EPI Regulation in Europe: Technical Guide to Regulation (EU) 2016/425 and EN Standards

The circulation of safety products in the European Union is subject to strict compliance with a harmonized legal framework. Since April 21, 2018, the legal landscape has changed dramatically with the full implementation of the Regulation (EU) 2016/425, which instructs all member states to adhere to it.

This regulation is a law of direct application in all member states of the European Union, aimed at ensuring a high and uniform level of protection for all PPE users in Europe and ensuring fair competition in the market. In this technical guide from Sekureco.eu, we analyze the pillars that support this regulation and why compliance with EN Standards is so crucial for any industrial equipment.

Technical Guide to the European Regulation - Regulation (EU) 2016/425

While the old Directive 89/686/EEC had to be "translated" into the laws of each country (such as RD 1407/1992 in Spain), the Regulation (EU) 2016/425 is fully binding and directly applicable. This unifies certification criteria from Germany to Spain.

Essential Health and Safety Requirements (RESS)

The Regulation does not specify how to manufacture a glove, but rather what safety objectives must be met. These are listed in Annex II and divided into:

• General requirements: applicable to all PPE (ergonomics, absence of additional risks, durability).
• Common supplementary requirements: such as adjustment systems or visibility marking.
• Specific requirements by risk: protection against cold, heat, electric shocks, among others.

Harmonized Standards (EN Standards)

At this point, let’s understand the Regulation as the law and the EN Standards (European Norms) as the "Instruction Manual." A manufacturer following a harmonized standard (published in the Official Journal of the EU) benefits from the presumption of conformity. Some of the most critical in the industry are:

• EN ISO 20345:2022: Requirements for safety footwear.
• EN 388:2016+A1:2018: Protection against mechanical risks in gloves.
• EN 361: Fall arrest harnesses.
• EN 166: Eye protection.
• EN 149: Respiratory protective devices.

Categorization and Assessment Procedures

The European regulation divides equipment according to the severity of the risk, which determines the quality control:

• Category I (Minimal risks): The manufacturer signs a declaration of conformity after an internal production control (Module A).
• Category II (Intermediate risks): Requires a EU Type Examination (Module B) conducted by a Notified Body.
• Category III (Deadly or irreversible risks): In addition to Module B, requires an annual external audit of production (Module C2 or Module D). This includes equipment for work at height, respiratory protection, and protection against electric arcs.

Mandatory Nature of European Regulation for PPEs and Critical Scenarios

This regulation is the mandatory reference framework in four critical scenarios:

1. In the design and manufacturing phase

Any entity that manufactures PPE under its own name or brand in the EU must comply with the Regulation. This includes the preparation of the Technical File, which must be kept for 10 years after the PPE has been placed on the market.

2. In importation and distribution

Importers have the legal responsibility to verify that the manufacturer has carried out the relevant conformity assessment procedure. It is not enough to sell; they must ensure that the product bears the CE marking and is accompanied by instructions in the language of the destination country.

3. In Prevention Audits (PRL)

Safety technicians use these standards to validate whether the equipment provided to the worker is appropriate. If a risk assessment requires protection against cuts of level D, the technician must verify that the glove complies with EN 388 under that specific parameter.

4. In Labor Inspection

In the event of a workplace accident, the authority will verify whether the PPE complied with Regulation (EU) 2016/425. The use of non-certified equipment or equipment certified under outdated regulations carries legal responsibilities for the company.

Examples of Products and Their Regulatory Marking

At Sekureco.eu, each product is labeled with its corresponding standard to facilitate traceability:

• Safety Footwear S3: Working S3 Safety Footwear PAREDES Must include protective toe (200 J) and puncture-resistant sole.
• Respiratory Protection FFP3: Disposable FFP3 Masks against Particles SAFETOP. Essential for highly toxic particles, with a marking indicating whether they are reusable (R) or not (NR).
• Fall Arrest Harnesses: Positioning Belt P02S - EN 361 and EN 358. Must bear the CE marking followed by the four-digit number of the body that audits the factory (e.g., CE 0123).
• High Visibility Clothing: Clothing EN ISO 20471, which regulates the square meters of reflective and fluorescent material according to the class (1, 2, or 3).

Summary of Mandatory Marking (Checklist for the Buyer)

All legal PPE in Europe must permanently display:

1. CE marking.
2. Name or registered trademark of the manufacturer.
3. Designation of type, batch, or serial number.
4. The specific EN Standard applied.
5. Protection pictograms and performance levels.

Compliance with regulations is not an option; it is a guarantee of life. At Sekureco.eu, we take European regulations with the rigor that your company deserves. All our suppliers undergo a strict documentation validation process to ensure that every boot, helmet, or harness you receive complies 100% with the Regulation (EU) 2016/425.

Do you have questions about which standard applies to your sector? Our team of experts is ready to advise you on the technical purchase of your equipment.

Discover the Workwear for Industry and Construction available at Sekureco.

Frequently Asked Questions about European Regulation in PPEs

What is a Notified Body?

It is a control entity (such as SATRA, AITEX, or APAVE) designated by a member state of the EU to assess the conformity of category II and III PPE before they are placed on the market.

Are PPEs certified under the old Directive still valid?

CE type examination certificates issued under Directive 89/686/EEC remained valid until April 21, 2023, unless they expired earlier. As of today, any new PPE must be certified under Regulation 2016/425.

Is it mandatory for the PPE to include the Declaration of Conformity?

Yes. The Regulation requires that each PPE be accompanied by the EU Declaration of Conformity or at least a website address where it can be easily accessed.

How does Brexit affect European Regulation?

For the EU market, nothing changes. However, to sell in the UK, equipment now requires the UKCA marking instead of or in addition to the CE marking, following very similar regulations but with British control bodies.

What does the marking "A1" or "2016" after an EN standard mean?

It indicates the year of the standard's update. It is crucial to use updated equipment, as revisions often tighten testing methods (as happened with the cut test in EN 388).