Retained EU Law
2016
United Kingdom
Regulation (EU) 2016/425 on personal protective equipment (retained)
At a glance
Enforced by
What's here
25 compliance obligations, 2 practical guides
Penalty landscape
5 of 25 obligations carry an unlimited fine. 1 carries different penalties and 19 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
- Any Person 4
- Operator 3
- Distributor 1
Plus 4 non-business duties on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
Relevant guidance
Practical guides for businesses affected by this Act, ordered by how closely they engage with it.
Supporting — topic alignment
1 guidesMentioned in related content
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 81 other Acts (top 5 shown)
- Toys (Safety) Regulations 2011 2011 27 duties
- Radio Equipment Regulations 2017 2017 25 duties
- Medical Devices Regulations 2002 2002 23 duties
- Lifts Regulations 2016 2016 22 duties
- Electromagnetic Compatibility Regulations 2016 2016 21 duties
Any Person also bound by 742 other Acts (top 5 shown)
- Human Medicines Regulations 2012 2012 101 duties
- Road Traffic Act 1988 1988 95 duties
- Air Navigation Order 2016 2016 83 duties
- Merchant Shipping Act 1995 1995 82 duties
- Road Traffic (NI) Order 1995 1995 61 duties
Operators also bound by 124 other Acts (top 5 shown)
- Space Industry Regulations 2021 2021 71 duties
- Payment Services Regulations 2017 2017 41 duties
- Air Navigation Order 2016 2016 34 duties
- The Quarries Regulations 1999 1999 31 duties
- Reservoirs Act (Northern Ireland) 2015 2015 22 duties
Distributors also bound by 33 other Acts (top 5 shown)
- Electricity Safety, Quality and Continuity Regulations 2002 2002 19 duties
- UK REACH Regulation (retained EU law) 2006 11 duties
- Electricity Act 1989 1989 9 duties
- Value Added Tax Regulations 1995 1995 7 duties
- Classification, Labelling and Packaging Regulation (UK CLP) 2008 7 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 is safe and compliant before placing it on the market Manufacturer
Essential health and safety requirements
- Ensure PPE meets essential health and safety requirements Manufacturer
Obligations of manufacturers
- Ensure PPE is safe, tested, and correctly documented Manufacturer
Authorised representatives
- Authorised representative obligations for PPE manufacturers
Obligations of importers
- Verify and label imported personal protective equipment (PPE) Manufacturer
Obligations of distributors
- Verify safety markings and documentation before selling PPE Distributor
Cases in which obligations of manufacturers apply to importers and distributors
Unlimited fine- Assume manufacturer duties if branding or modifying PPE Manufacturer
Identification of economic operators
- Keep records of your PPE supply chain for 10 years Operator
... Declaration of conformity
Unlimited fine- Create, update, and sign a Declaration of Conformity for PPE Manufacturer
Monitoring obligations
Other duties (1) — Crown / regulator
- Secretary of State must monitor PPE approved bodies Crown / Minister / Government department
Approved body requirements
- Ensure PPE assessment bodies meet strict independence and competence standards Any Person
Identification numbers and register of approved bodies
Other duties (1) — Crown / regulator
- Secretary of State must maintain a public register of approved PPE bodies Crown / Minister / Government department
Restriction, suspension or withdrawal of approval
Other duties (1) — Crown / regulator
- Secretary of State must restrict, suspend or withdraw approval of non-compliant bodies Crown / Minister / Government department
Operational obligations of approved bodies
Other duties (1) — Crown / regulator
- Approved bodies must assess PPE conformity and enforce corrections Statutory regulator
Appeal against decisions of approved bodies
- Approved bodies must provide a clear appeal process for PPE decisions Any Person
Information obligation on approved bodies
- Approved bodies must report certification changes and activities to the Crown Any Person
Procedure ... for dealing with PPE presenting a risk
- Cooperate with authorities and take corrective action for unsafe PPE Operator
Compliant PPE which presents a risk
Unlimited fine- Fix, withdraw, or recall compliant PPE that is found to be unsafe Operator
Penalties
2 years imprisonment- Fail to comply with PPE requirements Any Person
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
- Design, manufacture and document PPE to meet safety standards Manufacturer
(Module A)
- Control manufacturing and declare PPE compliance (Module A) Manufacturer
(Module B)
Unlimited fine- Apply for and maintain PPE type-examination certificates Manufacturer
(Module C)
- Ensure PPE manufactured matches approved type and issue declarations Manufacturer
(Module C2)
- Ensure PPE conformity through supervised random product checks Manufacturer
(Module D)
- Operate an approved quality system for PPE production Manufacturer
Browse 41 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
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
Presumption of conformity of approved bodies
Subsidiaries of, and subcontracting by approved bodies
Application for notification
Notification procedure
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
The technical documentation shall specify the means used by the...
The technical documentation shall include at least the following elements:...
a complete description of the PPE and of its intended...
This Annex lays down the categories of risk against which...
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature):
CORRELATION TABLE
... DECLARATION OF CONFORMITY No …
Designated standard
RISK CATEGORIES OF PPE
TECHNICAL DOCUMENTATION FOR PPE
Official guidance
Authoritative sources published by regulators or government explaining this legislation.
- Use of face masks designated KN95 (opens in a new tab) from HSE Detailed Guidance
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
Find other UK business legislation with related guidance.
Regulators
Learn more about the bodies that enforce this legislation.