EN Standards

REGULATION (EU) No 2016/425

On 9 March 2016, the European Union issued a new regulation on personal protective equipment (PPE), Regulation (EU) No 2016/425.
It is scheduled to replace Directive No 89/686/EEC, in force since 1989, on 21 April 2018. The amendment of the Directive follows adoption of new framework regulations changing the approach to horizontal technical provisions, in particular:
- Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework
for themarketing of products.
- Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements
for accreditation and market surveillance relating to the marketing of products.

Regulation (EU) No 2016/425 of the European Parliament and of the Council – the most important changes:
- Scope of products covered by the regulation’s requirements
- Conformity assessment procedures (modules)
- Requirements concerning documentation
- Categorisation of PPE according to risk
- Essential requirements concerning health and safety (minor changes)
Compliance with the horizontal decision No 768/2008/EC

The PPE Regulation determines and includes:
- scope, introduction on the market and free circulation
- certification procedures, EC-type examination
- “CE” marking and requirements associated with the marking
- basic safety and health protection requirements
- requirements concerning the product technical file
- conditions to be met by notified bodies, i.e. entities authorised to carry out the EC-type examinations
- template of the declaration of conformity

This Regulation also introduces a division of the personal protective equipment into three categories:
- Category I - gloves of simple design - includes exclusively the following minimal risks:
a) superficial mechanical injury;
b) contact with cleaning materials of weak action or prolonged contact with water;
c) contact with hot surfaces not exceeding 50 °C;
d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);
e) atmospheric conditions that are not of an extreme nature.
- Category II - gloves of intermediate design - for medium risks, other than those listed in Categories I and III; it requires
acquisition of a CE-type certificate from a notified body.
- Category III - gloves of complex design - includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:
a) substances and mixtures which are hazardous to health;
b) atmospheres with oxygen deficiency;
c) harmful biological agents;
d) ionising radiation;
e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;
f) low-temperature environments the effects of which are comparable to those of an air temperature of - 50 °C or less;
g) falling from a height;
h) electric shock and live working;
i) drowning;
j) cuts by hand-held chainsaws;
k) high-pressure jets;
l) bullet wounds or knife stabs;
m) harmful noise.
Another requirement is the annual control of the manufacturing process and verification of the gloves’ quality.
Without such control the gloves cannot receive the CE marking.
The notified body ID code (four digits) is placed directly after the CE marking, e.g. CE 1437.

In compliance with the provisions of the Recommendation for Use Sheet no CNB/P/00/136, i.e. documents in which the European Commission publishes its recommendations for interpretation and application of Directive 89/686/EEC, on 1 January 2011 the notified bodies introduced the procedure of issuing the CE-type examination certificates for personal protective equipment with 5 years’ period of validity.

EN 420:2003 + A1:2009 - Safety gloves

All safety gloves shall comply with the requirements of the European standard EN420, setting forth general requirements and relevant research procedures concerning the design and construction of gloves and forearm protections, definition of size and comfort of use, dexterity, gloves performance and their inoffensiveness. It imposes on the manufacturer the obligation to correctly mark the gloves and enclose information on the method of use, storage and cleaning.
Graphic mark signalling the necessity for the user to acquaint themselves with the information of the manufacturer enclosed to the gloves. iko.jpg

Each glove handed over to the user shall be marked in an indelible, legible and visible way. The marking shall contain the following information:name, trademark or other data identifying the manufacturer or its authorised representative
  • name of the glove or its symbol allowing the user to connect the product to the manufacturer or its authorised representative
  • identification of size
  • “CE” marking
  • relevant pictographs with the levels of protection and reference to the EN standard
  • Gloves belonging to Category II and III need to have additional marking:
  • a pictograph corresponding to the risk type against which the glove was tested, together with its name;
  • performance levels and name of the relevant EN standard, e.g. 407, next to or below the pictograph;
  • for Category III gloves, a four digit laboratory code placed after the CE marking, e.g. CE 1437.

EN 388:2016 - Gloves protecting against mechanical hazards

The standard sets forth the requirements, research methods, marking and information to be supplied with regard to gloves and forearm protections protecting against mechanical hazards such as abrasion, cutting, tearing and piercing. Such data shall be presented in the form of a pictograph including the number of the standard and data determining the level of protection against the hazards.

Below, we present the changes introduced by the amendment of the EN 388:2016 (PN-EN 388:2017-02) standard:
1) the “Coup Test” (test with round blade) has been made more precise by better control over the test blade; in particular,
if the result of the test after cutting a sample of gloves is more than three times higher than the result before cutting the glove material, then the suggested test method is that according to EN ISO 13997.
2) A fifth character (letter A, B, C, D, E or F) has been added below the pictograph, determining the level of cut resistance according to the ISO 13997 method, obtained after the test using the TDM-100 tool (tonodynamometer).
3) If, during the test, the material of the glove does not dull the test blade, then the Coup Test remains the test of reference.
However, it is possible to voluntarily provide information on the resistance level according to the ISO 13997 standard.
4) Abrasion resistance test is carried out with a new type of sandpaper (Klingspor PL31B 180), which gives more repetitive results than the hitherto used one.
5) New test according to the EN 13594:2015 standard allows for provision of information on the impact protection level.
If the gloves were subject to the test, letter “P” is added to the five characters below the pictograph.


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- abrasion resistance: determines the number of cycles required to abrade through the sample glove at a constant speed (from 0 to 4);
- blade cut resistance: determines the number of cycles required to cut through the sample at a constant speed (from 0 to 5);
- tear resistance: determines the amount of force required to tear the sample [N]. (from 0 to 4);
- puncture resistance: determines the amount of force required to pierce the sample with a standard sized point [N] (from 0 to 4).


EN 407 - Gloves protecting against thermal hazards

The standard sets forth thermal performance of safety gloves in protection against high temperatures and/or fire. Gloves protecting against hot thermal factors are gloves protecting the employee’s hands against heat and/or fire occurring at the work station in one or several forms, i.e. fire, contact heat, convection heat, radiation heat, fine splatters of molten metals, high volumes of molten metal. In accordance with the norm, the gloves shall comply with the general requirements and requirements concerning their resistance to abrasion and tearing.
For each of the above parameters, four protection levels were identified, to be determined for a given type of glove based on the results of laboratory tests. Depending on the expected scope of application of the gloves, they should be characterised with relevant protection levels with regard to different parameters. Here, it should be stressed that only such parameters are evaluated which correspond to threats related to the scope of use of the gloves assumed by the manufacturer. The table below presents the parameters and adopted corresponding protection levels in accordance with the EN 407 standard with regard to direct contact with hot objects.



Gloves protecting against heat factors are marked with the pictogram presented above. Next to the mark, the number of the standard is given, i.e. EN 407, together with six digits of the code referring to the protection parameters.

EN 511 - Gloves protecting against low temperatures

This standard refers mainly to gloves that are designed to protect hands against convection and contact cold, to the temperature of -50°C. The information on protection against low temperatures is given in the form of a pictogram with a series of 3 levels of protection, regarding given protection properties. The abrasion and tearing resistance of all gloves must be at least at the level 1.


EN 1149-1 - Antistatic gloves

The standard sets forth the requirements and the methodology of research on protective wear capable of discharging static electricity in order to prevent discharges that may initiate an ignition. The standard does not require placing any graphic mark in the instructions for use of the product, but only the results of tests and conditions in which the tests were carried out.


Contact with food

Materials and products intended for contact with food shall comply with the requirements of the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food. Regulation
(amending regulation) (EC) No 10/2011 of 14 January 2011. In each case, such products may not cause penetration of substances to the food in quantities that might endanger human health, generate an unacceptable change in the composition of the food products or a deterioration in its organoleptic characteristics. The materials and products that, at the moment of their introduction on the market, have not yet come into contact with food are accompanied by the symbol of
a glass and fork.


In the scope of certification of products admitted for contact with food we cooperate with the Polisch National Institute of Public Health – National Institute of Hygiene.