Standards are slipping

Up until recently, the process under which EN standards are ‘harmonised’ on their publication in the EU Official Journal has worked reasonably well. However, there is an issue with current drafting of new standards, and revisions to older standards, that could upset the harmonisation process with potentially serious consequences.

The Background

To place any item of Personal Protective Equipment (PPE) on the market in Europe requires the product to be CE marked. To gain a CE mark the product must meet all the relevant Essential Requirements (ER’s) of the EU PPE Directive. The most straightforward way to do this is to have it approved to a harmonised EN standard. A harmonised standard has a set of clauses laid out in its Annex ZA, which shows how a product meets the performance requirement of the standard whilst also satisfying the ER’s.

Recently, there has been evidence of where the first drafts of new or revised standards have been issued for comment without their Annex ZA being fully prepared. It is apparent that correct drafting of this annex has slipped down the priorities of those undertaking the drafting work. This is particularly prevalent in the drafting of ISO Standards, as these are aiming to become a single global standard, while a requirement to satisfy the PPE Directive’s ER’s only applies to Europe.

The PPE Directive is currently under revision with the new version scheduled for submission to the European Parliament towards the end of this year. After the European Parliament has deliberated the proposal for the newer version, it could come into force within a further two to three years.

However, to complicate matters, those who have drafted the revision do not see this as essential. They acknowledge the importance of the Annex ZA in fully demonstrating compliance with the ER’s, but suggest this is ideal and not always possible to achieve.

The consequences

Without the ability to automatically demonstrate that a product satisfies and meets the performance requirements of a product standard through the use of ER’s, then it will be left to the Notified Body, who certifies the product, to agree with the product manufacturer to any additional tests that will have to be done to gain the CE mark.

Of course with the possibility of extra testing there are associated additional costs for the manufacturer, but with different Notified Bodies having differing opinions on what additional testing is necessary. This is more than likely going to result in manufacturers gravitating towards the Notified Bodies, who demand the least by removing the ‘level playing field’ and dragging down benchmarks within testing and certification.

Companies need to ensure that their Annex ZA’s are drafted to ensure full compliance with the ER’s, without doing so there is the possibility of the manufacturer product approval costs going up whilst the value of that approval goes down. The process of harmonisation of European standards is expensive but worthwhile, creating a clear understanding of the value of holding an EC Type Certificate and what it means. If this trend continues then standards will not be able to be harmonised and the process will become meaningless.

What can be done?

The CEN Consultant is currently taking an increasingly tough line on the approval and testing of products, highlighting the vital nature of having an Annex ZA that covers all relevant ER’s adequately. They are also highlighting that this should be addressed as early as possible in the process and should be completed with the first working draft. It has been made clear that if a standard is published without addressing these compulsory provisions then it can never be harmonised. 

Let’s hope it is taken up, and this issue is soon resolved.