In this way, EU Regulation 2016/425 facilitates the free movement of PPE in the internal market with due respect of the minimal requirements regarding the consumer’s safety and security (the so-called fundamental requirements). The actual technical elaboration of the fundamental requirements is based on harmonised European standards, which confer an irrefutable presumption of conformity with the legislation.
As a visible indication of conformity with the fundamental requirements, the producer is obliged to affix the CE-mark onto its equipment.
The EU Regulation 2016/425 appeals to notified bodies for a number of tasks. This is especially the case for the CE-type examination of PPE belonging to categories II and III and for the monitoring of PPE of category III. PPE of category I doesn’t require any formal intervention by a Notified Body, although it may act as a consultant or laboratory.
EU legislation and PPE
The European Union issued a number of regulations to improve health and safety at work and to ensure high quality personal protective equipment (PPE). The PPE Regulation (EU) 2016/425 covers the manufacturing and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the European market provides the highest level of protection against hazards. The CE marking affixed to PPE provides evidence of this protection.
Personal protective equipment (PPE) means:
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;
Interchangeable components for equipment referred to (in point 1) which are essential for its protective function;
Connection systems for equipment referred to (in point 1) that are not held or worn by a person, which are designed to connect the equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and do not require fastening works before use.
“statistics on fatal and major work accidents underline the importance of protection and prevention, for which personal protective equipment plays an important role”
PPE Regulation (EU) 2016/425
The PPE Regulation is aligned to the New Legislative Framework policy and slightly modifies the scope and the risk categorisation of products in comparison with the Directive 89/686/CE. It also clarifies the documentary obligations of economic operators. As this is a “New Approach” Directive, manufacturers or their authorised representative in the EU can comply with the technical requirements directly or with European Harmonised Standards. The latter provides a presumption of conformity to the essential health and safety requirements.
If you want to place PPE on the market as a manufacturer or as an importer, you have to prove that the PPE in question conforms with the fundamental requirements. To this end, you always have to draw up a technical file including all elements producing this proof. You have to keep this technical file until 10 years after the production of the PPE has stopped and submit it on demand of the supervising authority. PPE is divided into three categories according to the gravity of the risk against which they protect. The category determines the procedure you have to complete before placing PPE on the market. Statistics on fatal and major work accidents underline the importance of protection and prevention, for which personal protective equipment plays an important role.
Declaration of conformity
The EC type examination certificate holder also produces a ‘declaration of conformity’ – a document including details of the company, information on the product, a list of the European Legislations and the standards the product complies with, and a legallybinding signature on behalf of the organisation. The certificate holder has the responsibility to ensure that all supplied products are consistent with the type-approved model and continue to meet all the essential requirements of the PPE EU Regulation 2016/425.
The manufacturer is obliged to affix CE-marking on his equipment as a visible indication of conformity with the fundamental requirements.
The EU Regulation 2016/425 appeals to notified bodies for a number of tasks. This is especially the case for the EU-type examination of PPE belonging to categories II and III and for the monitoring of PPE of category III.
The categorisation of PPE according to the Regulation (EU) 2016/425 is as follows.
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
Category II includes risks other than those listed in categories I and III.
Category III 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 agents
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
Cuts by hand held chainsaws
Bullet wounds or knife stabs
Hand and arm protection
Potential hazards to hands and arms include skin absorption of harmful substances, chemical or thermal burns, electrical dangers, bruises, abrasions, cuts, punctures, fractures or amputations. Protective equipment includes gloves, finger guards and arm coverings. There are many types of gloves available to protect against a wide variety of hazards. The nature of the hazard and the operation involved will affect the selection of gloves. The variety of potential occupational hand injuries makes selecting the right pair of gloves challenging. In the new Legislation (EU) 2016/425 regulation gloves for domestic use are now also PPE and need CE marking. So, oven gloves and BBQ gloves will need an EU Type examination certificate starting 21 April 2019.
These are (among others) some of the product standards that are used for the certification of protective gloves:
EN 420: Protective gloves - general requirements and test methods
EN 388: Protective gloves against mechanical risks
EN 374-1: Protective gloves against chemicals and micro-organisms
EN 374-5: Protective gloves against dangerous chemicals and micro-organisms
EN 407: Protective gloves against thermal risks
EN 511: Protective gloves against cold
EN 659: Protective gloves for firefighters
EN 12477: Protective gloves for welders
EN 420 is the general standard that is always used in the certification process of gloves. This standard defines the general requirements and relevant test procedures for glove design and construction, resistance of glove materials to water penetration, innocuousness, comfort and efficiency, marking and information supplied by the manufacturer applicable to all protective gloves. It can also be applicable to arm protectors and gloves permanently incorporated in containment enclosures. This European Standard does not address the protective properties of gloves and therefore should not be used alone, but only in combination with the appropriate specific European Standard(s). So it always needs to be used in combination with another product standard that describes the protection of the hands and arms. Some examples of these standards were listed just above.
Resistance to penetration and permeation are two variables related to the barrier properties of materials. When determining the penetration resistance, the material is exposed on one side to the test liquid. In general, the test liquid is put under pressure and one visually observes whether the liquid penetrates through the material. Exactly this visual detection is the weakness of this test. The test result is a pass/fail.
A more complex test method is used to determine the permeation resistance. Whereas in the case of a penetration test, the bulk liquid is forced through the barrier, the permeation test is based on a molecular diffusion of chemicals through the barrier. The sample is exposed to the test liquid on one side. By means of an instrumental method it is then determined when the test liquid breaks through the material on the other side. In such a test one determines the breakthrough time and sometimes also the permeation speed. A test cell is composed of two compartments where the material is brought into contact with the test liquid. The textile to be tested is placed in a test cell. One side of the textile is brought into contact with a test liquid. On the other side of the textile, the collection medium is located, which has to be screened continuously.
The collection may be done either with gas (air) or liquid (water). The detection in the case of gas permeation is performed by means of a PID. It is important that the test liquids are sufficiently volatile. The detection in the case of liquid permeation is performed by means of a conductometric detector. It is important that the test liquids are sufficiently water-soluble. A test is typically performed for a maximum of eight hours, and the performance level of the material is determined by the time a test liquid needs to break through. During this period the sample is continuously exposed to the test liquid.
A new test method was introduced in the EN 374:2016 version: Degradation. In this test the glove material is brought into contact with the same chemical that is used to determine the permeation resistance of the glove and the perforation resistance of the materials is compared before and after one hour of contact with this chemical.
All textile products, from fibre to finished product (apparel, sports article, car or aeroplane component) have to meet very strict quality requirements during their entire life span. Textile products include textile fibres, yarns, woven, knitted or non-woven, laminated, coated and finished textile products (such as fabrics and carpets).
In order to assess these textile qualities, the physical testing laboratories in Gent perform entire panoplies of physical analyses, such as fastness to light, fastness to rubbing (wet and dry), elongation, tear resistance, burst resistance, dimensional stability, pilling and abrasion, seam slippage, next to resistance to ageing under the influence of light, humidity and heat, conductive and antistatic properties.
Centexbel also determines the air and water permeability and the water 22 and/or oil repellent or absorbing properties of textiles, next to resistance to wear and slippage of carpets, the isolating properties of textiles (by means of IR images).
The most important activities of the physical testing laboratory in Grâce-Hollogne are electric safety and comfort assessment of protective clothing for which Centexbel disposes of state-of-the-art test methods and equipment:
Based on the number of cycles required to abrade trough the sample glove.
Blade cut resistance
Based on the number of cycles required to cut through the sample at a constant speed
Based on the amount of force required to tear the sample
Based on the amount of force required to pierce the sample with a standardised point.
ISO Cut resistance
Based on the force required to cut through a sample using a specified cut test machine – this test is used for high cut resistant gloves
Based on the measured transmission of energy and force when the sample experiences a dropped load – this is an optional test in EN 388:2016
Fire and thermal tests
When textiles are applied in (public) buildings and means of transport as curtains, upholstery, floor and wall covering, or when they are used as sunblind or PPE, very strict standards apply in respect of their burning behaviour. Several disasters in the recent past have made these standards even more severe. Centexbel carries out tests commissioned by the authorities, expedition companies, importers, producers, and consumers in order to verify the conformity of the products with the label’s requirements.
It’s important to analyse the burning behaviour of textiles, the smoke propagation and the toxic composition of liberated smoke.
For PPE the most important test that are carried out are:
Limited flame spread
Based on the length of time the material continues to burn and glow after the source of ignition is removed
Based on the temperature range (100- 500°C) at which the user will feel no pain for at least 15 seconds. This will be the mandatory test for household oven gloves
Based on the length of time the glove is able to delay the transfer of heat from a flame
Based on the length of time the glove is able to delay the transfer of heat when exposed to a radiant heat source
Small splashes of molten metal
The number of molten metal drops required to heat the glove sample to a given level
Large quantities of molten metal
The weight of molten metal required to cause smoothing or pin holing across a simulated skin placed directly behind the glove sample
Not all these properties are tested on each glove – only the ones that are claimed by the manufacturer.
In many areas of society, labelling is frowned upon. To label someone based on a preconceived stereotype may result in massive errors in judgement. Yet when it comes to personal protective equipment, labelling equates to clarity, peace of mind, and improved workplace safety. That little label indicating a CE mark indicates an assured level of safety and compliance with European standards.