PPE Regulations and Certificates You Need to Know About in Europe- EU 2016/ 425

Are you an employer who needs to know more about the legal aspects and regulations of providing PPE for your workers?

Whether you’re an employer, manufacturer, importer, or distributor, it’s your lucky day because here you can find all the answers you want about PPE regulations and certification!

Additionally, if you’re an employee who needs to understand more about your rights when it comes to PPE you use in your work.

Welcome to the party. This article is your guide.

PPE  is an industry of utmost importance.

With the global market expected to grow from $80.38 billion in 2022 to $110.85 billion by 2029 (1)

Furthermore, PPE is crucial in maintaining the health and safety of individuals.

There’s no simple equation for the production or distribution of PPE.
The industry is regulated by many laws, standards, and certifications across different countries. 

As a manufacturer, you must be familiar with PPE regulations to keep your spot in the market.

And as an employer, you have a legal obligation to protect your workers with many control measures and infection control measures if you’re in the medical field, including personal protective equipment.

And as a worker, you have responsibilities towards applying and adhering to PPE regulations.

They are industrial and construction PPE, medical-grade PPE, or chemical PPE.

Understanding and taking responsibility for these regulations is not just a luxury; it’s a necessity.

Here at MedRux, as part of the PPE industry, we wanted to make things easier for you.

Our series of articles will try to give you a simplified and comprehensive look at how things work in PPE regulations and certifications.

In today’s article, we will be covering them in the European Union through the following:

• What is PPE, and what is it used for?
• When and when not to use PPE in the workplace
• What are the EU 2016/425 PPE Regulations?
• Reclassification of PPE according to the EU Regulation
• A simple analysis of the PPE Regulation (EU) 2016/425
• A quick look at EU PPE Standards (EN-Standards)
• A quick look at EU PPE certifications (CE Mark and EC certificate)
  

What is PPE? What are they used for?

As most know, PPE stands for “Personal Protective Equipment.” Your safety kit keeps you safe at work, home, or leisure activities.

How?

PPE minimizes exposure to hazards, workplace injuries, and illnesses that may result from contact with chemical, radiological, physical, electrical, mechanical, or other workplace hazards.

In addition to exposure to blood, body fluids, and and many other hazards.

About 2.3 million people worldwide have work-related accidents every year.

Slips, trips, falls, bodily reactions, and contact with objects and equipment account for more than 84% of all non-fatal injuries.

Furthermore, hazardous substances alone are estimated to cause 651,279 deaths a year. (2)

These statistics emphasize the rule of PPE.

However, PPE doesn’t reduce the risk itself and doesn’t guarantee total protection.

In other words, wearing PPE is just one element and last resort in the safety equations and hierarchy of hazard control and implementing strategies to maintain a safe and healthy work environment.

So, when do you need to use PPE, and why is it the last resort?

When and when not to use PPE in the workplace? 

It would help if you remembered that PPE doesn’t eliminate the hazard; it is still there, but the risk of being injured or harmed by it is reduced.

However, PPE has limitations, such as limited mobility, dexterity, and visibility, and can add an extra weight that hinders movement. It could be a source of the hazard itself.

What’s more, it’s not always possible to assess the level of protection they provide because this depends on many factors, including individual variations and operational techniques, etc.

Moreover, PPE only protects the wearer. Meanwhile, the measures that aim at controlling the risk protect everyone.

Before resorting to PPE, employers should consider other control measures in the following order:

• Elimination

Physically remove the hazard. For example, use mechanical handling instead of manual. (Most Effective)

• Substitution

Replace the hazard with something less risky.

• Engineering control

Isolate workers from the hazard. For example, build a barrier between the worker and the source of risk.

• Administrative controls

Change the way people work; for example, rotating employees to reduce exposure to vibrations.

• PPE

Protect the workers with personal protective equipment (least effective).

How do you know what PPE your workplace needs?

All workplaces are full of risks, from construction sites to manufacturing goods and food preparation.

Consequently, protective equipment is different, should be personalized for the individual, and be suitable and fit.

Employers first need to do a risk assessment to determine whether they need to provide PPE or not and what type of PPE they should provide. 

How do they do this?

They inspect each work area and put into consideration the following potential risks:

(Impacts, penetration, compression, chemicals, heat, harmful dust, light, radiation)

After the survey, they should be able to select the proper PPE that matches and protects against the possible risks.

The bottom line is that even though PPE is the last control measure you should seek in the hierarchy of controls, it’s an essential part of many industries.

Wearing PPE is mandatory in many fields, including the industrial and medical sectors.

You might be asking how we know these rules about using PPE. The simple answer is the PPE Regulations, EU 2016/425.

What are these regulations?

Let’s find out.

What are the EU 2016/425 PPE Regulations?

In April 2018, the European Parliament and the Council compiled the laws of the European Member States relating to personal protective equipment.

This led to the “PPE Regulation (EU) 2016/425”. These regulations were fully implemented in April 2019 and replaced the PPE Directive 89/686/EEC.

The PPE Regulation is a set of rules and legal laws to ensure that all PPE is correctly identified and used. In addition to providing a high level of protection for the health and safety of users. 

On April 6, 2022, the UK Personal Protective Equipment at Work (Amendment) Regulations 2022 (PPER 2022) came into force. 

This replaced the 2002 and 1992 regulations (PPER 92). 

What about medical PPE regulations?

Other products, such as medical gloves and face masks, fall under the scope of the EU legal framework on medical devices – Council Directive 93/42/EEC.

However, in May 2021, this was entirely replaced by Regulation (EU) 2017/745. With many industries out there, there are numerous PPE available for protection against different hazards.

Reclassification of PPE according to the EU Regulations

According to the EU regulation, PPE is any device or appliance worn or held by an individual for protection against one or more health and safety risks.

In the latest update to these PPE regulations, PPE was recategorized according to the risk it protects against. 
Each category will have additional testing and certification requirements that we will go through later.

Category I “Simple Design PPE”

The most basic, designed to protect you from minor hazards.

In other words, the minimal risks you can safely identify and deal with during everyday daily life, such as:

• 1. Superficial mechanical injury
  2. Contact with water or weak cleaning materials
  3. Contact with hot surfaces (Maximum 50°C)
  4. Sunlight exposure (relative risk of eye damage)
  5. Non-extreme atmospheric conditions
     

Category I PPE examples are: cleaning gloves, gardening gloves, cut-resistant gloves, and sunglasses.

Category II “Neither simple nor complex.”

This category protects against physical, chemical, and electrical injuries.

In particular, injuries are not severe enough to cause death or permanent, irreversible damage—similarly, the intermediate risks between categories I and III.

They include most types of safety footwear, safety spectacles, goggles, industrial helmets, bump caps, and high-visibility clothing.

Category III “Complex design PPE.”

PPE in this category protects against risks that may cause serious events such as death or irreversible health damage.

These risks include:

• Hazardous substances and mixtures
• Oxygen-deficient atmosphere
• Harmful biological agents
• Ionizing radiation
• high-temperature environments (air temperature of at least 100 °C).
• Low-temperature environments (air temperature of – 50 °C or less)
• Falling from a height
• Electric shocks
• Drowning
• Cuts by hand-held chainsaws
• High-pressure jets
• Bullet wounds or knife stabs
• Harmful noise.

Category III PPE includes fire protective clothes, electrical insulation protective helmets, safety goggles, respirators, and footwear offering chainsaw cut, chemical, severe thermal, and high voltage protection.

In short, some types of PPE are for everyday use, while others are for specialized use in specific work environments. 
It depends on the level of protection you need and the risk you’re exposed to.

With such variety, there must be facilities, rules, and regulations to control the use of PPE.

In the next section, we will provide a simple analysis of the recently published PPE regulations (EU) 2016/425

Let’s dig in.

A simple analysis of PPE regulations

Here are the primary important things to know about the EU PPE regulations.

When should PPE be provided?

If the risk cannot be controlled by other effective means, PPE is required.

After risk evaluation, employers must ensure that the workers are provided with suitable PPE to protect them against potential hazards. 

Moreover, the employer must ensure PPE’s adequacy, including proper maintenance and sanitation, even if it’s the workers themselves provide it must be of suitable design.

All PPE should be of safe design and construction to ensure the work is done effectively and safely simultaneously. 

The design must not hinder the face, eyes, the field of vision, or respiratory system.

Moreover, it shouldn’t impose another source of risk to the wearer, such as sharp edges and points, electric or electrostatic charges, or impact-induced sparks. 

Eventually, the PPE should be as light as possible and comfortable enough for the wearer without hindering its strength, effectiveness, or protection.

• Free of charge

If your employees need a PPE item, it must be free. Furthermore, employers must pay for the replacement and maintenance of the PPE, except when the worker has lost or intentionally damaged the PPE.

• Suitable and compatible
  

PPE should be appropriate and compatible to protect workers effectively. The workers might be exposed to, without increasing the risk through prevention or adequate risk control.

Before selecting a PPE, you should know who is exposed, what they are exposed to, how much they are told, and how long they will be exposed to this risk.

It’s an excellent idea to involve the person using this PPE in the selection process. This assessment should be reviewed in case significant changes to the work environment may cause the risk to be less or more.

If there’s more than one risk, it’s necessary to use more than one item of PPE simultaneously. On the condition that they are compatible and that neither can obstruct the other’s protection or effectiveness. 

• Fit the wearer correctly

PPE isn’t considered suitable unless it considers the ergonomic requirements and health of the person who wears it. In other words, PPE must be of the proper size. It must fit the person comfortably.

Why?

To motivate the workers to use it. Additionally, the fit can be vital in protecting or exposing the wearer to danger.
Unfit PPE can be entangled in machines or expose body parts to risks.

• Maintained and replaced

Whether an employer or a self-employed person, you must ensure that the provided PPE is maintained cleanly and appropriately or replaced if needed.

Why? 
Because if there’s something wrong with the PPE, this could lead to potential risk or injury.

• Stored appropriately

You should ensure a suitable place to store and keep the PPE when it’s not in use to help maintain its effective state.

• PPE training

Employers are responsible for providing enough information, understandable instructions, and sufficient training for the workers about the PPE they will use.
 
If you’re a worker, you must be familiar with the risks you are exposed to, how the PPE will protect you against them, and what the PPE limitations are.

More importantly, you must know how to use it properly, put it on, adjust it, and take it off correctly.

And know what measures you should take to keep your PPE in an effective state and to work just fine. 

Furthermore, you must know how to return and store it safely unless you take the PPE away from the workplace, e.g., footwear or clothing, or how to discard them safely if they’re disposable.

Defected or lost PPE must be reported.

You should inspect your PPE well before using it. Defective or damaged PPE should not be used. 

Why?
Because it could expose you to more harm.

If you lose your PPE or if it goes wrong with it, you must report it to your employer.

Furthermore, unless you’re trained to maintain the PPE and authorized to do so, you shouldn’t attempt to fix it.

• PPE responsibility isn’t just for employers and workers

The regulation now mandates manufacturers to ensure the PPE is manufactured per the regulation. In addition to authorized representatives, importers, and distributors of PPE.

Each of them has a vital role to play in the safety and adherence to the PPE regulations before the PPE is placed on the market and eliminates the risks that could come from it.

Enforcing such regulations over the PPE can range from verbal or written advice to enforcement notices and, in the most severe cases, prosecution of duty holders. Such actions can be included in routine inspections.

In short, as an employer, you should know when and when not to provide PPE, what PPE you should provide, and what training you need to give your workers to ensure they will use and maintain it correctly.

And if you’re a worker across different industries, you need to understand your responsibilities for using, storing, and maintaining your PPE correctly.

And as a manufacturer, authorized representative, importer, or distributor, you’re now legally bound to follow EU regulations.

Following the regulations means that the PPE must meet certain requirements and testing standards and have specific certifications before it can be placed and introduced to the end user.

Let’s see these standards.

A Quick look at EU PPE Standards (EN-Standards)

For a PPE to reach you, it must comply with some standards.

Why?

To ensure they’re safe and will not cause any risk to your health.

This technical requirement is directed through a set of standards (EN Standards) for each PPE.

EN safety standards, also known as harmonized standards, are technical standards that help PPE manufacturers learn how to comply with regulations to produce high-quality and safe PPE for use.

EN stands for the German term “Europäische Norm,” which means European standard.

Who sets these standards?

1. CEN (European Committee of Standardization)
2. CENELEC (European Committee for Electrotechnical Standardization)
3. ETSI (European Telecommunications Standards Institute).
   

The standard testing and certification requirements for PPE in the EU regulation depend mainly on the categorization of the PPE.

All the following are examples of EN standards incorporated into the EU 2016/425 Regulations.

• EN Standards examples for Category I
  

EN 388 – Protective gloves against mechanical risks provide abrasion resistance, cut resistance, tear resistance, puncture resistance, impact protection, and other requirements for importers or manufacturers. 

EN ISO 12312 – Eye and face protection, sunglasses, and related eyewear that protects against solar radiation for general uses, including road use and driving.

• Examples of EN Standards for Category II

EN 511-Protective gloves against cold up to -50°C; Provides guidelines for complex resistance classification and water permeability for gloves.

EN 381-7 – Protective clothing for users of hand-held chainsaws; provides the typical design of hand-held chainsaw protection gloves, including protection requirements on the back and the fingers of the gloves.

EN 175 explains the safety requirements and tests for PPE for eye and face protection during welding processes.

EN 1077 – helmets for skiers and snowboarders; This offers safety requirements for impact testing, product classification and design, helmet retention systems, and shock absorption.

• EN standards examples For Category III

EN 397– is a guideline for mandatory tests such as shock absorption, resistance to penetration, and resistance to flame tests for industrial safety helmets.

EN 142 and EN 143 require respiratory protective devices, including Mouthpieces and particle filters. 

EN 407 provides test methods for Protective gloves against thermal risks (heat or fire) 

EN 374 Standard for protective gloves against penetration, permeation, and degradation by dangerous chemicals and microorganisms.

After ensuring the product is up to standards, it’s time to place it in the European market.

To do this, it must obtain some certification. Let’s see them.

A quick look at EU PPE certifications (CE Mark and EC certificate)

All personal protective equipment sold in the European market must be CE-marked.

What is a CE mark?

CE stands for Conformité Européenne, French for European Conformity “EC mark.” It is a visible sign that manufacturers are on their products.

Why?

This PPE meets specific basic or minimum safety requirements and complies with EU health, safety, and environmental protection regulations.

CE-marked products can move freely throughout the European market.

However, a CE mark isn’t a quality mark that doesn’t guarantee that the product meets all relevant PPE requirements.

What is the process of getting a CE mark for your PPE?

The process goes as follows:

1. Learn and identify the standards and specific PPE specs.
2. PPE testing
3. EU-type certificate
4. Technical documents
5. CE marking.

We’ve covered the first step; let’s move to the second.

PPE conformity testing is a series of tests that should be conducted according to the EN Standard mentioned above.

Why?

• To assess the safety of PPE design and construction.
• To assess the risks that may happen during its lifecycle.
• To check that your PPE meets the specific standards.
  

Tests are based on PPE categories; PPE Category I doesn’t require certification. 

PPE categories II and III must be tested by a notified body using an EU-type examination.

Category III requires additional monitoring and quality tests to be carried out. These tests are regulated through Modules C2 and D in the EU regulations.

What is a notified body?

A notified body is an organization selected by the European Union to assess the adherence of PPE or specific products to the regulation before they can be placed on the market.

It must be independent, impartial, and with a high level of professionalism. Around 120 PPE-notified bodies across Europe.

You can check the list of these bodies on the European Commission’s website.

What is the EU-type examination?

The EU-type examination is an essential part of the conformity assessment procedure of PPE, in particular categories II and III of PPE and medical devices.

Why?

Because such PPE has higher requirements than different products.

 If the PPE meets the requirements, they get an EU-type examination certificate. (EC)

After getting the EC, PPE should have specifications. These are covered in detail in the EU regulation’s internal production control (module A).

This includes: Testing Reports, Authorized Representatives Written Mandate (if needed) 

A technical file contains information about the material, design, testing, and construction process, labels, and means by which it complies with the essential requirements of PPE regulations. 

A Declaration of Conformity (DoC) is a legal document that declares that this PPE complies with all safety regulations.

User Manual: This is a comprehensive instruction guide to help the user understand the PPE and how to use it properly. Hence, it must be in the language of the customer.

Finally, the CE Mark is placed on the package or the PPE itself to declare it suitable for users.

Final thoughts

The process of CE marking is long, complicated, and full of tests.

However, if you’re familiar with it and know precisely what your PPE needs, you will know which way to follow.

The following articles will cover CE marking and testing in detail. Stay tuned for it.

We hope this article gave you broad information on PPE in Europe.

We’ll be waiting for your comments and questions! Stay safe!