European Regulation (EU) 2016/425
The European PPE Directive 89/686/EEC has now been replaced by Regulation (EU) 2016/425.
Pan-European PPE legislation, in the form of Personal Protective Equipment (PPE) Directive 89/686/EEC, was first published in 1989. Apart from some minor revisions early on, it remained unchanged until it was repealed on 21st April 2018. It has now been replaced by European Regulation (EU) 2016/425. This article identifies some of the potential implications of the legislative changes to anyone currently, or considering, supplying the European market with PPE.
A new regulation
The European Commission considered that the basic principles of the original directive appeared to work well, and that they should be maintained. Therefore, the obligation to carry out the complete conformity assessment procedure under the new regulation remains solely that of the manufacturer. Also, the majority of core health and safety requirements and procedures remain the same, although a few specific areas were changed. One major legislative alteration was that the PPE Directive was replaced by a regulation that applies directly in all member states without the need for transposition into national legislation. While the practical impact on suppliers will be relatively minor, a number of amendments relevant to PPE were implemented at the same time, including scope changes and certification requirements.
The scope of the regulation extends beyond that of the original directive and now covers items intended to provide protection to private users from heat (for instance, domestic oven gloves). Commercial users were already covered by the directive.
The regulation clearly defines the obligations and responsibilities of manufacturers, authorised representatives, importers and distributors of PPE. It also introduced 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 PPE products have been moved from Category II (intermediate) to Category III (complex). These include products designed to protect against harmful noise, drowning, cutting by hand-held chainsaws, bullet wounds or knife stabs, harmful bacteria and 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 original directive being Articles 10, 11A and 11B).
To ensure easy access to the declaration of conformity, manufacturers will now 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 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 it 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 that 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 is now applicable
The new regulation was published in the Official Journal of the European Union on 31st March 2016 as (EU) 2016/425, came into force 20 days later on 21st April and was fully applied on 21st April 2018. This was two years after it first came into force, and there is now a one-year transition period until 21st April 2019. During this one-year transition period, it will be possible to place on the market PPE complying with either the directive or the regulation. After 21st April 2019, only PPE complying with the regulation can be placed on the market.
EC type-examination certificates to the old PPE Directive will 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).
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 imported 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.
EU type-examination certificates under the new regulation could have been issued before 21st April 2018, but the certification could not have been applied to products placed on the market before that date. All SATRA EC type-examination certificates under the old 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|
|21 April 2018
Directive withdrawal – Regulation application
|21 April 2019
End of possibility to place on the market PPE with a certificate according to the Directive (Article 47 paragraph 1)
|21 April 2023
End of validity for all EC type-certificates and decisions made according to the Directive (Article 47 paragraph 2)
|PPE Category I||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 II||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 III||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 II to Category III||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
Some requests have been made to the European Commission to extend the 21st April 2019 deadline. Subsequent additional guidance on the interpretation of Article 47 relating to the transition arrangements to the new PPE Regulation (EU) 2016/42 states that if:
- the ‘state of the art’ has not changed (that is, the applicable standard has not been revised with significant changes on such aspects as safety clauses and withdrawal of current versions) and
- the design and manufacturing arrangements remain the same as when the product was last subject to EC type-examination, and
- the product category under the regulation has not changed
then the product can be placed on the market using a PPE Directive EC type-examination certificate until 21st April 2023 (or until the expiry date of the certificate if it is earlier).
However, the product itself must be in compliance with the regulation from 21st April 2019. Therefore, the product markings and user instructions must be updated as required by the regulation and a new EU declaration of conformity must be produced. This means that the new EU declaration of conformity can be based on a valid EC type-examination certificate produced under PPE Directive 89/686 until 21st April 2023 (or the expiry date of the certificate if earlier).
The new guidance does provide many current EC type-examination certificate holders with a longer timescale to transfer. However, for a number of types of products, recent standards changes will still mean EU type-examination certificates in accordance with the new regulation will be required by 21st April 2019. SATRA advises that having an EU type-examination certificate (and corresponding module C2 or D evidence for Category III products) to Regulation 2016/425 is considered the preferable approach to being able to demonstrate compliance to the latest EU legislation to the various EU authorities and customs officials.
Preparing for the changes
If you have not yet made arrangements to update your production, there are some points that should be considered in preparation for the recertification procedure.
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 that you 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, work on changes to your website should be started in good time.
For Category I products, ensure that you are ready to meet the obligations as laid down in Module A (Annex IV) of the regulation.
How can we help?
15 PER CENT DISCOUNT ON FIRST SATRA TEST - please click here.
Please email firstname.lastname@example.org for further information on the new European PPE Regulation.