Understanding the new
Machinery regulations

As part of the 3rd edition of Printemps de la Robotique, we asked a specialist in safety solutions, Adrien Marque – Product Manager at SICK, to help us understand the new Machinery Regulations. He was accompanied by Eva Borisov, Project Manager at Meanwhile, and a member of the technical committee responsible for checking the standards required to comply with the new Machinery Regulations.

This online conference gave us a better understanding of the fundamental changes brought about by the new Machinery Regulations and the reasons behind them.

A few definitions

a. What is a machine?

A machine is an assembly equipped or intended to be equipped with a drive system, other than directly applied human or animal force, consisting of linked parts or components, at least one of which is movable and which are joined together for a defined application.

Adrien Marque insists on this notion of defined application , because it demonstrates that a machine is made to respond to a specific application. If this is not the case, we speak of a quasi-machine.

b. What is the Machinery Directive?

The current Machinery Directive is 2006/42/EC, which lays down health and safety requirements for the design and construction of machinery in order to improve the safety of machines placed on the market.

This directive was put in place by the European Union to create a level playing field between different machine manufacturers by setting them uniform requirements. Following this definition, Eva Borisov explains that mobile robots are therefore machines that must comply with the Machinery Directive, which can be visualized by the CE mark.

“The Machinery Directive 2006/42/EC is set to evolve into Regulation 2023/1230,” says Adrien Marque. So, unlike a directive, which leaves member states free to decide how to achieve this within a given timeframe, the regulation applies directly and uniformly as soon as it comes into force, with no possibility of adjustment.

Why the change?

Adrien Marque explains that in the current text of the Machinery Directive, it became necessary not only to clarify the scope of application, but also to integrate new technologies such as artificial intelligence, the Internet of Things and robotics. These new technologies have also raised new issues that need to be clarified, particularly with regard to the safety of operators working around these machines.

Another objective mentioned by Adrien Marque is to lighten the procedures required to demonstrate machine conformity to this directive.

When will this change take place?

This Machinery Regulation was published in June 2023 and applies a 42-month transition period. This means that from January 20, 2027, all machines arriving on the European market will have to comply with these health and safety requirements.

During this transitional period, Adrien Marque insists that all players must continue to apply the Machinery Directive 2006/42/EC.

Standards and harmonized standards

The Machinery Regulations are accompanied by standards that specify how the requirements are to be met. According to Adrien Marque, some of these standards can be harmonized by groups of industrial players (manufacturers, end-users, component suppliers, etc.) who will agree on the recommendations needed to meet the objectives of the Machinery Regulations.

Eva Borisov also points out that the experts on the technical committees – of which Meanwhile is a member – have until October 2024 to check whether the standards harmonized with the Machinery Directive can be assigned to the new requirements of the Machinery Regulation.

What are the fundamental changes brought about by the Machinery Regulation?

At this conference, Adrien Marque will explain the fundamental changes brought about by the Machinery Regulation, in particular the increased requirements for autonomous and remote-controlled machines.

a. Risk assessment

It is necessary and compulsory to carry out a risk assessment with the end customer.

This risk assessment will enable us to understand the conditions under which the machine will be used, and to define the safety devices required to guarantee personal safety. Ultimately, autonomous mobile machines will have to satisfy one or both of the following conditions:

  • Operate in an enclosed area equipped with a perimeter protection system to prevent operators from entering the area.
  • Be equipped with devices designed to detect nearby humans, pets or other obstacles

b. New zone concepts

Depending on the zone in which the robot will be operating (open or closed zone), safety requirements will differ. The NF EN ISO 3691-4 standard covers these requirements for driverless industrial trucks, and has recently been harmonized with the 2006/42/EC Machinery Directive.

Harmonized standard 3691-4 defines several types of zone in which a forklift can operate. For example, a work zone is defined as an area where there is no moving machinery, and where only people are working. If a person can be in the same working area as an autonomous forklift truck, this is referred to as a hazardous working area.

In general, and regardless of the type of zone, the requirements associated with harmonized standard 3691-4 are as follows:

  • The autonomous mobile machine must be equipped with a device for detecting persons in the direction of travel of the vehicle.
  • The self-contained mobile machine must maintain a minimum clearance of 500mm on each side.

In the case of a hazardous work area, the requirements are even more stringent:

  • The autonomous cart must maintain a reduced travel speed (0.3m/s; 0.7m/s; 1.2m/s depending on conditions).
  • The area must be designated as a “hazardous work area” and marked accordingly.
  • The autonomous cart must emit audible or visual warnings.

c. Watch out for trailers

The Machinery Regulations specify that towed equipment must not pose a risk to people, animals or other obstacles in the area. If these mobile machines are not sufficiently equipped with safety devices, then the safety of surrounding personnel cannot be guaranteed.

d. The supervision

Supervision within the meaning of the Machinery Regulation is the non-permanent remote monitoring of an autonomous mobile machine by a device enabling information or alerts to be received and limited orders to be given to the machine. With the new regulation, for autonomous machines,

  • The control system must be designed to execute safety functions itself, even when actions are ordered by means of a remote supervision function.
  • Failure of the steering system must not affect the safety of the machine.
  • Movements must take into account the risks associated with the area where it is to be moved and worked (slopes, holes, etc.).

If the autonomous machines have an autonomous monitoring function :

  • The monitoring function must enable the supervisor to receive information from the machine remotely.
  • The monitoring function may only be used to remotely stop and start the machine, or to move it to a safe position and state.
  • The supervisory function is designed and built to allow these operations only when the supervisor can directly or indirectly see the machine movement and the work area. Protective devices must be operational throughout this phase.

As Eva Borisov explains in this conference, all Meanwhile robotic solutions are CE marked. As an integrator and designer of autonomous mobile machines, it is our responsibility to guarantee the safety of agents working in the vicinity of robots. We are therefore committed not only to complying strictly with the safety requirements laid down by the European Commission, but also to actively following the fundamental changes introduced as part of its revision.

To find out more about the new Machinery Directive, watch the replay of the conference:

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