Explanatory Memorandum to COM(2021)202 - Machinery products - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2021)202 - Machinery products. |
|---|---|
| source | COM(2021)202  |
| date | 21-04-2021 |
1. CONTEXTOFTHE PROPOSAL
1.1. Reasons for and objectives of the proposal
The Machinery Directive (hereafter ‘MD’)1 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 evaluation2 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)3 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’4. 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.
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery. SWD (2018) 160 final, Evaluation of the Machinery Directive.
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery. Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en SWD (2021) […] final, Impact assessment of the Machinery Directive.
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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/EU6 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.
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits, available at:
data.europa.eu/eli/dir/2014/35/oj.
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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.
1.2. Consistency with existing policy provisions in the policy area
This initiative is in line with the Single Market Act7, which stressed the need to restore consumer confidence in the quality of products on the market and the importance of reinforcing market surveillance. With this purpose, the regulation on machinery products is aligned to the provisions of Decision No 768/2008/EC8.
Furthemore it reinforces the coherence with the low voltage directive 2014/35/EU9 by considering the fact that electrical and electronic products excluded from this Regulation will
Contents
- Communication from the Commission to the European Parliament, the Council, the Economic and
- Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
- Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the
- This option would leave the standardisation process evolve as usual, without particular focus risks ste mming from new technologies, and with no pa rticular focus on areas for improvement
- This option would make no changes to the current act. Clarifications would be introduced in
- The proposal sets up classification rules for high-risk machinery empowering the Commission to adopt delegated acts to adapt the list of high-risk machinery in Annex I. This list is obsolete
- The safety of machinery increasingly relies on the software behaviour once the machinery has been placed on the market. In view of supporting the conformity assessment process and the
Social Committee and the Committee of the Regions (COM(2011) 206 final).
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.08.2008, p. 82).
harmonisation of the laws of the Member States relating to the making available on the market of
electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 35).
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2014/53/EU10
be also excluded from the radio equipment directive 2014/53/EU when they incorporate wi-fi.
1.3. Consistency with other Union policies
This proposal is coherent with the Union policy on artificial intelligence (AI) and the upcoming Regulation on artificial intelligence, which will address the risks having an impact on safety for high-risk AI systems embedded in a machinery or that are safety components under the future regulation on machinery products.
In addition, this proposal is coherent with the Union policy on cybersecurity, making the link with the future cybersecurity schemes pursuant to Regulation (EU) 2019/881 for the purpose of demonstrating compliance with the future regulation on machinery products.
Furthermore it contributes to simplification of the regulatory environment.
2. LEGALBASIS, SUBSIDIARITYAND PROPORTIONALITY
2.1. Legal basis
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union because the purpose of the Regulation is to harmonise health and safety requirements for machinery in all Member States and to remove obstacles to trade in machinery between Member States.
2.2. Subsidiarity (for non-exclusive competence)
The subsidiarity principle arises in particular with regard to the newly added provisions aiming at the improvement of effective enforcement of Directive 2006/42/EC and the coherence with the AI Union policy. Without a Union wide regulation, Member States could impose diverging safety requirements, which would lead to differences in the safety of the products for the users for manufacturers when trading machinery across different countries. For instance, some market surveillance authorities consulted found necessary to ensure that software updates not foreseen in the initial manufacturer’s risks assessment and having an impact on safety would require the machine to go through a conformity assessment procedure leading to a new CE marking. Furthermore, the future regulation on machinery products sets up Union wide requirements underpinned by the solutions provided in European standards. Given the Union broad level of the standardisations activities, any changes to the scope or requirements of the future regulation on machinery products must be made at Union level to avoid distorting the market, creating barriers to the free movement of products and undermining the protection of human health and well-being. In addition, the newly added provisions will align the economic operators’ obligations, the traceability provisions, the provisions on the assessment and notification of conformity assessment bodies and on market surveillance.
As for the added value of action at Union level, regulatory action at the Union level, contributes to the development of the Internal (and Digital) Single Market, provides legal certainty and a level playing field for the industry, and establishes a high level of trust among machinery users.
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
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2.3. Proportionality
The preferred policy option is option 3 - Burden minimisation and enhanced safety.
This policy option addresses all identified problems in the most effective and efficient way, proposing a revised MD that is not only fit for purpose now, but also in the years to come, and ensures coherence with existing product safety legislation and with the future AI framework.
Policy option 3 adds new requirements and clarifies existing ones, in a targeted and proportional way, only when necessary and often applicable to certain types of machinery. Legal clarity is added to the current act in its scope, definitions and requirements, including those covering risk stemming from new technologies and drive the standardisation activities in this area, which enhances safety and ensures a higher level of trust and industry competitiveness in the (digital) market. It also adapts the machines presenting high risks to the state of the art, removes the internal check option for the conformity assessment of the high-risk machines, and ensures full coherence with the AI Regulation proposal. It proposes a burden reduction measure highly requested by the industry which is allowing digital documentation, while at the same time ensuring that end users and consumers can have a printed version free of charge if they so request. Finally, the revised MD will gain in coherence and legal certainty by aligning to the NLF and becoming a Regulation. To ensure proportionality, this policy option includes the standardisation process with a new Standardisation Request issued by the Commission for detailed technical solutions to be developed by the standardisation bodies, and the Machinery Guide for detailed clarification and examples.
As explained in the Impact Assessment, the preferred policy option adheres to the principle of proportionality. The proposed changes to the safety requirements are targeted, limited to certain machinery types: machinery including new technologies, specific machinery, and high-risk machinery. The burden reduction measures are on the contrary aimed at all machinery types (such as clarification of substantial modification, digital documentation, alignment to the NLF, conversion to a regulation). Proportionality is also ensured by the MD being technologically neutral. The proposed clarifications or additions to the safety requirements are kept to the strict minimum in the proposal, to be complemented by a new Standardisation Request issued by the Commission to empower the standardisation bodies to develop voluntary technical solutions.
2.4. Choice
of the instrument
The proposal takes the form of a Regulation. The proposed change from a Directive to a Regulation takes into account the Commission’s general objective to simplify the regulatory environment and the need to ensure a uniform implementation throughout the Union of the proposed legislation.
In addition, the machinery directive is a total harmonisation directive, which means that it establishes a high level of safety, and does not allow the Member States to impose more restrictive obligations. In this respect, a Regulation by its legal nature, would better ensure that Member States do not impose national technical requirements that go beyond the safety requirements laid down in Annex I of the current Directive and/or contradict those safety requirements.
The change from a Directive to a Regulation will not lead to any change in the regulatory approach. The characteristics of the New Approach will be fully preserved, in particular the flexibility given to manufacturers in the choice of the means employed to comply with the
essential requirements (harmonised standards or other technical specifications) and in the choice of the procedure used to demonstrate compliance from among the available conformity assessment procedures. The existing mechanisms supporting the implementation of the legislation (standardisation process, working groups, market surveillance, Member States
administrative cooperation (AdCo), and the development of guidance documents…) will not
be affected by the nature of the legal instrument and will continue to operate in the same manner under the Regulation as they currently do under the Directive.
Finally, the use of Regulations in the area of internal market legislation, in accordance also with the preference expressed by stakeholders, avoids the risk of gold plating . It also allows manufacturers to work directly with the Regulation text instead of needing to identify and examine 27 transposition laws. On this basis, it is considered that the choice of a Regulation is the most appropriate solution for all involved parties as it will allow a more rapid and coherent application of the proposed legislation and will establish a clearer regulatory environment for economic operators.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER
CONSULTATIONS AND IMPACT ASSESSMENTS
3.1. Ex-post evaluations/fitness checks of existing legislation
The evaluation of the directive concluded that a revision should aim to: i) address the risks stemming from new technologies while allowing for technical progress; ii) improve the legal clarity of some major concepts and definitions in the current text of the MD; iii) simplify the requirements for documentation by allowing digital formats, hence reducing administrative burden for economic operators, with an additional positive impact on environmental costs; iv) ensure coherence with other Directives and Regulations for products and improve enforcement of the legislation through the alignment to the New Legislative Framework, v) reduce costs of tra nsposi t ion by converting the Directive into a Regulation.
The results of the evaluation have been taken on board in the proposal.
3.2. Stakeholder consultations
Stakeholders have been consulted throughout the preparation of the revision of the MD, including Member States, manufacturers federations, consumers and workers associations, notified bodies and representatives from standardisation organisations.
The consultation included meetings for a selected group of experts as well as consultation of the machinery Working Group and the machinery AdCo Group of market surveillance authorities.
Some stakeholder’s views have evolved following discussions in the machinery Working Group and bilateral meetings, in particular on the need to address explicitly the new risks stemming from digital emerging technologies.
• Specific objective 1: Cover new risks related to digital emerging technologies
While most stakeholders consider that the MD takes innovations sufficiently into account, some expressed concerns over the potential impacts of emerging digital technologies on safety.
• Specific objective 2: Ensure coherent interpretation of the scope and definitions and improve safety for traditional technologies
On the scope and definitions most stakeholders agreed on adapting the current exclusion of low voltage products covered by the Low-Voltage Directive (LVD) in Art. 1.2(k) of the MD to the products integrating W i - F i and clarifying the definition of partly completed machinery. As for introducing conformity assessment obligations linked to the substantial modification of a machinery placed on the market or put into service, the stakeholders views diverge. Regarding the adaptation of the essential health and safety requirements for traditional machinery, most of stakeholders agree to a greater or lesser extent, except for some specific cases in which they consider that an adaptation is not necessary because other Union legislation already covers the risks.
• Specific objective 3: Reassess machines considered as high risk and reassess related conformity procedures
The question to whether the manufacturer internal checks option in Annex I of the MD leads to safety concerns received mixed responses in the public consultation. The interview responses, on the other hand often referred to an adaptation and regular updates of the Annex I as potential to bring benefits.
• Specific objective 4: Reduce paper-based requirements for documentation
On allowing digital formats for documentation, almost all the stakeholder groups representing the industry indicated that are in favour. Most Member States and consumers organisations are in favour of ensuring also paper format.
• Specific objective 5: Ensure coherence with other product safety legislation Alignment to the New Legislative Framework received nearly universal support.
• Specific objective 6: Avoid divergences in interpretation derived from transp osition
Most stakeholders wish to reduce the possible divergences in the interpretation of the machinery directive derived from transposition and mention potential benefits of converting the Directive into a Regulation. For manufacturers, a conversion could lead to a decrease of additional costs related to diff eren ces in i nterpretati on across Member States.
3.3. Collection and use of expertise - I m p act assess m e n t
The Commission carried out an impact assessment on the revision of the machinery Directive. The Regulatory Scrutiny Board (RSB) issued an opinion on the draft impact assessment on 5 February 2021. The opinion of the Board as well as the final Impact Assessment and its executive summary are published together with this proposal.
Based on the information collected, the impact assessment examined and compared four options to address problems and issues relating to the Machinery Directive.
Option 0 Baseline - ‘no change’
This option would leave the standardisation process evolve as usual, without particular focus risks ste mming from new technologies, and with no pa rticular focus on areas for improvement
related to traditional technologies. It would also revise the ‘Guide to application of the MD’
following the normal process, with limited ambition and no particular push for consensus.
Option 1 Self-regulation by industry an d c h a n ges to t h e G u id e
the ‘Guide to application of the MD’ with a push for consensus to clarify where possible the
main problems as described in section 1.1. New risks stemming from new technologies (as well certain risks from traditional technologies) would be addressed through the issuance of a new commission standardisation request to drive the normal standardisation process.
Option 2 Burden
minimisation
The rationale behind this option is to reduce economic operators’ burden. In view of achieving this objective this option aims to increase the legal clarity of some provisions and simplify some administrative obligations.
However, to minimise the economic operators’ burden there would be no adaptations in the safety requirements for products, thus with no changes in the manufacturers’ obligations for designing and manufacturing the machinery. The new risks stemming from new technologies (as well certain risks from traditional technologies) would be addressed through the issuance of a dedicated commission standardisation request to drive the normal standardisation process as much as possible.
Option 3 Burden
minimisation and enhanced safety
This option aims also to increase the legal clarity of some provisions and simplify some administrative obligations. In addition, it seeks enhancing safety by adapting the safety requirements and tailoring the conformity assessment to the risk related to the machinery product, including new technologies.
Option 3 was found to be the preferred option because:
Option 0 means no action and would not address the problems and issues identified, with the risk of not addressing the problems and objectives.
Option 1 achieves limited results. It does not ensure an effective response to the problems.
Option 2 boosts competitiveness by minimising burden for manufacturers, without diminishing the number of unsafe products in the market.
On the contrary, option 3 boosts competitiveness by minimising burden for manufacturers, and additionally enhances safety by clarifying or adding requirements. This comes with additional costs for compliance, but also benefits related to less unsafe products in the market. This is also the most future-proof option because addresses the risks from new technologies.
3.4. Regulatory fitness and simplification
The alignment to the NLF means a better functioning of the directive and its enforcement, but also a burden simplification for manufacturers dealing with several product safety acts applying to their products (e.g. machinery to which both the machinery directive and the radio equipment directive apply). It streamlines the process of safeguard procedures, by involving manufacturers and Member States before the Commission is notified and triggers a Commission decision only in cases where there is disagreement between Member States.
Another simplification aspect is the complementarity between the AI and machinery legal proposals, where the AI regulation delegates the conformity assessment to the machinery, so that the risk assessment for the whole machinery with AI systems is done only through the future regulation on machinery products.
Finally, the change from a directive to a regulation, will avoid Member States transpositions and will ensure coherence in the interpretation of the legal act and in its implementation.
4. BUDGETARYIMPLICATIONS
This proposal does not have any implications for the Union budget.
5. OTHERELEMENTS
5.1. Implementation plans and monitoring, evaluation and reporting arrangements
The Commission will monitor the implementation, the application and the compliance to these new provisions with a view to assessing their effectiveness. The regulation will request a regular Commission’s evaluation and review and the submission of a public report in this respect to the European Parliament and to the Council.
5.2. Detailed explanation of the specific provisions of the proposal
Scope and definitions
The scope of the proposed Regulation remains the same but is clarified by adding the subject matter in Article 1, adapting the wording of the scope and adding a new indent in the definition of machinery that includes assembly missing only the upload of a software intended for its specific application to prevent manufacturers classifying them as partially completed machinery. Furthermore, the definition of safety component has been also clarified to include non-physical components such as software.
There is a new definition of substantial modification to ensure that machinery, placed on the market and/or put into service, that suffers substantial modifications is in conformity with the essential health and safety requirements in Annex III.
Additionally, the general definitions of the NLF Decision 768/2008/EC have been inserted.
The Regulation clarifies also the application of other specific Union harmonisation legislation when the risks to be addressed in the machinery are not contemplated in Annex III.
Exclusions
The exemption of the means of transport on road is extended beyond the Union type approval legislation to increase the legal certainty. The reason is to prevent that vehicles not covered by that legislation are covered by default by the machinery legislation, as this legislation is not meant to regulate risks other than those stemming from the machinery function (such as sawing, excavating, etc.), and not the risks exclusively related to its transport function of persons or goods. Furthermore, as for the exemption on the list of electrical and electronic products regulated by the Low Voltage Directive as some of those products are progressively incorporating Wi-Fi functions, e.g. washing machines, and are therefore covered by Directive 2014/53/EU of the European Parliament and of the Council 11as radio equipment, those products should also be excluded from the scope of this Regulation.
High-risk machinery
The proposal sets up classification rules for high-risk machinery empowering the Commission to adopt delegated acts to adapt the list of high-risk machinery in Annex I. This list is obsolete
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).
and needs to be adapted to the technical progress and new type of machinery presenting high risks such as machinery with AI ensuring safety functions.
Obligations of economic operators
The proposal incorporates obligations for manufacturers, importers and distributors to be aligned with the NLF Decision 768/2008/EC. This will clarify the respective obligations, which are proportionate to the economic operators’ responsibilities. Furthermore, when a machinery is substantially modified according to the definition, the one that modifies the machinery becomes manufacturer and must comply with the relevant obligations. As the complexity of the machinery supply chain is increasing, there is a general obligation of cooperation of third parties involved in the machinery supply chain, other than the economic operators.
Presumption of conformity of machinery
The presumption of conformity of machinery when manufacturers apply the relevant harmonised standards or parts thereof published in the Official Journal of the European Union remains. However, in order to ensure the presumption of conformity when there are not harmonised standards the Commission will be empowered to adopt technical specifications. This will be a fall-back option to be used only in cases the standardisation bodies are not able to provide standards or provide standards that do not respond to the Commission standardisation request and the essential health and safety requirements of Annex III.
Conformity assessment
The proposal keeps the manufacturer internal check option for machinery that is not classified as high risk. However, for high-risk machinery, considering that Annex I will be adapted to the technological progress when needed and the NLF alignment, only third party certification will be accepted, even when manufacturers apply the relevant harmonised standards.
The proposal updates the corresponding modules in line with the NLF Decision 768/2008/EC.
Notified bodies
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and for the confidence of all interested parties in the New Approach system. Therefore, in line with the NLF Decision, the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State.
Union market surveillance, control of machinery entering the union market and union safeguard procedure
The proposal integrates the NLF Decision 768/2008/EC provisions. This will reinforce the market surveillance and will clarify the safeguard close procedure. Commission decisions on measures taken by Member States on products placed on the EU market will be required only if other Member States disagree with such a measure, which will simplify Commission’s work.
Essential health and safety requirements (EHSRs) traditional machinery:
The proposed Regulation adapts or adds following EHSRs to address specific machinery risks:
1.1.2. Principles of safety integration has been adapted to allow the machinery users to test the safety functions of the machinery.
1.6.1 on maintenance has been adapted to facilitate a timely and safe rescue when operators are trapped in the machine.
Digital documentation: EHSRs 1.7.4 on instructions and Annex V on the manufacturer’s declaration of conformity allow that manufacturers provide digital instructions and the declaration of conformity. Nevertheless, a paper format is mandatory upon request.
EHSR 1.7.4 on instructions has been further adapted to request information on emissions of hazardous substances from the machinery and EHSRs 2.2.1.1 and 3.6.3.1 on vibrations from portable handheld and hand-guided machinery to adapt the instructions on vibrations in order to reduce the exposure occupational injury.
EHSR 2.2 on portable hand-held and/or hand-guided machinery is adapted to capture or reduce emissions of hazardous substances.
Section 3 on offset risks due to the mobility of machinery has been adapted to address the risks on autonomous machines and remote supervisory stations.
EHSR 3.2.2 seating for mobile machinery has been adapted to reinforce the drivers’ safety.
EHSR 3.5.4 on risks of contact with live overhead power lines has been added to avoid the accidents when machinery makes contact with overhead lines.
EHSR 6.2 on control devices has been adapted allowing when possible on slow-speed lifts control devices other than hold-to-run to allow innovation.
Installation of lifting appliances: in view of facilitating market surveillance activities the manufacturer’s declaration of conformity will add the address where the machine is permanently installed only for lifting machinery installed in a building or a structure.
Essential health and safety requirements machinery with new digital technologies:
The risk assessment that manufacturers must carry out before the machinery is placed on the market/ put into service will need to include also the risks appearing after the machinery is placed on the market due to its evolving and autonomous behaviour.
Cybersecurity with an impact on safety
In view of addressing, the risks stemming from malicious third party actions and that have an impact on the machinery safety the proposal adds a new EHSR 1.1.9 and clarifies EHSR 1.2.1 on safety and reliability of control systems.
Human-machinery interaction
Machines are becoming more powerful, autonomous and some look almost like humans, which requires adapting the EHSRs related to the contact between the human and the machinery i.e. EHSRs 1.1.6 on ergonomics and 1.3.7 on risks related to moving parts and psychological stress.
Machinery with evolving capacity
Although AI system risks will be regulated by the Union legislation on AI, the proposal must ensure that the entire machinery is safe, considering the interactions between the machinery components including the AI systems. In this respect following EHSRs have been adapted: general principles, 1.1.6 on ergonomics, 1.2.1 on safety and reliability of control systems and 1.3.7 on risks related to moving parts and psychological stress.
Traceability of machinery safety
The safety of machinery increasingly relies on the software behaviour once the machinery has been placed on the market. In view of supporting the conformity assessment process and the
market surveillance, a few new requirements have been added in EHSR 1.2.1 on safety and reliability of control systems and in the information required in the technical file in Annex IV.
Implementing acts
The proposal empowers the Commission to adopt, where appropriate, implementing acts to ensure the uniform application of this Regulation. Those implementing acts will be adopted in accordance with the provisions on implementing acts laid down in Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers.
Delegated acts
The proposal empowers the Commission to adopt delegated acts in order to adapt the list of high risk machinery in Annex I to take into account the progress of technical knowledge or new scientific evidence and the indicative list of safety components in Annex II.
Evaluation and review
The Commission will monitor the implementation, the application and the compliance to these new provisions with a view to assessing their effectiveness. The regulation requests a regular Commission’s evaluation and review and the submission of a public report in this respect to the European Parliament and to the Council.
Final provisions
The proposed Regulation will become applicable 30 months after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the safeguard clause procedure needs to be applied shortly after the entry into force of this Regulation to simplify the mechanism. Transitional provisions are foreseen for products manufactured and the certificates issued by notified bodies under Directive 2006/42/EC so as to allow stocks to be absorbed and ensure a smooth transition to the new requirements. Directive 2006/42/EC will be repealed and replaced by the proposed Regulation.