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) became applicable as of December 2009. It 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), and 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 harmonised 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 from 2018 concluded that the Directive was generally relevant, effective, efficient, coherent and had EU added value. It also identified a number of issues (e.g. concerning enforcement and innovation in AI and IoT).

An impact assessment study on the revision of the Directive was published in August 2020.

In 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 in November 2021 a progress report summarising the main developments in Council. 

In 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 final compromise amendments, covering all the amendments tabled in IMCO and EMPL, were all adopted on 2 May 2022 in IMCO. The final report, as well as the decision to enter into interinstitutional negotiations, with the committee report as mandate (including 179 amendments), were both adopted by 38 votes in favour and 7 against, on 3 May 2022. The Plenary endorsed that decision on 20 May 2022, opening the way for the committee to start interinstitutional negotiations with the Council.

The Council adopted its mandate for negotiations with Parliament on 24 June 2022.

The first trilogue took place on 12 July 2022. On 8 September, the rapporteur reported back to IMCO on the on-going interinstitutional negotiations. The second trilogue took place on 17 November 2022. The co-legislators provisionally agreed on the topics of terminology, common specifications, SME fees for conformity assessment and the option for economic operators to provide instructions in a digital format. The third trilogue is planned for 15 December 2022. The third trilogue took place on 15 December 2022 and a provisional agreement was reached between the co-legislators. They agreed for instance that only six categories of machinery will be subject to mandatory third-party conformity assessment. 


Further reading:

Author: Guillaume Ragonnaud, Members' Research Service,

As of 20/02/2023.