New PPE supply Regulation: what to know

Employers have duties concerning the provision and use of personal protective equipment at work. Edward Crick, HM Inspector of Health & Safety, HSE Safety Unit, looks at the current legislation on the issue

On 21 April 2018 the EU’s Personal Protective Equipment Regulation 2016/425 comes into force and replaces the Personal Protective Equipment Directive 89/686/EEC, which is enacted in the UK by the Personal Protective Equipment Regulations 2002. The Regulation concerns the supply and ‘placing on the market’ of Personal Protective Equipment (PPE) and places duties on economic operators throughout the supply chain (manufacturer, authorised representative, importer and distributor) to ensure compliance with the Regulation.

The 2016/425 Regulation, which is direct acting and will be enforced in the UK by the PPE (Enforcement) Regulations 2018, has been developed and implemented for a number of reasons. The previous directive is almost 30 years old and PPE manufacture and supply has developed in such a way that the old legislation was not necessarily suitable for the market as it has developed. The Regulation has also been aligned to other product supply law, such as electrical equipment, to ensure consistency across sectors.

Categories of risk
PPE is assigned to one of three categories depending on the risk it protects from, ranging from minimal risk (Category I) to death or irreversible damage to health (Category III) with all other products covered by Category II.

Each of these categories has different conformity assessment modules from: Category I (simple) equipment which can be self-declared against the Regulation by the manufacturer; Category II (intermediate) which requires an EU Type Examination by a notified body, then ongoing internal production; and Category III (complex) which also requires EC Type Examination, but then also subject to one of two quality assurance procedures defined in the Regulation.

Transition periods have been built into the Regulation whereby products certified against the previous Directive can be placed on the market until 21 April 2019. Therefore the Directive and the EU Regulation will run concurrently for 12 months. Until 21 April 2023, existing type examination certificates will be valid unless expiry occurs beforehand so long as product category has not changed.

Little has changed around the technical requirements of the EU Regulation and the focus of it is still very much to ensure that PPE is ‘safe by design’. The main changes include duties for all parties in the PPE supply chain including importers and distributors who were not captured previously; ‘importer’ means any natural or legal person established within the Union who places PPE from a third country on the Union market; ‘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.

Furthermore, among the changes are: additional risks (harmful biological agents, drowning, cuts by hand held chain-saws) have been added to Category III and, as such, PPE that protects from these risks, have a more stringent compliance procedure; the Declaration of Conformity drawn up to evidence compliance with the Regulations shall either accompany the product, or the instructions should include an internet address at which it can be accessed; the scope of the Regulation has been extended to include PPE for private use which protects against heat (i.e. oven gloves); and PPE type examination certificates now have a time limit of five years.

There are some technical exemptions, such as nuclear sites, but generally for PPE designed and manufactured for private use, the enforcing authority will be Trading Standards. For PPE designed and manufactured, whether exclusively or not, for people at work, HSE will be the enforcing authority.

The benefits of the new regulations
Clearly, businesses and employees are entitled to expect that the PPE they purchase and use is fit for purpose and will protect them accordingly. The new Regulation builds on the existing requirements.

The addition of obligations throughout the supply chain should give businesses and their employees increased reassurance of the safety and efficiency of PPE on the market. Both importers and distributors have a duty to ensure that PPE is CE marked and accompanied by instructions, among other requirements, but these very simple checks will go some way to identifying  PPE that has been placed on the market incorrectly.

The Regulation provides very prescriptive information as to what the respective economic operators are expected to do to ensure they are complying with the requirements of the Regulation, with these being proportionate to the level of control the party has over the manufacturing/supply process.

If you are responsible for buying PPE, you should ensure that: the product is CE marked; it is accompanied by a Declaration of Conformity (or weblink where this can be found); and it is supplied with instructions, in English.

There are no changes to the law on the use of PPE at work.