ICS is pleased to present a summary of changes to be expected with the transition from the EU PPE Directive 89/686/EEC to the new PPE Regulation (EU) 2016/425.
Main Changes to the New PPE Regulation (EU 2016/425):
The Regulation text was adopted on the 12th February 2016, published on 31 March 2016 and has been published in the Official Journal 21 April 2016. This starts the two year transition period for Member States and Notified Bodies to prepare for the introduction of the new Regulation. There are a number of changes that are being proposed taking place including:
- Moving hearing protection from Category II to Category III PPE
- Moving life jackets from Category II to Category III PPE
- Issuing a Declaration of Conformity with each PPE or at least a link to where it can be obtained
- A compulsory maximum five-year certificate validity
- Responsibilities outlined for importers and distributors
- Bespoke PPE covered in the Regulation.
- PPE Directive 89/686/EEC is repealed effective 21 April 2018
- This PPE Regulation (EU) 2016/425 shall apply starting 21 April 2018
- Member States shall not impede the making available on the market of products covered by the old PPE Directive 89/686/EEC before 21 April 2019
- EC type-examination certificates issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date
What All Manufacturers of PPE Need to be Aware of:
All manufacturers of PPE need to be aware of what existing certifications they currently hold and when they will expire now that the transition period has started. It is important to keep up to date with these changes and prepare for the impact on your business.
At this stage, we encourage you to consider the following:
- If you are placing products on the market that will change category (such as life jackets, hearing protection, etc.) be aware of what the change in classification will mean and the possible need to institute an on-going surveillance system.
- Because new EU-Type Examination certificates will have to reference the standards where applicable, all products currently certified to old withdrawn standards will have to be tested to the latest/current versions.
- Look at existing product ranges and ensure that they are tested to the latest product specifications
- If you are a distributor, be aware that there are parts of the Regulation that will have direct implications on you as you will have to ensure the PPE you sell complies with the new Regulation.
Main changes to technical files:
- Marking – adding the postal address of the manufacturer. In case of import from outside the EU, also the name, registered trade name or trade mark and the postal address of the importer have to be indicated on the PPE (or at least on the packaging or documents accompanying the PPE)
- Instructions – making sure the risk against which the PPE is designed to protect and the references of the applied harmonized standards are included. Change the reference of the legislation to the Regulation 2016/425 and either add the full text of the DoC or an internet link where the DoC can be obtained easily. For Cat III PPE, add also the information of the Notified Body responsible for Module C2 or D next to the information of the Notified Body responsible for the Type Examination
- DoC – draw up a new DoC referring to the Regulation 2016/425according to Annex IX of the Regulation