Pressure Equipment Safety Regulation

Pressure Equipment Safety Regulation

This Guide is designed to help you understand The Pressure Equipment (Safety) Regulations.
The 2016 Regulations 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 from unsafe products by requiring manufacturers to show how their pressure equipment or assemblies meet the ‘essential safety requirements’.

Scope

The 2016 Regulations 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. “Assembly” means several pieces of pressure equipment assembled to form an integrated, functional whole.

Product classification

In order to know how the 2016 Regulations apply to specific items of pressure equipment, the manufacturer will need to know:

a) the type of equipment concerned, i.e. vessel, steam generator or piping
b) the state of the intended fluid contents – gas or liquid and
c) the fluid group of the intended contents –

Group 1 or Group 2. Group 1 comprises those substances and mixtures:

(i) unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5
(ii) flammable gases, category 1 and 2
(iii) oxidising gases, category 1
(iv) flammable liquids, category 1 and 2
(v) flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint
(vi) flammable solids, category 1 and 2
(vii) self-reactive substances and mixtures, type A to F
(viii) pyrophoric liquids, category 1
(ix) pyrophoric solids, category 1
(x) substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3
(xi) oxidising liquids, category 1, 2 and 3
(xii) oxidising solids, category 1, 2 and 3
(xiii) organic peroxides types A to F (xiv) acute oral toxicity, category 1 and 2
(xv) acute dermal toxicity, category 1 and 2
(xvi) acute inhalation toxicity, category 1, 2 and 3 and
(xvii) 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 2016 Regulations 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 2016 Regulations 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 the UKCA mark. This is set out in regulation 8 of the 2016 Regulations.

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

Definitions

Approved Body – A conformity assessment body which has been approved by the Secretary of State or was previously a UK ‘notified body’ before 1 January 2021.

Authorised Representative – A person appointed in writing by a manufacturer to perform specific tasks for the manufacturer. From 1 January 2021, authorised representatives for the GB market must be based in the UK. Manufacturers remain ultimately responsible for ensuring these tasks are carried out properly.

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

o The specific equipment to which the declaration is referring
o 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 Great Britain, 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 GB on the 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 UK or the EU or from Switzerland will now be 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 UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including pressure equipment or assemblies) being placed on the GB market, in place of the CE marking, which is the conformity marking used in Northern Ireland and the European Union.

UKNI Marking (also known as the UK(NI) indication) – The UKNI marking is a new marking applied in addition to the CE marking, where a good requiring mandatory third-party conformity assessment has been tested against EU requirements by a UK body. The UKNI marking applies when placing such products on the Northern Ireland market. Under the Government’s unfettered access commitments, products lawfully marked with the UKNI marking can also be placed on the GB market if they are also qualifying Northern Ireland goods.

Module A Category I

Internal production control can only be applied when the pressure equipment when categorised falls within Sound Engineering Practices (SEP) or Category I

Internal production control is the conformity assessment procedure whereby the manufacturer conducts a hazard risk assessment and completes the technical documentation laid down below and supplies with the product instructions for use, and declaration of conformity which declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this regulations and any other applicable regulations.

Module A2, D1 & E1 Category II

These requirements require some sort of approval body involvement, although the manufacture is responsible for the hazard risk assessment and technical documents, as detailed below, plus supplying the customer with the instruction and DoC with a copy of the UK type-examination certificate or unit verification certificate

Module A2 requires an Internal production control with monitoring of the final assessment by an approval body

Module D1 requires QA system for production to be assessed by an approval body

Module E1 requires QA system and final inspection assessment by an approval body

Module H Category III

Module H requires the approval body to evaluate the full quality system, production, design, final inspection and test

Module H1 Category IV

Module H1 requires the approval body to evaluate the full quality system, conduct a design examination and surveillance assessment

All the other categories the Approval Bodies produce an UK type examination for production or design dependent on quality assessments except module G which is a one-off examination of the design and produces a Unit verification certificate

Obligations of manufacturers

A manufacturer is a person who manufactures pressure equipment or has pressure equipment 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, a 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 classify the equipment or assembly into the appropriate category, determine the conformity procedure that applies and carry out the relevant conformity assessment procedure and draw up the relevant technical documentation.

3. Once this has been done, a manufacturer must draw up a declaration of conformity, ensure that declaration accompanies the product and affix the UKCA marking to the product. Where it is not possible or not warranted on account of the nature of the equipment or assembly to affix the UKCA marking on the pressure equipment or assembly (or its data plate), then it can be affixed to the packaging and accompanying documents.

4. In any event, there is a dispensation until 31 December 2022, 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. Where applicable, they must also ensure that the identification number of the relevant conformity assessment body is affixed to the equipment or assembly.

5. Qualifying Northern Ireland goods can be placed on the GB market with the CE and CE UKNI conformity markings.

6. Manufacturers must draw up and keep the declaration of conformity up to date and keep it and the relevant technical documentation for 10 years.

7. Manufacturers must label their products with their name, registered trade name or registered trademark and address; 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.

8. When placing pressure equipment or an assembly on the GB market, a 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).

9. When appropriate, with regard to the risks to the health and safety of consumers and other users, manufacturers must carry out sample testing and they must investigate any complaints that the pressure equipment or assemblies are not in conformity and keep records of these complaints.

10. Manufacturers must take action where they have reason to believe that any product is not in conformity with the 2016 Regulations.

Manufacturers based in Northern Ireland can follow the legislation as it applies to Northern Ireland and place qualifying Northern Ireland goods on the GB market without any additional approvals.

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 Northern Ireland but after 1 January 2021 cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK, under the 2016 Regulations 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 Northern Ireland or EEA markets. Therefore, a GB manufacturer selling pressure equipment or assemblies to the EEA or into Northern Ireland, 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 Northern Ireland 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 representative's mandate (e.g. retention of technical documentation).

A 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.

Obligations of importers

An importer is a person or business based in the UK who places pressure equipment and assemblies on the GB market from a country outside the UK. This means that UK businesses which used to act as a ‘distributor’ before the end of the transition period legally become an ‘importer’ if they place products from an EEA country on the GB market.

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

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 its packaging or in accompanying documentation.

To assist with the transition, the UK is applying a transitional period ending on 31 December 2022 to allow UK suppliers of goods from the EEA or Switzerland (who from 1 January 2021 become 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 Northern Ireland 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 goods from an EEA state on the GB market for the first time, you may provide your contact details in a document that accompanies the product. This will be allowed until 31 December 2022.

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 the 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 2022. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address were 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.

The obligations of importers include:

1. The importer must ensure that where relevant, the relevant conformity assessment has been carried out by the manufacturer; the manufacturer has drawn up technical documentation; the pressure equipment or assembly has the UKCA marking, when relevant, and is accompanied by the required documents and that the manufacturer has complied with the labelling requirements imposed on the manufacturer.

2. Where it is not possible or warranted on account of the nature of the equipment or assembly to affix the UKCA marking on the pressure equipment or assembly (or its data plate), then it can be affixed to the packaging and accompanying documents. In any event, there is a dispensation until 31 December 2022, allowing the UKCA marking (when relevant) to be affixed to a label affixed to, or a document accompanying, the pressure equipment or assembly, rather than to the product itself.

3. The importer must keep a copy of the declaration of conformity 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. 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.

5. The importer must provide their name, registered trade name and a postal address at which they can be contacted on the pressure equipment or assembly, or where this is not possible on its packaging or in its accompanying documentation.

6. 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.

7. 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 2016 Regulations and keep a register of those complaints.

8. The importer must take action where they have reason to believe that the pressure equipment or assembly that they have placed on the GB market is not in conformity with the 2016 Regulations.

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 Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may also be placed on the GB market

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. The same applies to distributors of goods from the EEA and Switzerland.

The obligations of distributors include:

1. Before making available on the GB market, a distributor must take due care to ensure that it is in conformity with Part 2 of the 2016 Regulations, 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, a distributor must verify that the pressure equipment or assembly bears the UKCA marking (when relevant), 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

3. Where it is not possible or warranted on account of the nature of the equipment or assembly to affix the UKCA marking on the pressure equipment or assembly (or its data plate), then it can be affixed to the packaging and accompanying documents. In any event, there is a dispensation until 31 December 2022, 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.

4. The distributor must ensure that while pressure equipment or assembly is 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 the pressure equipment that they have made available on the GB market is not in conformity with the 2016 Regulations.

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

Self-declaration:

Manufacturers selling pressure equipment and assemblies on the GB market can affix the new UKCA marking (when relevant) before placing the equipment and assemblies on the GB market. CE marking based on self-declaration of conformity by the manufacturer is still possible until 31 December 2021 for the GB market.

It will also be possible to affix both the UKCA marking and the CE marking to the same product on the basis of self-declaration, as long as the EU and GB requirements remain the same. When selling to the EU, the CE marking remains mandatory.

HOW WE CAN HELP:

Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.

The CE Marking Authority have a positive attitude and approach regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialise in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations

Our expert team is here to help you meet the UKCA and CE Marking the requirements

• Free initial consultation to assess your requirements and plan the UKCA marking of your product.
• Identify the statutory instruments, the essential safety requirements and designated standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the UK safety regulations.
• Provide a draft UK Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.

The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonisation of your systems