Personal Protective Equipment Regulation

Summary

As of 21 April 2018, Directive 89/686/EEC will be repealed by the new Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.

• Personal Protective Equipment (PPE) directive covers “any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards”.
  
  
• All manufacturers of personal protective equipment are required to meet common standards of quality and performance. In addition, the directive lays down a series of basic health and safety requirements which can be complied with directly for simple equipment and which form the basis of a series of standards for the design and performance of more complex equipment.
  
  
• The directive makes no distinction between PPE used for work purposes and that used for leisure.
  
  
• The directive came fully into force in June 1995; non-compliant equipment must not be sold, this includes old stock manufactured before the directive came into force.
  
  
• The manufacturer is responsible for ensuring that the directive is adhered to. In the UK, the Trading Standards Service enforces the directive. Failure to comply can lead to up to 3 months in prison and/or a fine of up to £5000. Furthermore, manufacturers can be required to recall and replace any equipment found to be faulty.

Purpose

The aim of the PPE Directive is to provide common standards for PPE throughout the EEA and provide health and safety requirements, which all PPE must comply with to ensure the health and safety of users.

Scope

The PPE directive covers any equipment designed to protect against safety and health hazards. In addition, this covers combined PPE intended to protect against multiple hazards, and interchangeable components essential to its satisfactory functioning. “(a) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks; (b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity; (c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.”

All protective equipment is required to comply, whether it is intended for use at work or in the home.

Responsibility for deciding if a product is PPE rests with the manufacturer (or their authorised representative). Manufacturers may seek guidance from various sources, including trade associations, notified bodies, the Department for Business, Energy & Industrial Strategy and independent legal advisors.

The Directive defines three classes of PPE:

Category I  Category II  Category III
Simple design PPE, PPE which is neither simple nor complex Complex design PPE

The equipment in categories I and III are listed in the Directive. These lists are comprehensive and any PPE that does not clearly fall within the descriptions of either category I or III, will fall within Category II.

Exclusions

Some items of PPE are specifically excluded from the Directive. Again, this list is comprehensive and items of PPE which do not appear on it must be included in one of the three categories mentioned above.

Timescale

The Directive came into force on 1 January 1993 with a transitional period ending on 30 June 1995. As of this date, all PPE as defined in the Directive must comply and be CE marked accordingly. The amending directives concerning CE marking and the transitional period are also now fully in force.

Equipment which is not compliant with the health and safety requirements of the Directive must no longer be sold even if it is old stock. The Directive does not require suppliers to scrap un-marked PPE so long as it is compliant with the other requirements of the Directive, but distributors and retailers must keep any applicable invoices etc to prove the equipment pre-dates 1 Jul 1995.

Manufacturing and Certificates Requirements

For all PPE the Directive lays down requirements for technical documentation and CE marking and for the manufacturer to prepare and make available a Declaration of Conformity.

Category I PPE does not require certification but must be manufactured in accordance with the essential health and safety requirements of the Directive.

PPE in Categories II and III must be independently type tested by a Notified Body to demonstrate that it meets the requirements of the applicable standards. It is not necessary for the production procedure to be independently assessed, but regular samples of production must be submitted for testing.

Category III PPE must be manufactured under an assessed quality management system to ensure on-going production performance matches type tested sample.

Enforcement

Enforcement in the UK is by the local authority Trading Standards Service. Maximum penalties for non-compliance with the Directive itself include 3 months in prison and a fine of up to UK £5000. However, manufacturers may also be required to recall and replace faulty product so the actual costs of non-compliance may be very much higher.

Additionally, non-compliance may only be noticed after an accident or other incident in which case the manufacturer is very likely to also face civil or criminal proceedings resulting from the injuries sustained by the user.