REGULATION (EU) 2016/425 of the European Parliament on PPE: what is new about gloves?

With the aim of harmonizing the Member States laws in relation to the Personal Protection Devices (PPE), on 31 March 2016 the new Regulation 2016/425 / EU on Personal Protective Equipment (PPE) was published in the Official Journal of the European Union. which replaces Directive 89/686/EEC of 21 December 1989.

The regulation applies from April 21st 2018, when Dir 89/686/EEC is repealed. In the new regulation some test procedures have remained unchanged, while others have been modified to provide a better data analysis by the user.

WHAT ARE THE HIGHLIGHTS AND NEWS OF THE REGULATION?

Let’s try to summarize below the news about gloves production:

1) Until the new Regulation 2016/425/EU application, the Dir 89/686/EEC still applies

2) Certifications conforming to Dir 89/686/EEC will be valid until April 21st 2023

3) Starting from April 21st 2017 the test methods required to obtain the PPE certifications have changed and consequently also the pictograms for EN374 (protective gloves against Chemical Agents and Microorganisms) and for EN388 (protective gloves from risks mechanical)

EN 374 AMENDMENTS

EN ISO 374-1: 2016 Requirements for chemical risks

  • The chemical protection index will be expressed only with the pictogram showing the flask. 6 new chemical agents were added to the list of 12 of the old legislation, for a total of 18 chemical agents (chemical agent list). Each chemical agent tested is identified with a letter code, which must be reported under the pictogram.
EN ISO 374-1:2016

 

Code letter Chemical CAS number Class
A Methanol 67-56-1 Primary alcohol
B Acetone 67-64-1 Ketone
C Acetonitrile 75-05-8 Nitrile compound
D Dichloromethane 75-09-2 Chlorinated paraffin
E Carbon disulphide 75-15-0 Organic compound containing sulphur
F Toluene 108-88-3 Aromatic hydrocarbon
G Diethylamine 109-89-7 Amine
H Tetrahydrofuran 109-99-9 Heterocyclic and ether compound
I Ethyl acetate 141-78-6 Ester
J n-heptane 142-82-5 Saturated hydrocarbon
K 40% Sodium hydroxide 1310-73-2 Inorganic base
L 96% Sulphuric acid 7664-93-9 Inorganic mineral acid
M 65% nitric acid 7697-37-2 Inorganic mineral acid
N 99% acetic acid 64-19-7 Organic acid
O 25% ammonium hydroxide 1336-21-6 Organic base
P 30% hydrogen peroxide 7722-84-1 Peroxide
S 40% hydrofluoric acid 7664-39-3 Inorganic mineral acid
T 37% formaldehyde 50-00-0 Aldehyde

Gloves will be classified as:

  • TYPE A if they obtain a passage time ³ 30 minutes (level 2) for 6 chemical agents, among those listed in the normative EN 16523-1.
  • TYPE B if they obtain a passage time  ³ 30 minutes (level 2) for 3 chemical agents, among those listed in the EN 16523-1
  • TYPE C if they obtain a passage time ³ 10 minutes (level 1) for only 1 chemical agent, among those listed in the EN 16523-1

EN 374-1 2016 A            EN 374-1 2016 C

EN 374-4:2013 Degradation resistance

The degradation index has been added to the legislation. It’s not is not mandatory to get the certification, but it must be explicitly explained on the user information sheet and also on the packaging of the product. It indicates the percentage of degradation value obtained for each standard, for which resistance to permeation according to EN ISO 374-1: 2016 has been tested.

EN ISO 374-5:2016 Requirements for risks from micro-organisms

EN 374-2: 2003 is replaced by EN ISO 374-5: 2016 and gloves will be classified as:

  • PROTECTIVE GLOVES AGAINST BACTERIA AND FUNGI

 EN 374-5 2016

  • PROTECTIVE GLOVES AGAINST BACTERIA AND FUNGI AND VIRUS

EN 374-5 2016 virus

Only if the determination of the resistance to the passage of viruses will be performed and passed as required by the ISO 16604: 2004 standard (bacteriophage Phi-X174), the indication “VIRUS” can be applied under the pictogram

NEWS ON EN 388

EN 388 Mechanical risks

For disposable gloves, compliance with EN 388 is no longer required. It has been replaced by the degradation test according to EN 374-4: 2013.

For all the other types of glove, some revisions have been made on the methodologies of CUTTING and ABRASION resistance tests, as per ISO 13997 standard.

  • The cut resistance test (Couptest) did not allow to correctly qualify the performance of high shear strength, so it was made more reliable, with a greater control of the blade (blade change every 5 tests).

If the glove specimen does not wear the blade, the Couptest remains the reference test. If the specimen bevels the blade, the reference test must be in accordance with ISO 13997 and a fifth digit should be indicated under the pictogram to indicate the level of shear strength test.EN 388 gloves

  • The abrasion resistance test requires the use of a more consistent quality abrasive paper.
  • The possibility of inserting a test (EN 13594: 2015) for impact protection on joints and fingers has been added. The letter “P” is added after the 5-digit pictogram, if the glove passes the test.

 

WHAT WILL THE CONSEQUENCES OF THE REGULAR ADJUSTMENT BE?

The Certification Bodies have started to adapt the tests according to the new regulations from April 2017. This means for the economic operators a starting process of products adjustment – products already present or to be introduced on the European market – which will lead to revision of the technical sheets, declarations of conformity and labelling according to the new requirements.

We believe it is plausible, over the next few months, to see changes in certification approaches depending on the response of the tests currently being performed.