The new EU machinery regulation, here’s what will change

There Machinery Directive 2006/42 / ECafter 16 years (12 if we consider Legislative Decree No 17 of 27 January 2010, with which it was implemented in Italy), should perhaps be replaced before the end of 2022 by new machine regulations. The last, approved as an official proposal by the European Commission on 21 April 2021, has undergone several changes to date, the most recent of which dates back to 3 May (here the European Parliament’s report published on 5 May, which contains the latest changes ). Notwithstanding the final version of the text, it should first be noted that the legal form chosen, namely the Regulation, implies immediate applicability in the Member States, in contrast to what happened with the Directive. The intention is to create a homogeneous standard for the whole of Europe, which is not subject to any territorial discretion. It must also be said that the machinery regulations from its entry into force will become mandatory within the next 30 months, without forgetting that a transitional period of 42 months is foreseen, during which the old directive will continue to represent the reference. legislation. However, the fact that the implementation deadlines for the new regulation are being extended must not mislead the subjects who have been called upon to implement it. There relationship on which it is based actually takes into account the technological changes that have made Directive 2006/42 / EC obsolete in recent years, cyber security OT (Operational Technology). It is no coincidence that there is an international standard such asIEC 62443 which, although voluntary, aims to make industrial plants safe, especially with regard to those operating under the paradigm of Industry 4.0.

The new Machine Regulations will be one of the topics addressed on 21 June from 4.30 pm to 6 pm during the event “IIoT connectivity and cybersecurity: with Siemens to the digital transition”. Subscriptions to this link

The most important innovations in the machine regulations

The first novelty of the Regulation concerns the definition of the term “machine”, divided between cars, related products (replaceable equipment, safety components, chains, ropes and belts, removable mechanical transmission devices) e closest to machines. With reference to the latter, Directive 2006/42 / EC gave way to different interpretations, while the new regulation proposes a definition that limits the field to those who cannot function alone to achieve a specific application, which is built to be incorporated into a machine or alternatively to be assembled with others to create a machine product.

The regulation also renews the definition of safety component which in the latest version of the text may be “physical or digital, including software, for a machine product, with the exception of partially completed machinery designed or intended to perform a safety function and put into circulation independently. On the list of safety components are those that are based onartificial intelligencebuilt or not in the machinery, is classified as a potential advertising machine product high risk. Therefore, the assessment of their conformity must involve a third party, as required by the Regulation for all high-risk machines.

The Regulation fills a gap with Decree 2006/42 / EC on software, which now falls under the products that must have CE marking and EU conformity in the same way as any “physical” product, especially if they perform security functions such as eg. the case mentioned above. The Machinery Regulation actually prescribes the obligation that the software used for cyber security must be equipped with adequate certification in accordance with EU Regulation 2019/881 on competences regarding.ENISAthe former European Network and Information Security Agency which from 2019 has taken the name European Union Agency for Cyber ​​Security. In practice, the manufacturer must design-wise ensure that the connection between the machine and other devices is naturally protected, in order to avoid possible attacks or involuntary errors. Which in addition the adoption of the IEC 62443 standard on IACS (Industrial Automation Control System) allows already today to realize. In addition, the obligation to insert the source code and the programmable logic in the technical file, which as with all the technical documentation that comes with the machine, can also be in digital format. Finally, the standard stipulates the obligation to have a storage of all hardware and software interventions for the purpose of their full traceability.

Another novelty focuses on the connection between RES (Essential safety requirements) And significant change. Any physical or digital modification (such as modification of software) of a machine or related product that could compromise the original security requirements is the responsibility of the person who made it. Therefore, the manufacturer, importer or even the end user is responsible for the changes they make. Therefore, it is necessary to move on to one conformity assessment to verify whether the change falls under the case of a material change or not. If this is the case, only the component of the machine affected by the change must be “repaired”.

  • Compliance officers

A further news is that the charges related conformity of the productsas in the Directive were the sole responsibility of the manufacturer, in the Regulation they are also the responsibility of the importer, distributor and any agent, with emphasis on the criteria for easily identifying and tracing each of these issues.

  • Human-machine interaction in the new machine regulations

Finally, the attempt in the legal text to adapt to the latest technologies, such ashuman-machine interaction which occurs, for example, through in collaborative robots. The latest amended version of the Machinery Regulations states that it is necessary to “adapt the product’s human-machine interface, including safety systems and emergency stop systems, to the predictable characteristics of operators, even in the case of a product machine with wholly or partly evolutionary behavior or logic, designed to work with different levels of autonomy ”.

The new Machine Regulations will be one of the topics addressed on 21 June from 4.30 pm to 6 pm during the event “IIoT connectivity and cybersecurity: with Siemens to the digital transition”. Subscriptions to this link

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