A guide to the categories of personal protective equipment according to the PPE Regulation (EU) 2016/425

When and why was the PPE Directive changed? The new PPE Regulation 2016/425 has been in force since April 2018 and replaces the PPE Directive 89/686/EEC. The PPE Regulation was introduced to harmonize the process of developing PPE and bringing it to market in Europe, taking into account current practice. For the implementation of the published regulations, a transitional period between April 2018 and April 2019 applies. By April 2019 at the latest, all CE-marked PPE products brought to market must comply with the PPE Regulation.

Category I - Minor Risks: PPE that covers minor risks falls into this category. Examples include simple protective glasses or gardening gloves. Manufacturers carry out an internal production control and issue an EU declaration of conformity.

Category II - Risks outside of Category I and III: This category includes PPE that protects against medium risks, such as protective glasses with a higher level of protection or hearing protection. An EU type-examination by a notified body is required.

Category III - Risks with serious consequences: PPE in this category offers protection against risks that can lead to serious consequences such as death or irreversible health damage. This concerns areas such as handling hazardous substances or biological agents. An EU type-examination and ongoing monitoring by a notified body are required.

The PPE Regulation (EU) 2016/425 categorizes PPE according to the risks they are intended to protect against. Manufacturers must meet the specific requirements of each category. While protective gowns are usually assigned to Category I, DACH offers protective clothing even a Category III protective gown: the IsoCoat Zytex®, which has been certified as Category III PPE and can therefore be used in extremely demanding environments. This illustrates the different levels of protection. The correct classification and certification of PPE ensures the safety of those who are exposed to potential hazards on a daily basis.