On April 21, 2021, the text of the proposal for the new machinery regulation (Regulation of the European Parliament and of the Council on machinery product s ) was made available, which in the coming months, once the approval process has been completed, will replace the current machinery directive 2006/42 / EC .
This will result in the transformation of the directive (legislative act of the European Union which provides for transposition by the Member States) into a regulation (legislative act of the European Union directly applicable in each of the Member States).
The benefits of transforming the directive into a regulation include more uniform implementation, no transposition problems and greater legal certainty; the conversion of the directive into a regulation thus makes it possible to reduce delays in transposition and the differences in interpretation between Member States.
The new machinery regulation has been drawn up in compliance with the indications of the new legislative framework, therefore it will be consistent with other directives typically applicable to machinery, such as the low voltage directive 2014/35 / EU and the electromagnetic compatibility directive 2014/30 / EU.
The new machinery regulation will come into force on the twentieth day after its publication and will be applied after a further 30 months; the current directive 2006/42 / EC will be repealed on the same date, but it will be possible to place on the market machines compliant with directive 2006/42 / EC for 42 months after the date of entry into force of the new regulation.
The machinery directive applies to new machines and has never taken into consideration the modification interventions, so far regulated only by national laws, different from one country to another.
The new regulation, on the other hand, also applies to products that have undergone "substantial changes", that is, such as to affect their compliance with safety requirements.
In this case, the person making these changes must meet all the obligations established by the regulation for manufacturers.
Consistent with the provisions of the new legislative framework, the figures of the importer and distributor have been introduced in the new machinery regulation.
The importer is the person who places a product from a third country on the European Union market, while the distributor is a person, other than the manufacturer or the importer, who makes a product available on the market.
The importer must ensure that the manufacturer has completed the appropriate procedures for assessing the conformity of the product and must indicate on the product his name, postal address and e-mail address; in fact, therefore, the importer is responsible for the conformity of the product and is personally responsible for it.
The obligations of distributors are decidedly minor and essentially consist in verifying that the product is correctly identified (including the references of the manufacturer and any importer) and accompanied by the necessary documentation and due diligence in the transport and storage of the product so as not to compromise it compliance with safety requirements.
The safety components fall within the scope of the machinery directive and, as such, must be CE marked.
In the definition of "safety component" of the new machinery regulations, digital components, including software, have also been introduced; for the first time the machinery regulations therefore also apply to an intangible product.
The software that performs safety functions placed on the market separately must therefore be CE marked in accordance with the machinery regulation and be accompanied by an EU declaration of conformity and, where necessary, by instructions for use.
Documentation and language
The language of the information and documentation (instructions for use, EU declaration of conformity, human / machine interfaces, warnings) must be easily understood by users and market surveillance authorities and must be defined by each Member State (this approach is common to other directives, such as low voltage and electromagnetic compatibility).
The documentation may be provided in digital format, for example by making it available on an internet site; however, the user may request, at the time of purchase, a paper copy of the documentation which must be provided free of charge.
The new machinery regulation applies to systems that use artificial intelligence technologies for the aspects concerning the possible influences on the safety of the machine.
In particular, the risk assessment must take into account the evolution of the behavior of machines designed to operate with different levels of autonomy.
The learning phase must also be considered, limiting the behavior of the machine, by means of adequate safety circuits, so as not to exceed the limits considered in the risk assessment.
Finally, also in the essential safety and health protection requirements applicable to mobile machines, specific parts have been included for autonomous mobile machines, ie without driver; these products, called AGVs, are increasingly widespread and are supplanting the manual handling of objects in the most disparate sectors, from production lines, to warehouses, to hospitals.
Computer security is an aspect that can no longer be neglected for machines: in fact today practically all machines are connected to data networks that can be the object of attacks by malicious people; facts of this kind have already happened and are destined to increase in the future.
For this reason, the new machinery regulation requires that the control circuits that perform safety functions are designed in such a way as to prevent malicious attacks from causing dangerous behavior of the machines.
A new essential safety and health protection requirement was also introduced explicitly dedicated to the protection of IT systems against corruption.
Traditional methods of protecting people by segregating hazardous areas are not suitable when humans and machines need to share a common workspace, as is the case in applications with collaborative robots (or cobots).
The essential safety and health protection requirement relating to the risks due to moving elements has therefore been modified to take into account the new solutions to be adopted to ensure the safety of people in collaborative applications, also taking into account the psychological stress aspects that these work situations can cause.
EU declaration of conformity
The EC declaration of conformity has been replaced in the new machinery regulation by an EU declaration of conformity, in line with the new legislative framework.
When several European Union acts are applied to a product, a single EU declaration of conformity must be drawn up, which includes them all.
High risk products
Annex IV of Directive 2006/42 / EC, containing the list of products considered to be at high risk, has become Annex I of the new machinery regulation.
The products included in this annex have remained unchanged and systems providing safety functions and using machine learning approaches and machines incorporating systems providing safety functions which have not been independently placed on the market and which use approaches have been added. machine learning, compared to just these systems.
For some of these products the possibility for the manufacturer to apply the conformity assessment procedure with internal manufacturing control has been removed and therefore, for these products, the intervention of a notified body will always be required.
If you want to know what are the main innovations of the Machinery Regulations of 21 April 2021, watch the video of our webinar with UNI, or sign up for our course dedicated to the news of the new Machinery Regulations.