Statutory guidance

Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018: Great Britain

Updated 7 November 2023

Guidance on the regulations as they apply to equipment being supplied in or into Great Britain.

This guidance has not yet been amended to reflect the announcements on 1 August 2023 and 24 January 2024 that the Government intends to introduce legislation to extend recognition of certain goods that meet EU requirements (including the CE marking), indefinitely, beyond 2024 for many products. When that legislation is passed, certain goods that meet EU requirements will be able to be placed on the GB market.

Read information on the announcements.

January 2024

1. Introduction

This Guide is for businesses placing personal protective equipment (PPE) on the market in Great Britain. See footnote 1

Read guidance on the regulations in Northern Ireland

Regulation (EU) 2016/425 (as incorporated into UK law) sets out the essential health and safety requirements that must be met before PPE products can be placed on the GB market. The purpose of the legislation is to ensure safe and effective products are placed on the GB market by requiring manufacturers to show how their products meet the ‘essential health and safety requirements’. The Personal Protective Equipment (Enforcement) Regulations 2018 provide a system for the enforcement of the 2016 Regulation.

This guidance is designed to help you understand Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018, (collectively the “Amended PPE Regulations”, and individually the “2016 Regulation” and the “2018 Regulations” respectively), as they apply in Great Britain from 1 January 2021.

2. Legislative Background

EU Regulation 2016/425 was directly applicable in the UK from 21 April 2018. The enforcement and sanctions system was implemented into UK law by the Personal Protective Equipment (Enforcement) Regulations 2018 (SI 2018 No. 390). The EU Withdrawal Act 2018 preserved these 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 2 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 Amended PPE Regulations, but some of the provisions apply differently in GB and in NI (under the terms of the Windsor Framework). References to the Amended PPE Regulations in this guidance are references to those Regulations as they apply in Great Britain.

Read guidance on the regulations in Northern Ireland

3. Scope

The Amended PPE Regulations apply to PPE which is:

• equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety
• interchangeable components for equipment referred to in point (a) which are essential for its protective function
• connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use

The Amended PPE Regulations do not apply to PPE:

• specifically designed for use by the armed forces or in the maintenance of law and order
• designed to be used for self-defence, except for PPE intended for sporting activities

• designed for private use to protect against:

  • atmospheric conditions that are not of an extreme nature
  • damp and water during dishwashing
• for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable to the UK
• for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds

4. Requirements

The essential health and safety requirements (listed in Annex II) apply to PPE within the scope of the 2016 Regulation as amended as appropriate. Under Article 19, all PPE within scope must undergo a conformity assessment procedure in accordance with its risk categorisation (specified in Annex I) to demonstrate compliance with the essential requirements.

Access free standards relevant to PPE for COVID-19 from the British Standards Institution.

Access guidelines on COVID-19 from the World Health Organisation.

5. Obligations of manufacturers

A manufacturer is a person who manufactures PPE, or has PPE designed or manufactured, and markets that PPE under their name or trademark.

The obligations of manufacturers of PPE include:

1. Before placing PPE on the GB market, the manufacturer must ensure that it has been designed and manufactured in accordance with the applicable essential health and safety requirements. These are set out in Annex II to the 2016 Regulation.
2. The manufacturer must also have had a relevant conformity assessment procedure carried out and technical documentation drawn up.
3. Once this has been done, the manufacturer must draw up a declaration of conformity; ensure that the declaration accompanies the product (or information as to where it can be accessed); and affix the UKCA marking see footnote 3 visibly, legibly and indelibly to the PPE. Where it is not possible or warranted, on account of the nature of the PPE, to affix the UKCA marking to the PPE, it must be affixed to the packaging and the accompanying documents. In any event, until 31 December 2027 see footnote 4, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the PPE.
4. Qualifying Northern Ireland goods can be placed on the GB market with the CE and CE UKNI conformity markings, see further detail in Section 11 on Qualifying Northern Ireland Goods.
5. The manufacturer must keep the declaration of conformity and the technical documentation for 10 years after the PPE has been placed on the GB market.
6. The manufacturer must ensure that procedures are in place for series production to remain in conformity. Changes in the design or characteristics of the PPE and changes in the designated standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account.
7. When deemed appropriate with regard to the risks presented by PPE, the manufacturer shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the GB market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.
8. The manufacturer must ensure that all PPE placed on the GB market bears a type and serial or batch number, or other element allowing its identification. The manufacturer should also include its name, registered trade name or registered trademark and postal address on the product. Where the size or nature of the PPE does not allow this then it may be provided on the packaging or accompanying documentation.
9. The manufacturer must ensure that PPE is accompanied by instructions and safety information as set out in point 1.4 of Annex II to the Regulation, which is clear, legible and in easily understandable English.
10. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the enforcement authority to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken. Read more information on how to notify the MSA.

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. See further detail in Section 11 on Qualifying Northern Ireland Goods.

6. Obligations of authorised representatives

Manufacturers are able to appoint authorised representatives to perform certain tasks on their behalf under a written mandate.

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 PPE being placed on the Northern Ireland and EEA markets. Therefore, a GB manufacturer selling PPE to the EEA or into Northern Ireland, who wishes to appoint an authorised representative to carry out tasks for them in respect of that PPE, must appoint an authorised representative based in Northern Ireland or the EEA.

The mandate shall at least allow the authorised representative to perform the following tasks:

• keeping the declaration of conformity and the technical documentation at the disposal of the market surveillance authority in the UK for 10 years after the PPE has been placed on the GB market
• further to a reasoned request from the enforcement authority in the UK, providing that authority with all the information and documentation necessary to demonstrate the conformity of the PPE
• cooperating with the enforcement authority in the UK, at its request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative’s mandate

An authorised representative must comply with all the duties, imposed on the manufacturer under the 2016 Regulation, that they are appointed for and mandated by the manufacturer to perform. The manufacturer remains responsible for the proper performance of any obligations the authorised representative performs on their behalf and an authorised representative is under a duty to perform those tasks, and any failure to do so may make the authorised representatives liable to penalties.

7. Obligations of importers

An importer is a person or business based in the UK who places PPE 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 PPE 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 11 on Qualifying Northern Ireland 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 its packaging or in accompanying documentation.

To assist with the transition, the UK is applying a transitional period ending on 31 December 2027 see footnote 5 to allow UK suppliers of PPE into the GB market from the EEA or Switzerland (who from 1 January 2021 are importers for the purposes of the law in GB) to provide their details on the accompanying documentation as an alternative to placing them on the equipment itself. This applies to goods that are not qualifying Northern Ireland goods. For further detail on qualifying Northern Ireland goods, please see Section 11 on 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 regime you may have the new status of an importer when placing PPE from an EEA state or Switzerland on the GB market, you are temporarily permitted when placing such PPE on the market (until 31 December 2027) to indicate your name, registered trade name or registered trade mark and a postal address on the PPE’s packaging or in a document accompanying the PPE, instead of on the PPE itself. As set out above, this is usually only permitted where it is not possible to provide the specified information on the PPE itself. This additional temporary easement is permitted until 31 December 2027.

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 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, PPE being sold from GB to NI or the EU must be labelled with the NI or EU-based importer’s address.

Read guidance on the regulations in Northern Ireland

The obligations of importers include the following:

1. Before placing PPE on the GB market, an importer must ensure that the appropriate conformity assessment procedures referred to in Article 19 have been carried out by the manufacturer. This means that the PPE must comply with the essential health and safety requirements set out in Annex II of the 2016 Regulation. They must ensure that the manufacturer has drawn up technical documentation; the PPE bears the UKCA marking see footnote 3 and is accompanied by the declaration of conformity and required documents and identification marks. Until 31 December 2027, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the PPE.
2. When deemed appropriate, regarding risk presented by an item of PPE, the importer must carry out sample testing, investigate and, if necessary, keep a register of complaints, of non-conforming PPE and recalls of such PPE, and keep distributors informed of any such monitoring.
3. The importer must indicate on the PPE their name, registered trade name or registered trademark and postal address. This obligation does not apply where the importer has set out such information on the packaging of the PPE and either: (i) it is not possible to indicate that information on the PPE; or (ii) the importer has imported the PPE from an EEA state or Switzerland and places it on the GB market before 31 December 2027.
4. The importer must ensure that PPE is accompanied by instructions and safety information as set out in point 1.4 of Annex II to the 2016 Regulation ensure that they are clear, legible and in easily understandable English.
5. The importer must keep a copy of the declaration of conformity and technical documentation for a period of 10 years after the PPE has been placed on the GB market at the disposal of the market surveillance authority and ensure that the technical documentation can be made available to that authority, upon request.
6. The importer must ensure that PPE under their responsibility is safely stored and transported in such a way that does not jeopardise conformity with the essential health and safety requirements.
7. Importers who consider or have reason to believe that PPE which they have placed on the GB market is not in conformity with the PPE Regulation must immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the enforcement authority in GB to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken. Read more information on how to notify the MSA.
8. The importer must, further to a reasoned request from the enforcement authority in the UK, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the GB market.

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 11 on Qualifying Northern Ireland Goods.

8. Obligations of distributors

UK businesses which were distributors of PPE within the EU single market should now consider whether they are importers from the EU single market and therefore what additional requirements they may face – see section 7 above. 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 PPE available on the GB market.

The obligations of distributors include the following:

1. Before making PPE available on the GB market, the distributor must act with due care to ensure that it is in conformity with the PPE Regulation, which includes ensuring that the PPE must be in conformity with the essential health and safety requirements.
2. Before making PPE available on the GB market, the distributor must ensure that it bears the UKCA marking see footnote 3 is accompanied by instructions and information as set out in point 1.4 of Annex II to the Regulation and ensure and that they are clear, legible and in easily understandable English; and that the manufacturer and importer have complied with the marking requirements as to required labelling. Until 31 December 2027, the UKCA marking may be affixed to a label affixed to, or a document accompanying, the PPE.
3. The distributor must ensure that PPE under their responsibility is safely stored and transported in such a way that does not jeopardise its conformity with the essential health and safety requirements.
4. A distributor who considers or has reason to believe that PPE which they have placed on the GB market is not in conformity with the 2016 Regulation must immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, the distributor shall immediately inform the enforcement authority in GB to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken. Read more information on how to notify the MSA.
5. Distributors must, further to a reasoned request from the enforcement authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of PPE in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the GB market.

9. Conformity assessment and marking – products placed on the GB market before 11pm 31 December 2024

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 2024, 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 2024.

A fully manufactured good is ‘placed on the market’ when 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:

• contracts of sale concerning goods which have already been manufactured and meet the legal requirements
• invoices
• documents concerning the shipping of goods for distribution

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 2024.

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).

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 11pm 31 December 2024.

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.

10. Conformity assessment and marking – products placed on the GB market from 11pm 31 December 2024

Assessment through third-party organisations

From 11pm 31 December 2024, PPE intended for the GB market should be conformity assessed by a UK approved body and UKCA marked, not CE marked. See footnote 4

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 11pm 31 December 2024. See further detail in Section 11 on Qualifying Northern Ireland Goods.

Rules around physically affixing the new UKCA marking mirror those which applied for the application of the CE marking, including where the size or nature of the PPE does not allow this the provision to provide it on the packaging or an accompanying document. Irrespective of the latter provision, until 31 December 2027, the UKCA marking may be affixed to a label affixed to the PPE or a document accompanying the PPE, rather than being affixed to the PPE itself.

Self-declaration

Where conformity assessment procedures allows for self-declaration of conformity with the Regulations (i.e. Category I PPE as set out in Annex I), manufacturers placing PPE on the GB market from 1 January 2021 can affix the UKCA marking.

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 exporting to the EU, the CE marking remains mandatory.

Reducing re-certification/re-testing costs for UKCA marking

The Government has introduced legislation to allow conformity assessment activities undertaken by EU-recognised Conformity Assessment Bodies (CABs), for CE certification before 11pm 31 December 2024, to be used by manufacturers, and other relevant persons, to declare existing product types as compliant with UKCA requirements. Products must still bear the UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate or after 31 December 2027, whichever is sooner. 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 31 December 2027, whichever is sooner.

Before 11pm 31 December 2024, if an EU-recognised CAB has completed the relevant conformity assessment activities applying to a product intended for placing on the market after 11pm 31 December 2024, this would allow manufacturers to apply the UKCA mark without the need for any UK Approved Body involvement. They could continue to place their goods on the market on the basis of their existing CE certification following the end of 2024, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner).

Where manufacturers are using conformity assessment under existing CE certification before 11pm 31 December 2024 as the basis to demonstrate compliance with UKCA requirements for their products, it is recommended they 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-recognised CAB (or CAB recognised under an EU Mutual Recognition Agreement with a third country) which carried out the conformity assessment procedures.

This measure applies across all relevant module types.

Read guidance on UKCA marking

11. Qualifying Northern Ireland Goods

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:

• 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
• 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 new 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 PPE 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 Northern Ireland goods

12. Approved Bodies

The UK has established a new framework for UK based bodies to assess PPE against GB rules. Existing UK notified bodies have been granted new UK ‘approved body’ status and listed on a new UK database.

Approved bodies are conformity assessment bodies which have been approved by the Secretary of State to carry out the procedures for conformity assessment and certification for the UK market as set out in the 2016 Regulation.

These approved bodies retain their 4-digit identification body 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 PPE 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 a product 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.

13. Enforcement

As set out in the Enforcement Regulations (Personal Protective Equipment (Enforcement) Regulations 2018 (SI 2018 No. 390)), for PPE intended for workplace use, or for use otherwise than at work in non-domestic premises made available to persons at a place where they may use the PPE provided for their own use there, the Health and Safety Executive (HSE) has a duty to enforce the Regulations in Great Britain.

In Great Britain local trading standards authorities have a duty to enforce the Amended PPE Regulations in relation to PPE retained for private use or consumption (other than in circumstances subject to the remit of HSE).

Where the PPE are intended to be used exclusively or primarily on relevant nuclear sites as defined in Regulation 3(4) of the 2018 Regulations, the Office for Nuclear Regulation is responsible for enforcing the Amended PPE Regulations.

The Enforcement Regulations provides a range of powers to enforcement authorities to take action to protect workers, users and consumers and take action against economic operators for PPE that present a risk or are not in conformity with the 2016 Regulation. There are requirements on manufacturers, distributors and importers to co-operate with the enforcement authority as appropriate on request.

The 2018 Regulations also provide powers to the Secretary of State to enforce the 2016 Regulation and RAMS (Regulation (EC) 765/2008) as retained in GB legislation, that sets out requirements and powers for effective market surveillance of products.

UK market surveillance authorities will take all appropriate measures to withdraw from the market or to prohibit and restrict the supply of products which may endanger the health and safety of persons, property or the environment.

Regulators’ Code

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 his regulatory functions.

Read the Regulators’ Code.

Penalties

A person committing an offence under the 2018 Regulations may be liable to a penalty. Penalties can include a fine or a prison sentence of up to three months for the most serious offences. It is matter for the enforcement authority to decide whether prosecution is appropriate in each case taking into account the circumstances of the case and the enforcement authority’s 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.

14. Where to find EU guidance about The EU Regulation on Personal Protective Equipment 2016/425

EU Regulation 2016/425 was directly applicable in UK law before 1 January 2021 but is EU legislation. It has been retained in UK law and adapted for GB purposes in the form of the 2016 Regulation (as defined above). As a result, while the general principles may be the same, there may be differences between EU Regulation 2016/425 as applied in the EU and the 2016 Regulation as applied in the GB.

Find further and more detailed guidance on Regulation (EU) 2016/425.

15. 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.

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

  • the specific product to which the declaration is referring; and
  • 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 product 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 a PPE available on the GB market.
• Enforcement Authority – In Great Britain, for products in use in the workplace, this is the Health and Safety Executive. For PPE for consumer use this is local trading standards authorities. For nuclear sites in Great Britain, the Office for Nuclear Regulation is the enforcing authority.
• Importer – A person established in the UK who places PPE 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 PPE within the EU (including the UK) or from Switzerland will now be an importer if they are bringing PPE into GB from another country (including EU Member States, the EEA and Switzerland).
• Manufacturer – A person who manufactures PPE or has PPE designed or manufactured and markets that PPE under their name or trademark.
• UKCA Marking – The UKCA (UK Conformity Assessed) marking is the new UK conformity marking used for certain goods (including PPE) 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.

16. Footnotes

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

2: 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 Great Britain only, and not to Northern Ireland, 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 (subject to Parliamentary approval) to provide for a 24 month transition period for importer labelling (for goods from the EEA), and transitional arrangements for 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 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) give 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.

3: Until 11pm 31 December 2024, PPE conforming to EU rules, including the CE marking, may be placed on the market of Great Britain – see below; qualifying Northern Ireland goods complying with NI rules, including the CE marking, may also be placed on the GB market – see below.

4: 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 labelling would be extended until 31 December 2025. On 14 November 2022 the Government announced it would be extending the transition period for UKCA marking until 31 December 2024 and 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.

5: 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.