Revision of the Machinery Directive (REFIT)

In “A Europe Fit for the Digital Age”

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The Machinery Directive (Directive 2006/42/EC), which became applicable as of December 2009, regulates products of the mechanical engineering industries. Its objectives are to ensure a high level of safety and protection for machinery users (workers, consumers and other exposed persons), as well as to ensure the free movement of machinery in the internal market. Regarding machinery used in pesticide applications, the Directive also aims at protecting the environment.

The Directive defines machinery as an assembly of components, at least one of which moves, joined together for a specific application, the drive system being powered by energy other than human or animal effort. The products covered include for instance construction machinery, lawnmowers, 3D printers or robots. In addition to machinery stricto sensu, the scope covers other related products, such as safety components or partly completed machinery.

The Directive is based on the principles of the so-called ‘New Approach to Technical Harmonisation and Standards’: it sets the essential health and safety requirements that machinery must fulfil to be placed on the market, as well as the conformity assessment procedures to be used to demonstrate that the machine fulfils these requirements. Demonstrating compliance with the requirements can be done through application of European harmonized standards, or another solution that demonstrates a similar level of safety. The Directive requires manufacturers to produce a technical file, sign a Declaration of Conformity and affix the ‘CE’ marking.

An evaluation released in 2018 concluded that the Directive was generally relevant, effective, efficient, coherent and had EU added value. It however identified a number of issues, for example concerning the monitoring and enforcement of the Directive or the need for better legal clarity and for a clarification of its interaction with other legislation. It has also shown that some administrative requirements were challenging its efficiency. Furthermore, the evaluation highlighted that the Directive was sufficiently flexible to allow technological developments in a digital era, but stressed that further innovation in fields such as Artificial Intelligence (AI) and Internet of Things (IoT) may test the Directive's effectiveness in the future. In particular, AI robots could pose much higher risks than purely software AI systems, due to their mechanical moving parts.

The Commission published an inception impact assessment on 10 January 2019. A public consultation was open between 7 June and 30 August 2019. An impact assessment study on the revision of the Directive was published on 31 August 2020.

On 21 April 2021, the Commission put forward a proposal for a new Regulation on machinery products, as part of a wider 'AI package'. The proposal on machinery products addresses a number of problems identified in the current EU framework: insufficient coverage of new risks stemming from the new digital technologies (such as AI, the IoT and robotics); legal uncertainty concerning the scope and definitions and potential safety gaps in 'traditional' technologies; insufficient coverage for 'high risk machines'; costs due to the required paper-based documentation; inconsistencies with other pieces of product-safety legislation; and divergences in interpretation across Member States due to transposition (hence the choice of a Regulation instead of a Directive). The proposal for a Regulation laying down harmonised rules on AI (the 'AI Act'), included in the AI package, aims to set harmonised rules for the development, placement on the market and use of AI systems, following a risk-based approach. It addresses the safety risks of AI systems, while the proposal on machinery products focuses on the safe integration of AI systems into machinery. 

Feedback on the Commission proposal was open until 2 August 2021.

In the Council, the Commission proposal was first discussed in the meeting of 26 April 2021 of the Working Party on Technical Harmonisation. The Presidency published on 18 November 2021 a progress report summarising the main developments in Council. 

In the European Parliament, the file has been allocated to the Committee on Internal Market and Consumer Protection (IMCO). The proposal was first discussed in IMCO on 27 May 2021. On the same day, Mr Ivan ŠTEFANEC (EPP, Slovakia) was appointed Rapporteur (i.e. the MEP in charge of drawing up the report on the proposal on IMCO’s behalf, and who will lead Parliament's negotiating team during interinstitutional negotiations). The draft report prepared by the Rapporteur was debated in IMCO on 28 October 2021. The Rapporteur has amended the proposal to clarify the scope and definitions. He has also proposed to keep the possibility for the manufacturers to use the internal production control procedure for conformity assessment of high risk machinery products. Furthermore, the Rapporteur has amended the proposal so that technical specifications could be drafted by the Commission only if standardisations organisations have not delivered harmonised standards three years after the standardisation request. The Rapporteur has also proposed postponing the deadlines and transitional period by 18 months (e.g. the transitional period has been extended from 42 to 60 months).

In total, 438 amendments were tabled to the Commission proposal (of which 100 by the Rapporteur). The consideration of 10 compromise amendments took place in IMCO on 28 February 2022. The vote in committee is planned for 2-3 May 2022. The file is expected to go to Plenary in May 2022.


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Author: Guillaume Ragonnaud, Members' Research Service,

As of 20/04/2022.