1. PPE Regulation (EU) 2016/425

1.1 Scope of PPE Regulation (EU) 2016/425

1.2 Responsibilities (manufacturer, importer, distributor)

1.3 PPE Categories (Category I, II, III)

1.4 CE / UKCA marking and Notified Body involvement


1. PPE Regulation (EU) 2016/425

1.1 Scope of PPE Regulation (EU) 2016/425

PPE Regulation (EU) 2016/425 is the primary legal framework governing personal protective equipment placed on the European market. It applies to all PPE intended to protect users against health and safety risks, including protective gloves used in industrial, laboratory, and cleanroom environments.

The regulation defines the essential health and safety requirements that PPE must meet before it can be placed on the market. It applies to both reusable and single-use gloves and covers a wide range of PPE types, including hand protection, protective clothing, footwear, respiratory protection, and eye and face protection.

PPE Regulation (EU) 2016/425 replaced Directive 89/686/EEC, strengthening compliance requirements and improving traceability across the supply chain.


1.2 Responsibilities Within the Supply Chain

Under PPE Regulation (EU) 2016/425, responsibility for compliance is shared across the supply chain.

  • Manufacturers are responsible for designing and producing PPE that meets the regulation’s essential health and safety requirements. They must carry out the appropriate conformity assessment, prepare technical documentation, and issue a declaration of conformity.
  • Importers must ensure that PPE manufactured outside the EU complies with the regulation before it is placed on the market. This includes verifying that conformity assessment procedures have been completed and that technical documentation is available.
  • Distributors must act with due care to ensure that PPE they supply is compliant, correctly marked, and accompanied by the required documentation and instructions.

This shared responsibility model ensures that non-compliant PPE cannot enter the market due to gaps in oversight.


1.3 PPE Categories (Category I, II, III)

PPE is classified into three categories based on the level of risk it is intended to protect against:

  • Category I (Simple Design)

PPE designed to protect against minimal risks, such as minor mechanical risks or low-level cleaning tasks.

  • Category II (Intermediate Design)

PPE intended to protect against risks that are neither minimal nor life-threatening. This category includes many general-purpose protective gloves used in industrial and laboratory environments.

  • Category III (Complex Design)

PPE designed to protect against risks that may cause serious or irreversible harm, such as exposure to hazardous chemicals or biological agents. Many chemical-resistant and specialist gloves fall into this category.

The category determines the conformity assessment route required before PPE can be placed on the market.


1.4 CE / UKCA Marking and Notified Body Involvement

For Category III PPE, conformity assessment must involve an independent Notified Body. This third-party organisation assesses the PPE against the applicable standards and confirms compliance with the regulation’s requirements.

Once compliance is demonstrated, PPE is marked with:

  • CE marking (EU market), or
  • UKCA marking (UK market),

accompanied by a four-digit Notified Body identification number.

This marking indicates that the product has undergone the required conformity assessment and meets the essential health and safety requirements defined by PPE Regulation (EU) 2016/425.