Personal protective equipment (PPE) regulations explained for Great Britain

Regulation (EU) 2016/425 on personal protective equipment (PPE) first applied from 21 April 2018, replacing the previous PPE Directive 89/686/EEC. In Great Britain (GB), the Regulation has been assimilated into UK law and is enforced through the Personal Protective Equipment (Enforcement) Regulations 2018 (SI 2018/390).

The main ethos behind the changes is to strengthen confidence that PPE placed on the market is genuinely safe, effective, and traceable, not just in how it is designed, but in how it is controlled and evidenced. The newer framework puts more weight on proving compliance against essential health and safety requirements through the right conformity assessment route, backed by clear technical documentation, declarations of conformity, and consistent manufacturing controls. It also reflects a shift towards taking long-term health risks more seriously and ensuring higher-risk PPE is treated as such through tighter assessment and ongoing surveillance.

 

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A comprehensive overview of the PPE regulations 2018

The below details the different elements of the legislative changes from 2018, please use it as a guide and ensure you reference the full document available from Legislation.gov for more detail.

Under the amended rules, PPE includes:

• Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to health or safety

• Interchangeable components that are essential to the protective function of that equipment

• Connexion systems (such as anchorage and connection systems) that connect PPE to an external device or reliable anchorage point, where they are not designed to be permanently fixed and do not require fastening works before use

Examples of PPE you will commonly see in workplaces

PPE can include items such as:

• Eye and face protection (goggles, spectacles, visors)

• Head protection (helmets, bump caps)

• Hearing protection (ear defenders, plugs)

• Respiratory protective equipment (respirators, breathing apparatus)

• Protective gloves and chemical protective clothing

• Protective footwear

• High visibility clothing and weather protection for extreme conditions

• Fall protection (harnesses, lanyards)

What is not covered by the PPE Regulation

The amended PPE rules do not apply to PPE:

• Specifically designed for the armed forces or for the maintenance of law and order

• Designed for self-defence (except 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 covered by relevant international treaties applicable to the UK

• For head, face, or eye protection covered by UNECE Regulation No. 22 (motorcycle and moped helmets and visors)

The UK also continues to follow pre EU Exit guidance that emergency parachutes are not within scope of Regulation 2016/425.

The core aim of the Regulation

Before PPE can be placed on the GB market, it must meet the essential health and safety requirements set out in Annex II of the Regulation. In practice, this means manufacturers must be able to show, using technical evidence and appropriate conformity assessment, that the product is safe and performs as intended.

All PPE within scope must undergo a conformity assessment procedure aligned to its risk category, as set out in Annex I, in line with Article 19.

What changed in 2018 and why it mattered

One of the biggest practical shifts introduced in 2018 was that compliance expectations became clearer across the whole supply chain, not only the manufacturer.

Risk category updates that affected common products

The Regulation continues to use a three-category risk structure, but it refined what falls into the higher-risk group. Commonly referenced changes include:

• Hearing protection moving from Category II to Category III

• Life jackets moving from Category II to Category III

Category III products are subject to stricter conformity assessment and ongoing surveillance, such as continued product checks or factory production controls, depending on the conformity route.

The 2018 to 2019 transition period

There was a transition period from 21 April 2018 to 20 April 2019, when PPE compliant with the old Directive could still be placed on the market. Certificates issued under the old Directive could remain valid until 21 April 2023, unless they expired earlier.

GB, Northern Ireland, and what “assimilated” rules mean

There is one set of amended PPE rules, but some provisions apply differently in GB and Northern Ireland (NI) under the Windsor Framework.

• This guide focuses on GB requirements

• If you place PPE on the NI market, you must follow the Regulation as it applies in NI and consider CE and UKNI marking requirements

Supply chain responsibilities

Who is a “manufacturer” in law

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

Manufacturer duties before placing PPE on the GB market

Manufacturers must:

1. Design and manufacture PPE in line with the essential health and safety requirements (Annex II)

2. Classify PPE according to risk category

3. Decide which marking they intend the PPE to carry when placed on the GB market, UKCA or CE

4. Draw up technical documentation

5. Carry out the relevant conformity assessment procedure

Manufacturer duties when the PPE meets requirements

Before placing PPE on the market, manufacturers must:

• Draw up a declaration of conformity (UK DoC for UKCA, EU DoC for CE)

• Ensure the declaration accompanies the product or provide information on where it can be accessed

• Affix the relevant conformity marking visibly, legibly, and indelibly to the PPE (or to the packaging and accompanying documents if marking the product is not possible or warranted)

Manufacturer record-keeping and traceability

Manufacturers must:

• Keep the declaration of conformity and technical documentation for 10 years after the PPE has been placed on the GB market

• Ensure PPE bears a type and serial or batch number (or another identifier)

• Include the manufacturer’s name and postal address on the product, or on packaging / accompanying documents if size or nature prevents it

• Provide instructions and safety information that are clear, legible, and in easily understandable English

• Maintain controls so series production remains in conformity, including accounting for design changes and changes to designated standards

• Investigate issues, sample test where appropriate, and keep registers of complaints, non-conformities, and recalls

• Take corrective action where PPE is non-conforming, and inform the enforcement authority immediately if PPE presents a risk

Authorised representatives

Manufacturers can appoint an authorised representative under a written mandate to carry out specific tasks.

For the GB market:

• Authorised representatives can be based in GB or NI

• They cannot be based outside the UK

• GB-based authorised representatives are not recognised under EU law, so they cannot act for placing PPE on NI or EEA markets

At minimum, the mandate must allow the authorised representative to:

• Hold the declaration of conformity and technical documentation for 10 years

• Provide information to the UK market surveillance authority on request

• Cooperate with enforcement authorities on actions to eliminate risks

The manufacturer remains responsible overall.

Importers

An importer is a UK-based business placing PPE on the GB market from outside the UK. Since 1 January 2021, many businesses that previously acted as “distributors” for EU products became “importers” when bringing PPE into GB from the EEA or Switzerland.

Importer duties

Importers must ensure:

• Conformity assessment has been done by the manufacturer and PPE meets Annex II requirements

• Technical documentation exists

• PPE bears the relevant marking and is accompanied by the declaration of conformity and required documents

• PPE has clear English instructions and safety information

• PPE is stored and transported in a way that does not jeopardise conformity

• They keep a copy of the declaration of conformity and ensure technical documentation can be made available to the market surveillance authority for 10 years

• They take corrective action for non-conforming PPE and notify enforcement authorities if there is a risk

• They cooperate with enforcement authorities and provide documentation on request

Importer labelling easement until 31 December 2027

To support traceability during the transition, GB allows certain importers (bringing PPE from the EEA or Switzerland) to provide their details on:

• the packaging, or

• documentation accompanying the PPE,

instead of on the PPE itself, until 31 December 2027, where permitted by the rules. The contact information must remain accessible through the distribution chain and ultimately to end users and regulators. Acceptable approaches can include shipping documents, invoices, outer packaging labels, or inclusion on the declaration of conformity.

This is time-limited and should not be relied on after 31 December 2027.

Distributors

A distributor is any person in the GB supply chain, other than the manufacturer or importer, who makes PPE available on the GB market.

Distributors must ensure, before making PPE available:

• It is in conformity with the Regulation (including Annex II essential requirements)

• It bears the relevant marking (UKCA or CE, as applicable)

• It is accompanied by clear English instructions and safety information

• The manufacturer and importer have met labelling requirements

Distributors must also store and transport PPE safely, take corrective action if PPE is non-conforming, and cooperate with enforcement authorities.

When importers and distributors become “manufacturers” in practice

If an importer or distributor places PPE on the market under their own name, brand, or trademark, they can become responsible for full manufacturer obligations.

Conformity assessment and marking in GB

CE and UKCA marking in GB

Following UK Government changes and the Product Safety and Metrology etc. (Amendment) Regulations 2024, GB now recognises CE marking indefinitely for many products, including PPE, from 1 October 2024.

This means, for many goods, businesses can use either CE or UKCA markings when placing goods on the GB market, beyond 31 December 2024.

Where third-party conformity assessment is needed

Where a third party is required, the route depends on which market you are placing the product on and which body carried out the assessment.

In simple terms:

• CE marking relies on an EU Notified Body where third-party assessment is required

• UKCA marking relies on a UK Approved Body where third-party assessment is required

From 1 October 2024, there is also a “fast-track” approach in some situations where steps taken toward CE marking can count toward UKCA marking, provided UK essential requirements are met.

Where to place the marking

The marking must be affixed visibly, legibly, and indelibly to the PPE. If that is not possible or not warranted due to the nature of the PPE, it can be placed on the packaging and accompanying documents.

Until 31 December 2027, UKCA marking may be placed on a label affixed to the PPE or a document accompanying the PPE, rather than on the PPE itself.

Placing on the market, components, and spare parts

What “placing on the market” means

A product is placed on the GB market when there is a written or verbal agreement (or offer) to transfer ownership, possession, or other rights in the product. Physical transfer is not required.

Imported components and further manufacture

Products imported into GB for further manufacture are not considered “placed on the market” until they are fully manufactured and ready for market placement. The GB manufacturer of the finished product carries ultimate responsibility for compliance.

Spares, repair, and refurbishment

Repair, replacement, and maintenance that does not change the original performance, purpose, or type does not make a product “new”, so it does not need recertification and remarking.

If a product is substantially modified and its performance, purpose, or type changes, it is treated as a new product and must meet current requirements when placed on the market.

Qualifying Northern Ireland goods

Qualifying NI goods that can lawfully be placed on the NI market can generally be sold in GB without additional approvals. In practice this can include goods:

• CE marked via self-declaration

• CE marked following third-party assessment by an EU-recognised notified body

• CE and UKNI marked where third-party assessment was done by a UK body for NI purposes

NI businesses importing goods from the EEA and placing them on the GB market must also meet importer duties, including conformity assessment, technical documentation, and importer labelling requirements.

Enforcement in GB

Enforcement depends on the use context:

• For PPE intended for workplace use (or used in non-domestic premises where it is made available to users), enforcement is led by the Health and Safety Executive (HSE)

• For PPE retained for private use or consumption (outside HSE remit), enforcement is led by local trading standards authorities

• For relevant nuclear sites, enforcement is by the Office for Nuclear Regulation

Penalties under the 2018 Enforcement Regulations can include fines and, for the most serious offences, imprisonment of up to three months.

What about employers and end users purchasing PPE

Regulation (EU) 2016/425 does not impose duties directly on end users. Employers selecting and using PPE are primarily covered by the Personal Protective Equipment at Work Regulations 1992, which remain the key workplace selection and use framework.

From a purchasing perspective, organisations should still ensure PPE is appropriately conformity marked (CE or UKCA as applicable) and suitable for the risk.

Practical compliance checklist for GB businesses

If you manufacture PPE

• Confirm the product is within scope and correctly risk categorised

• Compile technical documentation and select the correct conformity route

• Produce and retain the declaration of conformity for 10 years

• Ensure marking, labelling, batch identification, and English instructions are in place

• Set up production controls and a complaints, non-conformance, and recall process

If you import PPE into GB

• Verify the manufacturer’s conformity assessment and documentation

• Ensure correct marking and that you can access the declaration of conformity

• Put traceability in place, including importer name and address, and plan ahead for the 31 December 2027 deadline

• Maintain storage and transport controls

• Prepare to provide documentation quickly if market surveillance authorities ask

If you distribute PPE

• Confirm marking, English instructions, and labelling before supply

• Maintain storage and transport controls

• Act quickly on non-conforming products and cooperate with enforcement authorities