I. Definition & Purpose of PPE Directive EU 2016/425
The PPE Directive EU 2016/425 applies to personal protective equipment (PPE), and it lays down the conditions governing its placing on the single market and free movement. Moreover, it contains all basic safety requirements which personal protective equipment must satisfy to guarantee the health protection and safety of users. The directive was adopted on Feb 12th, 2016, and published in the Official Journal several weeks later. The full effect of the PPE directive is expected to be from April 21st, 2019.
PPE refers to any device or appliance intended to be worn or held by users for protection against health and safety hazards. The PPE Directive covers all PPE designed for use in professional, domestic, leisure and sports activities.
II. Scope of the PPE Directive
The PPE directive applies to:
- PPE placed or intended to be placed on the EU Single Market for the first time;
- New PPE manufactured in one of the EU Member States;
- New and used PPE produced outside of the EU and, consequently, placed on the EU market.
Within the scope of the PPE directive:
- PPE constituted by several devices or appliances which have been integrally united by the manufacturer for the personal protection of an individual against any simultaneous risks;
- Interchangeable components of PPE which are essential to its satisfactory functioning and used solely for such equipment.
- A protective device or appliance combined, separable or inseparable, with personal non-protective equipment and worn or held by a user for the execution of a specific activity;
- Any system placed on the EU market in conjunction with PPE for its connection to another additional external device must be regarded as an integral part of the same equipment even if the system is not supposed to be worn or held permanently by the user for the entire period of risk exposure.
Outside of the Directive's scope:
- Any PPE intended to be placed on a non-EU market, as well as imported into the EU for re-export to a third country outside of the European Union;
- PPE covered by another directive that has the same objectives about placing on the single market, free movement of goods and users’ safety;
- The PPE classes stated in the list of excluded products in Annex I:
- Explicitly used by the armed forces or in the maintenance of law and order (e.g. helmets and shields);
- PPE for self-defence (e.g. personal deterrent weapons);
- Equipment for private use against atmospheric conditions, damp, water and heat;
- PPE for the protection or rescue of individuals on vessels or aircraft;
- Helmets and visors meant for users of two- or three-wheeled motor vehicles.
III. PPE Categorisation
The new PPE Directive (EU) 2016/425 came with some changes in regards to the PPE categorisation:
- Simple PPE – products designed to protect users against minimal risks, such as superficial mechanical injury, contact with hot surfaces which temperature don’t exceed 50°C, etc.
- Intermediate PPE – PPE designed to protect users against any risks not included in the scope of category I and category II.
- Complex PPE – PPE, falling under this category, must be able to protect users against risks with severe and/or fatal, irreversible consequences. As examples of such risks can be mentioned the following: harmful biological agents, ionising radiation, harmful noise, etc.
More information on the different PPE categories.
IV. Types of PPE
There are several types of PPE made available for use in the workspace:
- PPE designed to protect a specific part of the human body (eyes, head, arms, legs, etc.) physically;
- PPE for hearing protection or respiratory protection;
- Equipment meant for height and access protection.
The need for a specific type of personal protective equipment is assessed on a case by case basis and it depends upon the type of operations performed and the nature and quantity of the materials the users/employees have to work with. It is of extreme importance that the individuals who rely on PPE understand the way it functions, its proper use and limitations.
V. Selection of Suitable PPE
The selection of suitable PPE depends upon the different hazards in the workplace. Suppliers are usually capable of giving good advice on the different types of PPE available on the market and how appropriate they are for different tasks. However, in some cases, employers may even ask for advice specialists or the PPE manufacturers themselves. The PPE selected must ensure the employees’ health and safety protection. Besides that, the employees must receive instructions on how to use it, keep it clean and store it.
There are a few things to consider when assessing the suitability of a given PPE:
- Is it appropriate for the hazards its user will be exposed to?
- Does it provide protection against workplace risks?
- Would the person wearing it feel comfortable?
- Does it fit the user properly? Is it available in different sizes?
- What do you need it for?
- Are the different pieces of PPE required for a specific task compatible?
Except for the above, factors, such as durability in use, maintenance required, disposable vs reusable PPE, must also be taken into consideration during the selection process.
VI. Obligations of Economic Operators
The PPE directive affects the entire supply chain, including manufacturers, importers, distributors, authorised representatives, etc. That means that anyone taking part in the supply and distribution of PPE within the EU/EEA borders is required to take appropriate measures to ensure that PPE complies with all relevant legal requirements. Some of the general obligations that all parties have are related to ensuring that:
- All proper CE certification procedures have been carried out;
- Only PPE, compliant with the EU regulations, is placed on the Single Market;
- The CE mark and any other legally required trademarks are present on the product;
- Market surveillance authorities are informed for the presence of any non-compliant PPE on the market;
- Documentation, such as examination protocols, Declaration of Conformity, user instructions, is kept in record for at least 10.
VII. Conformity of personal protective equipment
Depending on the specific PPE category, manufacturers will be required to follow different certification paths to conform to the new PPE regulations that are, as follows:
- Simple PPE of Category I: Given the type of low-risk PPE included within this category’s scope, manufacturers will be able to self-declare compliance and place their product on the European Single Market;
- Intermediate PPE (Category II): Simple self-declaration is not possible because the EC-type examination procedure (conformity assessment Module B) is an obligatory part of the PPE’s certification process. In other words, a notified body must examine the product’s technical design and, consequently, verifies and attests that all applicable legislative requirements have been met. In the end, upon positive evaluation, manufacturers receive an EC-type examination certificate.
- Complex PPE (Category III): PPE falling under this category has the most complicated certification process. In addition to the need for passing an EC-type examination procedure (similarly to PPE of Category II), on-going surveillance through testing (Module C2) or factory auditing (Module D) will be further required so that PPE’s compliance is fully ensured.
Of importance here is to say that the validity of the mentioned above ‘EC-type examination certificate’ is 5 years, applicable from April 2018.
After undertaking all necessary conformity procedures successfully, manufacturers must affix CE marking on their PPE to officially declare compliance with the European legislation. The CE marking needs to be placed on the product by clearly-defined rules stated in the Directive. Read more about affixing CE marking on products.
Get in touch with the experts of Clever Compliance. The company is an expert in product compliance. They partner with some of the Notified bodies in Europe that can provide testing and conformity assessment for several types of PPE, including face masks and face shields. Additionally, Clever Compliance will help you compile rock-solid technical documentation and will create a Declaration of Conformity for your product.