Simple Pressure Vessels Regulation

Simple Pressure Vessels Regulation

This Guide is for businesses placing simple pressure vessels on the market in Great Britain (GB) from 1 January 2021

The 2016 Regulations set out the requirements that must be met before simple pressure vessels can be placed on the GB market. The purpose of the legislation is to ensure safe vessels are placed on the GB market by requiring manufacturers to show how their vessels meet the ‘essential safety requirements’.

Scope

The 2016 Regulations apply to simple pressure vessels manufactured in series with the following characteristics:

• the vessels are welded, intended to be subjected to an internal gauge pressure greater than 0.5 bar and to contain air or nitrogen, and are not intended to be fired;

• the parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys;

• the vessel is made of either of the following elements:

- a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part; and

- two dished ends revolving around the same axis.

• the maximum working pressure of the vessel does not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS × V) does not exceed 10 000 bar.L; and

• the minimum working temperature is no lower than – 50 °C and the maximum working temperature is not higher than 300 °C for vessels constructed of steel and 100 °C for aluminium or aluminium alloy vessels.

Assessment Process

There are different requirements according to the category of vessel.

Category A vessels must be designed and manufactured in accordance with the ‘essential safety requirements’ before being placed on the market. Compliance with the terms set out in a designated standard is one way that may demonstrate compliance with the essential safety requirements of the 2016 Regulations. A “designated standard” means a technical specification which has been adopted by a recognised standardisation body3 for repeated or continuous application and which has been designated by the Secretary of State by publishing its reference. A “technical specification” is a document listing the technical requirements which a product must meet.

More information on designated standards will be made available and a link to it will be provided here.

Category B vessels (of a lower capacity and pressure and therefore a lower risk than Category A) must be designed and manufactured in accordance with sound engineering practice.

• Category A vessels are simple pressure vessels of which the product of PS x V exceeds 50 bar.L.
• Category B vessels are simple pressure vessels of which the product of PS x V is 50 bar.L or less.

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.

Obligations of manufacturers

A manufacturer is a person who manufactures simple pressure vessel or has pressure vessel 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 a Category A vessel on the GB market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements. These are set out in Schedule 1 to the 2016 Regulations. They must also have had a relevant conformity assessment procedure carried out and technical documentation drawn up.

2. Once this has been done for Category A vessels, before placing a vessel on the GB market, a manufacturer must draw up a declaration of conformity, ensure that declaration accompanies the product and affix the UKCA marking to the vessel or its data plate and the last two digits of the year in which the UKCA marking is affixed. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the vessel.

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

4. The manufacturer must also affix the inscriptions (that is, the maximum working pressure and temperature, the minimum working temperature and the capacity of the vessel).

5. Before placing a Category B vessel on the GB market, a manufacturer must ensure that the vessel has been designed and manufactured in accordance with sound engineering practice.

6. For Category B vessels, the manufacturer must affix the inscriptions (that is, the maximum working pressure and temperature, the minimum working temperature and the capacity of the vessel) to the vessel or its data plate.

7. For category A vessels, manufacturers must draw up and keep the declaration of conformity up to date and must keep it and the technical documentation for 10 years after the vessel has been placed on the GB market.

8. Manufacturers must also label vessels or their data plates with the type and serial or batch identification, the manufacturer’s name, registered trade name or registered trademark and address and ensure that they are accompanied by instructions and safety information which are clear, legible and in easily understandable English.

9. Manufacturers must, when appropriate with regard to any risk posed to end-users, carry out sample testing of vessels that they have placed on the GB market and investigate any complaints that the vessels are not in conformity with the relevant legal requirements in the Regulations and keep records of these complaints.

10. Manufacturers must take action where they have reason to believe that the vessels are not in conformity with the relevant legal requirements in the Regulations.

11. Manufacturers must also cooperate with and provide information to enforcing authorities following any requests.

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 vessels 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 vessels 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 EEAsupplied 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 the 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 vessels 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. Before placing a Category A vessel on the GB market, an importer must ensure that it is in conformity Part 2 of the 2016 Regulations. This means that the vessel must comply with the essential safety requirements set out in Schedule 1 and that each economic operator has complied or is complying with their obligations under Part 2 of the 2016 Regulations.

2. For Category A vessels, the importer must ensure that the relevant conformity assessment has been carried out by or on behalf the manufacturer; the manufacturer has drawn up technical documentation; the vessel bears the UKCA marking and is accompanied by the Declaration of Conformity. For Category B vessels, the importer must ensure the vessel has been designed and manufactured in accordance with sound engineering practice and that the manufacturer has complied with their labelling obligations. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the vessel.

3. The importer must keep a copy of the Declaration of Conformity and technical documentation for a period of 10 years after the vessel has been placed on the GB market.

4. The importer must provide their name, registered trade name and a postal address at which they can be contacted on the vessel or (in certain circumstances – see above) on documentation accompanying the vessel.

5. The importer must ensure that when placing vessels on the GB market, it is accompanied by instructions and safety information which are clear, legible and in easily understandable English.

6. The importer must ensure that Category A vessels under their responsibility are safely stored and transported.

7. The importer must, when appropriate with regard to any risk posed to consumers, carry out sample testing of vessels and investigate complaints about vessels 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 vessels that they have placed on the GB market are not in conformity with the 2016 Regulations.

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

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 simple pressure vessels 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.

A distributor is any person, other than the manufacturer or importer, who makes a simple pressure vessel available on the GB market.

The obligations of distributors include:

1. Before making a simple pressure vessel available on the GB market a distributor must act with due care to ensure that it is in conformity with Part 2 of the 2016 Regulations.

2. Before making a Category A vessel available on the GB market a distributor must ensure that it bears the UKCA marking and for all vessels subject to the Regulations the distributor must ensure that the vessel bears the inscriptions, that it is accompanied by instructions and safety information, that the manufacturer has complied with the requirements as to labelling and the importer has complied with the requirements as to identification. Until 31 December 2022, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the vessel.

3. The distributor must ensure that the Category A vessels under their responsibility are safely stored and transported.

4. The distributor must take action where they have reason to believe that the vessels that they have made available on the GB market are not in conformity with the Regulations.

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

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