Revision of the Machinery Directive: what can be the change for CEMA manufacturers?

The Machinery Directive is the core European legislation regulating the design and the manufacture of products of the mechanical engineering industries to ensure their safe use at workplaces.

“Machinery products” are defined as 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 the 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. 

Since 2019 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.

According to the results of the assessment done on the Machinery Directive, the European Commission revealed that:

  • the new text will be a Regulation ‘Machinery Products Regulation – MPR’: this means that once the text is published, there is no more need to transpose it into national law, as it is the case for a Directive; the text can apply at once.
  • the new European regulation will cover new technologies for machinery.

Today, CEMA is looking at all the aspects included in the new EC proposal to present a common industry view, which can be read HERE. Assessing well in advance the challenges of this new regulation will help manufacturers adapt properly the machines to the new ‘essential health and safety requirements - EHRS’ requirements, implement necessary changes and spread R&D costs over an adequate timeline.

Artificial Intelligence 

The MPR uses the AI definition provided in the Regulation. This definition is very wide and could affect almost all machinery including AI, as long as it impacts the safety behaviour of the machinery.

In particular, AI ensuring a safety function, placed independently on the market or a machinery containing AI ensuring a safety function will be considered as a high-risk machinery, and will require a validation by a third party.

This will also impact software ensuring a safety function.

No longer self-conformity assessment for high-risk machinery 

The principles related to high-risk machinery were modified with the removal of the possibility to proceed to self-compliance under specific conditions. A validation done by a third party would be mandatory for high-risk machinery. Besides, the Commission will be empowered to update the list of high-risk machinery through Delegated Acts, using new criteria. 

Autonomous mobile machinery

New safety requirements have been added to cover autonomous mobile machinery. In particular, the use of a supervisory station is imposed: CEMA is reluctant to this provision, which implies an increase of the cost, especially for small machinery.

Substantial modification 

The notion of “substantial modification” (i.e. a modification brought to a machine – for example, an update of a software, which would generate new behaviour of the machine) is introduced. The person responsible of a substantial modification, whether he/she is a manufacturer, a dealer or a final user, will need to have the modified machinery submitted to a further conformity assessment. On that, industry stakeholders showed concerns considering these provisions for two main reasons:

  • this will imply the need for the original manufacturer to provide confidential information to the modifier 
  • the border between a machine substantially modified and a machinery modified under the directive for the use of work equipment is thin and will result in various interpretations

Mobile machinery

Compared to Directive 2006/42/EC, the proposal includes additional requirements for mobile machinery:

  • a machine fitted with a protective structure against overturning (ROPS) and a restraint system must be fitted with a warning, which will inform the operator that the restraint system is not active.
  • machinery whose main function is to spray hazardous substances must be fitted with a filtered cab
  • the design of the machine must ensure that there is no contact with electric power lines, or at least that a contact will not generate electrocution

User manual under digital format mainly but not only 

The instructions will be able to be provided under digital format although the paper format may be requested by the customer when the machine is sold.

Legislative Timeline

The proposal from the EC will be followed at the Parliament level by the IMCO Committee (rapporteur: Ivan Stefanec), with the following provisional timeline:

  • Deadline to provide a draft report containing amendments to the proposed text to the rapporteur: 7 October 2021
  • Deadline for comments by IMCO members on the draft report: 9 November 2021
  • Vote at IMCO Committee: 22 February 2022
  • Vote at plenary session of the Parliament: March / May 2022

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CEMA intro to the Position Paper with amendments on the proposal for Machinery Product Regulation