EUROPEAN COMMISSION Brussels, 21.4.2021 SWD(2021) 82 final COMMISSION STAFF WORKING DOCUMENT



IMPACT ASSESSMENT

Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products {COM(2021) 202 final} - {SEC(2021) 165 final} - {SWD(2021) 83 final}



Table of contents 1.Introduction: Political and legal context 2.Problem definition 3.Why should the EU act? 4.Objectives: What is to be achieved? 5.What are the available policy options? 6.What are the impacts of the policy options? 7.How do the options compare? 8.Preferred option 9.How will actual impacts be monitored and evaluated? 1.Lead DG, Decide Planning/CWP references 2.Organisation and timing 3.Consultation of the RSB 4.Evidence, sources and quality 1.Practical implications of the initiative 2.Summary of costs and benefits Glossary Term or acronym Meaning or definition AI Artificial intelligence CAGR Compound average growth rate CE European conformity marking CEN European Committee for Standardization Cenelec European Committee for Electrotechnical Standardisation DoC Declaration of conformity EC European Commission EEA European Economic Area EEC European Economic Community EFTA European Free Trade Association EHSRs Essential health-and-safety requirements EMCD Electromagnetic Compatibility Directive EN European standards ESO European standardisation organisation ETSI European Telecommunications Standards Institute EU European Union EU-28 EU-28 Member States (as of 1/12/2019) FTE Full-time equivalent GDP Gross domestic product IIoT Industrial internet of things IoT Internet of things ISO International standards LD Lifts Directive LVD Low-Voltage Directive MD Machinery Directive ML Machine learning MS Member State (of the EU) MSA Market surveillance authority NACE Statistical classification of economic activities in the EC NBs Notified bodies n.e.c. Not elsewhere classified NGO Non-governmental organisation NLF New legislative framework OEM Original equipment manufacturer OJEU Official Journal of the European Union OND Outdoor Noise Directive OSHA Occupational Safety and Health Administration PCM Partly completed machinery PED Pressure Equipment Directive pp. Percentage points RED Radio Equipment Directive REFIT Regulatory fitness and performance programme SME Small and medium-sized enterprises TEU Treaty on European Union TFEU Treaty on the Functioning of the European Union





1.Introduction: Political and legal context The revision of the Product Safety Directive 2006/42/EC on Machinery (‘the Machinery Directive’ or ‘the MD’) contributes to the digital transition and to the strengthening of the single market. It is part of the Commission’s 2020 work programme under the priority ‘A Europe fit for the digital age’. The Commission has been active in studying emerging technologies and their impact on safety legislation. For example, the Commission published a white paper on artificial intelligence in February 2020. The white paper was accompanied by the Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics. This report analysed the impact of emerging technologies and the challenges they pose to EU safety legislation. It concluded that current product-safety legislation contains a number of gaps that need to be addressed. One such piece of product-safety legislation that contains gaps is the MD. Addressing the gaps in this Directive is especially important for a sustainable recovery from the COVID-19 pandemic, since the machinery sector is an essential part of the engineering industry and one of the industrial mainstays of the EU economy. The MD is the main piece of legislation regulating products made by the mechanical engineering industry. The scope of the MD covers a wide range of products. Machinery is broadly defined as an assembly ‘of linked parts or components, at least one of which moves’. This definition applies to a great variety of products, from lawnmowers to 3D printers, and from powered hand-tools to robots or construction machinery. The MD applies across the whole value chain, from the design and manufacturing stages until the machinery is placed on the market (or put into service) for consumer and professional use. The machinery manufacturers must take the appropriate measures to ensure safety risk throughout the foreseeable lifetime of the machinery before it is placed on the market. The MD lays down a regulatory framework for placing machinery on the single market, based on Article 114 of the TFEU (the approximation of laws). The MD was adopted on 17 May 2006 and implemented in 2009. It was the result of a comprehensive revision of previous legislation dating back to the first piece of legislation on this topic, Directive 89/392/EEC (which was reviewed in 1991 and 1993), replaced by a subsequent piece of legislation, Directive 98/37/EC. An amendment in 2009 to the current Directive 2006/42/EC added a ‘protection of the environment’ objective, although this amendment was limited to machinery used in pesticide applications. The MD is a piece of product-safety legislation that aims to ensure a high level of protection for workers, consumers and other exposed people. It seeks to achieve this by focusing on the safety of machinery itself, and thus imposes obligations on machinery manufacturers to produce inherently safe machinery designs (safety by design). The general objectives of the MD are to: (i) ensure the free movement of machinery within the single market; and (ii) ensure a high level of protection for users and other exposed people. The MD imposes obligations on machinery manufacturers, but not on users. The MD follows the ‘new approach’ principles of EU legislation. As opposed to the ‘Old approach’, where technical specifications are embedded in the legal text, the ‘New approach’ implies that the legal text, the MD in this case, is intentionally written to be ‘technology neutral’ by laying down the essential health-and-safety requirements (hereinafter ‘safety requirements’) to be complied with, without prescribing any specific technical solution for complying with those requirements. The choice of the technical solution is a prerogative of manufacturers, which leaves space for innovation and the development of new designs. The safety requirements are set out in Annex I of the MD. Some safety requirements are more general in nature, while others are specific to certain types of machinery. The manufacturers must make a risk assessment to determine what risks the machinery presents. Based on these risks, the manufacturers must identify the safety requirements with which the machine must comply. To help manufacturers prove that their machinery conforms to the requirements, and to allow inspection of conformity with the requirements, harmonised standards at EU level are commonly used (see Chapter 1.1 of this impact assessment). These standards are drawn up by private-law bodies and their use is voluntary. Manufacturers have the choice of implementing other technical solutions as long as they can prove that all relevant legal requirements are complied with. Compliant machinery is put on the market with a ‘CE marking’ affixed to it. This is a way for the manufacturer to declare that the product meets all the legal requirements and can be sold throughout the EU. During the REFIT evaluation of the MD, all interested parties confirmed that the MD is an essential piece of legislation necessary to guarantee: (i) the right level of safety for the wide range of products covered; and (ii) a level playing field in the machinery market. The evaluation was also positive about the MD’s flexibility and openness to innovation. Nevertheless, the evaluation also identified a necessity to improve, simplify, and adapt the MD to the needs of the market. In particular, the evaluation concluded that a revision should aim to: ·address the risks stemming from emerging technologies while allowing for technical progress; ·improve the legal clarity of some major concepts and definitions in the current text of the MD; ·simplify the requirements for documentation by allowing digital formats, thus reducing administrative burden for businesses while also cutting environmental costs; ·ensure coherence with other directives and regulations for products and improve enforcement of the legislation through the alignment to the new legislative framework; and ·reduce the costs of transposition by converting the MD into a regulation. Some members of the European Parliament’s IMCO committee European Parliament’s Committee on Internal Market and Consumer Protection (IMCO) expressed their support for the revision of the MD. In particular, they supported the idea of ‘bringing the legislation into the 21st century’ and promoting innovation for the EU economy. 1.1 The role of harmonised standards in the machinery sector As indicated above, an important part of the application of the MD is the role of harmonised standards. These harmonised standards are developed by the European standardisation organisations (CEN/CENELEC and ETSI) following a standardisation request from the European Commission, according to Regulation (EU) No 1025/2012. Machinery manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union (OJEU), are presumed to comply with the requirements covered by such a harmonised standard. The voluntary nature of the standards makes the framework flexible enough to: (i) enable innovation and technical development; and (ii) facilitate the placing on the market of new products for which a harmonised standard does not yet exist. Under the MD, there are three types of standards: A, B and C. Type-A standards cover principles common to all machines. Type-B standards cover: (i) safety and ergonomic principles; (ii) safety components; and (iii) devices. Type-C standards cover specific types or groups of machines. The references of harmonised standards are published in the OJEU. The most recent list comprising all three types of standards includes a total of 1 112 standards relevant for the MD, of which 782 will still apply after 2022, meaning that 330 have been withdrawn or will be withdrawn by then.

The Commission may, within the limitations of the powers laid down in the Treaties, ask one or several European standardisation organisations (ESOs) to draft a European standard within a set deadline. European standards and European standardisation deliverables must: (i) be market-driven; (ii) take into account the public interest as well as the policy objectives clearly stated in the Commission’s request; and (iii) be based on consensus. The Commission must determine the content requirements to be met by the requested document and set a deadline for its adoption. 1.2 The Machinery Directive in the broader EU legislative context The MD is a piece of EU, harmonised, sectoral, product-safety legislation. As such, it is also part of the EU’s body of law (‘the acquis’) dealing with product safety. There are more general EU rules dealing with safety across different product types (i.e. the General Product Safety Directive and the new legislative framework) and sectoral rules for specific product types. The General Product Safety Directive is a safety-net legislation that applies to consumer products if: (i) there are not more specific provisions in harmonised, sectoral, product-safety legislation; and (ii) there are aspects and risks (or categories of risks) not covered by that sectoral product-safety legislation. The MD covers all safety risks that manufacturers must address to be able to place their machinery on the EU market. The specificities of the products covered and their risks confirm the need for sectoral legislation. Therefore, because the safety requirements of the MD are more specific than the general safety requirements of the General Product Safety Directive, the MD takes precedence. The MD ensures a high level of protection for machinery users and other exposed persons by ensuring the safety of machinery. It applies at the moment the machine is placed on the market (or put into service). Another directive, EU Directive 2009/104/EEC lays down minimum safety and health requirements for the use of work equipment, after it has been placed on the market (or put into service). The two Directives are therefore complementary. In some cases, depending on the machinery’s characteristics, the MD may apply together with other pieces of legislation, such as: (i) the Outdoor Noise Directive (OND); (ii) the Radio Equipment Directive (RED); (iii) the Electromagnetic Compatibility Directive (EMCD); or (iv) Regulation (EU) 2016/1628 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery (recently amended by Regulation (EU) 2020/1040 in order to address the impact of the COVID-19 crisis). For instance, machinery with radio equipment may be subject to both the MD and the RED, while machines for use outdoors (such as in construction sites, road maintenance, gardening and forestry activities) may be subject to both the MD and the OND. In other cases, the MD applies alternatively to other product-safety legislation, such as the Low-Voltage Directive (LVD), the Pressure Equipment Directive (PED), the Lifts Directive (LD) or the Medical Devices Directive. In such cases, some categories of machinery are explicitly excluded from the scope of one of the legal acts, falling only under the scope of the other. For instance, certain machinery is excluded from the MD as listed in Article 1(2)(k) of the MD, and falls instead under the LVD. Other machinery is excluded from the PED (Category I products under PED) or the LD (lifting appliances whose speed is not greater than 0.15 m/s), and falls under the MD. The Commission is also active in assessing artificial intelligence (AI), the internet of things (IoT), and other digital technologies and their implications for safety legislation. As mentioned in Introduction 1.1, the Commission published in February 2020 its Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics . The report concluded that current product-safety legislation contains a number of gaps that need to be addressed, in particular in the MD. The revision of the MD is taking into account those recommendations. The white paper on AI also outlined the Commission’s objective to propose new legislation covering safety and fundamental requirements for AI systems. A new AI regulation is being drawn up in this area. The Commission intends to adopt proposals for both a new AI regulation and a revised MD in the second quarter of 2021. The link between a new AI regulation and the revised MD is further detailed in the policy options set out for AI. Coherence between this new AI regulation and the revised MD will be sought at the level of: (i) the safety requirements; (ii) the concepts and definitions used (e.g. the ‘high-risk’ concept); and (iii) the conformity-assessment procedure. This coherence is essential to ensure that no duplication or additional unnecessary burden is placed on businesses. On cybersecurity, the MD is focused on product safety, and addresses only those risks that may have an impact on safety. This means that the revision of the MD should be limited to ‘cyber safety’ (related to the machine), rather than to cybersecurity in broad terms (related to the network). On cybersecurity more broadly, the Cybersecurity Act represents a point of reference as an existing market initiative on network security. The Cybersecurity Act is a voluntary, EU-wide certification framework for digital products, services and processes. It is based on a comprehensive set of rules, technical requirements, standards and procedures. Manufacturers can choose to follow this voluntary certification framework if they wish. The Cybersecurity Act also has the potential to cover emerging cybersecurity risks for machinery products that use emerging technologies, but only to a certain extent due to its voluntary nature. In addition, under the RED, preparatory work is under way for possible delegated acts addressing: (i) privacy; (ii) data protection; (iii) protection from fraud; and possibly (iv) protection to ensure that the equipment does not harm the network. Those delegated acts would apply to connected machines incorporating radio equipment. The Commission is also taking a broader look at the impacts of EU regulation, paying attention to other aspects, such as environmental or circular-economy effects. The MD is a piece of pure product-safety legislation. It is true that the 2009 amendment added a ‘protection of the environment’ objective limited to machinery used in pesticide applications. Nevertheless, extending such an objective to the very wide range of machinery products would render the MD too broad and unmanageable. On pollution and noise, there is already specific legislation referred to above, namely the OND and Regulation (EU) 2020/1040 on engine emissions from mobile machinery. Some environmental and circular-economy effects are being taken into account in the revision of the MD where possible. Indeed, one of the improvements sought by the revision has a significant environmental benefit, namely to allow digital documentation which would help save paper and decrease carbon emissions. In addition, some improvements proposed would favour the circular economy, such as the clarification of what constitutes a ‘substantial modification’, subject to which substantially modified machinery can be put on the market again with a new CE marking. 1.3 The machinery sector The machinery and equipment sector is one of the major sectors of the EU’s manufacturing industry. Detailed information on the machinery sector can be found in the Impact assessment study on the revision of Directive 2006/42/EC on machinery. A snapshot of the main data from that impact assessment study is set out in the following three bullet points. -In 2017, the machinery sector recorded turnover of EUR 663 billion, production of EUR 609 billion, and a value added of EUR 191 billion. -In 2017, the machinery sector employed 2.8 million people and comprised 82 239 enterprises. The machinery sector accounted for 9.4% of manufacturing turnover, 9.5% of manufacturing production, and 11.2% of value added in the EU. The machinery sector employed 9.9% of all people employed in manufacturing and accounted for 4.1% of all manufacturing enterprises. -In 2017, total EU machinery and equipment exports amounted to EUR 503 billion, of which 49% were exported to EU member countries (i.e. intra-EU exports), while 51% were exported to countries outside the EU (extra-EU exports) . Among the 82 239 enterprises registered in the machinery sector, only 1 703 (2%) are large companies, while 81 024 (98%) are SMEs. Although the sector has important large players, SMEs are its main driving force. For this reason, SMEs were extensively consulted for this report, as detailed in Annex 5: SME TEST. Impacts on SMEs have also been carefully analysed. 1.4 Digitalisation, robotics, the IoT and AI in the machinery sector

The uptake of emerging technologies in machinery depends on the type of machinery and the sector it is used in. One of the most relevant sectors for the uptake of emerging technologies is the factory-automation market. In 2018, the EU had the second largest factory-automation market after Asia-Pacific, putting it ahead of North America. In the factory-automation market, we can distinguish between traditional and ‘smart’ manufacturing systems. The traditional manufacturing system is based on two parts: humans and physical systems. In a traditional manufacturing system, machine-operation controls are completely manual. This traditional manufacturing system requires humans to complete tasks (e.g. information sensing, decision-making, operating and checking) and may therefore be defined as a human-physical system. In comparison, there are three categories of smart-manufacturing systems. These three categories are presented in the bullet points below. I)Digital manufacturing: This is sometimes called ‘the third industrial revolution’. In digital manufacturing, physical systems continue to act as the ‘executing body’, but humans develop the underlying: (i) analysis; and (ii) methods and rules for computation and control models. The operation relies on the knowledge and experience of the operator. Industrial robots without advanced AI applications fall under this category. II)Digital-networked manufacturing: This adds the internet component to digital manufacturing. For instance, machine-tool manufacturers can engage with their suppliers in remote-operation maintenance of their products through networks. III)‘Next generation’ smart manufacturing: This is sometimes called the ‘fourth industrial revolution’. In this type of system, the knowledge in the cyber system is jointly built by humans and the self-learning/cognition module of the cyber system. Humans remain as the creators, managers and operators of intelligent machines. This stage is currently at the level of ‘weak’ or ‘narrow’ AI (used to accomplish a narrow set of goals). The broad definition of ‘smart manufacturing’ covers many different technologies. Some of the key technologies in the smart-manufacturing movement include advanced robotics, industrial-connectivity devices, and machine learning (ML). Robotics in the machinery sector Robots can be defined and classified as set out in the figure below. A robot is an actuated mechanism programmable in two or more axes with a degree of autonomy, and moving within its environment to perform intended tasks. Industrial robots are for use in industrial-automation applications (e.g. grinding, welding, assembling, handling or packaging). Service robots perform useful tasks for humans or equipment, excluding industrial-automation applications (e.g. floor-cleaning robots, robotic lawnmowers, and robots for entertainment). Personal-service robots or service robots for personal use are used for a non-commercial task, usually by laypersons (e.g. domestic servant robots, automated wheelchairs, robots to assist with personal mobility, or pet-exercising robots). Professional-service robots or service robots for professional use are service robots used for a commercial task, usually operated by a trained operator (e.g. cleaning robots for public places, delivery robots in offices or hospitals, etc.). Industrial robots can bring great benefits for health and safety by substituting for people working in unhealthy or dangerous environments, or in other highly repetitive, risky or unpleasant tasks. Europe accounts for 18.5% of total global sales of industrial robots and is the leading continent for the number of robots per 10 000 employees. Germany ranks third globally for industrial robot density , while four more European countries make it into the top 10 (Sweden, Denmark, Belgium and Italy) . Collaborative robots are a growing segment of the market. Also known as ‘co-bots’, these robots are intended for direct human-robot interaction within a shared space, as opposed to traditional industrial robots which are isolated from human contact. A number of new robotics companies have emerged in the EU in recent years, including Universal Robots, FerRobotics, Franka Emika, BioRob-Arm, F&P Robotics and MRK Systeme. Many of these new European players specialise in co-bots. The EU co-bots market was worth EUR 343 million in 2019 and is expected to grow at a rate of 41% annually between 2020 and 2026. Indeed, most established European robotics manufacturers have co-bots in their product portfolios, with key players including Comau, Festo, ABB, Bosch, Stäubli, and Mabi Robotic. Of the key players in the global co-bots market, most are European companies. The global market for non-industrial robotics in the consumer sector is projected to reach an added value of USD 286 billion (EUR 260 billion) by 2025. Smaller markets will include robotics for use in agriculture and logistics, among others. Of the service robots for domestic use, 96% of sales are estimated to be vacuum and floor-cleaning robots, while 70% of the entertainment robots are estimated to be toy and hobby robots. The International Federation of Robotics counts 700 registered companies that make service robots. Of these, 43% (300 manufacturers) are based in Europe. The IoT in the machinery sector The IoT can be defined as a global infrastructure for the information society, enabling advanced services by interconnecting (physical and virtual) things based on existing and evolving interoperable information and communication technologies. For machinery, the IoT opens up the possibility of improving machine-to-machine communications in complex processes and operating work equipment remotely. Increased interconnectivity requires embedding software in a machine, which entails using some form of network such as the internet. The industrial IoT (IIoT) is the use of smart sensors and actuators to enhance manufacturing and industrial processes. The IIoT leverages the power of smart machines and real-time analytics to take advantage of the data that machines have produced in industrial settings for years’. While the IIoT is still in its infancy, manufacturing is considered the largest market that will be affected by developments in this area, considering that a ‘smart’ production unit could consist of a large connected industrial system of materials, parts, machines, tools, inventory and logistics that are connected to each other. ‘Smart’ manufacturing ranked fourth in terms of growth potential after smart energy, smart health and smart transport. And ‘smart manufacturing’ also ranked third in terms of the EU’s industrial potential. The IIoT is projected to increase global GDP by about USD 15 trillion (EUR 12 trillion) by 2030. Although in 2014 only about 10% of industrial machines were connected, the projections indicate rapid growth in uptake of connectivity in the future. In comparison to the overall IoT, the number of IIoT connections is expected to increase by 70.5% from 2016 to 2025. AI in the machinery sector

In the Commission’s White Paper on Artificial Intelligence - A European approach to excellence and trust, AI systems are defined as follows. software (and possibly also hardware) systems designed by humans that, given a complex goal, act in the physical or digital dimension by perceiving their environment through data acquisition, interpreting the collected structured or unstructured data, reasoning on the knowledge, or processing the information, derived from this data and deciding the best action(s) to take to achieve the given goal. AI systems can either use symbolic rules or learn a numeric model, and they can also adapt their behaviour by analysing how the environment is affected by their previous actions. AI can be categorised according to the following three stages of development. I)Basic AI, or artificial narrow intelligence, is limited in scope and restricted to just one functional area (e.g. AlphaGo, a computer programme that plays the board game Go). II)Advanced AI, or artificial general intelligence (AGI), usually covers more than one field, such as the power of reasoning, abstract thinking, or problem solving on a par with human adults. III)Autonomous AI, or artificial super intelligence (ASI), is where AI surpasses human intelligence across all fields. This stage of AI is not expected to be fully developed for several decades. Machine learning (ML) is the study of computer algorithms that improve automatically through experience and by the use of data. It is seen as a part of artificial intelligence. A traditional programmer would write computer code setting the rules needed to process data inputs to get an answer as output. In ML, the computer receives input data as well as the answers expected from the data, and the ML programme must then produce the rules itself. These rules can then be applied to new data to produce original answers. An ML-system is ‘trained’ rather than ‘programmed’ . To date, the manufacturing sector is using AI in only a few ways, and AI is not yet considered to have come close to its full potential. The main applications of AI in the market are in ML. In robotics, these applications include: assembly (AI combined with advanced vision systems to help with real-time remedying of errors in assembly); packaging (AI for quicker, lower-cost and more accurate packaging); customer service (AI natural-language-processing abilities to interact with customers); and open-source robotics (robotic systems sold as open-source systems with AI capability that enable users to teach their robots to carry out tasks based on their specific application). One emerging market is the market for fully automated self-driving robots, also known as autonomous mobile robots (AMRs). AMRs can autonomously navigate in an uncontrolled environment by integrating sensors, 3D vision, and AI. They are often designed to interact and cooperate with humans. Due to the novelty of AMRs and the rapidly evolving market for these robots, there are no dependable figures on the market volume and adoption rate of self-driving robots. Despite this lack of data, analysts concur that the annual growth rate of the self-driving robot market will remain high over the next 5 years, ranging between 12.9% and 21.5% per year , . Another emerging market is driven by ML applications in service robots for professional use. The International Federation of Robotics estimates the combined value of the market for professional-service robots for the 2019-2021 period will be around EUR 34 billion . Examples provided by the French Ministry of Agriculture include robots with ML capabilities to: (i) distinguish between crop plants and invasive plants (weeds); (ii) operate spray booms (so spraying stops in areas not contaminated by weeds); (iii) sort lettuces from foreign objects before bagging; (iv) sort general waste on a conveyor; and (v) follow an operator in a warehouse and ‘learn’ using smart sensors to memorise routes and obstacles while it transports loads. Additional information on emerging technologies in the machinery sector is available in the Impact assessment study on the revision of Directive 2006/42/EC on machinery. 2.Problem definition 2.1.What is/are the problems? Problem 1: The MD does not sufficiently cover new risks originating from emerging technologies The evaluation of the MD found that most stakeholders believe that the MD takes new innovations and technologies sufficiently into account either to a moderate or to a large extent. However, a number of stakeholders expressed their concern about: autonomous machines/systems, AI, collaborative robotics, mobile robotics, electrified machines, hybrid engines, smart appliances, wireless applications and cybersecurity. If accidents occur in these areas, trust in emerging technologies would be undermined. And unless the MD provides legal clarity about those technologies, existing gaps (as identified in the Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics) could remove the level playing field for manufacturers. This would in turn impact the efficiency of the MD. 1. A first source of potential risk is in human-robot collaboration. Accidents at work related to industrial robots are not tracked at EU level. Some of these incidents may occur due to the robot malfunctioning, but others are due to human error, such as entering the fenced-off areas reserved for robots while the robots are operating. Industrial robots are designed to work autonomously, with safety ensured by isolation from human contact. However, co-bots are designed to work alongside human employees. Unlike industrial robots, co-bots are often lightweight and portable, which makes them ideal to use for multiple tasks within a factory. The safety of collaborative and autonomous robots may depend on: (i) designing them with lightweight construction materials and rounded edges; (ii) placing inherent limitations on their speed and force; or (iii) adding sensors and software to them to ensure their safe behaviour. Annex 6 illustrates an example of a collaborative robot and its particularities, as well as the potential hazards of physical contact with co-bots. A stakeholder consultation gathered some information on how to adapt the requirements for co-bots to better account for the risks of human-robot collaboration. Most stakeholders indicated that human-robot collaboration was not sufficiently covered by the MD. In particular, some authorities in charge of market surveillance for the MD considered that the MD’s Annex I requirements in Section 1.3.7. ‘Risks related to moving parts’ could be problematic. For example, one of these requirements is that ‘the moving parts of machinery must be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or must, where risks persist, be fitted with guards or protective devices’. Some authorities felt that these requirements may not be sufficient in cases of human-robot coexistence in a shared space, or in cases where humans and robots are simultaneously working on something, or in cases where humans and robots are alternating in their work on something. Why did some stakeholders not consider that the current requirements sufficiently covered human-robot collaboration? Most industry associations and manufacturers cited concern over cybersecurity and the lack of physical separation between robots and humans. Notified bodies mostly said that the limits on force, speed, and energy in the current standards were not sufficient given the agility of interaction between humans and co-bots. Market-surveillance authorities also said that the current requirements did not sufficiently cover software traceability. 2. A second source of potential risk comes from connected machinery. Connected machinery may generate new risks such as: (i) a permanent loss of communication; (ii) intermittent connection; (iii) denial of service; or (iv) other situations when a sensor or camera capturing the physical world creates erroneous or still/frozen data. If data from the physical world (or the created and aggregated data) are incorrect or delayed, two problems are possible. Firstly, the analysis performed may not be correct depending on the extent of the delay. Secondly, the decision taken (such as stopping a machine to prevent overheating) may no longer be valid depending on the extent of the delay. The severity of safety issues due to incorrect control decisions taken based on erroneous sensorial data was highlighted by the analysis of accidents from the industrial-automation study conducted by the French Ministry of Ecology, Sustainable Development and Energy . According to the study, sensor-related accidents were observed mostly in operations such as restarting, stopping and shutting down. Unlike standalone machinery, the safety of connected machinery requires consideration of all interactions between networked machinery assets. Malfunction accounted for more than 50% of accidents related to sensors, of which 66% were caused by human error, a lack of maintenance, insufficient connectivity or lack of cleaning. Another cause for concern is the inclusion of communication devices to link the machine to the internet (IoT). This allows data on the machine’s use and operation to be monitored or the machine to be started and controlled remotely. If an unauthorised third party managed to upload code or software to a safety-critical piece of machinery, this could have serious consequences for machinery users. For example, warning systems could be turned off or the functionality of the machinery could be changed to sabotage operations. For robotics, one study found that hackers could access co-bots, allowing them to stop safety programmes designed to protect the people working with the devices.

It is worth distinguishing between cybersecurity, related to the network, and cyber safety, related to the machine. It is also worth considering how and whether a machine enters into a ‘safe mode’ if it is subjected to a cyber attack. Although cybersecurity in broad terms does not fall under the scope of the MD, safety is well within its scope. For example, there is a requirement in the current MD’s Annex I 1.2.1 on the ‘Safety and reliability of control systems’. This requirement states that control systems ‘must be designed and constructed in such a way that they can withstand the intended operating stresses and external influences’. An assessment should be made as to whether this requirement appropriately addresses cyber-safety risks. On this issue, several stakeholders and national authorities said it was unclear whether the notion of ‘external influences’ included cyber attacks. 3. A third area of concern is the way that software updates affect the ‘behaviour’ of the machinery after its placing on the market. Nowadays, the functionality of a machine can be updated using standalone software. On modern machinery fleets, machines are designed in such a way that updates can be performed either on-site or remotely. This means that the resulting updated software is not embedded in the original product, but provided separately, sometimes by a third party different from the machine manufacturer. Such situations raise questions about the risks (and the management of these risks) emerging from software updates that change the functionality and operation of machinery in unintended ways. Some market-surveillance authorities that were consulted said they found it necessary to ensure: (i) that requirements are satisfied after the integration of independent software to any (standalone or networked) machinery. They also said it was necessary to ensure that software updates not considered in the initial manufacturer’s risk assessment and that had an impact on safety should be considered as a substantial modification, thus requiring a new CE marking. In addition, software with a safety function that is placed independently on the market is not considered a safety component under the current MD (see Annex V of the MD for an indicative list of the safety components). Most stakeholders consulted saw this as a gap in the current MD. 4. A fourth concern relates to the ability of original equipment manufacturers (OEMs) to conduct a full risk assessment of ML applications before the product is placed on the market. Chapter 1.4 of this report shows that narrow AI – and more specifically ML applications – are increasingly present in the machinery market. If the AI used for the machinery is set to learn and adapt as it is used, then its scope of operation could develop beyond what the designer took into account in their original risk assessment. With the development of collaborative robots that can move around and work closely with a person, these risks are much more difficult to control. These risks depend almost entirely on the safety of the AI programme running them, such as the quality of the computer’s vision and image-recognition abilities. In addition, some of the market-surveillance authorities interviewed said that the MD lacks an explicit requirement for the manufacturer to provide test procedures/devices to maintain/adjust the relevant machinery. Indeed, while there is such a requirement for automated machinery (see MD Annex I 1.6.1 ‘a connecting device for mounting diagnostic fault-finding equipment must be provided’), it is not clear whether the MD’s wording sufficiently covers the specificities of the new generation of machines with learning capabilities. Another key area is that of the ‘control logic’. A control logic is a part of a computer programme that controls the operations of the programme. It can be highly complex, and is used to determine the learning process through which the machine uses the data sets to be trained on. The current MD lacks requirements on control systems to prevent unsafe, unpredictable outcomes during the ML phase and during the use phase. Combined with extensive and automated data collection, it can become very complicated to identify which data were used to reach certain decision outcomes, thus hindering the correction of faulty data or assumptions. Some of the market-surveillance authorities consulted highlighted that the current MD contains no obligations for source codes or programmed logics to be made available to the authorities, and that this does not facilitate the product-safety inspections. 5. Finally, there is the issue of autonomous machines and remote supervisory stations. The current MD assumes there is a driver or an operator responsible for the movement of a machine. The driver may be transported by the machinery or may accompany the machinery, or may guide the machinery by remote control. However, the MD does not consider the possibility that there might be no driver, and it sets no requirements for autonomous machines. All the above problems may undermine the competitiveness of the machinery sector unless they are properly addressed. Legal uncertainty on the requirements that machinery with emerging theologies must comply would cause a distortion of competition in the market, with diligent manufacturers taking the necessary steps whereas other companies might take advance of this lack of precision in the legislation. 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 evaluation of the MD indicated the need for greater legal clarity in its scope and definitions. Both the scope and definitions generated some difficulties for manufacturers in understanding the correct legal framework they should apply. In addition there are a number of requirements in the MD not related to emerging technologies that have been identified as either: (i) not clear or safe enough; or (ii) too prescriptive and potentially hindering innovation. (i) Legal uncertainty due to a lack of clarity on the scope and definitions -The Low-Voltage Directive (LVD): The evaluation of the MD indicated that the lack of clarity on scope was most common in the relationship between the LVD and the MD. Within the current MD, Article 1(2)(k) lists the categories of low-voltage electrical and electronic machinery that are excluded from the scope of the MD. As an example, one of the excluded categories is ‘household appliances intended for domestic use’, such as: refrigerators; freezers; ovens; dishwashers; washing machines and dryers; vacuum cleaners; irons; and toasters. These appliances thus fall under the LVD. A lack of consistency arises from the fact that these products are no longer excluded from the MD if they use radio equipment. If they contain radio equipment, these products shift from the LVD to the RED, which applies in addition to the MD. In 2018, the home-appliance industry in Europe generated EUR 53 billion turnover and comprised over 3 300 enterprises and more than 200 000 direct employees . -Exclusion of means of transport: Tractors and other vehicles primarily intended for the transport of persons are excluded from the MD, since they fall under an ad-hoc EU type-approval legislation. Currently, the borderline is not clear enough, and allows that certain vehicles, such as multipurpose vehicles of the type All-Terrain Vehicles and Side-By-Side, can be considered as falling under the MD or under EU type-approval legislation, sometimes by the same manufacturer. In addition, recently proliferating light vehicles such as electrically power assisted cycles, hover boards or self-balancing scooters can be considered under the scope of the current MD, even if the MD is not meant and do not cover road circulation aspects. All this creates problematic distortions in the market. -Partly Completed Machinery (PCM): As defined in Article 2 of the MD, PCM means an ‘assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies’. PCM is widely considered as a useful concept in the MD. The manufacturer of PCM determines with which health-and-safety requirements of Annex I of the MD it complies. According to the MD, the manufacturer only needs to specify in the declaration of incorporation those requirements that are actually relevant (in terms of the specified enabled applications of the machinery), and complied with. Buyers of such PCM thus often need to enter into specific private-law agreements to ensure the PCM’s compliance with applicable requirements before purchase . This incurs additional costs to solve any potential issues between supplier and customer in relation to PCM . However, stakeholders have often stated that a clearer definition and/or further clarification would help buyers and sellers of PCM. Sometimes the definition is applied inconsistently by manufacturers, leading to incorrect classifications (e.g. products that are partly completed machines are defined as components) and/or to the incorrect CE marking of PCMs. This may generate safety issues or create an unlevel playing field in the market. Companies, particularly SMEs manufacturing or buying PCM, incur compliance expenses to obtain clarifications and legal certainty, by hiring external consultants or lawyers. -Substantial modification: This problem relates to machinery that has undergone substantial changes. The Guide to application of the Machinery Directive 2006/42/EC-Edition 2.2 (‘the Guide’), refers in paragraph 82 to: some cases [whereby] machinery is sold to an importer or a distributor who then modifies machinery at the request of a customer before the machinery is put into service (…). If the modifications were foreseen or agreed by the manufacturer and covered by the manufacturer’s risk assessment, technical documentation and EC declaration of conformity, the original manufacturer’s CE marking remains valid. (…) If the modification is substantial (for example, a change of function and/or performance of the machinery) and not foreseen or agreed by the manufacturer, the original manufacturer’s CE marking becomes invalid and has to be renewed. The public consultation asked stakeholders about the potential issues resulting from substantially modifying machines. Just over a half (53.1%) of the stakeholders said they had modified their machines, of which 36.5% were companies. The large majority of respondents (78.3%) claimed they had not encountered any problems with the modification. Despite not encountering many problems, most of the respondents to the public consultation (61.2%) claimed that the MD should lay down the criteria for modifying machinery substantially. Otherwise, there a risk of different interpretations by market-surveillance authorities. This could potentially lead to uneven protection of safety across the EU and unequal terms for manufacturers, who may or may not be subject to costly conformity-assessment procedures, depending on the practices of the different national authorities . (ii) Possible safety gaps in traditional technologies

For a few types of machinery, a number of requirements have been identified as: (i) insufficient to ensure safety; or (ii) too prescriptive and potentially hindering innovation. These requirements are set out in the paragraphs below. -Installation of lifting appliances: A lift under the Lifts Directive (LD) is considered to be placed on the market only after its installation, when it can be inspected and CE-marked. Lifting appliances under the MD (or so-called slow-speed lifts, the speed of which is not greater than 0.15 m/s) are often placed on the market and CE-marked by the manufacturer, and then installed by a third party following the manufacturer’s instructions for installation. Issues have arisen in some Member States where installer and manufacturer consider the other party responsible for failures in installed lifts. The evaluation of the Lifts Directive in 2017 estimated the number of companies active in the lift market equal to 0.1% of all manufacturing-sector companies in the EU-28. According to the European Lift & Lift Component Association, the estimated number of existing lifts in 2014 in the European Economic Area (EEA) was 5 361 896, although most of these fall under the scope of the LD rather than the MD. -Slow-speed lifts: For slow-speed lifts, and the uncontrolled movement of objects in the carriers of slow-speed lifts, the MD states that ‘the control devices for these movements must be of the hold-to-run type except where the carrier itself is completely enclosed’. Hold-to-run push buttons allow the platform to stop immediately once the button is released. Automatic controls may be used when the carriage is fully enclosed. Manufacturers claim this requirement limits innovative technologies such as light-barrier curtains. Also, some authorities consulted find it an anomaly that the MD, supposedly technologically neutral in its approach, prescribes a technical solution rather than a safety requirement. As indicated in the paragraph below, slow-speed lifts fall under the scope of the MD. In 2005, the EU stair-lift industry was estimated to have sold about 100 000 units (62 000 straight lifts and 38 000 curved lifts) and have turnover of EUR 188 million. The global market was also expected to grow. For example, the share of the US population owning a stair lift was expected to grow from 13% in 2005 to 19% in 2030. -Seating: For ‘ride-on’ mobile machinery, such as excavators or agricultural sprayers, the current MD includes safety requirements for seating (Annex I 3.2.2.) that are seen as insufficient and hindering innovative solutions to prevent the risk of falling off. All stakeholder groups (national authorities, notified bodies, market-surveillance authorities, and workers’ representatives), except for manufacturers agree that the health-and-safety requirements for seating should be revised and/or updated. According to these stakeholder groups, machines should be constructed in such a way as to prevent the worker from becoming unattached to the machinery. The current regulation in the MD requires a restraint system to be attached directly to the driver’s seat, but this system is sometimes by-passed by users, thus increasing the risk of accidents. This requirement may also limit innovation, as there are other technological solutions on the market, such as restraint systems that keep operators within the framework of the protective structure (e.g. doors or door-bar systems). The EU market for mobile machinery is estimated to be worth EUR 90 billion in annual turnover. -Overhead power lines: Overhead power lines have different heights in EU Member States. Accidents occur when vehicles or machinery make contact with overhead lines. If a vehicle or machine becomes ‘live’ by touching a power line then anyone touching the machine or vehicle is in mortal danger. Anyone in the cab of such a vehicle or machine may be in less danger, but they may still be threatened by the vehicle or machine catching fire. This may happen in a number of different scenarios, for example: (i) the equipment is tall enough to reach the line while driving along in its normal configuration; (ii) a trailer is tipped up, making contact with the line and rendering the entire vehicle ‘live’; (iii) a hydraulic boom controlled from a cab makes contact with an overhead line, e.g. a crane lifting a load, etc. Because of the height of equipment used in agriculture, farmers and those using high agricultural equipment can be at risk if they hit an overhead line. In 2019, eight serious or fatal accidents were recorded in France resulting from contact between an agricultural machine and a live overhead power line. One of these accidents resulted in two deaths. The machines involved were irrigators, mobile elevating work platforms, trailers, grape harvesters, and combine harvesters . In the former EU-28, the UK also reported several accidents of this nature. The French and other national authorities believe the requirements in the current MD to avoid or mitigate this risk are not sufficient. It was not possible to assess the more detailed market for other machinery which, because of its height, could potentially be impacted by this problem. -Protection against hazardous substances: The current MD does not address the issue of protecting workers from exposure to hazardous substances. For example, many machines generate fine dust or metal micro parts, and these are considered very harmful to workers’ lungs. Workers’ associations and market-surveillance authorities believe it necessary to protect workers from hazardous substances, whereas consumer organisations and manufacturers do not find it necessary. According to workers’ associations, the emissions of hazardous substances from machinery should be assessed and mitigated at design stage. On the other hand, manufacturers argue that the exposure of workers to hazardous substances is handled by Directive 89/391/EEC and is mainly the responsibility of the employer. Manufacturers also argue that they cannot address safety integration on their own in cases where employers often select machinery from multiple manufacturers for a final application. Consumer organisations agreed that there is other legislation in place that ensures workers’ protection from hazardous substances. -Vibration from portable handheld and hand-guided machinery: It is estimated that around 400 000 employees every year are exposed to vibrations from portable handheld and hand-guided machinery in Sweden. An occupational injury caused by vibration can lead to painful and disabling conditions, which usually involve major limitations and inconveniences in everyday life for those affected. If the proportion of workers exposed to vibrations is the same in the rest of the EU, over 20 million workers in the EU could be exposed to vibrations from handheld and hand-guided machinery every year. The Swedish authorities, supported by other Member States, propose to ask manufacturers to better specify in the instructions for these kinds of machines the vibrations to which the hand-arm system is subjected, including continuous vibrations and the peak amplitude of the acceleration from repeated shock vibrations. Problem 3: Insufficient provisions for high risk machines The MD requires manufacturers to carry out a risk assessment for machinery they wish to place on the market. Manufacturers must determine which requirements are applicable, and therefore which measures must be taken to certify compliance. Compliance with the MD is primarily assessed through internal checks by the manufacturer and without the involvement of a third party. Nevertheless, there is an exception for a certain sub-category of machines: machines considered as presenting high risks that are listed in Annex IV. If these high-risk machines are not manufactured in full accordance with all relevant harmonised standards listed under the MD, or if there are no harmonised standards listed under the MD covering all applicable requirements for that machinery, then conformity through internal checks is not allowed, and a third party must be involved instead. There is discussion about whether the internal-checks option leads to safety concerns. On this issue, the Rapid Alert System for Non-Food Dangerous Products (Safety Gate/RAPEX) has shown over the years that some of the products falling under Annex IV of the MD were identified as not being compliant with the requirements of the MD and the relevant European standards. The products identified in Safety Gate/RAPEX include circular saws and vehicle lifts, which are part of Annex IV. Some of these products were manufactured outside the EU. Some market-surveillance authorities and notified bodies challenged the effectiveness of dealing with high-risk machines using a procedure that does not systematically impose a third-party conformity assessment. For these concerned stakeholders, third-party certification ensures higher quality and safer machinery, and minimises the need for surveillance authorities to intervene at later stages. However, since third partly involvement is costly, manufacturers of Annex IV machinery prefer to have the choice of involving or not a third party whenever they follow the relevant harmonised standards. Another problem is that the current list of high-risk machines in Annex IV was first drawn up 15 years ago, and the market has developed greatly since then. Several market-surveillance authorities believe it is necessary to: (i) remove from Annex IV machines no longer considered high risk; and/or (ii) introduce new machines to Annex IV (such as machinery embedding AI systems which fulfil a safety function); and/or (iii) even re-arrange the high-risk machine list in categories of risks in a more efficient and comprehensive way. Disagreeing with this view, manufacturers of non-Annex IV machinery oppose any reclassification of their machines to the high-risk category, mainly due to the additional costs associated with third-party conformity procedures. Problem 4: Monetary and environmental costs due to extensive paper-based documentation Article 5 of the MD details the requirements for documentation. Before placing machinery on the market and/or putting it into service, manufacturers must: ·provide the necessary information, such as instructions;

·follow the appropriate procedures for assessing conformity in accordance with Article 12; draw up the EC declaration of conformity (DoC) in accordance with Annex II, part 1, Section A; and ensure that this declaration is included with the machinery; and ·ensure that the technical file referred to in Annex VII, part A is available. Currently, the Guide clarifies that manufacturers must provide paper documentation for health-and-safety-related instructions and the conformity declaration. This is largely due to market characteristics during the early years of the MD’s implementation, namely the lack of access to the internet and other digital formats. Thus, to ensure that every machine user had 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. Manufacturers state that the requirement to provide printed versions increases costs and administrative burden for economic operators and has a negative impact on the environment. On the other hand, some authorities and users (workers and consumer associations) have concerns about ending this requirement because of: (i) users that are less digitally savvy and that may prefer paper documentation; (ii) a lack of internet access in certain environments; and (iii) changes or updates to an online manual that might not match the version of an already purchased product. The technical file and other information gathering foreseen in the MD other than the instructions and the DoC are already allowed in electronic formats. Problem 5: Inconsistencies with other pieces of Union product-safety legislation The new legislative framework (NLF) is a package of measures aimed at improving market surveillance and the quality of conformity assessments. It consists of Regulation (EC) 765/2008, Decision 768/2008 and Regulation (EC) 764/2008. A main objective of the Commission is to bring legislation on product-harmonisation in line with the reference provisions of Decision 768/2008/EC. While the MD is already a ‘new approach’ directive (as explained in Chapter 1 of this report), it is not yet aligned to the NLF. One of the issues raised in the evaluation of the MD is the lack of appropriate enforcement. The evaluation also argued that aligning the MD to the NLF could ‘help to increase the quality of machinery and the confidence in products in the European market, as well as ensure good levels of safety and create a common framework for market surveillance’. In addition, the fact that the MD is not aligned to the NLF creates inconsistencies with other pieces of Union product legislation. For instance, there are differences: ·in the definitions of the economic operators and their obligations (including the conformity-assessment modules); ·in where the CE marking must be placed on the product; ·in the detailed information to be provided on the declaration of conformity (DoC); ·in the format or layout required of the DoC and whether the DoC has to be provided along with the product or product documentation. All this creates confusion for manufacturers and other economic operators whose products fall within the scope of more than one piece of product-safety legislation. Contributors to the evaluation of the MD would like to see an alignment in the MD to ensure the coherence of its horizontal provisions. In particular they would like to see: (i) a harmonisation of the compliance documents (with the same DoC model and technical-file requirements as in other pieces of NLF legislation); (ii) the obligations of economic operators extended to importers and distributors; and (iii) enforcement of the requirements and conformity-assessment procedures in the wider EU legal framework and other NLF-aligned pieces of legislation. In addition, the current MD presents a burdensome procedure for the management of the safeguard clauses, where the Commission needs always to intervene in the process, which is suboptimal. An alignment to the NLF would render the handling of safeguard clauses lighter and more efficient as the Commission will have to intervene only when a MS objects to the safeguard measure taken by another MS. Currently, there are 23 pieces of product-safety legislation aligned to the NLF. In the engineering and manufacturing sector, the MD is one of the few pieces of product-safety legislation not yet aligned to the NLF. Indeed, most of the product-safety legislation on machinery and equipment has already been aligned to the NLF, including the Low Voltage Directive, the Lifts Directive, the Radio Equipment Directive or the Pressure Equipment Directive. This means that all these pieces of legislation benefit from the following NLF improvements: ·better coherence and consistency across the range of directives and regulations; ·improved market-surveillance rules to provide better protection for consumers and professionals from unsafe goods; ·a clarified notification process for conformity-assessment bodies; ·improved accreditation of conformity-assessment bodies;

·greater credibility and a clearer meaning for the CE mark; ·clarified obligations for importers and distributors where the manufacturer of the CE-marked product is based outside Europe. Problem 6: Divergences in interpretation due to transposition Differences in interpretation have arisen due to transposition. For instance there have been different definitions of PCM and ‘safety component’, and whether to consider software a safety component. Other differences occurred when one or several Member States consider that a product placed on the market does not comply with the essential health-and-safety requirements, although that product is available in many other Member States. This causes additional costs when the machine is traded in the single market, and thus poses an obstacle to the single market. These differences proved difficult to eliminate through many years of the MD’s history. By preventing Member States’ individual interpretation of the essential health-and-safety requirements, interpretation of technical solutions will also be prevented. Furthermore, there have been delays in the transposition of the MD in some Member States . A directive leaves Member States free to choose the means to comply with the legislative objectives. There have been cases in the past where, following to accidents, Member States have taken national measures, in theory on the basis of the MD but in praxis going beyond the MD. Impact of the COVID-19 pandemic on the machinery sector The COVID-19 pandemic damaged the performance of the engineering industry, including the machinery sector. In the following graph, the main indicator for confidence in the machinery sector (C28) is calculated (black line) as a combination of recent supply and demand factors and expected supply and demand in the months ahead. This confirms the picture of a slow but steady recovery from COVID-19 during 2020: Source: GROW elaborations on data provided by the Joint Harmonised EU Programme of Business and Consumer Surveys. An analysis of the situation of this sector at the beginning of 2021 showed that: ·the biggest shock took place in April 2020 amid concerns about disruptions in the supply chain (supply factors went down, driven by very pessimistic expectations about supply); ·expectations of demand were stable throughout the year 2020 and until now; ·excessively weak demand is holding back recovery in this sector. Just like the overall economy, this sector is suffering from the prolonged scarcity of aggregate demand, which is the lasting effect of the initial double shock (on both supply and demand). 2.2.What are the problem drivers? The problem drivers were explained above together with the problems. A summary is presented below.

2.3.How will the problem evolve? On the risks stemming from emerging technologies, the lack of appropriate requirements will likely lead to more non-compliant products coming onto the market, including imports from outside the EU. A lack of EU action would undermine user trust in machines that incorporate emerging technologies. Indeed, there is a danger that machines could be allowed onto the market that do not feature the necessary safety requirements. On the other hand, there is also a danger that manufacturers wanting to do the right thing might find their machinery development is hindered by the lack of legal clarity and guidance on what product types can or cannot be placed on the market. In this legal vacuum, Member States might decide to issue their own national rules. This could also create barriers in the single market, unfair competition, and a suboptimal level of safety. On the lack of clarity in some areas of the MD, the room for different interpretations could generate additional costs and burden for manufacturers and market-surveillance authorities due to the need for clarifications. This could also disrupt the level playing field. Without a reassessment of the concept of high-risk machines, high-risk machines could potentially be placed on the market without passing the appropriate conformity-assessment procedures, diminishing the level of safety for those types of machinery. The current list of high-risk machines, already outdated today, will become even more outdated with future market developments. On documentation, unless digital documentation is allowed to a certain extent, the industry will keep incurring economic and environmental costs for the printing and handling of extensive documentation. This would mean the industry would lose the opportunity for greater digitalisation and fail to benefit from the advantages that digital formats can have for certain types of users and/or in certain environments (such as speed in finding information). Paper consumption will keep increasing unnecessarily, with the accompanying environmental damage and additional costs for industry that this brings. On the lack of broader coherence with NLF legislation, the MD risks not taking advantage of the NLF’s improved framework for market surveillance and therefore not benefiting from the related improvement in safety. Manufacturers might continue to be obliged to deal with different approaches in the various product-safety rules applying to their products. This burden would be even more difficult to bear for SMEs. Not taking action would also contradict the European Commission’s commitment to aligning existing legislation to the NLF, where appropriate. Finally, the current transpositions in the Member States have generated certain differences of interpretation that will create additional costs and burden. This is particularly true in cases where manufacturers and users are based in different EU countries. Without further harmonisation of the market potentially brought by revising the MD, there is a risk that the opportunity to decrease the share of non-compliant products on the market might not be exploited. Moreover, not taking action would likely lead to Member States taking additional actions at national level (e.g. issuing additional requirements or providing clarifications of concepts that might differ from those of other Member States). This would further undermine the functioning of the single market and its level playing field. It could also potentially undermine the safety and health of machinery users and others exposed to machines. 3.Why should the EU act? 3.1.Legal basis The MD is a ‘total harmonisation’ directive based on Article 114 TFEU (ex-Article 95 TEC) and follows the ‘new approach’ legislative technique. As explained in Chapter 1 of this report, under the ‘new approach’ principles, EU product legislation sets the ‘essential health-and-safety requirements’ (referred to in this report as ‘safety requirements’) which products must satisfy to benefit from the free movement of products across the internal market. 3.2.Subsidiarity: Necessity of EU action This initiative addresses the issues identified in the evaluation of the MD, which was carried out as part of the Commission’s regulatory fitness and performance (REFIT) programme. The evaluation concluded (see SWD (2018)160) that the MD is generally relevant, effective, efficient and coherent, and has EU added value, but that there was a need for specific improvements and simplification. The machinery sector is a highly important part of the engineering industry and one of the industrial drivers of the EU’s economy, exporting more than half its production. The MD is a key driver of safety for machinery users in the EU. The main objective of the MD is to ensure a high level of health-and-safety protection for these users, and to allow the free circulation of machinery in the EU. In particular, the MD helps to reduce social costs by preventing accidents that may be caused by the use of machinery. A key rationale for an EU-level machinery directive is to provide harmonisation across Member States based on Article 114 TFEU. Any changes to the scope or requirements of such a directive must be made at EU level to avoid distorting the market, creating barriers to the free movement of products, or undermining the protection of human health and well-being. Proportionality of approach is ensured by the MD being technologically neutral (i.e. the MD lays down the safety requirements to be complied with, without prescribing any specific technical solution to comply with those requirements). It is also ensured by the Member States being responsible for the enforcement of the MD in their countries. As explained in Chapter 1 of this report, the technical solutions to comply with the safety requirements set out in the MD are provided in European standards. These standards are developed by stakeholders, and the standards: (i) ensure interoperability and safety; (ii) reduce costs; and (iii) facilitate companies’ integration into trade and the value chain. Further development of standards might pave the way to provide solutions to the problems outlined in Chapter 2. Given the widespread nature of these standardisation activities, any changes to the scope or requirements of the MD must be made at EU level to avoid: (i) distorting the market; (ii) creating barriers to the free movement of products; and (iii) undermining the protection of human health and well-being. Without an EU-wide regulation, Member States could impose diverging safety requirements. This would lead to: (i) differences in the safety of products for users; (ii) inequalities in prices; and (iii) an increase in adaptation costs for manufacturers when trading machinery across different countries. For instance, some market-surveillance authorities consulted found it necessary to ensure that software updates not considered in the initial manufacturer’s risk assessment and having an impact on safety would require the machine to go through a conformity-assessment procedure leading to a new CE marking. Unless these requirements are regulated in the revised MD, there is a risk of divergent Member State interpretations, with some imposing such procedures and others not. A subsidiarity grid is provided in Annex 8 to this report. 3.3.Subsidiarity: Added value of EU action

A regulatory action at EU level would ensure coherent implementation of the safety requirements for machinery and thus a greater level of safety. It would also allow the free movement of machines within the EU. But all this would only happen if the regulatory action at EU level laid down EU-wide requirements for ensuring the health and safety of machinery users, and allowing market enforcement at the national level according to the NLF principles. Regulatory action of this sort would: (i) help develop the internal (and digital) single market; (ii) provide legal certainty and a level playing field for the industry; and (iii) build a high level of trust among machinery users. 4.Objectives: What is to be achieved? 4.1.General objectives There are two general policy objectives to be pursued when revising the MD to address the problems outlined above. These two general policy objectives are discussed in the paragraphs below and follow those of the original MD. 1.General objective 1: Keep ensuring a high level of safety and protection for users of machinery and other people exposed to it, and build a high level of trust in innovative digital technologies for consumers and users. The EU has a competitive edge in world-leading industries such as manufacturing and robotics, producing more than a quarter of the world’s industrial and professional-service robots. With the emergence of new digital technologies such as AI and the IoT, the EU must remain competitive in a transforming global market. Emerging digital technologies are increasingly gaining a foothold not only in consumer applications but also at commercial/industrial level, where they can bring new degrees of efficiency and productivity. With this general objective, the revision of the MD aims to ensure that the level of safety for traditional machinery is the same as that for machinery using emerging technologies which are being developed or will be developed in the future. 2.General objective 2: Keep ensuring the good functioning of the single market, including the digital single market. Create a level playing field for economic operators and preserve the competitiveness of the machinery sector in global digital markets. This objective is natural to the MD as it is a ‘total harmonisation’ directive. The MD is based on Article 114 TFEU and on the ‘new approach’ that sets the safety requirements that products must satisfy to benefit from the free movement of products across the single market. The single market has brought benefits to businesses and the public through this free movement of products. Nevertheless, administrative obstacles and a lack of appropriate enforcement leave room for further improvement. This second general objective for the revision of the MD is to implement uniform rules across the EU so that: (i) manufacturers and other economic operators exploit the full potential of the single market; and (ii) consumers and the public benefit from the same level of high safety protection across the EU. 4.2.Specific objectives There are six specific objectives (SOs) for the revision of the MD, and they are set out in the paragraphs below. ØSO1: Cover new risks related to emerging digital technologies The aim of this objective is to ensure that the MD covers any potential new risks stemming from emerging technologies used in machinery to improve product safety for users and others exposed to machinery. This will help build a high level of trust in innovative digital technologies among consumers and users. It will also improve the functioning of the single market and the digital single market by ensuring the free movement of machinery within the EU. A revised MD covering potential new risks will create a level playing field for economic operators and will preserve the competitiveness of the machinery sector in global digital markets. And addressing challenges stemming from the use of emerging technologies in machinery has another benefit: it can ensure the desired level of safety in both current market developments and future trends, making the MD conducive to technological progress in digitalisation. ØSO2: Ensure coherent interpretation of the scope and definitions and improve safety for traditional technologies This specific objective aims at improving the legal clarity of some major concepts and definitions in the current text of the MD. This will: (i) guarantee that interpretations are consistent across the EU; and (ii) help create a level playing field for economic operators. It will also ensure the desired level of safety across the EU. Adapting certain definitions will help to reduce uncertainties in the implementation of the Directive, thus reducing cross-border trade barriers and compliance costs, among other benefits. ØSO3: Reassess machines considered as ‘high risk’ and reassess related conformity procedures This specific objective relates in particular to the general objective of ensuring a high level of safety. It does so by reassessing the machines considered as high risk, and the conformity procedures that manufacturers of high-risk machines must follow. ØSO4: Reduce paper-based requirements for documentation The aim of this objective is to ensure that the MD is as efficient as possible, minimising administrative burden where feasible. Revising the allowed format (from paper to digital) for manuals would entail economic benefits, such as savings on printing costs for manufacturers. It would also bring environmental benefits, such as reduced paper consumption and a decrease in carbon footprint. ØSO5: Ensure coherence with other product-safety legislation Coherence with the wider EU legislative framework will improve enforcement of the legislation, thus leading to safety benefits. In addition, it will help economic operators to manage their activities more effectively and be more competitive in global markets. This improved coherence will provide further simplification, particularly for those machines that are covered by different NLF legislative acts. Together with the new mechanisms for enforcement and compliance provided for in the Commission’s ‘goods package’, a revised MD is expected to provide a clearer legal framework. Further simplification of the MD through its revision would decrease barriers to trade and cut the social costs of accidents by strengthening market-surveillance activities. It would also promote the removal of non-compliant machinery from the market.

ØSO6: Avoid divergences in interpretation derived from transposition This specific objective aims to reduce the shortcomings of different national transpositions of the MD in Member States, thus improving the legal clarity of the MD. 5.What are the available policy options? Four policy options were considered. They are set out in the bullet points below. -Option 0 - Baseline: The baseline scenario is ‘no action’. This option would leave the standardisation process to develop as usual, without any particular focus on risks stemming from emerging technologies, and with no particular focus on areas for improvement related to traditional technologies. It would also include revision of the Guide following the ordinary process (discussions among stakeholders and decision taken only by consensus). -Option 1 - Self regulation by industry and changes to the Guide: This option would make no changes to the current act. Instead, clarifications would be introduced in the Guide. The Commission would push for consensus on: (i) scope and definitions; (ii) reducing paper-based documentation; (iii) clarifications on existing high-risk machinery; (iv) better coherence with other pieces of NLF product-safety legislation; and (v) fewer divergences in interpretations in the various Member States. On this last point, this option would also involve setting up dedicated sessions of the Machinery Expert Group. New risks stemming from emerging technologies (as well as certain risks from traditional technologies) would be addressed by issuing a new Commission standardisation request, within the boundaries of the current legal text. -Option 2 - Burden minimisation: This option would focus on clarifying the legal text and achieving simplification. To this end, this option would change the current MD to increase legal clarity in scope and definitions. It would also achieve simplification by: (i) allowing digital documentation in the legal text; (ii) aligning the MD to the NLF; and (iii) avoiding divergence in interpretations by converting the MD into a regulation. Changes to the current act would also include an empowerment to the Commission for reviewing in the future the list of high-risk machines under certain criteria. However, all this would be done without adaptations of the safety requirements for products, and thus with no changes in the manufacturers’ obligations for designing and manufacturing the machinery. As a result, the following four annexes of the MD would remain unchanged: (i) Annex I: safety requirements; (ii) Annex IV: high-risk machinery; (iii) Annex V: indicative list of safety components; and (iv) Annex VII technical-file descriptions. The new risks stemming from emerging technologies (as well as certain risks from traditional technologies) would be addressed by issuing a dedicated Commission standardisation request, within the boundaries of the current legal text. This would be complemented by the issuance of a new Commission standardisation request, within the boundaries of the current safety requirements in legal text. -Option 3 - Burden minimisation and enhanced safety: This option is the most ambitious and would strive for a better safety while taking advantage of all burden reduction possibilities. To this end, this option would change the current MD to increase legal clarity in scope and definitions. It would also achieve simplification by: (i) allowing digital documentation; (ii) aligning the MD to the NLF; and (iii) avoiding divergences in interpretations by converting the MD into a regulation. This option would also include an empowerment to the Commission for reviewing the current list of machines presenting high risks to new market developments in this area, remove the internal check option for the conformity assessment of the high risk machines, and make a first adaptation of the list of high risk machines. In addition, it would also adapt the safety requirements of Annex I with which manufacturers must comply when designing and manufacturing machinery, to address risks stemming from emerging technologies, as well as specific risks from traditional technologies. This would be complemented by the issuance of a new Commission standardisation request, taking into account any new and/or revised safety requirements in the legal text. Changes to the current act would also include: (i) a limited update of the list of high-risk machines in Annex IV; (ii) making it possible to adopt a delegated act to further review the list in the future under certain criteria; and (iii) making mandatory the involvement of a third party in the conformity assessment for high-risk machines. Additional changes would be planned for Annex V: indicative list of safety components, and Annex VII: technical-file descriptions. 5.1.What is the baseline from which options are assessed? Policy Option 0 is the current baseline scenario for the revision, against which the potential impacts of the policy options are measured. It consists in no EU action, meaning no change to the current regulatory framework. This option would include the usual standardisation process, without any particular focus on the gaps identified. It would also include the normal process of revision to the Guide, which requires consensus by all stakeholders and is therefore limited to minimum changes. This would lead to the continuation and consolidation of the shortcomings identified in the evaluation of the MD, and the effects of these shortcomings, as described in Chapter 2.3 of this report. The baseline option is not the current state but the state that would develop without any additional EU action. 5.2.Description of the policy options Policy Options 0 to 3 address all specific objectives in ways that may gradually present higher compliance costs but that may also be more ambitious. These four options all tackle the problems to some extent. It could be said that they evolve from: (i) doing nothing (PO0); to (ii) purely ‘soft law’ (PO1); to (iii) a mix of ‘soft law’ and ‘hard law’ (PO2) that would revise the current act without changes to the obligations of manufacturers; to (iv) a ‘hard law’ option (PO3) that would revise the current act with some clarifications and additions of new obligations for manufacturers when designing and producing machinery. The ‘hardest law’ option (complete overhaul of the current act) was discarded from the beginning, as explained in Chapter 5.3. Following this logic, each specific objective can be addressed from a ‘softer’ or a ‘harder’ approach. However, the extent to which these approaches meet the objectives may vary. The bullet points below set out different policy options that could be taken for each specific objective. ·SO1 – Cover new risks related to emerging digital technologies: oby the usual standardisation process (PO0); oby issuing a new Commission standardisation request (PO1, PO2); oby adapting the safety requirements in the MD, followed by a new Commission standardisation request (PO3). ·SO2 – Ensure coherent interpretation of the scope and definitions and improve safety for traditional technologies:*

oby revising the Guide following the normal process (PO0); oby revising the Guide with a push for consensus (PO1); oby adapting the legal text (PO2, PO3). ` *Approaches for traditional technologies are the same as in SO1 ·SO3 – Reassess machines considered as high risk and reassess related conformity-assessment procedures: oby revising the Guide following the normal process (PO0); oby revising the Guide with a push for consensus (PO1); oby adapting the legal text to allow a delegated act for reviewing in the future the list of high-risk machines under certain criteria (PO2); oby updating the list of high-risk machines in Annex IV, allowing the adoption of a delegated act for future updates under certain criteria, and by making it mandatory to have third-party involvement in the conformity assessment (PO3). ·SO4 – Reduce paper-based requirements for documentation: oby revising the Guide following the normal process (PO0); oby revising the Guide with a push for consensus (PO1); oby adapting the legal text to allow digital documentation (PO2, PO3). ·SO5 – Ensure coherence with other product-safety legislation: oby revising the Guide following the normal process (PO0); oby revising the Guide with a push for consensus (PO1); oby adapting the legal text to align it to the NLF (PO2, PO3).

·SO6 – Avoid differences in interpretation derived from transposition: oby revising the Guide following the normal process (PO0); oby dedicated sessions of the Machinery Expert Group and the revision of the Guide with a push for consensus (PO1); oby adapting the legal text to convert it into a regulation (PO2, PO3). The policy options are further explained in the following table:

Specific objectives (SOs) PO0 – Baseline PO1 – Self regulation by industry and changes to the Guide PO2 – Burden minimisation PO3 – Burden minimisation and improved safety SO1 - Improve safety by covering new risks related to emerging digital technologies Standardisation as usual Standardisation with focus on emerging technologies Clarifications and targeted new provisions in Annex I safety requirements + standardisation Address risks derived from human-robot coexistence in a shared space with and without direct collaboration Stakeholders tend to agree on narrower interpretations of the legal requirements. For this reason, whenever existing standards for different types of machinery are up for revision, such revised standards may or may not include the following areas depending on standardisers’ interpretation of the MD’s requirements on: ·risks derived from human-robot coexistence ·threats to cyber safety as external hazards ·risks derived from ML capabilities. A Commission standardisation request would be issued. However, stakeholders tend to agree on narrower interpretations of the legal requirements. Hence the extent to which actual improvements are required depends on how stakeholders involved in standardisation interpret the MD’s current requirements on: ·risks derived from human-robot coexistence ·threats to cyber safety as external hazard ·risks derived from ML capabilities. Adapt Annex I requirements in the section on risks related to moving parts to specify that the prevention of risks of contact leading to hazardous situations must be also adapted to include human-robot coexistence. Address machine cyber safety, i.e. the machine should be designed to go into ‘safe mode’ in the event of cyber attacks Clarify that ‘external hazards’ include cyber threats and add requirements in Annex I sections 1.1.9 and 1.2.1. on protection against corruption and safety and reliability. Machinery certified under the Cybersecurity Act will be presumed to be in conformity with the revised MD in so far as those requirements are covered by the cybersecurity certificate or statement of conformity. Address risks derived from ML capabilities and software updates potentially altering the behaviour of the machine Clarify in Annex I that, for machines with ML capabilities, manufacturers must be able to plan out or at least frame in the initial risk assessment all potential future states of the machine. This will make it possible to ensure that safety is guaranteed at all times during the whole life cycle of the machine. Explicitly cover software that has a safety function and is placed independently on the market Bring for discussion a potential clarification in the Guide that: ·‘logic units’ include software ·driverless machines are covered. Push for consensus on clarifying in the Guide that: ·‘logic units’ include software ·driverless machines are covered. Software with a safety function that is placed independently on the market would be added to the list of safety components in Annex V. Explicitly cover driverless machines (autonomous or remotely controlled) To cover autonomous machines and remote supervisory stations, the definitions in Annex I are amended to consider the possibility of ‘no driver’. Specific objectives (SOs) PO0 – Baseline PO1 – Self regulation by industry and changes to the Guide PO2 – Burden minimisation PO3 – Burden minimisation and improved safety SO2 – Ensure coherent interpretation of the scope and definitions and improve safety for traditional technologies Clarifications in the Guide following the normal process Clarifications in the Guide with a push for consensus Clarifying the legal text to provide legal certainty Remove inconsistency in the exclusion of low-voltage products, specifically when such products are equipped with radio equipment Bring for discussion a potential clarification in the Guide that: ·in the same way that certain products are excluded from the MD and fall under LVD, equivalent products using radio equipment and falling under the RED would also be excluded; ·there would be a potential enlargement in the exclusion of means of transport; ·machines for which the specific applications are not activated until a piece of software is uploaded (e.g. non-pre-programmed robots) are not PCM; ·new responsibilities when installing lifts are laid down; ·the concept of substantial modification is defined. Push for consensus on these topics in the Guide that: ·in the same way that certain products are excluded from the MD and fall under LVD, equivalent products using radio equipment and falling under RED would also be excluded; ·there would be a potential enlargement of the exclusion of means of transport; ·machines for which the specific applications are not activated until a piece of software is uploaded (e.g. non-pre-programmed robots) are not PCM; ·new responsibilities when installing lifts are laid down; ·the concept of substantial modification is defined. Make it explicit that in the same way that certain products are excluded from the MD and fall under the LVD, equivalent products using radio equipment that fall under the RED would also be excluded from the MD. Make more precise the exclusion of means of transport, currently limited only to means of transport by air, water and rail; and means of transport by road regulated in the EU type-approval legislation Clarify in the legal text that means of transport whose only objective is the transport of goods or persons (e.g. light vehicles such as electric-power-assisted cycles, hover boards, self-balancing scooters and multipurpose vehicles such as all-terrain vehicles and side-by-sides) are out of scope, regardless of their speed limits. Harmonise interpretation of the concept of PCM The legal text would clarify that those machines for which the specific applications are not activated until a piece of software is uploaded (e.g. non-pre-programmed robots) are not PCMs. Harmonise interpretation of responsibilities when installing lifts in some Member States Clarify in the legal text that that where the machinery cannot be assembled on the manufacturer’s premises, the appropriate measures must be taken at the place of use by the manufacturer ‘or on the manufacturers’ behalf’. Harmonise diverging approaches towards modifications of machinery during their use that are regarded as substantial, needing a new CE marking Add the definition of ‘substantial modification’ in the legal text.



Specific objectives (SOs) PO0 – Baseline PO1 – Self regulation by industry and changes to the Guide PO 2 – Burden minimisation PO3 – Burden minimisation and improved safety SO2 – Ensure coherent interpretation of the scope and definitions and improve safety for traditional technologies Standardisation as usual Standardisation with focus on identified gaps Clarifications and targeted new provisions in Annex I safety requirements + standardisation Allow alternative innovative solutions to the hold-to-run control devices obligatory for not completely enclosed carriers on slow-speed lifts Bring for discussion a clarification in the Guide that alternative solutions may be accepted if they provide an equivalent level of safety. Push for consensus on a clarification in the Guide that alternative solutions may be accepted if they provide an equivalent level of safety. Add the following to Annex I: if there is no risk to the people or the objects in the carrier of colliding or falling, and no other risks are added due to the upward and downward movements, then hold-to-run control devices may be replaced by other types authorising automatic stops at pre-selected positions. Prevent serious or fatal accidents that happen when ride-on mobile machinery (e.g. ride-on lawn mowers) rolls or tips over (such as when cutting the grass on a hill) and the restraint systems are not attached by their operators Stakeholders tend to agree on narrower interpretations of the legal requirements. Therefore, whenever existing standards for different types of machinery are up for revision, revised standards may or may not include the following areas depending on standardisers’ interpretation of the MD’s requirements on: ·warnings for the driver when the restraint system is not activated; ·avoiding overhead power lines; ·protection against exposure of workers to hazardous substances; ·vibration peaks. A Commission standardisation request would be issued. However, stakeholders tend to agree on narrower interpretations of the legal requirements. Hence the extent to which actual improvements are required depends on how stakeholders involved in standardisation interpret the MD’s current requirements on: ·warnings for the driver when the restraint system is not activated; ·avoiding overhead power lines; ·protection against exposure of workers to hazardous substances; ·vibration peaks. Add the following to Annex I: if the restraint system must keep the people in their seats and/or in the protective structure, and if such a system is not active, some kind of warning to the driver should be activated. Standards will be revised to provide for technical solutions to fulfil this requirement. Prevent serious or fatal accidents linked to mobile machinery hitting overhead power lines Add a requirement in Annex I for mobile machinery to avoid overhead power lines. Improve protection against exposure of workers to hazardous substances starting in the initial design phase of machinery Add a requirement in Annex I to tackle chemical risks in Sections 1.7.4.2: Contents of the instructions; 2.2.1: Portable handheld and/or hand-guided machinery; and 3.5.3: Emissions of hazardous substances. This requirement to tackle chemical risks only applies when hazardous substances are part of the intended use of the machinery. Prevent workers’ sicknesses and medical costs due to exposure to vibration peaks when using portable machinery Add a requirement in Annex I for portable handheld and hand-guided machinery in Annex I 2.2.1.1 Portable fixing and other impact machinery – General principles. The requirement is to ensure better measuring and declare values for vibration peaks.



Specific objectives (SOs) PO0 – Baseline PO1 – Self regulation by industry and changes to the Guide PO2 – Burden minimisation PO3 – Burden minimisation and improved safety SO3 – Reassess machines considered as high risk and reassess related conformity-assessment procedures Clarifications in the Guide following the normal process. No changes to the conformity-assessment procedures Clarifications in the Guide with a push for consensus. No changes to the conformity-assessment procedures Revision of the legal text to allow the adoption of a delegated act for reviewing the list of high-risk machines under certain criteria. No changes to the conformity-assessment procedures Revision of the legal text to allow the adoption of a delegated act for reviewing the list of high-risk machines under certain criteria. Removal of the conformity-assessment procedure based on internal-check options Clarify whether or not the concept of logic units includes all types of software including AI software. In addition, for types of machinery with a higher risk factor, a stricter certification procedure is desirable. Bring for discussion in the regular process for revising the Guide whether item 21 in the list of high-risk machine