The European directive regulating PPE products

Personal protective equipment 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 may be placed on the market within the European Member States (EU) and the European Economic Area (EEA).

Under the PPE Directive, 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.

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.

*A new Regulation (EU) 2016/425 on Personal Protective Equipment (PPE) came into force on 21st April 2018.

The old and new legislations were both effective during a transition period until 21st April 2019, after which the new Regulation came into full force, repealing the old PPE Directive. Products that were certified to the PPE Directive are still allowed to be sold and used even after 21st April 2019.


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 that are co-ordinated 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 standard has 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”, must test and approve Category II and III products and issue an EU 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 mark.

A manufacturer of PPE must ensure that the products it brings to the market comply with relevant requirements. This is done by issuing a Declaration of Conformity for all personal protective equipment. A Declaration of Conformity is a legally binding document that the manufacturer may be asked to submit to verify that the personal protective equipment complies with all relevant legal requirements.

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