PPE REGULATION
>> The manufacturers and distributors of PPE (Personal Protective Equipment)
They are subject to the new PPE (EU) 2016/425 regulation which entered into force on 21 April 2016, but applicable from 21 April 2018.
The Regulation sets out the different categories of PPE, the certification procedures and in a regulatory manner the essential requirements and rules they must meet in order to be put on the market.
The Regulation also lays down the obligations of all economic operators (manufacturers, authorised representative, importers and distributors) and lays down the rules for the assessment of notified bodies.
>> Employers
They are subjected to the 89/656/CEE directive dated November 30th, 1989 « regarding the minimal prescriptions of safety and health for the needs by the workers at the work of personal protective equipments. The directive retails the obligation for employers to supply personal protective equipments when risks cannot be avoided by other ways » techniques of collective protection, or by measure, methods or procedures of work of organization.
This responsibility is reminded in the labour (French) code article R.4321-4.
"The employer shall provide workers, when it is necessary, appropriate PPE, and in case of particularly dirty or unsanitary works, appropriate work clothes. It ensure their effective use."
>> The users of PPE
- Directive 89/656/CEE of 30 november 1989.
The directive is specifying the obligation given to the employers to supply personal protective equipement when hazards can not be avoided by other means.
From the facturer of PPE to the end-user through the employer, each player is empowered.
PPE DEFINITION
The European regulation 2016/425 gives us the following definition :
Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety (An interchangeable component or a connexion system for equipment is also a PPE)
They are 3 categories of PPE
Category 1
Category I includes exclusively the following minimal risks: superficial mechanical injury / contact with cleaning materials of weak action or prolonged contact with water / contact with hot surfaces not exceeding 50°C / damage to the eyes due to exposure to sunlight (other than during observation of the sun) / atmospheric conditions that are not of an extreme nature. The products shall be subject to the internal production control (module A) set out in Annex IV.
Category 2
These are the PPE which don’t belong neither to the category I nor to the category II. The products shall be subject to EU-type examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI.
Category 3
It includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following: substances and mixtures which are hazardous to health / atmospheres with oxygen deficiency / harmful biological agent / ionising radiation / high-temperature environments the effects of which are comparable to those of an air temperature of at least 100°C / low-temperature environments the effects of which are comparable to those of an air temperature of -50°C or less / falling from a height / electric shock and live working / drowning / cuts by hand-held chain-saws / high-pressure jets / bullet wounds or knife stabs / harmful noise.
The products shall be subject to an EU-type examination (module B) set out in Annex V, and either of the following:
- conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII,
- conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.
PPE and European Standards
What is a standard ?
Technical rules which defines the essential and relevant characteristics of a product (or a method) established in order to guarantee its quality, functionning or resistance.
Why a standard?
The standard has the advantage of giving the possibility to standardize, to harmonize and to compare. It is consequently easier for the consumer to make his choice; it improves his security and his confidence into the product.
Is it compulsory?
According to the reglementation the norm can be compulsory and restricting or it can comes in complement of the general requirements to bring additional security to the user.
General remarks :
Standards as well as all general information presented in this document are not exhaustive and may change at any time. They are given for information purpose and cannot engage our responsibility in 2 any case.
>> WARNING
In accordance with Regulation (EU) 2016/425 " Any economic operator who either places PPE on the market under his own name or trademark or modifies a product in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer. "
We therefore draw attention to the fact that marking on a high-visibility garment with the customer's logo or brand can reduce the area of the compulsory material (yellow, orange or red or retro-reflective stripes) used for the certification of the product and its classification according to EN ISO 20471.
It is therefore up to the person carrying out this operation to ensure that any marking will not reduce the mandatory minimum area of material used for the classification of the product.
Similarly, marking on PPE certified to other standards, such as resistance to heat and / or fire or chemical resistance, etc., can lead to the expected loss of protection of the equipment.
In all cases and more generally, Singert Frères cannot be held responsible for any modification that may have been made to PPE.
