Henkilösuojausasetus

Henkilösuojausasetus, often translated as the Personal Protective Equipment Regulation or PPE Regulation, is a European Union regulation that governs the placing on the market, making available, and putting into service of personal protective equipment within the EU. Its primary goal is to ensure that PPE sold and used in the EU meets high safety and health protection standards.

The regulation establishes a framework for the design and manufacture of PPE, specifying essential health and safety requirements that products must comply with. It categorizes PPE into three risk classes based on the severity of the risk they are intended to protect against. Class I covers minimal risks, Class II covers non-exceptional risks, and Class III covers risks that may cause very serious consequences such as death or irreversible damage to health.

Manufacturers are responsible for ensuring their PPE complies with the regulation. For Class I and Class II equipment, this typically involves self-declaration of conformity. However, for Class III PPE, which is designed to protect against life-threatening or irreversible health damage, a Notified Body must be involved to conduct a conformity assessment. This ensures a rigorous third-party check of the product's safety.

The regulation also details the obligations of economic operators, including manufacturers, importers, and distributors. Importers must verify that the PPE they place on the market is compliant, and distributors must ensure that the PPE they make available remains compliant throughout the supply chain.

Henkilösuojausasetus aims to harmonize the rules for PPE across all EU member states, facilitating the free movement of safe products and enhancing the protection of workers and consumers. It is periodically reviewed and updated to reflect technological advancements and evolving safety standards.