Will Harmonised Standards Continue Under the Machinery Regulation?
I was asked a question recently about what is going to happen to standards currently harmonised to the Machinery Directive and if these will continue to be applicable once the Machinery Regulation comes into force on 20th January 2027.
The harmonised standards concept does not go away with the Machinery Regulation. The same model is used for meeting the requirements of the essential health and safety requirements (EHSRs) and, as before, the use of these standards is voluntary. The concern is that the Machinery Regulation contains requirements additional to the soon-to-be superseded Machinery Directive, therefore can these previously harmonised standards be used to demonstrate conformity to the Machinery Regulation?
Now, I have intentionally not said “presumption of conformity” as this terminology is restricted to standards which are recognised by the EU Commission as meeting the EHSRs of any referenced regulation or directive, and currently no standards have yet been identified as harmonised to the Machinery Regulation.
Harmonisation, Presumption of Conformity, and the Current Limbo
For a standard to become harmonised, it has to be published in the Official Journal of the European Union (OJEU). Once that is the case, it can be presumed to meet the EHSRs in what is now Annex III of the Machinery Regulation.
Sadly, we cannot simply make the assumption that standards harmonised to the Machinery Directive will be harmonised to the Machinery Regulation. One problem is that the review of those harmonised standards is currently in an unknown state. Therefore, manufacturers (and other responsible parties) seeking to comply with the new regulation are left in a bit of a limbo because the existing harmonised standards are not automatically going to be harmonised to the new regulation.
Now, the existing harmonised standards are well known, well used and, by and large, suitable for the job they are trying to achieve. Therefore, I suspect that the current harmonised standards will (eventually) be harmonised to the Machinery Regulation.
Practical Approach Until New Standards Are Confirmed
It has been implied that some standards might receive some revision or realignment. However, what I suspect is going to be the case is that the existing Annex ZA will be revised to state that the new EHSRs (and there are not many at all) of the Machinery Regulation are not covered by these previously harmonised standards. As a result, these additional EHSRs will have to be satisfied by other means, which as a process is fairly straightforward and no more complex than anything required by the current Machinery Directive.
In this interim period, where there has been no confirmation about the future of current harmonised standards, I think a logical stance would be to “keep calm and carry on”, whilst taking into consideration the additional EHSRs. I believe this is going to be the safest and most sensible approach.
So, what do we need to do? We need to keep an eye out for any new OJEU publications containing implementing decisions related to the Machinery Regulation. But until that point, we must ensure we understand the new EHSRs and confirm that machine designs satisfy these requirements.
