CE Marking- Navigating Compliance with Category 3 Protection

What Makes PPE Category III?

The regulation classifies PPE into three risk categories, with Category III covering protection against the most serious hazards - think toxic chemicals, extreme heat, or hazardous biological agents. To be legally placed on the European market, Category III PPE must be assessed by a Notified Body to ensure compliance with the Annex II Basic Health and Safety Requirements of the regulation.

The Role of Harmonised Standards in PPE Compliance

Meeting compliance is not just about passing tests, but it’s about proving reliability and safety to the user. Harmonised standards provide a clear, industry-accepted path to proving compliance with the 2016/425 Regulation.

Examples of key harmonised standards for PPE include:

• EN 14605:2005+A1:2009– Protective clothing against liquid chemicals

• EN 943-1:2015+A1:2019– Gas-tight protective suits

• EN 943-2:2019– Emergency teams’ gas-tight suits

• EN 12941:1998+A2:2008– Powered filtering devices for respiratory protection

What Are Harmonised Standards, and Why Do They Matter?

A harmonised standard is a European standard developed by recognised organisations such as CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation) in response to a formal request from the European Commission. These standards are published in the Official Journal of the European Union (OJEU) and serve as a benchmark for demonstrating compliance with EU regulations.

Key Features of Harmonised Standards:

• Voluntary Use - While following harmonised standards provides a presumption of conformity with EU laws, manufacturers can technically use alternative compliance methods, but they’d have to understand how their product satisfies the appropriate EU regulation(s).
• Technical Clarity- These standards provide detailed specifications, test methods, warnings, and instructions that help manufacturers ensure compliance with relevant EU regulations.
• CE Marking & Market Access- Complying with harmonised standards simplifies the CE marking process, ensuring your PPE meets the stringent safety, health, and environmental protection standards required for sale in the EU.
• Legal Framework- These standards are directly linked to EU legislation, giving manufacturers a clear path to proving compliance while ensuring product safety and quality.

CE marking isn’t just about sticking a logo on your product, it’s about proving that your PPE can save lives. Whether you’re a manufacturer, distributor, or end-user, understanding the role of harmonised standards and Category III assessments is crucial for ensuring PPE meets the highest safety requirements.

A Declaration of Conformity (DoC) for Personal Protective Equipment (PPE) sold in Europe is a legal document in which the manufacturer (and where applicable an authorised representative) declares that their product complies with the European Regulation 2016/425.

What the DoC Confirms:

• The PPE meets the essential health and safety requirements outlined in the 2016/425 regulation.
• The product complies with the applicable harmonised standards (which must be listed in the Declaration of Conformity) or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared
• The manufacturer has carried out the appropriate conformity assessment procedure, which for Category 3 PPE includes testing and certification by a Notified Body (details of the notified body must be included as stipulated under Annex IX of 2016/425)

The Declaration of Conformity must be provided with the PPE or available via a website link referenced in the products user instructions. A Declaration of Conformity is required for CE marking to be valid.