24.04.2018
From April 21, 2018 the PPE “Regulation (EU) 2016/425” replaces the previous „Directive 89/686/EEC“.
The Regulation (EU) 2016/425 is a document developed over a process lasting several years, which covers requirements for the design and manufacture of personal protective equipment (PPE), the free movement of PPE in the EU and the certification process.
1. What is new? - significant changes compared to the previous PPE Directive
The previous Directive (Directive 89/686 / EEC) became a Regulation (Regulation (EU) 2016/425) which, after entry into force, applies to all EU member states and does not have to be transposed into national law.
The scope of the PPE Regulation has been slightly extended. Thus, the new regulation also applies to PPE for protection against heat that is used privately (eg for grill or oven gloves)
[see Regulation (EU) 2016/425, Chapter II; Article 2]
By adapting to the NLF (New Legislative Framework, https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en), the Regulation contains detailed obligations for economic operators: manufacturer, authorized representative, importer / importer and trader
[see Regulation (EU) 2016/425 Chapter II]
Declaration of conformity in accordance with a new ordinance must be issued and published for each PPE (also for Category I). These can either be attached to each PPE (analogous to the manufacturer's information) or a reference to or by the internet address at which the EU declaration of conformity can be accessed.
[see Regulation (EU) 2016/425 Annex II; Point 1.4]
Each PPE must (as before) be classified in one of the following risk categories
Category | Risks |
---|---|
Category I | minimal risks |
Category II | Risks other than those listed in Categories I and III |
Category III | Risks that may cause very serious consequences such as death or irreversible damage to health |
As with the PPE Directive 89/686 / EEC, the definitions are purely
risk-based. The risk categories are listed in detail in Annex I of the PPE
Regulation (EU) 2016/425.
[see Regulation (EU) 2016/425 Annex I]
The list of "Category III" risks has been extended by the following:
- Drowning
- cuts by hand-held chainsaws
- high-pressure jets
- bullet wounds or knife stabs
- harmful noise
As
before, different conformity assessment procedures have to be followed
depending on the category of PPE.
[see Regulation (EU) 2016/425 Annex I]
Conformity assessment procedures
The conformity assessment with the adaptation to the NLF is divided into the following modules
Category | Conformity assessment procedures |
---|---|
Category I | internal production control (module A) set out in Annex IV |
|
|
Category II | EU type-examination (module B) set out in Annex V |
|
+ conformity to type based on internal production control (module C) set out in Annex VI |
|
|
Category III | EU type-examination (module B) set out in Annex V |
|
+ conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII |
|
|
|
or |
|
|
|
EU type-examination (module B) set out in Annex V |
|
+ conformity to type based on quality assurance of the production process (module D) set out in Annex VIII |
[see Regulation (EU) 2016/425 Chapter IV, Article 19]
2. FAQ - answers to the most common questions
3. What else is to be considered!
Wir sind ein Notified body (NB 0534).
Head of
Textile Technology and Personal Protective Equipment (PPE)
Judith Pointner
Textile Technology and Personal Protective Equipment (PPE)
Marion Pfeiler
PROVEN SINCE 1846
© 2021 OETI - Institut fuer Oekologie, Technik und Innovation GmbH. All rights reserved.