PPE Directive (EU) 2016/425

1、 Definition and Purpose of EU Directive 2016/425

The EU PPE Directive EU 2016/425 applies to Personal Protective Equipment (PPE), which sets out the conditions for its placement and free movement on a single market. In addition, it includes all basic safety requirements that personal protective equipment must meet to ensure the health protection and safety of users. The directive was passed on February 12, 2016 and was published in official journals a few weeks later. The full effect of the PPE directive is expected to begin on April 21, 2019.

Personal protective equipment refers to any device or equipment that the user prepares to wear or hold to protect health and safety, and the PPE directive covers all PPE used for professional, family, leisure, and sports activities.

The main objectives of EU Directive 2016/425 are as follows:

Provide BHSRs that PPE must meet to ensure the safety of expected users;

Ensure the free movement of PPE within the EU.

2、 Scope of PPE instructions

The PPE directive applies to:

PPE to be placed or intended to be placed on the EU single market for the first time;

Manufacturing new PPE in an EU member state

New and used PPE produced outside the EU, therefore entering the EU market.

Within this range

Personal protective equipment consists of several devices or devices, which are collectively assembled by manufacturers to protect individuals from any simultaneous risks;

The interchangeable components of PPE are satisfactory in function and are only used for this type of equipment.

Protective devices or devices that can be separated or cannot be separated when combined with personal non protective equipment, worn or held by users to perform specific activities;

Any system connected to other additional external devices placed on the EU market together with PPE must be considered as part of the same device, even if the system should not be worn by users or permanently exposed to risk throughout the entire time period.

Out of range

Any PPE intended to be placed in non EU markets, imported into the EU, and then exported to third countries outside the EU;

PPE covers another directive with the same objectives as a single market, free flow of goods, and user safety;

Excluding PPE categories listed in the product list in Annex I:

The armed forces clearly use or maintain law and order (such as helmets and shields);

Personal protective equipment used for self-defense (such as personal deterrent weapons);

Privately used equipment that can withstand atmospheric conditions, humidity, water, and heat;

Personal protective equipment, used to protect or rescue personnel on ships or aircraft;

Helmets and goggles suitable for two or three wheeled motor vehicles.

3、 PPE classification

The new PPE Directive (EU) 2016/425 has made some modifications in the classification of PPE:

Simple PPE product design to protect users from minimal risks, such as surface mechanical damage, temperatures in contact with hot surfaces not exceeding 50 ℃, and so on.

Intermediate PPE aims to protect users from any risks that do not fall within the scope of the first and second categories.

Complex PPE belongs to this category and must be able to protect users from risks with serious and/or fatal, irreversible consequences. As an example of such risks, the following aspects can be mentioned: harmful biological agents, ionizing radiation, harmful noise, etc.

4、 PPE type

There are several types of PPE that can be used in the workspace:

PPE used to protect specific parts of the human body (eyes, head, arms, legs, etc.). On the body;

PPE for hearing or respiratory protection;

Equipment used for height and channel protection.

PPE directive - types of PPE (Personal Protective Equipment)

The need for a specific type of personal protective equipment is evaluated on a case by case basis, depending on the type of operation and the nature and quantity of materials that the user/employee must use. It is very important for individuals who rely on PPE to understand its operation, proper use, and limitations.

5、 Choose appropriate personal protective equipment

Choosing the appropriate PPE depends on the different hazards in the workplace. Suppliers are usually able to provide good advice on the different types of PPE available in the market and how they are suitable for different tasks. However, in some cases, employers may even request consultation with experts or PPE manufacturers themselves. The selected PPE must ensure the health and safety protection of employees. In addition, employees must also receive guidance on how to use, maintain cleanliness, and store.

When evaluating the applicability of a specific PPE, the following points need to be considered:

Is it suitable for the dangers its users will face?

Does it provide protection against workplace risks?

Will the person wearing it feel comfortable?

Is it suitable for users? Do you have different sizes?

What do you need it for?

Are the different parts of PPE required for specific tasks compatible?

In addition to the above factors, durability during use, required maintenance, and disposable or reusable PPE must also be considered in the selection process.

6、 Obligations of economic operators

The PPE directive affects the entire supply chain, including manufacturers, importers, distributors, authorized representatives, etc. This means that anyone involved in the supply and distribution of personal protective equipment within the EU/EEA border must take appropriate measures to ensure that personal protective equipment complies with all relevant legal requirements. Some general obligations undertaken by all contracting parties and ensuring:

1) All appropriate CE certification procedures have been executed;

2) Only PPE that complies with EU regulations can enter the single market;

3) There are CE trademarks and any other legally required trademarks on the product;

4) If there are any personal protective equipment on the market that does not comply with regulations, the market supervision agency will be notified;

5) At least 10 copies of documents, such as inspection procedures, conformity statements, and user instructions, should be recorded.

7、 Compliance of personal protective equipment

According to specific PPE categories, manufacturers must follow different certification pathways to comply with new PPE regulations, as follows:

Simple Type 1 PPE: Considering that low-risk PPE types are included in this category, manufacturers will be able to declare compliance on their own and market their products in the European single market;

Intermediate PPE (Type 2): A simple self declaration is not possible, as the EC style inspection procedure (conformity assessment unit B) is an indispensable part of the PPE certification process. In other words, the notified institution must review the technical design of the product to verify and prove that all applicable legislative requirements have been met. Finally, after a positive evaluation, the manufacturer obtained an EC type examination certificate

Complex PPE (Category 3): PPE belonging to this category has the most complex certification process. In addition to passing the EC type inspection procedure (similar to Class II PPE), continuous monitoring is also required through testing (Module C2) or factory audits (Module D) to ensure that PPE fully meets the requirements.

Importantly, the validity period of the aforementioned EC type examination certificate is 5 years, applicable from April 2018.

After successfully completing all necessary qualification procedures, the manufacturer must affix the CE mark on their PPE to officially declare compliance with European regulations. The CE mark needs to be placed on the product according to the rules specified in the directive. Read more about affixing CE marks on products

CE marking and CE inspection!

We can help you:

Determine all European directives and unified standards to ensure that your product meets CE requirements;

Book an accredited testing laboratory where you can test your product within 3 weeks;

Store technical documentation of your product in our system;

Automatically create a compliance statement;

Please continue to monitor the latest legislative amendments and updates.