As of 21st April 2018, the PPE Regulation (EU) 2016/425 of the European Parliament and of the Council will replace the PPE Directive 89/686/EEC.
On this date the transition requirements relating to the new Regulation come into force. If you are responsible for the purchase of PPE you need to ensure that your PPE suppliers are able to meet with the new Regulation in the same way as you needed to ensure they met with the old Directive.
We urge you to look into this matter now, if you do not, the updated Regulation means that you could be facing issues with continuity of supply. This could potentially leave your workers exposed in hazardous situations or affect productivity and deadlines.
In 2016 we issued a Summary of the Regulation to highlight the changes between the Regulation and the Directive, we have revised this to keep you informed of what the transition requirements mean to you. We’ve included:
- key dates
- a summary of the changes
- advice on working with a trusted supplier
- guidance on how to check your certificates for compliance.
We’ve also summarised everything you need to know on a summary poster
1. What you need to know about the Economic Obligations of Operators
The rules of the new PPE Regulation apply to the whole supply chain rather than just manufacturers. The PPE Regulation clearly defines that an importer or distributor who markets a product in Europe under their own name, brand or trademark becomes liable for the full manufacturer’s obligation.
Now everyone involved in the manufacture, supply and distribution of PPE, referred to in the new regulation as ‘Economic Operators’ must ensure their PPE meets with the standard requirements.
Their responsibilities include getting product approval, making sure products conform to the regulation and keeping technical files and records. Importers are also obliged to sample test their PPE where appropriate, unless they can provide a rationale why they do not need to. The responsibility falls to the manufacturer, importer and quasi-manufacturers of own brand products, however they may not have the resources in place to ensure the regular testing that this will involve.
Identifying true product compliance can be difficult for the purchaser and the end user.
Make sure that you are working with a trusted supplier, ask suppliers to:
1. Provide a declaration of conformity that shows original certification for the PPE you are purchasing.
2. Define their process for sample testing to ensure safety products continue to meet the required standards.
3. Define their process of quality assurance at the manufacturing facility to ensure the products are being manufactured as they were originally certified.
To see a full list of the Obligations of Economic Operators, see Page 7 of our Expert Guide. Download here
To view Arco’s Declarations of Conformity please click here.
To see Arco’s five step product assurance process please click here
2. What you need to know about the transition requirements relating to the PPE Regulation (EU) 2016 / 425.
Until 21st April 2023 product can be placed on the market using a current EC Type Examinations Certificate - or until the expiry date of the certificate if it is earlier.
Exceptions that you need to be aware of are:
1. Products where there has been a change in design and / or manufacture since their last EC Type Examination.
Even if products look the same, a change in the specification or the manufacture means that the old certification will no longer be acceptable.
From April 21st 2019 these products will need to be re-certified under the new Regulation.
Ask your supplier for new certification ensuring that your product is still compliant to the relevant, and the most recent, safety standards.
2. Products where there has been a change in the ‘state of the art’ i.e. the standards
If a standard applicable to a product has been revised, for example if there have been significant changes in safety clauses or the withdrawal of current versions then the old certification will no longer be acceptable. Suppliers should not be manufacturing or importing product to an old standard after April 21st 2019.
By April 21st 2019 the certification to the new regulation for the product must relate to the most recent version of the standard. IE Mechanical risk gloves change from the EN ISO 388:2003 version of the standard to EN ISO 388:2016
Check to see if you are buying PPE that is certified to the most current standard. If your supplier is not testing to current standards you’ll need to change buying processes now and switch to products tested to the new, most up to date standards.
3. Products that will change category under the Regulation.
Some risks, such as harmful noise, have been added to Category 3. PPE classified as Category 3 is designed to protect people from risks that may cause serious consequences such as death or irreversible damage to health.
By April 21st 2019 all PPE that has been reclassified as Category 3 must be recertified to the regulation.
Check the Declaration of Conformity for details of the notified body who has issued the ongoing conformity module D or C2 certification.
Look for updated marking on the product, packaging and user instructions. Under or beside the CE mark, there needs to be a notified body umber which is generally four digits and identifies the notified body who conducts the ongoing conformity assessment.
Download a summary of these guidelines here.