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This publication is available at https://www.gov.uk/government/publications/equipment-and-protective-systems-intended-for-use-in-potentially-explosive-atmospheres-regulations-2016/equipment-and-protective-systems-intended-for-use-in-potentially-explosive-atmospheres-regulations-2016-great-britain
Guidance on the regulations as they apply to equipment or systems being supplied in or into Great Britain.
This Guide is for businesses placing equipment and protective systems intended for use in potentially explosive atmospheres on the market in Great Britain.
This Guide is designed to help you comply with The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016, as they apply in Great Britain (referred to in this document as the “2016 Regulations”). The 2016 Regulations set out the requirements that must be met before products can be placed on the GB market. The purpose of the legislation is to ensure safe products are placed on the GB market by requiring manufacturers to show how their products meet the ‘essential health and safety requirements’.
The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 implemented Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres.
The EU Withdrawal Act 2018 preserved the Regulations and enabled them to be amended so as to continue to function effectively now that the UK has left the EU. Accordingly, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 see footnote 1 fixed any deficiencies that arose from the UK leaving the EU (such as references to EU institutions) and made specific provision for the GB market.
The 2016 Regulations apply to equipment and protective systems intended for use in potentially explosive atmospheres as defined in regulation 3. Specifically, the 2016 Regulations relate to:
The 2016 Regulations do not apply to products listed in regulation 3(3).
A manufacturer is a person who manufactures products, or has products designed or manufactured, and markets those products under their name or trademark.
Obligations of manufacturers of products:
Until 31 December 2020, the regulations explicitly required the manufacturer to supply a Notified Body with relevant technical documentation and the Notified Body to acknowledge receipt of the documentation provided by the manufacturer and retain the information so that it was available to market surveillance authorities.
Unfortunately, the requirement for the manufacturer to supply a Notified Body with relevant technical documentation was inadvertently deleted from the regulations as they apply from 1 January 2021 to Class I – category M2 and Class II – category 2 equipment which is neither electrical or powered by internal combustion engine, and which has been conformity assessed by the manufacturer on the basis of Module A – Internal Production Control. Nevertheless, the policy and intention of the regulations remains the same, and the omitted explicit obligation will be restored as soon as a legislative opportunity arises.
In the meantime, manufacturers should continue to supply the technical files to an Approved Body so that they in turn can meet their requirements in the regulations to retain the information for market surveillance authorities to review.
Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf.
Mandated authorised representatives for the GB market can be based in GB or Northern Ireland but cannot be based outside the UK. A manufacturer can only mandate an authorised representative established in the UK under the Regulations as they apply in GB.
No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry out tasks on the manufacturer’s behalf for products being placed on the Northern Ireland or EEA markets. Therefore, a GB manufacturer selling products to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of those products, must appoint an authorised representative based in 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 representatives mandate (e.g. retention of technical documentation).
The manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf.
Any references in the 2016 Regulations to the manufacturer are to be taken to include a reference to the authorised representative including in relation to penalties for failure to comply with those duties.
An importer is a person or business based in the UK who places equipment and protective systems on the GB market from a country outside the UK. This means that UK businesses which used to act as a ‘distributor’ before 1 January 2021 legally become an ‘importer’ if they place products from an EEA country on the GB market.
This includes equipment and protective systems that are supplied to NI businesses from the EEA and then placed on the GB market. In this instance the NI business will take on importer obligations for EEA-supplied goods that are placed on the GB market (see also Section 10 on Qualifying Northern Ireland Goods).
Importers have additional legal obligations that go beyond those of distributors, such as checking that manufacturers have carried out the required conformity assessment procedures and including their (the importer’s) name, registered trade name or mark and a postal address on the product or, where this is not possible, on its packaging or in accompanying documentation.
To assist with the transition, the UK is applying a transitional period ending 31 December 2025 See footnote 4 to allow those UK operators who import goods from the EEA or Switzerland (who from 1 January 2021 are importers) into the GB market to provide their details on the accompanying documentation or packaging as an alternative to placing them on the product itself (even where it would be otherwise possible to include it on the product). This applies to goods that are not qualifying Northern Ireland goods. For further detail on qualifying Northern Ireland goods, please see Section 10 on Qualifying Northern Ireland Goods.
A key principle underpinning product safety, for the benefit of consumers and regulators, is traceability of a product back to its source.
In recognition that under the new regulatory regime you may have the new status of an importer when placing products from an EEA or Switzerland state on the GB market, you are temporarily permitted when placing such products on the market (until 31 December 2025) to indicate your name, registered trade name or registered trade mark and postal address on the product’s packaging or in a document accompanying the product, instead of on the product itself. As set out above, this is usually only permitted where it is not possible to provide the specified information on the product itself. This additional temporary easement is permitted until 31 December 2025. See footnote 4
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:
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 2025. You are encouraged to put in place measures to ensure that individual items do carry the importer’s address where required ahead of this date.
The EU does not have any such transitional provision. In the absence of this, equipment and protective systems being sold from GB to NI or the EEA must be labelled with the NI or EU-based importer’s address.
The obligations of importers in the UK include:
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. See further detail in Section 10 on Qualifying Northern Ireland Goods.
UK businesses which were distributors of goods within the EU single market should now consider whether they are importers from the EU single market and therefore what additional requirements they need to comply with – see section 6 above, when placing products on the GB market. The same applies to distributors of goods from the EEA and Switzerland.
A distributor is any person, other than the manufacturer or importer, who makes products available on the GB market.
The obligations of distributors include:
If you place an individual fully manufactured product on the EEA or the UK market (either in Northern Ireland or Great Britain) before 11pm 31 December 2022, you do not need to do anything new. These individual goods can continue to circulate on either market until they reach their end user and do not need to comply with the changes that take effect from 11pm 31 December 2022.
A fully manufactured good is ‘placed on the market’ when there is a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other rights in the product. This does not require physical transfer of the good.
You can usually provide proof of placing on the market on the basis of any relevant document ordinarily used in business transactions, including:
The relevant economic operator (whether manufacturer, importer or distributor) bears the burden of proof for demonstrating that the good was placed on the EEA or UK market before 11pm 31 December 2022.
The UK will allow CE marked equipment and protective systems that have been either self-declared as compliant (where permissible), or where compliance must and has been demonstrated through assessment by an EU-recognised conformity assessment body (notified body), to be placed on the GB market until 31 December 2022.
Equipment and protective systems lawfully placed on the market with a CE marking by 11pm 31 December 2022 can continue to circulate on the GB market after this date. There is no requirement to re-test or re-mark such equipment.
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).
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 GB regulatory requirements, including the requirement for UKCA marking from 1 January 2023.
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 market surveillance authorities.
From 1 January 2023, equipment and protective systems intended for the GB market should be conformity assessed by a UK approved body and should be UKCA marked, not CE marked. See footnote 3
Qualifying Northern Ireland goods complying with the legislation as it applies in Northern Ireland, including affixing the CE marking, may be placed on the GB market after 31 December 2022. See further detail in Section 11 on Qualifying Northern Ireland Goods.
Rules around physically affixing the new UKCA marking mirror those which currently apply for the application of the CE marking although, until 31 December 2025, the UKCA marking may be affixed to a label affixed to the product, or a document accompanying the product, rather than being affixed to the product itself (even where it is otherwise possible to affix it to the equipment itself).
Where the conformity assessment procedures allow for self-declaration of conformity with the essential health and safety requirements (e.g. equipment falling in Category M2 and 2 equipment in Groups I and II respectively which are not electrical or powered by internal combustion machines) manufacturers selling goods on the GB market can affix the new UKCA marking before placing a product on the GB market. Alternatively, until 11pm 31 December 2022, manufacturers placing products on the GB market can affix the CE marking based on self-declaration of conformity with EU rules by the manufacturer, where this is permitted in the EU Directive.
It is possible to affix both the UKCA marking and the CE marking to the same product where self-declaration is permitted, as long as the EU and GB requirements remain the same. When selling to the EU or placing on the NI market, the CE marking remains mandatory.
On 20 June 2022, the Government announced it intends to introduce legislation which will allow completed conformity assessment activities carried out under EU requirements (including existing testing, certification, and contractual arrangements relating to the quality control or auditing of existing certificates) undertaken by non-UK conformity assessment bodies (CABs) (accredited by their national accreditation body) for CE certification before 1 January 2023 to be used by manufacturers to declare existing product types as compliant with UKCA. Products must still bear UKCA marking. For ongoing production, they will need to undergo conformity assessment with a UK Approved Body once any of the relevant CE certification has expired, or after 5 years (31 December 2027), whichever is sooner.
This will allow manufacturers to apply the UKCA mark without the need for any UK-recognised CAB involvement and continue to place their goods on the GB market, on the basis of an existing CE type examination completed before 31 December 2022, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).
Where manufacturers are using existing CE certification completed before 1 January 2023 as the basis to demonstrate compliance with UKCA for their products, they should include in the UK Declaration of Conformity the list of relevant UK designated standards and equivalent EU harmonised standards that apply to their product, as well as details of the EU CAB (or CAB recognised under an EU Mutual Recognition Agreement) which carried out the conformity assessment procedures.
If conformity assessment procedures have not been completed and a supporting CE certificate issued before 1 January 2023, these products are considered ‘new’ products. This also includes where goods are subject to important changes, overhauling its original performance, purpose, or type requiring new certification. Any ‘new’ good must comply with GB regulatory requirements, including the requirement for conformity assessment by a UK approved body from 1 January 2023.
This measure applies across all module types.
Read guidance on UKCA marking
The government committed to providing unfettered access for qualifying Northern Ireland goods to the rest of the UK market after 1 January 2021. Products that can be placed on the market in Northern Ireland in accordance with the legislation, as it applies to Northern Ireland, can be sold in the rest of the UK without any additional approvals.
This means that products that are qualifying Northern Ireland goods can be sold in the rest of the UK if any of the following apply:
This will be the case even if there are changes between the EU rules that the Northern Ireland Protocol applies to NI and the GB rules.
Read guidance on UKNI marking
NI businesses that are importing products from the EEA and placing them on the GB market must ensure that the relevant conformity assessment procedure has been carried out, that the technical documentation has been drawn up and that the equipment bears the CE marking. They will also have to comply with the importer labelling duties (see Section 6 on obligations of importers).
Read guidance on qualifying Northern Ireland goods
The UK has established a new framework for UK based bodies to assess products against GB rules. Existing UK notified bodies have been granted new UK ‘approved body’ status and are listed on a new UK database.
Approved bodies are UK based conformity assessment bodies which have been approved by the Secretary of State to carry out the procedures for conformity assessment and certification for the GB market as set out in the 2016 Regulations.
These approved bodies retain their 4-digit identification number. New approved bodies will be assigned a number by the Office for Product Safety and Standards on behalf of the Secretary of State.
Approved bodies can assess products for the GB market against GB essential health and safety requirements (which are, as yet, substantially the same as EU essential requirements).
UK approved bodies must be established in the UK and be independent of the manufacturer. Approved bodies must examine the technical documentation and supporting evidence in respect of equipment which falls within the scope of the 2016 Regulations to assess the adequacy of the technical design.
Where an approved body finds that essential safety requirements have not been met by a manufacturer, they must not issue a certificate of conformity and they must require the manufacturer to take corrective measures.
View the register of UK Approved Bodies
The register also contains details of bodies in other countries such as Australia, New Zealand, Canada, Japan, and the United States of America, which the UK is designating as Approved Bodies through Mutual Recognition Agreements.
For products intended for workplace use, the Health and Safety Executive (HSE) has a duty to enforce the Regulations in Great Britain.
The Office of Nuclear Regulation is responsible for enforcement in relation to products intended to be used on nuclear sites in Great Britain.
The 2016 Regulations provide powers to the Secretary of State or a person appointed to act on their behalf to enforce the Regulations and RAMS (Regulation EC 765/2008, as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which sets out requirements for market surveillance of products.
Note: ATEX has separate Regulations for Northern Ireland not covered by this guidance. The Health and Safety Executive for Northern Ireland (HSENI) is responsible for enforcement in Northern Ireland.
The 2016 Regulations also provide powers to market surveillance authorities to take action against economic operators for products that present a risk or are not in conformity with the Regulations, as set out in regulation 55 to 60. Economic operators are also required to co-operate with the enforcement authority and on request, must provide information and take action as appropriate.
The UK market surveillance authorities (HSE, ONR) will take all appropriate measures to withdraw from the GB market or to prohibit and restrict the supply of products which may endanger the health and safety of persons, property or the environment.
Market surveillance authorities must continue to have regard to the Regulators’ Code when developing the policies and operational procedures that guide their regulatory activities in this area. They should carry out their activities in a way that supports those they regulate to comply and grow, including choosing proportionate approaches that reflect risk.
In responding to non-compliance that they identify, regulators should clearly explain what the non-compliant item or activity is, the advice being given, actions required, or decisions taken, and the reasons for these. Unless immediate action is needed to prevent a serious breach, regulators should provide an opportunity for dialogue in relation to the advice, requirements or decisions, with a view to ensuring that they are acting in a way that is proportionate and consistent. The Secretary of State takes account of the provisions of both the Regulators’ Code and the Growth Duty in exercising their regulatory functions.
A person committing an offence under the Regulations may be liable to a penalty. Penalties can include:
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.
Declaration of conformity – A document prepared by the manufacturer which must detail the following:
This must be kept by the manufacturer for a period of ten years from the date on which product was placed on the GB market. This declaration must be made available to the enforcing authority upon request.
1: The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 were 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), and the 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 Northern Ireland 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 20 June 2022, the Government announced the provisions for UKCA marking and labelling and importer labelling would be extended until 31 December 2025. Legislation will be placed before Parliament in the autumn 2022 to give effect to this.
2: Until 11pm 31 December 2022 equipment conforming to EU rules, including the CE marking, may be placed on the market of Great Britain.
3: On 24 August 2021 the Government announced the transition periods for UKCA marking and UKCA labelling would each be extended until 31 December 2022 and 31 December 2023 respectively. The Product Safety and Metrology etc (Amendment) Regulations 2021 gave effect to this. On 20 June 2022, the Government announced the provisions for UKCA marking and labelling would be extended until 31 December 2025. Legislation will be placed before Parliament in the autumn 2022 to give effect to this.
4: On 20 June 2022, the Government announced the provisions for importer labelling would be extended until 31 December 2025. Legislation will be placed before Parliament in the autumn 2022 to give effect to this.
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