inform the MSA of the risk, giving details of (a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and (b) any corrective measures taken. Read more information on how to notify the MSA.

9) The importer must ensure that pressure equipment or assembly under their responsibility must be transported and stored in conditions that do not affect their conformity with the essential safety requirements.

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 11 on Qualifying NI Goods.

8. Obligations of distributors

UK businesses which were distributors of pressure equipment 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 7 above. The same applies to distributors of goods from the EEA and Switzerland.

A distributor is any person in the supply chain, other than the manufacturer or importer, who makes pressure equipment or assemblies available on the GB market.

The obligations of distributors include:

1) Before making available on the GB market, the distributor must take due care to ensure that it is in conformity with Part 2 of the PE(S)R, meaning that it conforms with the essential safety requirements and that each economic operator has complied or is complying with the obligations imposed on them under Part 2.

2) Before making pressure equipment or assembly available on the GB market, the distributor must verify that the pressure equipment or assembly bears the relevant conformity assessment marking ((see section 9 (or 10 for Qualifying NI goods)), ^{[footnote 4]} and is accompanied by the required documents, instructions and safety information, and that the manufacturer and importer have complied with their labelling and identification requirements. ^{[footnote 5]}

3) Where it is not possible or warranted on account of the nature of the equipment or assembly to affix the conformity assessment marking on the pressure equipment or assembly (or its data plate), then it can be affixed to packaging and accompanying documents.

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

5) Where the distributor has reason to believe that the pressure equipment or assembly is not in conformity with Part 2, they must not make it available on the market until it is brought into conformity.

6) The distributor must take action where they have reason to believe that any product is not in conformity with the PE(S)R. Where pressure equipment or an assembly presents a risk, the distributor must immediately inform the MSA of the risk, giving details of (a) the respect in which the pressure equipment or assembly is considered not to be in conformity with Part 2; and (b) any corrective measures taken. Read more information on how to notify the MSA.

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

9. Conformity assessment and marking before placing a product on the GB market

As set out in section 5 above, before placing pressure equipment or assemblies on the GB market or using it for their own purposes, the manufacturer must:

a) design and manufacture the equipment or assembly in accordance with the essential safety requirements; or, in the case of equipment falling within regulation 8, that it meets the requirements of that regulation

b) classify the equipment or assembly into the appropriate category, 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

Unless the pressure equipment or assembly falls under the limits referred to in regulation 8, it should be marked with the applicable conformity assessment marking, provided it meets the essential safety requirements, and the relevant conformity assessment procedure has been carried out and/or a certificate has been issued by the relevant body. ^{[footnote 4]}

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 [email protected].

Where do I affix the conformity assessment marking?

The conformity assessment marking should be affixed visibly, legibly and indelibly to the equipment or assembly. Where it is not possible or not warranted on account of the nature of the equipment or assembly to affix the conformity assessment marking directly on the pressure equipment or assembly (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 assembly or a document accompanying the equipment or assembly, rather than being affixed to the equipment or assembly itself (even where it is otherwise possible to affix it to the equipment or assembly itself).

Placing on the market

A fully manufactured good is ‘placed on the market’ when it is first made available for distribution, consumption or use on the GB market as part of a commercial activity. This can be in return for payment or free of charge.

This happens after a product has been fully manufactured. A product is placed on the market when an offer or agreement is made for the transfer of ownership, possession or any other property right. Placing on the market can take place before the physical transfer of a product. Indeed, placing on the market does not necessarily require the physical handover of a product.

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

Transactions between economic operators established outside of the UK do not constitute placing on the GB market where the product is not destined for the GB market.

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.

If you sell components separately that were once part of an assembly or installation, you must make sure they continue to meet the requirements in place when they were first placed on the GB market as part of an assembly or installation.

If the components required CE marking at the time they were first placed on the GB market, then the person selling the components must check they are currently CE marked. They must also check they are properly labelled and accompanied by the required documents. If the person selling the components has reason to believe they do not meet the requirements (including any essential safety requirements), they must not make them available.

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.

Read guidance on UKCA marking.

10. 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, or
• 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 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 7 on obligations of importers).

Read guidance on qualifying NI goods.

11. Approved Bodies

The UK established a new framework for UK based bodies to assess pressure equipment and assemblies against GB rules. Existing UK notified bodies were granted new UK ‘approved body’ status and listed on a new UK database. This includes recognised third-party organisations (RTPO) and user inspectorates (UI). 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, RTPOs and UIs can assess products and processes for the UK market against UK essential safety requirements (which are substantially the same as EU essential requirements) with respect to the activities for which they have been approved.

UK approved bodies and RTPOs must be established in the UK and be independent of the manufacturer; UIs must act exclusively for the group of which it is part and must be based in the United Kingdom.

Approved bodies that are tasked with assessing the conformity of pressure equipment and assemblies must, as well as test the equipment where necessary, also examine the technical documentation and supporting evidence in respect of pressure equipment to assess the adequacy of the technical design.

Where an approved body, RTPO or UI finds that essential safety requirements have not been met by a manufacturer, they must not issue a certificate of conformity or grant an approval 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.

12. Enforcement

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

In GB, local trading standards authorities have a duty to enforce the Regulations in relation to consumer goods i.e. those intended for private use or consumption.

In relation to equipment or assemblies intended for use on relevant nuclear sites, it is the Office for Nuclear Regulation.

The PE(S)R also provide powers to the Secretary of State or a person appointed to act on their behalf to enforce the PE(S)R.

The PE(S)R provide powers to the authorities to take action against economic operators for products that present a risk and/ or are not in conformity with the PE(S)R as set out in regulations 71 and 73. 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, local trading standards authorities, ONR) will take all appropriate measures to withdraw from the market, to prohibit or restrict the supply of pressure equipment which may endanger the health and safety of persons, domestic animals or property.

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 his regulatory functions.

Read the Regulators’ Code.

Penalties

A person committing an offence under the PE(S)R may be liable to a penalty. Penalties can include:

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

13. 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.
• Competent body – A body such as an approved body or a recognised third-party organisation (RTPO) or user inspectorate (UI) recognised as being able to carry out conformity assessment.
• CE marking – The conformity assessment marking used by the European Union. Certain goods (including pressure equipment) 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, among other things, the following:

  • the specific equipment 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 equipment 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 equipment available on the GB market.
• Enforcing Authority – In GB, for equipment intended for use in the workplace, this is the Health and Safety Executive. For products for consumer use this is local trading standards authorities. For equipment intended for use on nuclear sites it is the Office for Nuclear Regulation.
• Importer – A person established in the UK who places pressure equipment 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 pressure equipment within the EU (including the UK, and including Switzerland) is now an importer if they are bringing pressure equipment into the GB from another country (including EU Member States, the EEA or Switzerland).
• Manufacturer – A person who manufactures pressure equipment, or has pressure equipment designed or manufactured, and either markets that equipment under their name or trademark or uses it for their own purposes.
• UKCA marking – The UK Conformity Assessed (UKCA) marking is the UK conformity marking used for certain goods (including pressure equipment or assemblies) 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.

14. Footnotes

1. Great Britain comprises England, Scotland and Wales. It does not include the Isle of Man or the Channel Islands. ↩

2. As defined in paragraph 7(a) of Part 2 of Schedule 3 to the 2016 Regulations as amended by paragraph 46(c) of Schedule 24 to the 2019 Amendment Regulations. ↩

3. As introduced by paragraph 44 of Schedule 24 to the 2019 Amendment Regulations. ↩

4. There are exceptions to conformity marking the equipment or assembly. Regulation 11(2) excludes conformity marking under modules A2, C2 F or G, and where conformity assessment is carried out by a user inspectorate. ↩ ↩² ↩³ ↩⁴

5. Regulation 13 applies. There is also a dispensation until 31 December 2027 allowing the UKCA marking to be affixed to a label affixed to, or a document accompanying, the pressure equipment or assembly, rather than to the product itself. The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (SI 2022/1393) give effect to this. ↩ ↩² ↩³

6. 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. ↩