Retained EU Law SI 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)

Enforced by
OPSS
Status
Amended (in force with amendments)
Penalty ceiling
Imprisonment 5 of 69 obligations carry an unlimited fine. 1 carries different penalties and 63 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Manufacturer46 Any Person4 Conformity Assessment Body4 Operator3 Distributor1

Plus 11 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Manufacturer — also bound by 502 other Acts
Any Person — also bound by 2340 other Acts
Conformity Assessment Body — also bound by 47 other Acts
Operator — also bound by 746 other Acts
Distributor — also bound by 182 other Acts

What it requires

Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

uri:annex/ii/division/1/division/1.4 uri:annex/ii/division/1/division/1.4 Regulated
  • PPE instructions must include full storage, use and maintenance detailsManufacturer
uri:annex/ii/division/2/division/2.4 uri:annex/ii/division/2/division/2.4 Regulated
  • Mark PPE with manufacture / obsolescence dates and cleaning limitsManufacturer
uri:annex/ii/division/2/division/2.8 uri:annex/ii/division/2/division/2.8 Regulated
  • Provide competent-user instructions for very dangerous PPEManufacturer
uri:annex/ii/division/3/division/3.10/division/3.10.2 uri:annex/ii/division/3/division/3.10/division/3.10.2 Regulated
  • Ensure PPE prevents penetration of hazardous substances and provide test marking and instructionsManufacturer
uri:annex/ii/division/3/division/3.4/division/3.4.2 uri:annex/ii/division/3/division/3.4/division/3.4.2 Regulated
  • Ensure buoyancy clothing is safe, provides support, and allows movement/swimmingManufacturer
uri:annex/ii/division/3/division/3.5 uri:annex/ii/division/3/division/3.5 Regulated
  • Ensure PPE cuts noise to legal limits and is labelledManufacturer
uri:annex/ii/division/3/division/3.6/division/3.6.2 uri:annex/ii/division/3/division/3.6/division/3.6.2 Regulated
  • Ensure PPE limits heat transmission and prevents burnsManufacturer
uri:annex/ii/division/3/division/3.8/division/3.8.1 uri:annex/ii/division/3/division/3.8/division/3.8.1 Regulated
  • Ensure PPE for electric shock protection meets insulation and leakage standardsManufacturer
uri:annex/ii/division/3/division/3.9/division/3.9.1 uri:annex/ii/division/3/division/3.9/division/3.9.1 Regulated
  • Design and manufacture PPE to protect against non-ionising radiationManufacturer
uri:annex/ii/division/3/division/3.9/division/3.9.2/division/3.9.2.1 uri:annex/ii/division/3/division/3.9/division/3.9.2/division/3.9.2.1 Regulated
  • Choose or design PPE materials to block radioactive contaminantsManufacturer
uri:annex/ii/division/n1 uri:annex/ii/division/n1 Regulated
  • Perform risk assessment for PPE and design accordinglyManufacturer
uri:annex/iv/division/internal/division/2 uri:annex/iv/division/internal/division/2 Regulated
  • Manufacturers must prepare technical documentation for PPEManufacturer
uri:annex/iv/division/internal/division/3 uri:annex/iv/division/internal/division/3 Regulated
  • Ensure manufacturing process and monitoring comply with technical documentation and regulationsManufacturer
uri:annex/iv/division/internal/division/4/division/4.1 uri:annex/iv/division/internal/division/4/division/4.1 Regulated
  • Affix UK marking to each PPE item that meets requirementsManufacturer
uri:annex/iv/division/internal/division/4/division/4.2 uri:annex/iv/division/internal/division/4/division/4.2 Regulated
  • Provide EU declaration of conformity to authorities on requestAny Person
uri:annex/v/division/eu/division/3 uri:annex/v/division/eu/division/3 Regulated
  • Lodge type-examination application with a single approved bodyManufacturer
uri:annex/v/division/eu/division/4 uri:annex/v/division/eu/division/4 Regulated
Other duties (1) — Crown / regulator
  • Your approved body must examine and test PPE designs and production methodsStatutory regulator
uri:annex/v/division/eu/division/5 uri:annex/v/division/eu/division/5 Regulated
  • Approved bodies must draw up evaluation reports and keep them confidentialConformity Assessment Body
uri:annex/v/division/eu/division/6/division/6.2 uri:annex/v/division/eu/division/6/division/6.2 Regulated
Other duties (1) — Crown / regulator
  • Approved bodies must include all required details on EU type examination certificatesStatutory regulator
uri:annex/v/division/eu/division/6/division/6.4 uri:annex/v/division/eu/division/6/division/6.4 Regulated
Other duties (1) — Crown / regulator
  • Approved body must refuse type-examination certificate for non-compliant PPE and give detailed reasonsStatutory regulator
uri:annex/v/division/eu/division/7/division/7.1 uri:annex/v/division/eu/division/7/division/7.1 Regulated
Other duties (1) — Crown / regulator
  • Approved body must monitor changes in safety standards and inform manufacturers if re-assessment is neededStatutory regulator
uri:annex/v/division/eu/division/7/division/7.2 uri:annex/v/division/eu/division/7/division/7.2 Regulated
  • Inform approved body of modifications to PPE type and obtain additional approvalManufacturer
uri:annex/v/division/eu/division/7/division/7.3 uri:annex/v/division/eu/division/7/division/7.3 Regulated
  • Keep your PPE up to date with the latest safety standardsManufacturer
uri:annex/v/division/eu/division/7/division/7.4 uri:annex/v/division/eu/division/7/division/7.4 Regulated
  • Apply for renewal of type-examination certificate within 6–12 months before expiryManufacturer
uri:annex/v/division/eu/division/7/division/7.5 uri:annex/v/division/eu/division/7/division/7.5 Regulated
Other duties (1) — Crown / regulator
  • Approved body must review and renew PPE type-examination certificates before expiryStatutory regulator
uri:annex/v/division/eu/division/7/division/7.7 uri:annex/v/division/eu/division/7/division/7.7 Regulated
  • Stop selling PPE when the approved body withdraws the certificateManufacturer
uri:annex/v/division/eu/division/8 uri:annex/v/division/eu/division/8 Regulated
  • Appointed approved bodies must share and retain certificate informationConformity Assessment Body
uri:annex/v/division/eu/division/9 uri:annex/v/division/eu/division/9 Regulated
  • Keep type-examination certificates and technical docs for 10 yearsManufacturer
uri:annex/vi/division/conformity/division/2 uri:annex/vi/division/conformity/division/2 Regulated
  • Ensure manufacturing process and monitoring match the approved PPE typeManufacturer
uri:annex/vi/division/conformity/division/3/division/3.1 uri:annex/vi/division/conformity/division/3/division/3.1 Regulated
  • Affix UK marking to each PPE that meets the approved typeManufacturer
uri:annex/vi/division/conformity/division/3/division/3.2 uri:annex/vi/division/conformity/division/3/division/3.2 Regulated
  • Provide declaration of conformity when authorities requestManufacturer
uri:annex/vii/division/conformity/division/2 uri:annex/vii/division/conformity/division/2 Regulated
  • Ensure your PPE manufacturing process produces consistent, compliant productsManufacturer
uri:annex/vii/division/conformity/division/3 uri:annex/vii/division/conformity/division/3 Regulated
  • Apply for supervised product checks before placing PPE on the marketManufacturer
uri:annex/vii/division/conformity/division/4 uri:annex/vii/division/conformity/division/4 Regulated
Other duties (1) — Crown / regulator
  • Approved body must carry out random product checks on your PPE at least yearlyStatutory regulator
uri:annex/vii/division/conformity/division/5 uri:annex/vii/division/conformity/division/5 Regulated
  • Keep PPE test reports for 10 yearsManufacturer
uri:annex/vii/division/conformity/division/6/division/6.1 uri:annex/vii/division/conformity/division/6/division/6.1 Regulated
  • Affix UK marking and approved body number to each conforming PPE itemManufacturer
uri:annex/vii/division/conformity/division/6/division/6.2 uri:annex/vii/division/conformity/division/6/division/6.2 Regulated
  • Make declaration of conformity available to authorities on requestManufacturer
uri:annex/viii/division/conformity/division/2 uri:annex/viii/division/conformity/division/2 Regulated
  • Operate an approved quality system for PPE production and testingManufacturer
uri:annex/viii/division/conformity/division/3 uri:annex/viii/division/conformity/division/3 Regulated
  • Apply for quality system assessment and maintain it for PPE productionManufacturer
uri:annex/viii/division/conformity/division/4 uri:annex/viii/division/conformity/division/4 Regulated
  • Allow approved body access for quality system auditsManufacturer
uri:annex/viii/division/conformity/division/5 uri:annex/viii/division/conformity/division/5 Regulated
  • Affix UKCA marking and approved body number to each PPE itemManufacturer
uri:annex/viii/division/conformity/division/6 uri:annex/viii/division/conformity/division/6 Regulated
  • Keep PPE technical records for 10 years for enforcement authorityManufacturer
uri:annex/viii/division/conformity/division/7 uri:annex/viii/division/conformity/division/7 Regulated
Other duties (1) — Crown / regulator
  • Approved bodies must report quality system approvals to the Secretary of State and other approved bodiesStatutory regulator
s.004 Making available on the market (opens in a new tab) Prosecution
  • Ensure PPE is safe and compliant before placing it on the marketManufacturer

Unlimited fine

s.005 Essential health and safety requirements (opens in a new tab) Regulated
  • Ensure PPE meets essential health and safety requirementsManufacturer
s.008 Obligations of manufacturers (opens in a new tab) Regulated
  • Ensure PPE is safe, tested, and correctly documentedManufacturer
s.009 Authorised representatives (opens in a new tab) Regulated
  • Authorised representative obligations for PPE manufacturersManufacturer
s.010 Obligations of importers (opens in a new tab) Regulated
  • Verify and label imported personal protective equipment (PPE)Manufacturer
s.011 Obligations of distributors (opens in a new tab) Regulated
  • Verify safety markings and documentation before selling PPEDistributor
s.012 Cases in which obligations of manufacturers apply to importers and distributors (opens in a new tab) Prosecution
  • Assume manufacturer duties if branding or modifying PPEManufacturer

Unlimited fine

s.013 Identification of economic operators (opens in a new tab) Regulated
  • Keep records of your PPE supply chain for 10 yearsOperator
s.015 ... Declaration of conformity (opens in a new tab) Prosecution
  • Create, update, and sign a Declaration of Conformity for PPEManufacturer

Unlimited fine

s.023 Monitoring obligations (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must monitor PPE approved bodiesCrown / Minister / Government department
s.024 Approved body requirements (opens in a new tab) Regulated
  • Ensure PPE assessment bodies meet strict independence and competence standardsConformity Assessment Body
s.026 Subsidiaries of, and subcontracting by approved bodies (opens in a new tab) Regulated
  • Conditions when subcontracting or using a subsidiary for PPE conformity assessmentConformity Assessment Body
s.029 Identification numbers and register of approved bodies (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must maintain a public register of approved PPE bodiesCrown / Minister / Government department
s.030 Restriction, suspension or withdrawal of approval (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Secretary of State must restrict, suspend or withdraw approval of non-compliant bodiesCrown / Minister / Government department
s.032 Operational obligations of approved bodies (opens in a new tab) Regulated
Other duties (1) — Crown / regulator
  • Approved bodies must assess PPE conformity and enforce correctionsStatutory regulator
s.033 Appeal against decisions of approved bodies (opens in a new tab) Regulated
  • Approved bodies must provide a clear appeal process for PPE decisionsAny Person
s.034 Information obligation on approved bodies (opens in a new tab) Regulated
  • Approved bodies must report certification changes and activities to the CrownAny Person
s.038 Procedure ... for dealing with PPE presenting a risk (opens in a new tab) Regulated
  • Cooperate with authorities and take corrective action for unsafe PPEOperator
s.040 Compliant PPE which presents a risk (opens in a new tab) Prosecution
  • Fix, withdraw, or recall compliant PPE that is found to be unsafeOperator

Unlimited fine

s.045 Penalties (opens in a new tab) Imprisonment
  • Fail to comply with PPE requirementsAny Person
s.annex ii ESSENTIAL HEALTH AND SAFETY REQUIREMENTS Regulated
  • Design, manufacture and document PPE to meet safety standardsManufacturer
s.annex iv (Module A) Regulated
  • Control manufacturing and declare PPE compliance (Module A)Manufacturer
s.annex v (Module B) Prosecution
  • Apply for and maintain PPE type-examination certificatesManufacturer

Unlimited fine

s.annex vi (Module C) Regulated
  • Ensure PPE manufactured matches approved type and issue declarationsManufacturer
s.annex vii (Module C2) Regulated
  • Ensure PPE conformity through supervised random product checksManufacturer
s.annex viii (Module D) Regulated
  • Operate an approved quality system for PPE productionManufacturer
62 other provisions — procedural and definitional
uri:annex/ii/division/1/division/1.1/division/1.1.2/division/1.1.2.2 uri:annex/ii/division/1/division/1.1/division/1.1.2/division/1.1.2.2
uri:annex/ii/division/1/division/1.3/division/1.3.1 uri:annex/ii/division/1/division/1.3/division/1.3.1
uri:annex/ii/division/1/division/1.3/division/1.3.4 uri:annex/ii/division/1/division/1.3/division/1.3.4
uri:annex/ii/division/2/division/2.10 uri:annex/ii/division/2/division/2.10
uri:annex/ii/division/2/division/2.12 uri:annex/ii/division/2/division/2.12
uri:annex/ii/division/2/division/2.14 uri:annex/ii/division/2/division/2.14
uri:annex/ii/division/2/division/2.2 uri:annex/ii/division/2/division/2.2
uri:annex/ii/division/2/division/2.3 uri:annex/ii/division/2/division/2.3
uri:annex/ii/division/2/division/2.5 uri:annex/ii/division/2/division/2.5
uri:annex/ii/division/2/division/2.6 uri:annex/ii/division/2/division/2.6
uri:annex/ii/division/3/division/3.1/division/3.1.2/division/3.1.2.2 uri:annex/ii/division/3/division/3.1/division/3.1.2/division/3.1.2.2
uri:annex/ii/division/3/division/3.1/division/3.1.3 uri:annex/ii/division/3/division/3.1/division/3.1.3
uri:annex/ii/division/3/division/3.2 uri:annex/ii/division/3/division/3.2
uri:annex/ii/division/3/division/3.3 uri:annex/ii/division/3/division/3.3
uri:annex/ii/division/3/division/3.4/division/3.4.1 uri:annex/ii/division/3/division/3.4/division/3.4.1
uri:annex/ii/division/3/division/3.7/division/3.7.1 uri:annex/ii/division/3/division/3.7/division/3.7.1
uri:annex/ii/division/3/division/3.8/division/3.8.2 uri:annex/ii/division/3/division/3.8/division/3.8.2
uri:annex/ii/division/3/division/3.9/division/3.9.2/division/3.9.2.2 uri:annex/ii/division/3/division/3.9/division/3.9.2/division/3.9.2.2
uri:annex/ix/division/6 uri:annex/ix/division/6
uri:annex/ix/division/7 uri:annex/ix/division/7
uri:annex/v/division/eu/division/6/division/6.1 uri:annex/v/division/eu/division/6/division/6.1
uri:annex/v/division/eu/division/7/division/7.6 uri:annex/v/division/eu/division/7/division/7.6
s.annex iii para.1 The technical documentation shall specify the means used by the...
s.annex iii para.2 The technical documentation shall include at least the following elements:...
s.annex iii para.3 a complete description of the PPE and of its intended...
s.annex i para.1 This Annex lays down the categories of risk against which...
s.annex ix para.1 Signed for and on behalf of: …
s.annex ix para.2 (place and date of issue):
s.annex ix para.3 (name, function) (signature):
s.correlation table CORRELATION TABLE
s.... declaration of conformity no … ... DECLARATION OF CONFORMITY No …
s.designated standard Designated standard
s.risk categories of ppe RISK CATEGORIES OF PPE
s.technical documentation for ppe TECHNICAL DOCUMENTATION FOR PPE

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