EU – PPE Regulation 2016-425 Guidance
Vol. 906 | April 27, 2016
The new European PPE Regulation 2016/425 was listed in the Official Journal on 21st April 2016, starting its two-year transition period to replace the current Directive 89/686/EEC.
The Scope of the Regulation
The scope has remained the same as the Directive 89/686/EEC with the following inclusions:
- Interchangeable components which are essential for the protective function of the PPE.
- Connexion systems for PPE that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point , that are not designed to be permanently fixed and that do not require fastening works before use.
What are the main differences in the new PPE Regulation?
- Clothing intended for private use with reflective or fluorescent elements included for reasons of design or decoration is not PPE and therefore is not covered by this Regulation.
- Products for private use to protect against atmospheric conditions that are not of an extreme nature or to protect against damp and water are not covered (e.g., dishwashing gloves).
- PPE for private use against heat, i.e., oven gloves are now covered and should be in line with similar products designed for professional use.
- Products offering protection against the following have been moved from Category II to Category III PPE – drowning, cuts by hand-held chainsaws, high-pressure jets, bullet wounds or knife stabs and harmful noise. These items will need to be re-classified and include on-going surveillance.
- A web link to the Declaration of Conformity must be given in conjunction with the PPE.
- A five-year validity period for EU Type Certificates (this has changed from EC Type Certificates).
- Details for the responsibilities for importers and distributors are given.
- Bespoke PPE are now covered.
Changes to categories in the PPE Regulation 2016/425
PPE Directive 89/686/EEC
New Regulation 2016/425
Placing product on the market
Module A (Annex IV)
Initial product approval
EC Type Examination
Module B (Annex V)
EU Type Examination
Module C (Annex VI)
Conformity to type based on internal quality control
On-going surveillance through testing
Module C2 (Annex VII)
On-going surveillance through factory auditing
Module D (Annex VIII)
Timeline for implementation of the PPE Regulation 2016/425
- It was published on 31.03.2016
- It shall enter into force on the 20th day following its publication in the Official Journal
- It shall apply from 21.04.2018
- Members States shall not impede the making available of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21.04.2019
- EC Type Examination Certificates issued under Directive 89/686/EEC shall remain valid until 21.04.2023 unless they expire before that date
Obligations for manufacturers, importers and distributors
- It is a legal requirement for all manufacturers and their supply chain to comply with the regulation
- Importers, distributors and manufacturers should take appropriate measures to ensure that PPE meets all requirements and that they only make available on the market products which comply with Regulation 2016/425
- Importers shall ensure that the PPE is accompanied by the user information. The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the user information the internet address at which the EU declaration of conformity can be accessed
- Manufacturer shall detail their internal quality procedures with their technical documentation
- EU type certificates will have a validity of 5 years
- It will be the responsibility of the manufacturer to ask the notified body to review the EU type certificate either:
- In case of a modification
- In case of a change in standard, essential health and safey requirements (EHSR) or state-of-the-art
- At the latest, before the date of expiry of the certificate
(In order to allow the notified body to fulfill its tasks, the manufacturer shall submit its application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate.)
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