The PPE Regulation EU 2016/425 was published in March 2016 and came in force from 20th April 2016. However, this regulation was fully applicable from 21st April 2018 onwards. The EU regulation replaces the PPE Directive 89/686/EEC.
Important points – PPE Regulation EU 2016/425:
- Products already placed in the EU markets before 20th April 2018 under the PPE Directive 89/686/EEC, will stay valid up to 21st April 2023, unless they expire before this date.
- From 20th April 2019, all PPE being placed in the EU markets shall comply to the requirements of the new Regulation EU 2016/425, with updated standard versions.
- For the new EU Type Examination certificates issuance, all products currently certified to old withdrawn standard versions will have to be tested to the latest versions
- All notified bodies have stopped issuance of product certificates under the old PPE Directive since 21st of April of
- A importer / distributor in EU should ensure that the PPE sold by them complies with the new EU Regulation
Important Dates – PPE Regulation EU 2016/425:
Few highlighting changes that have taken place under this new regulation:
- Hearing protection and Life Jackets have been moved from Category II to Category III PPE
- PPE Risk assessment has to be mentioned in the technical file
- Compulsory to issue Declaration of Conformity (DOC) with each PPE or at least place a link on each PPE for the availability of this document on manufacturer’s website
- Specific responsibilities outlined for importers and distributors
- The need for manufacturers to place their name and address on the product
Validity Period for EU Type certificates:
- The PPE Regulation will have a five-year validity period on all EU Type Examination Certificates.
- The manufacturer shall ask the Notified Body to review the EU type-examination certificate either:
- In the case of a modification to the product or documentation
- In the case of any change in standards that the PPE meets
- Before the date of expiry of the certificate: The manufacturer shall submit their application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU Type-Examination certificate.
The Regulation provides for three categories of PPE, same to the earlier Directive. All these 3 categories with implication due to the new regulation has been described as below:
|PPE Category||Activity||Old PPE Directive 89/686/EEC||New PPE Regulation (EU) 2016/425|
|Placing product on to the market||Manufacturers Self-Declaration||Module A
(Annex IV) Manufacturers Self Declaration
Intermediate PPE &
|Initial Product approval||Article 10 EC Type Examination||Module B
EU Type Examination
Complex PPE only
|On-going surveillance through testing||Article 11A||Module C2
Complex PPE only
|On-going surveillance through factory auditing||Article 11B||Module D
Tarasafe assures that all new product placed in the EU markets are certified as per the latest versions of all norms. Also, Tarasafe factory is audited by BTTG, UK for the Module D certification. All Tarasafe Cat III products placed in the market are marked with CE and BTTG Notified Body number 0338.
Check certificate copy as below: