The June 1995 Personal Protective Equipment directive 89/686/EEC sets out the guidelines and regulations for all personal protective equipment seeking to enter the European Market. Under the directive, ‘personal protective equipment’ is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”. The aim of the directive is to ensure the safeguarding of public health, improve the quality of work safety, and guarantee user protection and ultimately contributes to the European Commission’s goal of facilitating free movement of quality goods throughout the European Economic Area through the use of universal Harmonized Standards.
The directive applies to any device or appliance intended to be worn or used by an individual for protection against one or more health and safety hazards. As such, its scope encapsulates a wide variety of products, including: equipment for protection against falls from a height, protective headgear (helmets and other protective headgear for use both privately and professionally), protective clothing (for example, heat or chemical resistant gloves, high visibility jackets, etc.), and protective eyewear (laboratory safety goggles or eyewear for use in sport).
Outlined in the directive are three distinct categories for included products. They are as follows:
I. Category I: Category I includes non-complex products intended mainly for home or non-specialized use. The examples of category I items include: gardening gloves, sunglasses, or ski goggles.
II. Category II: Category II is a catch-all term for products that fit into neither Category I nor III. As such, products within this category can range from personal to professional use items. Included in Category II are products like protective hearing equipment and clothing and protective sportswear.
III. Category III: Category III includes complex products chiefly intended for use by professionals or skilled individuals. Products within this category include products used for protecting against electrical risks and dangerous voltages or toxic/radiotoxic gases and respiratory support equipment.
In an attempt to provide upmost clarity, the directive also includes a list of PPE classes not covered. It includes: PPE designed and used only in conjunction with military or law and order practices (helmets, shields, etc.), PPE used in self-defence (aerosol canisters, personal deterrent weapons, etc.), PPE intended for the protection of individuals on aircrafts and vessels but not worn at all times (helmets, visors, etc.), and PPE designed for use against adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.), dampness and water (dish-washing gloves, etc.), and heat (heat resistant gloves, etc.).
The compliance process for all classes of personal protective equipment is relatively similar to most products requiring CE mark. The manufacturer must compile the correct Technical File, affix a CE Mark, and issue a Declaration of Conformity (Category II and III products may be subject to additional requirements). In many cases manufacturers will also have to get certification from the relevant Notified Body to ensure adequate transparency and uniformity across European member states. It is also extremely important to note that manufacturers based outside the European Union are obliged by law to appoint a European Authorized Representative with an address inside the union.
For more information on PPE directive 89/686/EEC, the PPE classification system, or to get a quote for Obelis’ European Authorized Representative and CE marking services, contact us today.