The Personal Protective Equipment Regulation (EU) 2016/425 sets the legal framework for placing personal protective equipment (PPE) on the EU market. Its goal is to ensure a high level of health, safety, and protection for users, whether they are professionals, industrial workers, or private consumers.
What is the PPE Regulation?
The current regulation replaced Directive 89/686/EEC and became fully applicable on 21 April 2018. Unlike the former directive, the PPE Regulation is a binding EU regulation, meaning it is directly applicable in all EU member states without national transposition.
The regulation ensures that all PPE sold in the EU complies with uniform safety standards, regardless of where it is manufactured. It applies to manufacturers, importers, distributors, and anyone involved in placing PPE on the European market.
Scope of the PPE Regulation
The regulation applies to any device or appliance designed to be worn or held by a person for protection against one or more risks to health or safety. Examples include:
- Safety helmets, gloves, and goggles
- Hearing protection
- Respiratory protective equipment
- Fall protection systems
- Protective footwear and clothing
- Face masks and visors
It also covers PPE for non-professional use, such as sports helmets or household protective gloves.
However, it does not apply to:
- PPE used exclusively by armed forces or law enforcement
- PPE for self-defense (e.g. pepper spray)
- PPE for use on seagoing vessels or aircraft
- Helmets and visors for use by two-wheeled motor vehicle users (covered under a different regulation)
Categories of PPE
The regulation classifies PPE into three categories based on the risk level:
- Category I: Simple PPE for minimal risks (e.g. gardening gloves, sunglasses)
- Category II: PPE for intermediate risks (e.g. safety goggles, hard hats)
- Category III: Complex PPE for life-threatening or irreversible health risks (e.g. respirators, chemical suits, fall arrest equipment)
Each category determines the level of conformity assessment and whether a Notified Body must be involved.
Conformity Assessment and CE Marking
Before PPE can be sold in the EU, it must undergo the correct conformity assessment procedure:
- Category I: Internal production control by the manufacturer
- Category II: EU-type examination by a Notified Body
- Category III: EU-type examination + ongoing surveillance (e.g. production audits or sample testing by a Notified Body)
Manufacturers must:
- Compile a technical documentation file
- Conduct a risk assessment for the intended use
- Issue an EU Declaration of Conformity
- Affix the CE marking to the product
For Category III, the CE mark must be followed by the Notified Body’s identification number.
Harmonised Standards and Presumption of Conformity
Using relevant harmonised EN standards offers a presumption of conformity with the essential health and safety requirements of the regulation. Examples include:
- EN 166: Eye protection
- EN 149: Respiratory masks (FFP1, FFP2, FFP3)
- EN 388: Protective gloves against mechanical risks
- EN 361: Full body harnesses for fall arrest
Manufacturers are encouraged to apply these standards as part of their compliance strategy.
Responsibilities of Economic Operators
- Manufacturers: Must ensure product compliance, maintain technical files, and label products correctly
- Importers: Must verify that third-country PPE complies with EU rules before placing it on the market
- Distributors: Must check that PPE is CE marked and accompanied by the EU Declaration of Conformity and instructions
All economic operators must cooperate with market surveillance authorities and take corrective actions if non-compliant products are found.
Contact Us
Ensuring PPE compliance is essential for protecting users and maintaining trust in your brand. Our team assists with product classification, risk assessments, CE marking, technical documentation, and coordination with Notified Bodies.
Contact us today to make sure your personal protective equipment meets all legal and safety requirements under the PPE Regulation (EU) 2016/425—so you can protect your users and confidently access the European market.
