EUROPEAN LEGISLATION FOR PERSONAL PROTECTIVE EQUIPMENT
Personal protective equipment, PPE, is designed to protect the wearer against risks to their health and/or safety. Only PPE products that comply with the EU’s Personal Protective Equipment (PPE) Regulation EU 2016/425 or Great Britain Regulation 2016/425 as incorporated into British law may be placed on the market within the European Member States (EU), the European Economic Area (EEA) and Great Britain.
Under the PPE legislation it is the responsibility of the manufacturer to ensure that the product placed on the market complies with the legal requirements. The legislation is interpreted in standards that specify the actual requirements that apply to each specific type of personal protective equipment. The requirements cover protective performance, safe use, marking and technical documentation.
All PPE that is placed on the market within the EU and the EEA must bear the CE mark. PPE placed on the market in Great Britain must bear the CE- or UKCA mark.
Under the legislation, personal protective equipment is divided into three categories:
Category I – Protective equipment of simple design where the user can assess the protection level. Products from Blåkläder: rainwear.
Category II – Protective equipment that is neither simple nor complex and which protects against medium risks. Products from Blåkläder: hi-vis garments, safety footwear, protective gloves and knee pads.
Category III – Protective equipment of complex design that protects the user against risks with very serious consequences or risks causing irreversible harm to health, the immediate effects of which the user cannot identify in sufficient time. Examples of products from Blåkläder: garments that protect against the thermal effects of an electric arc.
PPE STANDARDS
Standards defining test methods and other requirements are used to verify that a PPE product provides proper protection and can thus be placed on the European market. These standards are developed with the participation of national committees coordinated by a central organisation. The central organisation for standardisation in Europe is Comité Européen de Normalisation (CEN). Standards developed by or included under CEN are prefixed with “EN”. There are other standardisation organisations, for example, the International Organization for Standardization (ISO). Standards that have been developed by ISO and then adopted as a European standard are prefixed with “EN ISO”.
Personal protective equipment is labelled to show which standards have been used to demonstrate the protective performance of the products. Pictograms are also used on personal protective equipment to provide visual information about the type of protection afforded by the equipment. If there are varying levels of protection against a hazard, the equipment’s labelling will indicate which level of protection it provides.
Personal protective equipment in Category I can be verified using standards, but does not have to be certified by a third party. Personal protective equipment in Categories II and III must, however, be certified by a third party. An accredited test facility, a so-called “notified body” (for Great Britain “Approved Body”), must test and approve Category II and III products and issue an EU type examination certificate/ UKCA Type Examination Certificate. In addition, an annual quality assurance audit of the manufacturing process for Category III products is required.
All PPE must be correctly labelled, delivered with user instructions, and carry the CE- /UKCA mark.
A manufacturer of PPE must ensure that the products it brings to the market comply with relevant requirements. A Declaration of Conformity shall be issued for all protective equipment. This is the legally binding document that the manufacturer shall submit to verify that the personal protective equipment complies with all relevant legal requirements.