To allow the free movement of equipment within the European Union while guaranteeing a uniform level of safety for those who use it, the so-called “machinery” directive 2006/42/EC imposes technical rules on marketers. It is about to be revised. The commission proposed a text in the spring of 2021, which has been amended by the Council of the European Union. The final version should be adopted before the end of the year, after negotiations with Parliament.
The text clarifies certain concepts: “machines”, “related products”, “substantial modifications”… What other main changes does it include in the current state of discussions?
1. The directive becomes a regulation
A directive requires transposition into national law, which is likely to be a source of delay and differences in interpretation between the States. And so of legal insecurity. To avoid this, the text will become a regulation.
2. Obligations for each operator
Today, the directive is only concerned with the marketer, ie the manufacturer or his authorized representative. Tomorrow, the regulation will specify the obligations incumbent on each operator: manufacturer, importer and distributor. These last two already appear in the “blue guide“, soft European law. Tomorrow, they will be strictly mentioned in the regulations.
The natural or legal person (importer, distributor, or even user) who substantially modifies the machine will become the manufacturer and must comply with the corresponding obligations. Same thing if he puts a machine or related product on the market under his own name or brand.
3. A few more supervised machines
The manufacturer must comply with EESS (essential health and safety requirements, listed in appendix 1, which will be appendix 3 tomorrow). Harmonized standards specify the means of achieving these performance obligations. Compliance with them exempts from certification of conformity by a third party. This is what happens in the vast majority of cases.
However, according to Pierre Belingard, responsible for the coordination of French notified bodies at Eurogip, the standards are sometimes insufficient and/or poorly applied. The European Commission’s proposal provided for mandatory external certification for Annex 4 machines, ie high-risk machines. After one “shielding” manufacturers, according to Pierre Belingard, the draft text as it is today has somewhat reconsidered this change: only certain machines in this appendix 4 (which will be renamed appendix 1) will be concerned.
4. An update of the machines concerned
Until now, it was theoretically very tedious to update the lists of machines covered by the directive, following the classic revision process. Tomorrow, the European Commission will be able to more easily update the regulation for high-risk machines. It may take action on its own or be called upon by other parties to add or remove machines from the list, after an analysis of the probability and severity of the damage at risk, among other things.
5. New technologies taken into account
This is one of the main challenges of this revision: managing to anticipate technical and technological developments to guarantee the necessary stability to the various economic operators, at the same time as security. To respond to the issue of cybersecurity, that is to say the risks arising from malicious actions by third parties and having an impact on the security of machines, a new part will be added to the EESS.
To deal with the issue of autonomous machines, the parts of the EESS related to contact between man and machine, namely that on ergonomics and that on the risks related to moving parts and psychological stress, are reviewed.
Same thing for artificial intelligence: sections are modified to deal with the resulting risks, even if we are talking here, in the latest version, more specifically of machine learning given that the European directive dedicated to AI has taken on delay.
6. Possible digital documents
The directive requires manufacturers to provide the necessary information on machinery, such as instructions, in paper form. After compromise, the draft text as it stands today provides that the documents can be in digital form, but that the manufacturer provides free of charge at the request of the end buyer the instructions in paper format up to six months later. procurement.