Personal Protective Equipment (PPE) and Certification Process
What is the 2016/425/EU PPE Regulation?
Personal protective equipment (PPE) refers to products designed to protect workers’ health and safety. These products are used in workplaces, construction sites, the healthcare sector, and various industrial environments.
In the European Union (EU), the design, production, inspection, and market placement of personal protective equipment are regulated by the 2016/425/EU PPE Regulation. This regulation sets out the minimum requirements to ensure that PPE products are safe for human health. Under this regulation, products placed on the market must carry the CE marking.
PPE Certification Process
For PPE to receive CE marking, it must undergo specific conformity assessment procedures. This process varies depending on the product’s risk category, intended use, and type.
The main steps include:
- Compliance with Standards – Determining whether PPE products meet the relevant harmonized standards.
- Certification Process – Allowing products to be marketed with CE marking if EU requirements are met.
- Testing and Evaluation – Conducting laboratory tests and performance assessments of products.
- Technical Documentation – Preparing technical files that manufacturers are required to compile.
- Legal Compliance – Ensuring conformity with EU legislation.
- Ongoing Monitoring – Maintaining compliance with EU regulations even after products are placed on the market.
Types of Personal Protective Equipment
PPE is produced in various categories to provide protection against different occupational safety risks:
- Head Protection: Helmets (EN 397), hard hats, chemical splash hoods.
- Eye and Face Protection: Safety glasses, face masks, face shields (EN 166).
- Hearing Protection: Earplugs, earmuffs (EN 352).
- Respiratory Protection: Dust masks, respirators (EN 149).
- Hand and Arm Protection: Gloves and arm protectors against chemical and mechanical risks (EN 388, EN 407).
- Foot Protection: Steel-toe shoes, safety boots (EN ISO 20345).
- Body Protection: Disposable coveralls, workwear (EN 14126, EN 13034, EN ISO 13688, etc.).
Employers are responsible for providing PPE suitable to the risks identified in their risk assessments. Employees must also use this equipment correctly and effectively.
Why is the CE Certificate Necessary for PPE?
The CE certificate demonstrates that PPE products comply with EU standards and offers several benefits:
- User Safety – Confirms that products meet minimum safety standards.
- Legal Compliance – PPE products without CE marking cannot be placed on the EU market.
- Market Access – CE marking allows free circulation of products within the EU.
- Quality and Reliability – CE certification proves that the product meets quality and safety requirements.