Requirements for Pressure Equipment

EU requirements: Directive 2014/68/EU (the “PED”) sets out requirements relating to pressure equipment, in order to provide for a high level of protection of health and safety of persons, domestic animals, and property. The requirements include safety objectives for the design and manufacture of pressure equipment, labelling requirements, and the applicable conformity assessment procedures. The PED also sets out obligations of manufacturers, importers, and distributors.

If you manufacture, import or distribute pressure equipment, you must comply with the requirements of the PED. You must also comply with national laws and regulations in Member States, which implement the PED.

Please see below for further information about EU requirements.

UK requirements: The UK’s Pressure Equipment (Safety) Regulations 2016/1105 (the “PER”) sets out requirements relating to pressure equipment, in order to provide for a high level of protection of health and safety of persons, domestic animals, and property. The requirements include safety objectives for the design and manufacture of pressure equipment, labelling requirements, and the applicable conformity assessment procedures. The PER also sets out obligations of manufacturers, importers, and distributors.

Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales); and (2) Northern Ireland.

If you manufacture, import or distribute pressure equipment that is sold in the UK, you must comply with the requirements of the PER. If you also sell these products on Amazon EU websites, you must also comply with national laws and regulations in EU Member States, which implement the PED.

Please see below for further information about UK requirements.

This material is for informational purposes and you should not take it as a substitute for legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations related to your product. This material only reflects the position at the date of writing and requirements in the EU and the UK may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (see below) to learn more about changes that may affect you following the end of the transition period.

EU requirements: What products does the PED apply to?

The PED applies to pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.

This includes vessels, piping, safety accessories and pressure accessories, including, wherever applicable, elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, and lifting lugs. It also applies to assemblies, i.e. several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

Examples of products that are covered by the PED: shell and water tube boilers, heat exchangers, plant vessels, industrial pipework, safety valves, and buckling rods.

There are a number of exemptions to the scope of the PED. Examples include: aerosol dispensers, items specifically designed for nuclear use, bottles or cans for carbonated drinks for final consumption, radiators and pipes in warm water heating systems, and vessels designed to contain liquids with a gas pressure above the liquid of not more than 0.5 bar.

Who has obligations under the PED?

The PED sets out obligations for manufacturers, authorized representatives, importers and distributors of pressure equipment.

• You are a manufacturer if you manufacture pressure equipment or an assembly yourself, or have pressure equipment or an assembly designed and manufactured, and market it under your name or trademark or use it for your own purposes.
• You are an authorized representative if a manufacturer has given you a written mandate to act on their behalf in relation to specific tasks.
• You are an importer if you are established in the EU and you offer pressure equipment or assemblies for sale or supply from outside the EU into the EU.
• You are a distributor if you make pressure equipment available for sale or supply but are not a manufacturer or importer.

What are the key requirements of the PED?

Declaration of Conformity and CE marking

Manufacturer responsibilities include:

• Ensuring that the pressure equipment has been designed and manufactured in accordance with the essential requirements set out in the PED, and if applicable sound engineering practice;
• If required, carrying out the applicable conformity assessment and drawing up the relevant technical documentation;
• If required, drawing up an EU declaration of conformity in a language or languages required by the Member State in which the pressure equipment is sold; and
• Affixing the CE marking visibly, legibly, and indelibly to the pressure equipment or to its data plate, and to the packaging.

Importer responsibilities include:

• Ensuring that the appropriate conformity assessment procedure has been carried out by the manufacture, the manufacturer has drawn up the technical documentation, and that the pressure equipment bears the CE marking; and
• Ensuring that while an pressure equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements.

Distributor responsibilities include:

• Acting with due care in relation to the requirements of the PED; and
• Ensuring that while a pressure equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements.

Manufacturers and importers must keep a copy of the technical documentation and declaration of conformity for 10 years after the pressure equipment has been offered for sale or supply in the EU.

Labelling and information

Manufacturers and importers must ensure that the pressure equipment bears:

• For both the manufacturer and importer, the name, registered trade name or registered trade mark, and the postal address at which they can be contacted;
• The type, batch or serial number, or other element allowing the identification of the pressure equipment; and
• The CE marking.

Distributors must:

• Verify that the pressure equipment or assembly bears the CE marking;
• Verify that the pressure equipment or assembly is accompanied by the required documents, instructions, and safety information in a language that can be easily understood by consumers and other users in the Member State(s) where is to be sold;
• Ensure that the manufacturer and importer have complied with the requirement to indicate their name, registered trade name or registered trade mark, and the postal address at which they can be contacted on the pressure equipment or assembly (or wherever not possible, on the packaging); and
• Ensure that the manufacturer has complied with the obligation to mark the pressure equipment or assembly with a type, batch or serial number, or other element allowing their identification.

Where it is not possible for this information to be on the pressure equipment itself, the above information should be on its packaging or a document accompanying the pressure equipment.

In addition, the pressure equipment must be accompanied by instructions and safety information (containing information required by the Annex of the PED). The above information should be in a language that can be easily understood by consumers, other users, and the relevant authorities.

What should you do if pressure equipment is not in conformity with the PED?

Distributors should not make pressure equipment or assemblies available for sale if they find non-conformance with the essential safety requirements set out in Annex I of the PED. If the pressure equipment or assembly presents a risk, distributors must inform the manufacturer or the importer to that effect as well as the relevant authorities.

Manufacturers, importers, and distributors should immediately take the corrective measures necessary to bring pressure equipment into conformity, to withdraw or to recall it, as appropriate.

When the pressure equipment presents a risk, manufacturers, importers, and distributors should immediately inform the competent national authorities of the Member States where it was sold, along with details of the non-conformity and of any corrective measures taken.

Manufacturers, importers, and distributors should provide a competent national authority with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the pressure equipment with the PED, following a reasoned request. They must also cooperate with competent authorities at their request on action taken to eliminate risks relating to those products.

Additional Information

We strongly encourage you to visit the European Commission’s website for more information on the Pressure Equipment Directive:

https://ec.europa.eu/growth/sectors/pressure-gas/pressure-equipment/directive_de

http://ec.europa.eu/DocsRoom/documents/33402?locale=de

UK requirements: Where does the PER apply?

The PER applies to all products sold in the UK, but the provisions apply differently to Great Britain (England, Scotland and Wales, “GB”) and Northern Ireland. You can read more about the position in Northern Ireland (“NI”) below.

What products does the PER apply to?

The PER applies to pressure equipment and assemblies with a maximum allowable pressure PS greater than 0.5 bar.

This includes vessels, piping, safety accessories and pressure accessories, including, wherever applicable, elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, and lifting lugs. It also applies to assemblies, i.e. several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

Examples of products that are covered by the PER: shell and water tube boilers, heat exchangers, plant vessels, industrial pipework, safety valves, and buckling rods.

There are a number of exemptions to the scope of the PER. Examples include: aerosol dispensers, items specifically designed for nuclear use, bottles or cans for carbonated drinks for final consumption, radiators and pipes in warm water heating systems, and vessels designed to contain liquids with a gas pressure above the liquid of not more than 0.5 bar.

Who has obligations under the PER?

The PER sets out obligations for manufacturers, authorized representatives, importers and distributors of pressure equipment.

• You are a manufacturer if you manufacture pressure equipment or an assembly yourself, or have pressure equipment or an assembly designed and manufactured, and market it under your name or trademark or use it for your own purposes.
• You are an authorized representative if a manufacturer has given you a written mandate to act on their behalf in relation to specific tasks.
• You are an importer if:
  • until the end of the Brexit transition period (December 31, 2020), you are established in the EU and you sell pressure equipment from outside the EU into the UK; and
  • after the end of the Brexit transition period (December 31, 2020), you are established in the UK and sell pressure equipment from a country outside of the UK in GB.
  • For details of importing into NI, see the “Northern Ireland” section below.
• You are a distributor if you make pressure equipment available for sale or supply but are not a manufacturer or importer.

What are the key requirements of the PER?

Declaration of Conformity and conformity marking

Manufacturer responsibilities include:

• ensuring that the pressure equipment has been designed and manufactured in accordance with the essential requirements set out in the PER, and if applicable sound engineering practice
• if required, carrying out the applicable conformity assessment and drawing up the relevant technical documentation
• if required, drawing up a declaration of conformity in English
• affixing the required conformity marking visibly, legibly, and indelibly to the pressure equipment or to its data plate, and to the packaging. The relevant conformity marking is as follows:
  • for pressure equipment sold in the UK until the end of the Brexit transition period (December 31, 2020), the European CE mark;
  • for pressure equipment sold in GB after the end of the Brexit transition period (December 31, 2020), the UKCA mark;
  • for products sold in NI while the Northern Ireland Protocol remains in force, the European CE mark (see “Northern Ireland” section below).

Importer responsibilities include:

• ensuring that the appropriate conformity assessment procedure has been carried out by the manufacture, the manufacturer has drawn up the technical documentation, and that the pressure equipment bears the required conformity marking
• ensuring that while a pressure equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements

Distributor responsibilities include:

• acting with due care in relation to the requirements of the PER
• ensuring that while a pressure equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements

Manufacturers and importers must keep a copy of the technical documentation and declaration of conformity for 10 years after the pressure equipment has been offered for sale or supply.

Labelling and information

Manufacturers and importers must ensure that the pressure equipment bears:

• for both the manufacturer and importer, the name, registered trade name or registered trade mark, and the postal address at which they can be contacted
• the type, batch or serial number, or other element allowing the identification of the pressure equipment
• the required conformity marking

Distributors must:

• verify that the pressure equipment or assembly bears the required conformity marking
• verify that the pressure equipment or assembly is accompanied by the required documents, instructions, and safety information in English
• ensure that the manufacturer and importer have complied with the requirement to indicate their name, registered trade name or registered trade mark, and the postal address at which they can be contacted on the pressure equipment or assembly (or wherever not possible, on the packaging)
• ensure that the manufacturer has complied with the obligation to mark the pressure equipment or assembly with a type, batch or serial number, or other element allowing their identification.

Where it is not possible for this information to be on the pressure equipment itself, the above information should be on its packaging or a document accompanying the pressure equipment. The UK Government has released guidance on alternative means of providing GB importer traceability information until December 31, 2022. See the "Brexit: UK Government guidance" section below for links to this guidance.

In addition, the pressure equipment must be accompanied by instructions and safety information (containing information required by the Annex of the PER). The above information should be in English. A specific Declaration of Conformity that refers to UK legislation and standards will be required for products sold in GB with the UKCA mark from January 1, 2021. See the "Brexit: UK Government guidance" section below for links to the UK Government guidance on this.

What should you do if pressure equipment is not in conformity with the PER?

Distributors should not make pressure equipment or assemblies available for sale if they find non-conformance with the essential safety requirements set out in Schedule 2 of the PER. If the pressure equipment or assembly presents a risk, distributors must inform the manufacturer or the importer to that effect as well as the relevant authorities.

Manufacturers, importers, and distributors should immediately take the corrective measures necessary to bring pressure equipment into conformity, to withdraw or to recall it, as appropriate.

When the pressure equipment presents a risk, manufacturers, importers, and distributors should immediately inform Trading Standards (or HSE where the equipment is for use at work), along with details of the non-conformity and of any corrective measures taken.

Manufacturers, importers, and distributors should provide the competent national authority with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the pressure equipment with the PER, following a reasoned request. They must also cooperate with competent authorities at their request on action taken to eliminate risks relating to those products.

Northern Ireland

Please note that different rules will apply in NI from January 1, 2021, as a result of the Northern Ireland Protocol. In particular:

• You should ensure that products meet EU requirements and that you use the CE mark.
• You are an importer if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU / NI based importer.
• Authorised representatives can be based in NI or the EU. From July 16, 2021, new rules come into force under EU Regulation 2019/1020 and some businesses may need to appoint a responsible person in the EU or NI to carry out compliance functions (if there is no other entity in the supply chain who is able to carry out the functions). Further guidance on the new rules will be made available by the UK Government.
• If you are using a UK body to carry out mandatory third-party conformity assessment, you will need to apply a UKNI marking as well as a CE mark to products placed in NI from January 1, 2021. Goods with the CE and UKNI marking can’t be sold in the EU. You do not need to use the UKNI marking if you self-certify compliance or use an EU body to carry out a mandatory third-party assessment.
• “Qualifying Northern Ireland goods” will be able to be sold in GB with the CE mark. The UK Government is issuing guidance on how this will work.

Brexit: UK Government guidance

The UK Government has released guidance on selling products in GB and NI after Brexit. This guidance provides information for manufacturers, importers and distributors regarding compliance requirements from January 1, 2021, including on:

• whether you need to change your conformity assessment;
• when and how to use the UKCA mark;
• requirements for technical documentation and a specific Declaration of Conformity for products sold in GB;
• appointing an authorised representative or responsible person in the UK;
• whether your legal responsibilities will change as a result of Brexit;
• whether you need to provide GB importer information, and methods for doing this (including transitional arrangements until the end of 2022);
• how to deal with existing stock;
• what documentary evidence is required to show that products have been placed in the UK or EU before the end of the Transition Period; and
• specific rules for selling products in NI.

We encourage you to review this guidance, alongside any other specific UK Government guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from January 1, 2021.

The Brexit guidance can be found here:

• GB:
  • Placing manufactured goods in GB from January 1, 2021
  • Using the UKCA mark in GB from January 1, 2021
  • Product Safety and Metrology in GB from January 1, 2021
• NI:
  • Placing manufactured goods in Northern Ireland from Great Britain
  • Placing manufactured goods in Northern Ireland from the EU
  • Using the UKNI mark
  • Product Safety and Metrology – NI

Additional Information

We strongly encourage you to review guidance produced by the Office for Product Safety and Standards:

https://www.gov.uk/government/publications/pressure-equipment-safety-regulations-2016

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640795/nlf-pressure-equipment-regulations-2016-guidance.pdf

We also encourage you to visit the UK’s Business Companion website, which contains guidance on UK product compliance rules:

https://www.businesscompanion.info/en/get-started