Key points for discussion for the agricultural machinery industry

The Machinery Directive is the core European legislation regulating products of the mechanical engineering industries. A ‘machine’ is defined as a powered equipment fitted with a tool to carry out specific tasks. CEMA products categorised under “machines” can go from portable pesticide application equipment to harvester machines and trailers. To note, agricultural tractors are excluded of Machinery Directive’s scope.

Today, the Machinery Directive aims at:

  • ensuring a high level of safety and protection for machinery users and other exposed persons and
  • securing the free movement of machinery in the internal market. 

The Machinery Directive is under revision process, in particular to ensure that new technologies, such as Internet of Things IOT, Artificial Intelligence AI and the new generation of autonomous robots, are well taken into account.

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Moving forward – CEMA key points to the public consultation 2019

CEMA agreed with the overall conclusion of many stakeholders that the Machinery Directive is a very robust legislation and fit for purpose for upcoming technologies.

A public consultation to gather facts, data and knowledge on the areas to be improved and/or simplified in the Directive was run over the summer 2019.

Below you can find the key points CEMA stressed on its answer and that will feed the discussions in the coming months:

Health and Safety Requirements

The Machinery Directive provides general design requirements applicable to all types of machines. These provisions are related either on machine functions (e.g. travelling, lifting) or risks (e.g. contact with moving parts). These design requirements must be technology neutral.

For technical requirements specific to a machine, the task is left to standardization. The content of the standards is checked by an external consultant, who ensures it complies with the Machine Directive. These standards are called harmonised standards, and once they have their reference published in the Official Journal of the European Union (OJEU), their application provides what is called presumption of conformity to the Machinery Directive.

CEMA considers that the Machinery Directive already takes into account new technologies in its existing requirements. Any further update will need to be addressed in the form of standards.

Software updates of electronic components (including AI) on the machines

This point was raised in the public consultation: how can we ensure that a software update placed independently on the market, (e.g. a database update for object or people recognition in an AI module), will not have an impact on the behaviour of the machine once it is downloaded?

CEMA considers again this subject is already covered under the text of the current Machinery Directive.

Provide user manual under digital format only

A user manual is the piece of information intended to provide the customer all the necessary advice to use properly and safely the machine as well as instructions for maintenance. This document explains the warnings affixed on the machine to highlight the residual risks on the machine.

At the present time, the regulation sets the manual has to be provided on paper format. But CEMA considers that manuals should be available under digital format in order to:

  • guarantee the latest version available for the user,
  • enable the user to find more easily the information he is looking for
  • avoid re-printing and paper waste.

CE marking - Approval methods for products to be placed on the Single Market

One of the main pillars of the Machinery Directive sits on allowing manufacturers to use self-compliance principles. This offers the possibility to place products on the market without involving a third-testing body. Manufacturers certify to the user that the machine is in compliance with the applicable legislation by affixing a CE marking. Besides, manufacturers must prepare a technical file gathering all the necessary information proving machines are safe.

This procedure does not apply to a specific list of machines, where a certification by a third-party is requested, unless the machine is fully compliant with a harmonized standard which covers all the risks related to the machine.

CEMA is in favour of keeping these rules as they proved to work properly so far.

Cybersecurity

The word ‘Cybersecurity’ covers two main issues:

  • attack from the external environment, which could result in taking control of the machine in an unexpected way
  • miscommunication between systems inside a machine that could result in an unexpected action of the machine.

CEMA considers cyberattacks are already covered by the Machinery Directive as manufacturers must take this point into account in their risk assessment.

To deal with this issue, CEMA is in favour of covering cybersecurity directly in standards, but in case a regulation would be preferred, CEMA would opt for a horizontal Regulation to avoid having various requirements defined in different pieces of legislation.

Next steps - timeline

A meeting is planned with Members States only on 14 May.

The new Machinery Expert Group is planned to meet on 9-10 November 2020, with the aim to finalise the draft proposal (Directive or Regulation to be defined). CEMA as a key stakeholder attends and follows-up these meetings.