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ZHPPE Regulation (EU) 2016/425:2018 now implemented
Describing the current status of the new European PPE legislation.
On March 31st 2016, the European Commission published new Personal Protective Equipment (PPE) legislation as Regulation (EU) 2016/425. This was applied on 21st April 2018, when it replaced Directive 89/686/EEC.
The original Personal Protective Equipment (PPE) Directive 89/686/EEC was drawn up in 1989 and from 30th June 1995 until 21st April this year – when it was repealed – it required all PPE placed on the European market to be CE marked.
We are now in a one-year transition period between the old directive and the new regulation. During this phase (which ends on 21st April 2019), products can be ‘placed on the market’ (see box 1) in accordance with either the old directive or the new regulation. After 21st April 2019, any PPE, such as safety or protective or occupational footwear, will need to be in accordance with Regulation (EU) 2016/425 before it is placed on the European market.
Box 1: Placing and making available on the market
In very simplistic terms, ‘placing on the market’ is defined as when an individual product is made available on the European 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. The only economic operators that can ‘place product on the market’ are therefore manufacturers or importers.
‘Making available on the market’ is when an individual product, already ‘placed on the market’ 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.
However, provided that:
- 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 remains the same as that under the directive,
then the product can be placed on the market using a current EC type-examination certificate until 21st April 2023 (or until the expiry date of the certificate if it is earlier).
The product itself must be in compliance with the regulation from 21st April 2019. As a result, the product markings and user instructions must be updated as required by the regulation and a new EU declaration of conformity must be produced.
Hence, 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. For a number of types of products, however, 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.
How can we help?
Please email ppe@satra.com for further information on the new European PPE Regulation and for assistance with product testing.
Publishing Data
This article was originally published on page 6 of the June 2018 issue of SATRA Bulletin.
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