Slide background

Proposal for a Regulation on machinery products

ID 13380 | | Visite: 14774 | News Direttiva macchinePermalink:

Proposal Regulation Machinery Products

Proposal for a Regulation of the European Parliament and of the Council on machinery products

ID 13380 | 29.10.2021 / In allegato Proposta 2021 ed emendamenti Regolamento macchine

EC, 21.04.2021 Regolamento Macchine 2021: la proposta

Update 29.10.2021

In data 20 Ottobre 2021, pubblicato Report di emendamenti alla Proposta, per dettagli: (2021/0105(COD) 20.10.2021

Article 49 Transitional and final provisions

Directive 2006/42/EC is repealed with effect from … [30 months after the date of entry into force of this Regulation.]

Article 50 Transitional provisions

1. Member States shall not until … [42 months after the date of entry into force of this Regulation] impede the making available on the market of machinery which was placed on the market in conformity with Directive 2006/42/EC before … [the date of entry into force of this Regulation]

Article 52 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from … [30 months after the date of entry into force of this Regulation.]

In attachement: 

- 2021/0105/COD Emendament Proposal Regulation machinery 2021
- COM(2021) 202 - Proposal for a Regulation of the European Parliament and of the Council on machinery products
- COM(2021) 202 ANNEX - Annex to the Proposal for a Regulation of the European Parliament and of the Council on machinery products
- SWD(2021) 82 - Impact assessment
- SWD(2021) 83 - Executive summary of the Impact assessment


The Machinery Directive (hereafter ‘MD’) establishes a regulatory framework for placing machinery on the Single Market, based on Article 114 of the TFEU (the approximation of laws. The general objectives of the MD are to: i) ensure free movement of machinery within the internal market; and ii) ensure a high level of protection for users and other exposed persons. The MD follows the ‘new approach’ principles of EU legislation. It is intentionally written to be technology neutral, which means that it lays down the essential health and safety requirements (hereafter ‘safety requirements’) to be complied with, without prescribing any specific technical solution to comply with those requirements. The choice of the technical solution is a prerogative of manufacturers, which leaves space for innovation and new design development.

During the REFIT evaluation of the directive, all interested parties confirmed it is an essential piece of legislation although it identified a necessity to improve, simplify and adapt the MD to the needs of the market. Some Members of the European Parliament’s expressed their support to the revision of the Machinery Directive. In particular, by ‘taking the legislation’ to the XXI century and promoting innovation for the EU economy.

As part of the Commission Work Programme 2020 under the priority ‘A Europe fit for the Digital Age’, the revision of the product safety Directive 2006/42/EC on Machinery (MD) contributes to the digital transition and to the strengthening of the Single Market. Indeed, regarding new technologies and their impact on safety legislation, the Commission has published in February 2020 a White Paper on Artificial Intelligence accompanied by a ‘Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics’. The Report, which has conducted an analysis of the impact of new technologies and the challenges they pose to Union safety legislation, concluded that the current product safety legislation contains a number of gaps that need to be addressed, in particular, among other, in the Machinery Directive. This is even more relevant for a sustainable recovery from the COVID pandemic, since the machinery sector is an essential part of the engineering industry and one of the industrial mainstays of the EU economy.

In view of dealing with the elements highlighted in the evaluation and developed in the impact assessment report of the machinery directive5, as well as responding to the Commission policy objectives on digitalization, this proposal expects to tackle the following problems:

Problem 1: The MD does not sufficiently cover new risks originating from emerging technologies.

In order to boost the trust in digital technologies, the MD needs to provide legal certainty as regards those technologies, existing gaps could hinder a level playing field for manufacturers, which would impact the efficiency of the MD.

There are several aspects that need to be addressed within this problem. The first one relates to the potential risks that originate from a direct human-robot collaboration as the collaborative robots (co-bots) that are designed to work alongside human and employees are exponentially increasing. A second source of potential risk originates from connected machinery. A third area of concern lies with the way software updates affects the ‘behaviour’ of the machinery after its placing on the market. A fourth concern relates to the ability of manufacturers to conduct a full risk assessment on machine learning applications before the product is placed on the market. Finally, as far as the autonomous machines and remote supervisory stations, the current MD foresees a driver or an operator responsible for the movement of a machine. The driver may be transported by the machinery or may be accompanying the machinery, or may guide the machinery by remote control, but does not consider the possibility of no driver, and sets up no requirements for autonomous machines.

Problem 2:

(i) Legal uncertainty due to a lack of clarity on the scope and definitions; and
(ii) possible safety gaps in traditional technologies.

The MD needs greater legal certainty in its scope and definitions, which generated some difficulties for manufacturers to understand the correct legal framework they should apply.

Some overlaps or inconsistencies with other EU specific legislation were identified. With respect to the definitions set by the Directive, the definition of 'partly completed machinery' raised a number of concerns particularly centred at the borderline with the definition of 'machinery' and the definition of ‘machinery’ has been clarified. Besides, there is a need to clarify the exclusion of means of transport and to reinforce the coherence of the exclusion of some products covered by the Low Voltage Directive 2014/35/EU when those products integrate a Wi-Fi function.

Furthermore, it is a common practice that machines placed on the market are modified in order for example to add a function or improve the performance. The problem is that if the machine suffers a substantial modification, without the manufacturer’s agreement, may be not in conformity any longer with the essential health and safety requirements. The current MD does not address this situation.

There are a number of requirements on traditional technologies not related to new technologies that were identified either as not clear or safe enough, or as too prescriptive and potentially hindering innovation. These requirements are related to installation of lifting appliances, slow speed lifts, seating, protection against hazardous substances, overhead power lines and vibration from portable handheld and hand guided machinery.

Problem 3: Insufficient provisions for high risk machines.

The third party conformity assessment is considered by some Member States and stakeholders more adapted to address the high risks stemming from certain groups of machines.

Another problem is that the current list of high-risk machines in Annex I was elaborated 15 years ago, and the market has much evolved since then. It is necessary to remove machines no longer considered high risk and/or introducing new ones (such as machinery embedding AI systems, which fulfil a safety function).

Problem 4: Monetary and environmental costs due to extensive paper-based documentation.

The MD requires manufacturers to provide the necessary machinery information, such as instructions. To ensure that every machine user has access to the instructions, providing a printed version was considered as the most viable option. Since then, however, the use of the internet and digital technologies has increased. The requirement to provide printed versions increases the costs and administrative burdens for economic operators and has a negative impact on the environment. However, it must be also considered that some users are less digitally savvy, there is a lack of internet access in certain environments and the digital manual might not match the version of the product.

Problem 5: Inconsistencies with other pieces of Union product safety legislation.

The New Legislative Framework is a package of measures aimed at brought together all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of industrial products with the requirements adopted to protect the various public interests and for the proper functioning of the single market. A main objective of the Commission is to bring product harmonisation legislation in line with the reference provisions of Decision 768/2008/EC. While the Machinery Directive is already a New Approach directive, it is not yet aligned to the NLF.

The lack of MD’s alignment to the NLF creates inconsistencies with other EU product legislation.

Problem 6: Divergences in interpretation due to transposition.

The fact that the current machinery legislation is a Directive leaving Member States to choose the means to comply with the legislative objectives, has led to different interpretations of the MD provisions creating legal uncertainty and lack of coherence throughout the single market.

Furthermore, there have been delays in the transposition of the Directive in some Member States.

Fonte: EC


Descrizione Livello Dimensione Downloads
Allegato riservato 2021 0105 COD Emendament Proposal Regulation machinery 2021.pdf
Ivan Štefanec - 2021
272 kB 43
Allegato riservato Executive summary - Machinery.pdf
SWD(2021) 83
214 kB 60
Allegato riservato Assessment - Machinery.pdf
SWD(2021) 82
1680 kB 69
Allegato riservato Regulation annex machinery.pdf
COM(2021) 202
479 kB 62
Allegato riservato Regulation machinery.pdf
COM(2021) 202
416 kB 90

Tags: Direttiva macchine Abbonati Macchine Regolamento macchine

Articoli correlati

Più letti Direttiva macchine

Set 04, 2022 93352

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) (GU L 88/10… Leggi tutto

Ultimi archiviati Direttiva macchine

Regolamento delegato  UE  2023 1717
Set 11, 2023 674

Regolamento delegato (UE) 2023/1717

Regolamento delegato (UE) 2023/1717 / Adeguamento progresso tecnico Direttiva RED norma tecnica 62680-1-3:2022 ID 20373 | 11.09.2023 Regolamento delegato (UE) 2023/1717 della Commissione del 27 giugno 2023 che modifica la direttiva 2014/53/UE del Parlamento europeo e del Consiglio per quanto… Leggi tutto
Set 05, 2023 576

Decreto 9 giugno 2023 / Programma nazionale di HTA Dispositivi medici

Decreto 9 giugno 2023 / Programma nazionale di HTA Dispositivi medici ID 20332 | 05.09.2023 Decreto 9 giugno 2023 Adozione del programma nazionale di HTA. (GU n.207 del 05.09.2023) Entrata in vigore: 06.09.2023 ... Art. 1 Adozione e aggiornamento del Programma nazionale HTA 1. È adottato il… Leggi tutto
Regolamento di esecuzione  UE  2023 1667
Ago 31, 2023 206

Regolamento di esecuzione (UE) 2023/1667

Regolamento di esecuzione (UE) 2023/1667 ID 20284 | 31.08.2023 Regolamento di esecuzione (UE) 2023/1667 della Commissione, dell'8 agosto 2023, recante modalità di applicazione della direttiva 2014/90/UE del Parlamento europeo e del Consiglio per quanto riguarda i requisiti di progettazione,… Leggi tutto
Regolamento  UE  2023 1670
Ago 31, 2023 228

Regolamento (UE) 2023/1670

Regolamento (UE) 2023/1670 / Specifiche per la progettazione ecocompatibile di smartphone ID 20283 | 31.08.2023 Regolamento (UE) 2023/1670 della Commissione del 16 giugno 2023 che stabilisce le specifiche per la progettazione ecocompatibile di smartphone, telefoni cellulari diversi dagli… Leggi tutto
Regolamento delegato  UE  2023 1669
Ago 31, 2023 204

Regolamento delegato (UE) 2023/1669

Regolamento delegato (UE) 2023/1669 / Etichettatura energetica telefoni cellulari e tablet con display flessibile ID 20282 | 31.08.2023 Regolamento delegato (UE) 2023/1669 della Commissione del 16 giugno 2023 che integra il del Parlamento europeo e del Consiglio per quanto riguarda l’etichettatura… Leggi tutto
Ago 30, 2023 126

DPR 19 ottobre 2000 n. 369

DPR 19 ottobre 2000 n. 369 Regolamento recante modifica al decreto del Presidente della Repubblica 30 aprile 1999, n. 162, in materia di collaudo degli ascensori. (GU n.291 del 14.12.2000) Leggi tutto
Ago 30, 2023 107

DPR 7 maggio 2002 n. 129

DPR 7 maggio 2002 n. 129 Regolamento recante ulteriore modifica al decreto del Presidente della Repubblica 30 aprile 1999, n. 162, in materia di collaudo degli ascensori. (GU n.155 del 04.07.2002) Leggi tutto
Ago 30, 2023 97

Legge 24 ottobre 1942 n. 1415

Legge 24 ottobre 1942 n. 1415 Impianto ed esercizio di ascensori e di montacarichi in servizio privato. (GU n.297 del 16.12.1942)
Abrogato da: D.L. 22 dicembre 2008, n. 200, convertito con modificazioni, dalla L. 18 febbraio 2009, n. 9
Collegati[box-note]D.P.R. 24… Leggi tutto