Personal Protective Equipment (Enforcement) Regulations 2018
What this means for your business
- Enforced by
- OPSS
- Applies to
- United Kingdom
- On this page
- 6 compliance obligations, 1 practical guide
What you must do
6 compliance obligations under this legislation — 3 can result in imprisonment.
Risk assessment 1
Ensure EU type‑examination conformity assessment for Category II/III PPE before manufacture
If your business manufactures personal protective equipment that is classified as risk category II or III, you must have the EU type‑examination conformity assessment (Annex V of Regulation 2016/425) carried out before you start production. Once that assessment is completed, the other references to conformity assessment and technical documentation in the regulations are treated as satisfied.
Equipment and safety 1
Affix UK(NI) marking on PPE before selling in Northern Ireland
If you sell personal protective equipment (PPE) in Northern Ireland that carries a CE mark based on a UK‑approved assessment, you must also put a UK(NI) label on it. The label has to be clear, permanent and placed on the product before it is first offered for sale. Importers must check that the manufacturer has done this.
Management duties 1
Take corrective action or recall PPE when notified
If a market‑surveillance authority sends you a written notice under Article 38 telling you that your PPE poses a risk, you must act – either fix the problem, withdraw the product from the Northern Ireland market or carry out a recall – within the deadline they set. You also need to make sure the authority can serve you notices at your registered or designated service address.
Offences and prohibitions 3
Fail to comply with withdrawal or recall notice for UK(NI) indication
Unlimited fineIf personal protective equipment is required to be withdrawn, recalled or removed because the UK(NI) indication is missing or wrong, you must obey the withdrawal or recall notice. Anyone who does not follow that notice commits a criminal offence. On conviction in the magistrates' court you face an unlimited fine.
Fail to meet PPE obligations or obstruct enforcement
3 months imprisonmentIf your business (as a manufacturer, importer, distributor or other economic operator) does not follow the PPE marking, identification and cooperation requirements set out in the regulations, or if you intentionally obstruct, give false information to, or fail to assist the enforcement authority, you commit a criminal offence. A conviction can lead to fines and/or imprisonment as provided for in the regulations’ penalty provisions.
Liability for PPE offences caused by another’s act or omission
3 months imprisonmentIf a breach of the PPE regulations occurs because of something another person in your business did or failed to do, that person – for example a director, manager, secretary or other officer – can be prosecuted as well, even if they did not personally commit the primary breach. They face the same penalties as the principal offender, which may include an unlimited fine and/or imprisonment depending on the underlying offence.
Penalties for non-compliance
4 penalties under this legislation. 3 can result in imprisonment. 4 carry an unlimited fine.
Fail to meet PPE obligations or obstruct enforcement
Unlimited fine and/or 3 months imprisonment
Fail to reimburse enforcement costs for a PPE offence
Unlimited fine and/or 3 months imprisonment
Liability for PPE offences caused by another’s act or omission
Unlimited fine and/or 3 months imprisonment
Fail to comply with withdrawal or recall notice for UK(NI) indication
Unlimited fine
Practical guidance
Our guides explain how to comply with the requirements above.
Sections and provisions
29 classified provisions from this legislation.
Duties 7
- s.3 Designation of market surveillance authorities
- s.6 Notification to the Secretary of State of enforcement action etc
- s.12 Written notice under Article 38 and service of documents
- s.15 Compensation
- s.21 UK(NI) indication an importer
- s.23 Register of notified bodies established in the United Kingdom The Secretary of State
- Conformity assessment procedure obligation which i Conformity assessment procedure obligation which is met by complying with Regulation 2016/425 (pre-exit) reference
Offences and penalties 6
Powers 3
Definitions 5
- s.2 Application, transitional provisions, savings and revocation
- s.18 Review and consequential amendments
- s.20 Interpretation UK(NI) indication
- Further use of UK marking Further use of UK marking harmonised standard
- Qualifying Northern Ireland Goods Qualifying Northern Ireland Goods EU Regulation 2016/425 (Northern Ireland) applicable conformity assessment procedure technical documentation