Retained EU Law
2016
United Kingdom
Regulation (EU) 2016/425 on personal protective equipment (retained)
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
At a glance
Enforced by
What's here
21 compliance obligations, 1 practical guide
Penalty landscape
5 of 21 obligations carry an unlimited fine. 1 carries different penalties and 15 have no criminal penalty — flagged in the list below.
Who this Act binds
Business-side actors with duties under this Act, ranked by how often they appear.
- Manufacturer 12
- Trader 4
- Any Person 3
- Employer 2
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Supporting — topic alignment
1 guidesOther Acts binding the same actors
For each actor bound by this Act, the other UK Acts that bind them most often. Useful for understanding the full compliance landscape facing each role.
Manufacturers also bound by 50 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 91 duties
- Medical Devices Regulations 2002 2002 37 duties
- UK REACH Regulation (retained EU law) 2006 26 duties
- Toys (Safety) Regulations 2011 2011 25 duties
- Radio Equipment Regulations 2017 2017 24 duties
Traders also bound by 248 other Acts (top 5 shown)
- Value Added Tax Regulations 1995 1995 928 duties
- The Customs (Import Duty) (EU Exit) Regulations 2018 2018 93 duties
- Space Industry Regulations 2021 2021 70 duties
- Council Directive 2006/112/EC (EU VAT Directive - retained for reference) 2006 67 duties
- Payment Services Regulations 2017 2017 58 duties
Any Person also bound by 487 other Acts (top 5 shown)
- Insolvency (England and Wales) Rules 2016 2016 162 duties
- Air Navigation Order 2016 2016 106 duties
- Merchant Shipping Act 1995 1995 104 duties
- Road Traffic Act 1988 1988 101 duties
- Licensing Act 2003 2003 92 duties
Employers also bound by 192 other Acts (top 5 shown)
- Provision and Use of Work Equipment Regulations 1998 1998 176 duties
- The Income Tax (Pay As You Earn) Regulations 2003 2003 123 duties
- Employment Rights (Northern Ireland) Order 1996 (current NI employment law) 1996 84 duties
- Employment Rights Act 1996 1996 56 duties
- Electricity at Work Regulations 1989 1989 52 duties
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
Making available on the market
Unlimited fine- Ensure PPE meets safety requirements before sale Manufacturer
Essential health and safety requirements
- Ensure PPE meets essential health and safety requirements Manufacturer
Obligations of manufacturers
- Ensure PPE placed on the market complies with safety requirements Manufacturer
Obligations of importers
- Import only compliant PPE and keep required records Trader
Obligations of distributors
- Ensure distributed PPE complies with UK marking, documentation and safety rules Trader
Cases in which obligations of manufacturers apply to importers and distributors
Unlimited fine- Meet manufacturer obligations when re‑branding or modifying PPE Manufacturer
Identification of economic operators
- Keep and provide PPE supplier and customer details for 10 years Manufacturer
... Declaration of conformity
Unlimited fine- Prepare and keep a declaration of conformity for PPE Manufacturer
Approved body requirements
- Meet requirements to operate as an approved PPE conformity assessment body Employer
Operational obligations of approved bodies
- Conduct conformity assessments and enforce PPE compliance Any Person
Appeal against decisions of approved bodies
- Provide a transparent and accessible appeal procedure Any Person
Information obligation on approved bodies
- Provide information to the Secretary of State and other approved bodies Employer
Procedure ... for dealing with PPE presenting a risk
- Take corrective action on unsafe PPE Trader
Compliant PPE which presents a risk
Unlimited fine- Withdraw or recall risky PPE and take corrective action Trader
Penalties
2 years imprisonment- Fail to comply with PPE requirements Any Person
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
- Ensure PPE meets essential health and safety requirements Manufacturer
(Module A)
- Maintain technical files, UK marking and declaration of conformity for PPE Manufacturer
(Module B)
Unlimited fine- Obtain and maintain a type‑examination certificate for PPE Manufacturer
(Module C)
- Ensure PPE matches approved type and keep UK marking & declaration Manufacturer
(Module C2)
- Maintain PPE conformity with internal control and random product checks Manufacturer
(Module D)
- Maintain approved quality system for PPE production and keep records Manufacturer
Browse 38 other sections — procedural / definitional / commencement
Subject matter
Scope
Definitions
Provisions concerning the use of PPE
Making available, putting into service and exhibition at trade fairs, etc
Authorised representatives
Presumption of conformity of PPE
General principles of the UK marking
Rules and conditions for affixing the UK marking
Risk categories of PPE
Conformity assessment procedures
Approved bodies
Approval of conformity assessment bodies
UK national accreditation body
Monitoring obligations
Presumption of conformity of approved bodies
Subsidiaries of, and subcontracting by approved bodies
Application for notification
Notification procedure
Identification numbers and register of approved bodies
Restriction, suspension or withdrawal of approval
Challenge of the competence of notified bodies
Exchange of experience
Coordination of notified bodies
Market surveillance and control of PPE entering the United Kingdom market
Union safeguard procedure
Formal non-compliance
Regulation making powers
Exercise of the delegation
Committee procedure
Repeal
Transitional provision in relation to EU exit
Entry into force and application
CORRELATION TABLE
... DECLARATION OF CONFORMITY No …
Designated standard
RISK CATEGORIES OF PPE
TECHNICAL DOCUMENTATION FOR PPE
Enforcement and responsible bodies
The regulators that administer or enforce this legislation.
Office for Product Safety and Standards
Product safety regulator responsible for ensuring consumer products are safe. Enforces product safety regulations, UKCA marking requirements, and works with market surveillance …
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Browse legislation
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Regulators
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