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New European Regulation (EU) 2016/425

On March 31st 2016, the European Commission published new personal protective equipment legislation.

The current Personal Protective Equipment (PPE) Directive 89/686/EEC was drawn up in 1989 and, apart from some minor revisions early on, it has remained unchanged since that time. However, an impact study in 2010 and a public consultation in 2011 were carried out to consider a potential revision to the directive. During 2013 and 2014, a review of the outcome from these two studies resulted in changes to the PPE legislation being recommended and work on a new regulation being carried out. A trilogue between representatives of the European Council, Parliament and Commission on final draft proposals was completed at the end of 2015. During this development period, feedback from a number of stakeholders on the proposed changes has helped to influence and shape the final text.

This article identifies some of the potential implications of the changes to anyone currently, or considering, supplying the European market with PPE. It should be noted, however, that the new legislation will not be applied until 21st April 2018.

A new regulation

The European Commission considers that experience with the current directive shows the basic principles to work well, and that they should be maintained. Therefore, the obligation to carry out the complete conformity assessment procedure remains solely that of the manufacturer. Also, the majority of core health and safety requirements and procedures will remain the same, although a few specific areas are changing. One major legislative alteration is that the PPE Directive is being replaced by a regulation that will apply directly in all member states without transposition into national legislation. While the practical impact on suppliers will be relatively minor, a number of amendments relevant to PPE will be implemented at the same time, including scope changes and certification requirements.

The scope of the regulation will be extended beyond that of the current directive to cover items intended to provide protection to private users from heat (for instance, domestic oven gloves). Commercial users are already covered by the current directive.

The regulation clearly defines the obligations and responsibilities of manufacturers, authorised representatives, importers and distributors of PPE. It also introduces definitions and adapted conformity assessment procedures for made-to-measure and individually adapted PPE. This will be of particular interest to manufacturers of products such orthopaedic safety footwear or custom-made mouthguards.
 Some types of protection have been moved from Category II (intermediate) to Category III (complex). These include protection against harmful noise, drowning, cutting by hand-held chainsaws, bullet wounds or knife stabs, harmful bacteria and equipment protecting against high-pressure jets. For such types of protection, manufacturers will be subject to the strictest conformity procedures (EU type-examination in accordance with Module B of the regulation plus monitoring of ongoing production conformity in accordance with either Module C2 or Module D of the regulation – the equivalents under the current directive being Articles 10, 11A and 11B).

To ensure easy access to the declaration of conformity, manufacturers will need to ensure that when PPE is supplied to an end-user, it is accompanied by either a full hard copy of the declaration or the internet/website address where the declaration can be accessed. In situations where an item of PPE is covered by several EU harmonised legal acts, these should be addressed by a single declaration of conformity, albeit a compilation document.

In order to ensure that PPE is examined on the basis of the being state-of-the-art, a key change is the introduction of time-limited EU type-examination certificates. These will be valid for a maximum of five years, after which they will need to undergo a revalidation procedure in order to be extended. To ensure sufficient time for any required renewal, the regulation specifies the application must be submitted to the Notified Body at least six months prior to the certificate’s expiry date. A simplified renewal procedure is applied when there has been no change to the product, the harmonised standard or associated guidance. The regulation also specifies in more detail than the directive the information that must be contained on the certificate.

The regulation now in force

The new regulation was published in the Official Journal of the European Union on 31st March 2016 as (EU) 2016/425, and came into force 20 days later on 21st April. However, the regulation will not be applied until 21st April 2018, which is two years after first coming into force, and there will then be a one-year transition period until 21st April 2019. Current understanding is that during this one-year transition period, it will still be possible to place on the market PPE complying with the directive, but some commentators have suggested that during this time it will not be possible to manufacture PPE to the Directive. Hence, the intention of the transition is for manufacturers to place PPE on the market that has been produced under the directive but is still being held in a storage facility. Some requests have been made to the European Commission to extend the 21st April 2018 deadline for the manufacture of PPE to the Directive.

Box 1: Market terminology
In very simplistic terms, 'placing on the market' is defined as when an individual product is made available on the Union market for the first time. Hence, it is transferred from the stage of manufacture (if within the EU/or import to the EU) with the intention of distribution. Therefore, the only economic operators that can ‘place product on the market’ are manufacturers or importers.

'Making available on the market' is when an individual product is supplied on the EU market for distribution, consumption or use, so would be typically further down the supply chain. When 'made available on the market', products must have been in compliance with the relevant EU legislation applicable at the time of 'placing on the market'. Please note the published official definitions of these two terms include much greater detail, so these descriptions should not be taken as authoritative text.

EC type-examination certificates to the current PPE Directive will then become invalid at whichever date comes first – either at the stated expiry date or five years after application of the regulation (21st April 2023). During this time after the transition period, it will still be possible to make available on the market PPE in line with the directive but it will no longer be possible to place such PPE on the market (see box 1). EU type-examination certificates under the new regulation can be issued before 21st April 2018, but the certification cannot be applied to products placed on the market before that date. All current SATRA EC type-examination certificates under the directive will expire on 21st April 2023 (see table 1).

Table 1: Regulation (EU) 2016/425 –
Current interpretation of transition period

Directive 89/686/CEE Regulation (EU) 2016/425

to 21 April 2023
 

 
to 21 April 2019 End of validity for all EC-type certificates and decisions made according to the Directive (Article 47 paragraph 2)
to 21 April 2018 End of possibility to place on the market PPE with a Certificate according to the Directive (Article 47 paragraph 1)
Directive withdrawal
– Regulation application

PPE
Category l

Only PPE made according to the Directive may be placed and made available on the market Placing on the market of PPE made according to the Directive or the Regulation is possible Only PPE made according to the Regulation may be placed on the market
PPE made according to the Directive or the Regulation may be made available on the market
PPE
Category ll
Only PPE made according to the Directive may be placed and made available on the market Placing on the market of PPE made according to the Directive or the Regulation is possible Only PPE made according to the Regulation may be placed on the market
PPE may be made available on the market according to the Directive or the Regulation
PPE Category lll Only PPE made according to the Directive may be placed and made available on the market Placing on the market of PPE made according to the Directive or the Regulation is possible Only PPE made according to the Regulation may be placed on the market. Production control only according to Regulation (Modules C2 and D)
PPE may be made available on the market according to the Directive or the Regulation
PPE that moves from Category ll to Category lll May be placed and made available on the market as Category II PPE if made according to the Directive PPE made according to the Directive may be placed on the market as Category II. PPE made according to the Regulation may be placed on the market as Category III Only PPE made according to the Regulation may be placed on the market as Category III
PPE made according to the Directive may be made available on the market as Category II. PPE made according to the Regulation may be made available on the market as Category III

Production control only according to Regulation (Modules C2 and D) for those with EU Certificate

Preparing for the changes

It is clear that currently some time exists before the new legislation is applied, and SATRA Spotlight readers will be kept up-to-date with developments. In the meantime, there are some points that should be considered in preparation for the recertification procedure. While certificates cannot be issued under the new regulation until after 21st April 2018, all the preparatory work in terms of product testing and technical file assessments can be carried out before this time, so that certification can happen as soon as possible after the regulation is applied.

If you produce any of the products that will be reclassified from Category II to Category III, review the ongoing monitoring obligations as laid out in Module C2 (Annex VII) or Module D (Annex VIII) of the regulation. At this point in time, it is important to decide which is going to be most suitable for your business. If you opt for Module D and do not already have a suitable quality management or factory production control system, this will need to be introduced to your company.

Review your product range to identify which are the priorities for recertification and assess the associated technical files against the criteria laid out in Annex III of the new regulation. It is important that all information is current and validated. Also, any recertification will be based on the version of the standards harmonised at that time, so it is recommended to review these documents to ensure that your current product designs are fully compliant.

Determine the preferred option for making available your EU Declaration of Conformity information. If this is to be via the internet, start background construction on the necessary website code.

For Category I products, ensure that you are ready to meet the obligations as laid down in Module A (Annex IV) of the regulation.

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