PPE Regulation (EU) 2016/425
Regulation (EU) 2016/425 on personal protective equipment (PPE Regulation) has been fully applicable since 21 April 2018, replacing Directive 89/686/EEC.
Key areas of the PPE Regulation:
- Scope: PPE for private and professional use
- Categorisation: three risk categories (I, II, III) with different conformity requirements
- Essential health protection and safety requirements (Annex II)
- Technical documentation (Annex III)
- Labelling requirements and CE obligation
- Economic operators: manufacturers, importers, distributors
- Market surveillance and safeguard clause
Relevant for protective gloves:
- EN ISO 21420 (general) + product-specific standards
- EN 388 (mechanical) = Category II
- EN ISO 374-1 Type A/B/C (chemical) = Category III
- EN 16350 (electrostatic) = Category II
Distinction from MDR: the PPE Regulation protects the wearer. MDR protects the patient. A glove can fall under both frameworks.
Key difference from the replaced Directive: as an EU Regulation, the PPE Regulation is directly applicable in all Member States without national transposition.
Frequently asked questions
What changed with the PPE Regulation 2016/425 compared to the old Directive?
As an EU Regulation it is directly applicable (no national transposition needed). Requirements for economic operators (importers, distributors) were strengthened. Market surveillance authorities received extended powers. New obligations for online marketplaces were introduced.
Does the PPE Regulation apply to private use?
Yes. The PPE Regulation applies to both occupational and private protective equipment. There are however exceptions for PPE specifically designed for armed forces and police.
What obligations do importers have under the PPE Regulation?
Importers must ensure CE marking, EU Declaration of Conformity, and documentation are in place; indicate their name on the product; ensure appropriate storage; and inform authorities about non-compliant products.