Overview of EU PPE Regulation 2016/425 Changes

Slide Note

The EU PPE Regulation 2016/425, effective from 21/4/2018, brings significant changes to Personal Protective Equipment (PPE) rules. It replaces Directive 89/686/EEC and introduces stricter guidelines for economic operators, Notified Bodies, and authorities. The regulation includes updated definitions, responsibilities of economic operators, and new obligations for importers and distributors, such as limiting the validity of EU type examination certificates and providing clear user instructions. There are also changes in the scope of PPE coverage, including categories for specific risks and products. However, essential health and safety requirements remain mostly unchanged. Employers' obligations for care and maintenance of PPE have not altered. Overall, the new regulation aims to enhance safety standards and align with the evolving legislative framework.

dera337 Follow

Uploaded on Oct 07, 2024 | 0 Views

Download Presentation

Please find below an Image/Link to download the presentation.

The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.

E N D

Presentation Transcript

EU PPE Regulation 2016/425 Henk Vanhoutte secretary general European Safety Federation

New PPE Regulation Regulation (EU)2016/425 published 31/3/2016 Replacing Directive 89/686/EEC Applicable from 21/4/2018 1 year transition period for economic operators Alignment with New Legislative Framework Definitions Responsibilities economic operators Stricter rules for Notified Bodies, Authorities, PPE Regulation 2016/425 2 20/09/2017

New PPE Regulation Changes in scope : Including oven gloves for private use Change description of categories : risk based Change of category for some products Harmful noise Bullets wounds or knife stabs Cuts by hand-held chainsaws High-pressure jets Drowning PPE Regulation 2016/425 3 20/09/2017

New PPE Regulation New : validity of EU type examination certificates is limited to max 5 years New : Declaration of Conformity with each PPE (at least website link) New : obligations for importers and distributors (including online sales), e.g. Name and address of importer User instructions available and in correct language PPE Regulation 2016/425 4 20/09/2017

New PPE Regulation Very little change : Essential health and safety requirements (annex II) : only a few changes Most PPE do not change technically Most harmonised standards (published in OJ EU) do not have to change PPE Regulation 2016/425 5 20/09/2017

New PPE Regulation PPE use Directive not changed ! Obligations employers Care and maintenance PPE Regulation 2016/425 6 20/09/2017

Selling PPE making available on the market means any supply of PPE for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge placing on the market means the first making available of PPE on the Union market PPE Regulation 2016/425 7 20/09/2017

Economic operators manufacturer means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark PPE Regulation 2016/425 8 20/09/2017

Economic operators importer means any natural or legal person established within the Union who places PPE from a third country on the Union market PPE Regulation 2016/425 9 20/09/2017

Economic operators distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market PPE Regulation 2016/425 10 20/09/2017

Conformity assessment PPE Regulation 2016/425 11 20/09/2017

Obligations economic operators - marking Manufacturer Importer Distributor CE mark Do it Check it Check it For cat III : NB Name ( ) + postal address Pictograms + info Do it Check it Check it Do it Do it Check it Do it Check it Check it PPE Regulation 2016/425 12 20/09/2017

Obligations economic operators - documents Manufacturer Importer Do it Distributor Technical file Instructions Do it Check it + Check it + DoC Do it Check it + Check it PPE Regulation 2016/425 13 20/09/2017

Obligations economic operators - other +1 / -1 rule between economic operators Product identification Cooperation with market surveillance Keep documents (10 years) PPE Regulation 2016/425 14 20/09/2017

Economic operators What is my role ? Distributor ? Importer ? Manufacturer ? Agreements/contracts between economic operators ! User/employer is not economic operator PPE Regulation 2016/425 15 20/09/2017

Implementation Many questions raised FAQ published by EU Commission mid March 2017 update foreseen September NBs working on revision/update RfUs ESF working on guidance (see ESF website) Flowchart certification for manufacturers Flowchart who am I ? Q&A PPE Regulation 2016/425 16 20/09/2017

Implementation - NB Coordination of NBs strengthened Status of decisions coordination (e.g. RfUs) Challenge of competence of NB possible Active in standardisation PPE Regulation 2016/425 17 20/09/2017

Implementation Market Surveillance Clearer rules E.g. formal non compliance Different way of operating ? Internet sales ? How will they deal with transition ? PPE Regulation 2016/425 18 20/09/2017

Consequences for market PPE placed on the market before 21/4/2019 PPE placed on the market from 21/4/2019 onwards No technical change needed (for vast majority of products) ! PPE to Directive are not unsafe on 21/4/2019 ! PPE Regulation 2016/425 19 20/09/2017

Usefull links ESF : www.eu-esf.org EU Commission PPE : http://ec.europa.eu/growth/sectors/mechanical- engineering/personal-protective-equipment/ NANDO (list of NBs) : http://ec.europa.eu/growth/tools- databases/nando/index.cfm CEN PPE sector : http://www.cencenelec.eu/standards/Sectors/healthS afety/PersonalProtectiveEquipment/Pages/default.as px PPE Regulation 2016/425 20 20/09/2017