Don’t panic! The new PPE Directive and its likely effects on the market
15 July 2018
Frank Angear, General Manager of PPE trade association BSIF, argues that recent changes in EU PPE regulations will have very little effect on the selection and use of safety equipment and how it protects the user.
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The UK safety and health industry is highly regulated, as you would expect, and for nearly 30 years has adhered to the Personal Protective Equipment (PPE) Directive 89/686/EEC when producing and supplying product for this market. We now have new regulations as the PPE Regulation (EU) 2016/425 became applicable on 21st April 2018, and the old Directive was repealed.
But don’t panic: While the new Regulation is now applicable, PPE compliant with the Directive can continue to be placed on the market for a further year, so not until April 2019 will all PPE have to comply fully with the new Regulation, and since it ‘entered into force’ in April 2016 we have already had two years in which to prepare.
The PPE Directive was published in 1989. Since then, obviously, technologies have changed, and so it certainly needed updating in some of its references and applications, but it was also published long before the current template for European Regulations, the ‘New Legislative Framework’ (NLF), was in place. This framework brings a common legal template to EU Regulations so that the format is broadly common across all of them.
So let’s be clear, the intention for and outcome of replacing the Directive with the new Regulation was to create a modern version and bring it in line legally with Regulations across many other industries. The health and safety requirements that products need to comply with to be saleable within the EU have hardly changed at all, and the Regulation brings no technical changes to products themselves or to the EN performance standards that PPE is certified to.
An obvious difference is in the title: The former is a Directive and the new one is a Regulation. Directives need to be transposed into the national law of each member state, a process which can result in small anomalies, such as in translation, but a Regulation becomes European law as soon as it is published and all member states are subject to it from day one, there is no need to make it national law.
Another thing that eases the transition from Directive to Legislation is the use of current product certificates. While all PPE will have to comply with the new Regulation from April 2019, compliance can be based on a current certificate until April 2023. If you add in the two year transition period we have already had that has effectively given certificate holders three years to prepare their product for compliance, and seven years during which they need to get the certification renewed.
So there’s another thing you don’t need to go out and demand from tomorrow; while PPE must comply within the next year that compliance can be based on a valid certificate under the Directive for another five years (or until the certificate expiry date if that’s sooner). There is no need to insist on new certificates under the Regulation from day one. A small number of products, hearing protection is one of them, are changing from Cat II to Cat III (see the next paragraph). They will need new certification from next April.
Under both the Directive and the Regulation PPE is grouped into three categories, which you will see referred to as Cat I, Cat II and Cat III and described as ‘Simple Design’ (Cat I), ‘Intermediate Design’ (Cat II), and ‘Complex Design’ (Cat III). The Regulation provides greater detail on these categories and their emphasis has changed from describing product examples to categorisation based on the level of risk the products are designed to protect against. So, for example, instead of referring to Buoyancy Aids it refers to Risk of Drowning, and instead of Hearing Protection it refers to Harmful Noise, and so on.
The different categories are subject to different ‘conformity assessment’ procedures, which is the process of certification and applying the CE mark. It is a legal requirement for PPE to have a CE mark before it can be offered for sale in the EU. EN Standards, which test product performance, are actually optional but by far the most common route to securing a CE mark for PPE products. Assessment and testing, and the awarding of certificates, is carried out by an organisation known as a Notified Body.
Cat I products (there are not many examples now that fall into Cat I) require the manufacturer to produce a technical file which includes how their product meets the essential health and safety requirements of the Regulation, and the manufacturer can then apply a CE mark to the product. For Cat II, confirmation that the product meets those requirements must be done independently by a Notified Body, usually as part of testing the product to an EN Standard. This is also the case for Cat III, but in addition there is a requirement for a Notified Body to conduct ongoing surveillance of continued quality at least once a year.
One of the most significant changes is that all product certificates issued under the new Regulation will have a maximum validity of five years. In the past many certificates had no expiry date on them, which meant that even though the standard to which a product is certified may have been revised, or even superseded by a new one, it was still perfectly legal to sell that product under the existing certificate. From the first renewal under the Regulation certificates will only be valid for five years at the most, and a beneficial side effect of that is, as Notified Bodies will not certify to earlier versions of standards or superseded ones, soon all products certified to an EN standard will have been assessed and tested to the most current version.
Of course the Regulation has a number of other significant changes in it, but these are mostly about providing a great deal more detail than was present in the Directive. There is considerably more information for example on the obligations of Notified Bodies, and also on the obligations and powers of national Market Surveillance Authorities. These are the bodies that police the compliance of products entering the market, and in the UK they are Trading Standards and the Health and Safety Executive. New too are a number of obligations on what the Regulation calls ‘Economic Operators’.
The term ‘Economic Operators’ covers any organisation involved in the supply chain; manufacturers, authorised representatives, importers, and distributors. Obligations for the first two do not change from the Directive, and importers and distributors who market PPE under their own name or brand still assume all the obligations of the manufacturer, but in the Regulation there are a number of new obligations specifically on importers and distributors. There is also the welcome inclusion of ‘distance selling’, which means that any organisation conducting internet sales into the EU of PPE will have to ensure the products comply.
The new obligations on importers and distributors include requirements for record keeping, handling and storage, verification up the supply chain that all necessary processes have been performed and adhered to, and an obligation to prevent non-compliant products from reaching the market and ensuring the regulatory authorities are informed about any that are found to already be there.
These new obligations are not onerous, but are quite varied and need to be complied with fully. The British Safety Industry Federation (BSIF) has compiled separate documents for importers and distributors which its members can utilise as a checklist to demonstrate that their organisation and the products it supplies meet the new requirements of Regulation (EU) 2016/425.
How else can BSIF help? Well, the Federation believes strongly that specifiers and users of PPE and related safety equipment and services deserve good quality products from capable and responsible suppliers. Users need the confidence that product claims are genuine as they may trust their life or future health to that product or service.
To this end the BSIF operates and manages a quality assurance initiative called the Registered Safety Supplier Scheme (RSSS). All BSIF members involved in the supply of PPE or related products and services are members of the RSSS, within which:
• They sign a binding undertaking to supply only compliant products and services
• They embed an Industry Code of Practice into their company quality manual
• They submit to annual testing of one randomly selected product from their range, or annual audit of:
* Quality policies and documentation outside EN standards
* At least one method sheet test protocol
* Service authorisation from product manufacturers
• They commit customer facing staff to work towards attaining an OfQual Level 2 qualification in the Safe Supply of PPE and related products and services, or an equivalent
• For Importers and Distributors, submit to audit of the BSIF (or equivalent) product checklists demonstrating compliance with their obligations under the PPE Regulation (EU) 2016/425
Trading Standards has endorsed the integrity of this scheme and issued a supporting statement that BSIF members who are importers or distributors who adhere to the requirements of the RSSS and can complete the checklists appropriately have demonstrated their compliance with their obligations under the new Regulation.
Membership of the scheme is advocated up and down the supply chain, and end users can register their support of the scheme and an intention to source PPE from Registered Safety Suppliers whenever possible at www.registeredsafetysupplierscheme.co.uk, or via the BSIF main website www.bsif.co.uk.
Over time we can reassure users they will receive quality product as the market becomes a truly level playing field, unscrupulous suppliers are de-selected, and unfair competition is removed.
About the author
Frank Angear is General Manager of the British Safety Industry Federation (BSIF), controlling the Secretariat function for all BSIF Associations, Product Groups and Working Groups, as well as liaising with UK and EU bodies on issues affecting the PPE sector. He has over 40 years’ experience of the industry, mainly in sales and marketing positions, and is a member of a number of Technical and Standards Committees, including BSI and ISO Standards Drafting Groups.