The Personal Protective Equipment (PPE) directive is a CE marking directive which is intended to ensure that all PPE meets common standards of quality and performance. It also sets out basic health and safety requirements. The directive came fully into force in June 1995; non-compliant equipment must not be sold, even old stock manufactured before the directive came into force.
The responsibility for ensuring that the directive is adhered to falls upon the manufacturer. The directive is enforced in the UK by the local authority Trading Standards Service. 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.
Significantly, this directive makes no distinction between PPE used for work purposes and that used for leisure. The directive divides PPE into 3 categories; class 1 - simple, class 3 - complex and class 2 - neither of these. For classes 1 and 3 there are comprehensive lists of products covered; any products not included on either list are classed in the second category. There is also a comprehensive list of devices excluded from directive. There are general requirements for all 3 classes, including technical documentation, a CE mark and a Declaration of Conformity. For classes 2 and 3 there are additional requirements.
The PPE Directive is intended to require all manufacturers of personal protective equipment to meet common standards of quality and performance. It 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.
PPE is defined as “any device or appliance designed to be worn or held for protection against one or more safety and health hazards”.
The Directive also covers combined PPE intended to protect against multiple hazards, and interchangeable components essential to its satisfactory functioning.
No distinction is made between PPE used for work activities and for leisure. 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 BERR and independent legal advisors.
The Directive defines three classes of PPE:
The equipment in categories I and III are listed in the Directive. These lists are comprehensive and items which do not clearly fall within the descriptions of one list or the other must be Category II PPE, or not PPE at all.
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.
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.
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 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.
For further advice on any aspect of the Directive, please contact us at Conformance and we will be pleased to help you decide what standards apply to your products and advise on all other aspects of the Directive.