35 Amendments of Nikolaj VILLUMSEN related to 2021/0105(COD)
Amendment 16 #
Proposal for a regulation
Recital 2
Recital 2
(2) The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Union economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance. Hence, in view of the forthcoming implementation of the new EU framework on health and safety at work 2021-2027 and its “ vision-zero” approach to work-related death, one of the objective of this regulation is to set out ambitious occupational health and safety requirements for machinery products.
Amendment 17 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) High-level of occupational health and safety (OHS) requirements is essential to ensure good working conditions and safe workplaces. Participation of workers and their representatives is crucial to protect workers’ health and safety, including when installing and operating machinery products. Social partners and workers’ representatives play an important role in implementing and monitoring OHS requirements at workplace level. They should be closely involved in all phases of risk assessment and occupational health and safety policies.
Amendment 18 #
Proposal for a regulation
Recital 23
Recital 23
(23) In order to ensure that machinery products, when placed on the market or put into service, do not entail health and safety risks for persons or domestic, in particular workers and users, or animals and do not cause harm to property and, where applicable, the environment, essential health and safety requirements should be set out which have to be met in order for the machinery products to be allowed on the market. Machinery products should comply with the essential health and safety requirements when placed on the market or put into service. Where such machinery products are subsequently modified, by physical or digital means, in a way that is not foreseen by the manufacturer and that may imply that it no longer meets the relevant essential health and safety requirements, the modification should be considered as substantial. For example, users may upload software in a machinery product that is not foreseen by the manufacturer and that may generate new risks. In order to ensure the compliance of such a machinery product with the relevant essential health and safety requirements, the person that carries out the substantial modification should be required to perform a new conformity assessment before placing the modified machinery product on the market or putting it into service. That requirement should only apply with respect to the modified part of the machinery product, provided that the modification does not affect the machinery product as a whole. In order to avoid an unnecessary and disproportionate burden, the person carrying out the substantial modification should not be required to repeat tests and produce new documentation in relation to aspects of the machinery product that are not impacted by the modification. It should be up to the person who carries out the substantial modification to demonstrate that the modification does not have an impact on the machinery product as a whole.
Amendment 19 #
Proposal for a regulation
Recital 24
Recital 24
(24) In the machinery sector, around 98 % of the companies are small or medium sized enterprises (SMEs). In order to reduce the regulatory burden on SMEs, notified bodies should adapt the fees for conformity assessments and reduce them proportionately to the specific interests and needs of SMEs. The nature and composition of the economic actors in the machinery sector should not lead to exemption of health and safety requirements full implementation.
Amendment 20 #
Proposal for a regulation
Recital 25
Recital 25
(25) Economic operators should be responsible for the compliance of machinery products with the requirements of this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as the health and safety of persons, , in particular workers and users, where appropriate, domestic animals and property and, where applicable, the environment, as well as the fair competition on the Union market.
Amendment 23 #
Proposal for a regulation
Recital 32
Recital 32
(32) It is necessary to ensure that machinery products from third countries entering the Union market comply with the requirements of this Regulation and do not pose a risk to the health and safety of persons, , in particular workers and users, where appropriate, domestic animals and property and, where applicable, the environment, and in particular, that appropriate conformity assessment procedures have been carried out by manufacturers with regard to such machinery products. Provision should therefore be made for importers to ensure that machinery products that they place on the market comply with the requirements of this Regulation and do not pose a risk to the health and safety of persons, where appropriate, domestic animals and property and, where applicable, the environment. For the same reason, provision should also be made for importers to ensure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the competent national authorities.
Amendment 24 #
Proposal for a regulation
Recital 35
Recital 35
(35) In view of ensuring the health and safety of the users of the machinery product, economic operators should ensure that all relevant documentation, such as the user's instructions, whilst containing precise and comprehensible information, is easily understandable, including translations in relevant workers and consumers’ mother tongues, takes into account technological developments and changes to end-user behaviour, and is as up to date as possible. When machinery products are made available on the market in packages containing multiple units, the instructions and information should accompany the smallest commercially available unit.
Amendment 25 #
Proposal for a regulation
Recital 39
Recital 39
(39) This Regulation should be limited to setting out the essentialaims to set out health and safety requirements, supplemented by a number of more specific requirements for certain categories of machinery products. In order to facilitate the assessment of conformity with those health and safety requirements it is necessary to provide for a presumption of conformity for machinery which is in conformity with harmonised standards that are developed and which references are published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council24 for the purpose of expressing detailed technical specifications of those requirements. _________________ 24 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC(52), 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
Amendment 26 #
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39 a) The Commission shall establish an early alert mechanism within the current inter-institutional structure to detect needed adjustments and revisions of existing machinery products OSH regulations, as well as to seek the concurrence of the European Agency for Safety and Health at work (EU-OSHA), especially in the context of digitalisation and Artificial Intelligence; the commission shall set up an injury database (IDB), covering all types of injuries linked to the use of machinery products, to monitor emerging risks; underlines the need to involve sectorial social partners into this mechanism since they are the first confronted with changing elements.
Amendment 27 #
Proposal for a regulation
Recital 40
Recital 40
(40) In the absence of relevant harmonised standards, the Commission should be able to establish technical specifications for the essential health and safety requirements. Recourse to technical specifications should be used as a fall back solution to facilitate the manufacturer’s obligation to comply with the health and safety requirements, for instance when the standardisation process is blocked due to a lack of consensus between stakeholders or there are undue delays in the establishment of a harmonised standard. Such delays could for example occur when the required quality is not reached.
Amendment 28 #
Proposal for a regulation
Recital 41
Recital 41
(41) Compliance with harmonised standards and with technical specifications established by the Commission should be voluntary but must be considered as minimum requirements. Alternative technical solutions should therefore be acceptable where compliance of the machinery with the relevant essential health and safety requirements is demonstrated in the technical file.
Amendment 29 #
Proposal for a regulation
Recital 42
Recital 42
(42) The essential hHealth and safety requirements should be satisfied in order to ensure that the machinery product is safe. Those requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements. Nevertheless, reasonable anticipation of potentially hazardous development and use is to be expected during the certification process of health and safety requirements.
Amendment 30 #
Proposal for a regulation
Recital 43
Recital 43
(43) In view of addressing the risks stemming from malicious third party actions that have an impact on the safety of machinery products, this Regulation should include essential health and safety requirements for which a presumption of conformity may be given to the appropriate extent by a certificate or statement of conformity issued under a relevant cybersecurity scheme adopted pursuant to and in accordance with Article 54(3) of Regulation (EU) 2019/881 of the European Parliament and of the Council25 . _________________ 25 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
Amendment 31 #
Proposal for a regulation
Recital 45
Recital 45
(45) The list of high-risk machinery in Annex I to Directive 2006/42/EC is so far based on the risk emanating from the intended use or any reasonably foreseeable misuse of that machinery. Nevertheless, the machinery sector embraces new ways of designing and constructing machinery products that may imply high risks, regardless of such intended use or any reasonably foreseeable misuse. For example, software ensuring safety functions of machinery based on artificial intelligence, embedded or not in the machinery product, should be classified as a high-risk machinery product due to the characteristics of artificial intelligence such as data dependency, opacity, autonomy and connectivity, which might increase very much the probability and severity of harm and seriously affect the safety of the machinery product. Furthermore, the market for software ensuring safety functions of machinery products based on artificial intelligence is so far very small, which results in a lack of experience and data. Therefore, the conformity assessment of software ensuring safety functions based on artificial intelligence and machine learning should be carried out by a third party.
Amendment 33 #
Proposal for a regulation
Recital 60
Recital 60
(60) Member States should take all appropriate measures to ensure that machinery products covered by this Regulation may be placed on the market only if, when properly installed and used for its intended purpose, or under conditions of use which can be reasonably foreseen, it does not endanger the health or safety of persons, in particular workers and users, and, where appropriate, domestic animals and property and, where applicable, the environment. Machinery products covered by this Regulation should be considered as non-compliant with the essential health and safety requirements laid down in this Regulation only under conditions of use, which could result from lawful and readily predictable human behaviour. Nevertheless, reasonable anticipation of potentially hazardous development and use should be foreseen to assess compliance with health and safety requirements.
Amendment 34 #
Proposal for a regulation
Recital 65
Recital 65
(65) In order to take into account technical progress and knowledge or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending the list of high-risk machinery products and the indicative list of safety components. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including social partners at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Amendment 35 #
Proposal for a regulation
Recital 66
Recital 66
(66) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission establishing technical specifications for the essential health and safety requirements, requesting the notifying Member State to take the necessary corrective measures in respect of a notified body that does not meet the requirements for its notification and establishing whether a national measure in respect of compliant machinery which a Member State finds to pose a risk to health and safety of persons, in particular workers and users, is justified. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council26 . _________________ 26 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 36 #
Proposal for a regulation
Recital 76
Recital 76
(76) It is necessary to provide for sufficient, but reasonable, time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application of this Regulation should therefore be deferred,
Amendment 38 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down requirements for the design and construction of machinery products to allow the making available on the market or putting into service of machinery products, and establishes rules on the free movement of machinery products in the Union ensuring a high level protection for all EU workers and citizens.
Amendment 51 #
Proposal for a regulation
Article 17 – paragraph 3 – subparagraph 1
Article 17 – paragraph 3 – subparagraph 1
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3). The European commission shall also consult relevant stakeholders, including social partners and trade unions.
Amendment 53 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
Member States may lay down requirements including trainings, sufficient resources and equipment to ensure that persons, including workers, are protected when installing and using machinery products, provided that such rules do not allow for modification of a machinery product in a way that is not compatible with this Regulation.
Amendment 63 #
Proposal for a regulation
Annex III – point 1 – paragraph 1 – point c
Annex III – point 1 – paragraph 1 – point c
(c) identify the hazards that may be generated by the machinery product and the associated hazardous situations, including hazards that may be generated during the lifecycle of the machinery product that are foreseeable at the time of placing of the machinery product on the market as an intended evolution of its fully or partially evolving behaviour or logic as a result of the machinery product designed to operate based on machine learning technologies, potentially with varying levels of autonomy. In this respect, where the machinery product integrates an artificial intelligence system, the machinery risk assessment shall consider the risk assessment for that artificial intelligence system that has been carried out pursuant to the Regulation … of the European Parliament and of the Council+ on a European approach for Artificial Intelligence+30 ; . _________________ 30+ OJ: Please insert in the text the number of the Regulation contained in document … and insert the number, date, title and OJ reference of that Regulation in the footnote
Amendment 73 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.2 – point e a (new)
Annex III – Part 1 – point 1.1 – point 1.1.2 – point e a (new)
(e a) The provisions set out in this annex must be implemented and interpreted with the concurrence of the European Agency for Safety and Health at work (EU-OSHA) in a way that fully secures the health and safety of workers or machinery products operators. Manufacturers and suppliers of the machinery products must always aim to provide highest possible OHS standards in order to ensure accident prevention and safe use of machinery products. Machinery product operators must be provided with adequate protective equipment to ensure safe use and maintenance.
Amendment 75 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – introductory part
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – introductory part
Under the intended conditions of use, the discomfort, fatigue and physical and psychological stresscognitive workload and faced by the operator shall be eliminated or reduced to the minimum possible, taking into account ergonomic principles such as:
Amendment 77 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point c
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point c
(c) avoiding a machine-determined work rate by allowing its adaptivity;
Amendment 79 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point e
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point e
(e) (a) adapting the human-machinery product interface, as well as the security systems and the emergency stop systems, to the foreseeable characteristics of the operators, including with respect to a machinery product with intended fully or partially evolving behaviour or logic that is designed to operate based on machine learning technologies, potentially with varying levels of autonomy;
Amendment 82 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point f
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point f
(f) adapting a machinery product with intended fully or partially evolving behaviour or logic that is designed to operate based on machine learning technologies, potentially with varying levels of autonomy to respond to people adequately and appropriately (verbally through words and non-verbally through gestures, facial expressions or body movement) and to communicate its planned actions (what it is going to do and why) to operators in a comprehensible manner.
Amendment 83 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point f a (new)
Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point f a (new)
(f a) communicating its planned actions (what it is going to do and why) to operators in a comprehensible manner.
Amendment 87 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 1
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 1
The machinery product shall be designed and constructed so that the connection to it of another device, via any feature of the connected device itself or via any remote device that communicates with the machinery product does not lead to aother unintended and potentially hazardous situafunctions.
Amendment 90 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point a
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point a
(a) they can withstand, where appropriate to the circumstances and the risks, the intended operating stresses and intended and unintended external influences, including malicious attempts from third parties to create aother unintended (and potentially hazardous situa) function;s
Amendment 93 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point d
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point d
(d) the safety functions cannot be changed beyond the limits defined by the manufacturer in the machinery product risk assessment. The establishment of the limits of the safety functions shall be part of the risk assessment performed by the manufacturer, including any modifications to the settings or rules generated by the machinery product or by operators, covering also thits development based on machine learning phase, which cannot go beyond the limits addressed in the risk assessment;
Amendment 95 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point g
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point g
(g) recording of data on the safety related decision-makmachine-learning process after the machinery product has been placed on the market or put into service, is enabled and that such data is retained for one year after its collection, exclusively to demonstrate the conformity of the machinery product with this Annex further to a reasoned request from a competent national authority.
Amendment 96 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 4 – point c
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 4 – point c
(c) modifications to the settings or rules, generated by the machinery product or by operators covering also the process of machine learning phase, shall be prevented, where such modifications may lead to hazardous situations;
Amendment 99 #
Proposal for a regulation
Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – introductory part
Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – introductory part
The prevention of risks of contact leading to hazard situations and the psychological stresscognitive workload that may be caused by the interaction with the machine shall be adapted to:
Amendment 108 #
Proposal for a regulation
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 3
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 3
The instructions may be provided in a digital format. However, upon purchaser’s request at the time of the purchase of the machinery product, the instructions shall be provided in paper format free of charge, for up to five years after the time of the purchase.