PPE compliance in Europe: what legal framework?
PPE (Personal Protective Equipment) is governed at the European level by Regulation 2016/425. In order to comply, it is first necessary to know which category the PPE belongs to.
Although all PPEs are regulated by a European regulation which is directly applicable in each Member State, and therefore provides the basic foundation for regulation, there may be additional provisions on a state-by-state basis.
This is partly due to the fact that there are two directives in Europe that have since had to be transposed into national law before the Regulation was established. One of these directives was repealed with the introduction of Regulation 2016/425 but will continue to have effect until 2023. In France, for example, most PPE fall under the Labour Code, although they may also be used outside the workplace. Some PPE may also fall under the Sports Code (PPE-SL), such as buoyancy aids for swimming lessons, as well as most PPE intended to be worn for sports or leisure purposes.
PPE & CE Marking
The CE compliance marking is one of the essential steps of the regulation. It is mandatory for all PPEs to be marked by the manufacturer on the label or packaging. It guarantees that the products follow the required certification procedures and technical design rules.
The CE marking must be accompanied by a declaration of compliance which differs according to the risk category of the equipment:
- Self-certification for category I PPE:
The declaration of compliance is made directly by the manufacturer of the product. It shows the compliance of the product without laboratory testing. - EC type-examination certificate for category II PPE:
A Notified Body (NB) must carry out an EC type examination to establish the compliance of the product with the manufacturer's provisions and technical dossier. The CE marking must be attached to the year of manufacture. - The EC type and quality certificate for category III PPE:
In addition to the EC type-examination certificate, the NB shall carry out product control. To do this, the body may carry out a quality assurance check by selecting products for compliance testing once a year, or it may carry out a production quality assurance check by validating and controlling the quality system set up by the manufacturer. The CE marking remains the same as for category II, with the addition of the identification number of the approved laboratory.
Manufacturer's instructions
All PPE must then be accompanied by a manufacturer's leaflet containing numerous information for the user:
- the name and address of the manufacturer or its authorised representative established in the EU
- instructions for storage, use, cleaning, maintenance and disinfection
- the performance and protection class of the product, as well as the risk for which it has been designed, and its limits of use
- the expiry date
- the name and identification number of the NB
- the references of harmonised standards used or other technical specifications used for the design
The Regulation requires importers of PPE to ensure that products entering the EU market comply with the requirements of the Regulation and that manufacturers have applied the correct compliance assessment procedures.
The different types of PPE
Personal protective equipment (PPE) are a device or means intended to be worn or held by a person to protect themselves against one or more risks that may threaten their safety or health, mainly at work. The wearing of such equipment is always recommended and sometimes made compulsory for the exercise of certain activities.
PPE can be worn or held by the user for the duration of the exposure to the risk, and are therefore mobile and only concern the protection of the user.
PPE creates protection between the individual and the potential risk. Examples include clothing reinforcements, radiation filtering, sound filtering, gloves, waistcoats, suits, shoes, helmets, safety harnesses, hearing protection, etc.
PPE is classified into three categories for protection against risks:
I - Surface risks
Category I includes all PPEs that provide protection against superficial injuries such as vibration or sunlight. These are products such as sunglasses, gardening gloves, rainwear or washing-up gloves.
II - Intermediate risks
Category II PPEs provide specific protection against more serious injuries. They concern intermediate risks, for example hearing protectors, eye protectors, shoes, boots, visors, gloves, helmets.
III - Very serious or fatal risks
Category III covers all PPE intended for protection against very serious risks that may have irreversible or fatal consequences for the wearer. Category III includes, in particular, fall arrest harnesses, respiratory protection, protection against heat, electricity, chemical risks and life jackets.
FFP2 masks are considered Category III PPE because they protect against a life-threatening hazard (from a virus such as coronavirus).
A service provider such as EcoMundo can help you manage your project from the early determination of the type of product to the coordination with the NB(s) and the collection of technical documentation and the obtaining of CE certification.
Wish to know more about PPE compliance ?
For more information, do not hesitate to contact Ra�ssa Abdel Kader or one of our experts !
PPE compliance in Europe: what legal framework?
PPE (Personal Protective Equipment) is governed at the European level by Regulation 2016/425. In order to comply, it is first necessary to know which category the PPE belongs to.
Although all PPEs are regulated by a European regulation which is directly applicable in each Member State, and therefore provides the basic foundation for regulation, there may be additional provisions on a state-by-state basis.
This is partly due to the fact that there are two directives in Europe that have since had to be transposed into national law before the Regulation was established. One of these directives was repealed with the introduction of Regulation 2016/425 but will continue to have effect until 2023. In France, for example, most PPE fall under the Labour Code, although they may also be used outside the workplace. Some PPE may also fall under the Sports Code (PPE-SL), such as buoyancy aids for swimming lessons, as well as most PPE intended to be worn for sports or leisure purposes.
PPE & CE Marking
The CE compliance marking is one of the essential steps of the regulation. It is mandatory for all PPEs to be marked by the manufacturer on the label or packaging. It guarantees that the products follow the required certification procedures and technical design rules.
The CE marking must be accompanied by a declaration of compliance which differs according to the risk category of the equipment:
- Self-certification for category I PPE:
The declaration of compliance is made directly by the manufacturer of the product. It shows the compliance of the product without laboratory testing. - EC type-examination certificate for category II PPE:
A Notified Body (NB) must carry out an EC type examination to establish the compliance of the product with the manufacturer's provisions and technical dossier. The CE marking must be attached to the year of manufacture. - The EC type and quality certificate for category III PPE:
In addition to the EC type-examination certificate, the NB shall carry out product control. To do this, the body may carry out a quality assurance check by selecting products for compliance testing once a year, or it may carry out a production quality assurance check by validating and controlling the quality system set up by the manufacturer. The CE marking remains the same as for category II, with the addition of the identification number of the approved laboratory.
Manufacturer's instructions
All PPE must then be accompanied by a manufacturer's leaflet containing numerous information for the user:
- the name and address of the manufacturer or its authorised representative established in the EU
- instructions for storage, use, cleaning, maintenance and disinfection
- the performance and protection class of the product, as well as the risk for which it has been designed, and its limits of use
- the expiry date
- the name and identification number of the NB
- the references of harmonised standards used or other technical specifications used for the design
The Regulation requires importers of PPE to ensure that products entering the EU market comply with the requirements of the Regulation and that manufacturers have applied the correct compliance assessment procedures.
The different types of PPE
Personal protective equipment (PPE) are a device or means intended to be worn or held by a person to protect themselves against one or more risks that may threaten their safety or health, mainly at work. The wearing of such equipment is always recommended and sometimes made compulsory for the exercise of certain activities.
PPE can be worn or held by the user for the duration of the exposure to the risk, and are therefore mobile and only concern the protection of the user.
PPE creates protection between the individual and the potential risk. Examples include clothing reinforcements, radiation filtering, sound filtering, gloves, waistcoats, suits, shoes, helmets, safety harnesses, hearing protection, etc.
PPE is classified into three categories for protection against risks:
I - Surface risks
Category I includes all PPEs that provide protection against superficial injuries such as vibration or sunlight. These are products such as sunglasses, gardening gloves, rainwear or washing-up gloves.
II - Intermediate risks
Category II PPEs provide specific protection against more serious injuries. They concern intermediate risks, for example hearing protectors, eye protectors, shoes, boots, visors, gloves, helmets.
III - Very serious or fatal risks
Category III covers all PPE intended for protection against very serious risks that may have irreversible or fatal consequences for the wearer. Category III includes, in particular, fall arrest harnesses, respiratory protection, protection against heat, electricity, chemical risks and life jackets.
FFP2 masks are considered Category III PPE because they protect against a life-threatening hazard (from a virus such as coronavirus).
A service provider such as EcoMundo can help you manage your project from the early determination of the type of product to the coordination with the NB(s) and the collection of technical documentation and the obtaining of CE certification.
Wish to know more about PPE compliance ?
For more information, do not hesitate to contact Ra�ssa Abdel Kader or one of our experts !
