Changes to the conditions for the sale of personal protective equipment (PPE) in Europe are fast approaching. The new PPE regulation is more rigorous than its predecessor and designed so that the obligation for the sale of safe products is shared throughout the supply chain.
We spoke with Ansell’s Director of Regulatory Affairs — Guido Van Duren — about the new regulations and what the changes mean for manufacturers, importers and distributors.
First up, what is changing and why?
A new European Union Regulation is being introduced: PPE Regulation (EU) 2016/425. It is a more thorough regulatory system which will ensure that all PPE available for sale in Europe conforms to the latest defined requirements and can therefore be safely placed on the market.
It replaces PPE Directive 89/686/EEC, under which the manufacturer was solely responsible for the sale of compliant PPE products. Regulation 2016/425 is more formalised with respect to certification and compliance and is aligned to a new legislative framework. It clearly outlines the requirements applicable to all economic operators in the supply chain.
Why move from a Directive to a Regulation?
In the EU, a Directive needs to be translated into national law by each individual member state. That makes harmonisation difficult to achieve and leads to discrepancies across the EU. A Regulation becomes law for the entire EU-28 at the same time and without any alteration or loss of integrity.
What are the changes?
There are four key areas of change which I’ll address individually. In short, these are:
- Testing and certification
- Clearer risk-based category definitions
- Enhanced traceability
- Broadened supply chain obligations
1. Testing and certification
All PPE to be made available for sale must be re-certified to the latest standards. In some cases, this will mean re-testing.
Products must be supported by a Declaration of Conformity (EU DoC). This declares that the product meets the Regulation, including reference to the risk category as it applies to the product’s intended use.
In the case of products that were tested and previously certified under the existing Directive and against old standards, re-testing and re-certification must be carried out before the existing certificate expires. If no expiry date applies, the cut-off date for re-certification is 21 April 2023.
2. Clearer risk-based category definitions
The Regulation now clearly defines each risk-based category (i.e. Cat I, Cat II & Cat III). Most remain unchanged, although some risks have been reassigned to Cat III — protection against irreversible harm. These include; harmful biological agents, harmful noise, cuts by handheld chainsaws, bullet wounds or knife stabs, high-pressure jets and drowning. PPE designed for these risks must be re-tested and re-certified to meet the new requirements. They will also need a new EU DoC.
3. Enhanced traceability
Enhanced traceability is intended to allow the market surveillance authority to more easily remove dangerous or non-compliant PPE products from the market. Traceability via mandatory product labelling (for example, the marking of a European single point postal address) makes it easier to trace back to operators who may have placed non-compliant products on the market. This means non-compliant PPE manufacturers and distributors are quickly identified, facilitating faster product recalls and encouraging a practice of exhaustive compliance documentation.
4. Broadened supply chain obligation
The manufacturer still retains responsibility for testing, certification and the EU DoC, but the due diligence responsibilities have been broadened to incorporate increased obligation for importers and distributors.
Importers and distributors are now legally bound to ensure they only place fully compliant PPE in the market. This means they must confirm that the appropriate conformity assessment has been conducted by the manufacturer. If there is reason to believe PPE does not comply (and therefore presents a health and safety risk), the importer or distributor must remove it from sale and report it to the relevant market surveillance authority.
The importer and distributor must also guarantee that storage and transport conditions while the PPE is under their responsibility do not jeopardise product conformity.
What are the compliance timeframes and deadlines under the new Regulation?
The new requirements were established and published in March 2016, so there has been fair warning. It is also a transitional process, but there are key dates all supply chain operators should be aware of.
The formal transition period commences 21 April 2018 with a compliance deadline of 21 April 2019, at which point the old Directive will be repealed. This means that between these dates, new products can be supplied to either the Directive or the Regulation. From the 2019 deadline onwards it will only be permissible to sell new products that meet the Regulation.
Figure 1 - A diagram showing the timeline of the transition to the new standard
For existing products tested and declared under the old Directive, re-testing and re-certification must be completed prior to expiration of the existing certificate. If no expiry date applies, the cut-off for re-certification is 21 April 2023.