31 Amendments of Kateřina KONEČNÁ related to 2021/0105(COD)
Amendment 106 #
Proposal for a regulation
Recital 15
Recital 15
(15) Since the purpose of this Regulation is to address the risks stemming from the machinery function and not the transport of goods or persons, it should not apply to vehicles which only objective is the mere transport of goods or persons on road, by air, on water or on rail networks, regardless of the speed limits. However, machinery mounted on such vehicles or mobile machinery intended for facilitating works such as in construction sites or warehouses e.g. dumpers and forklifts, have a machinery function and should therefore be covered by this Regulation, as well as specific equipment for use in fairgrounds or amusement parks, together with e-bikes, e-scooters and similar means of transport. Since agricultural and forestry vehicles and two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, fall within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council19 and Regulation (EU) No 168/2013 of the European Parliament and of the Council20 respectively, they should be excluded from the scope of this Regulation. __________________ 19 Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1). 20 Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
Amendment 119 #
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 on an exceptional basis and in due respect of the standardisation organisations´ role and functioning. 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 121 #
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 should be carried out by a third party.
Amendment 131 #
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 of protection for EU workers and citizens.
Amendment 132 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) lifting accessories, including lifting appliances whose speed is not greater than 0.15 m/s’;
Amendment 134 #
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) specific equipment for use in fairgrounds or amusement parks;
Amendment 138 #
Proposal for a regulation
Article 2 – paragraph 1 – point g b (new)
Article 2 – paragraph 1 – point g b (new)
(gb) vehicles which have as their objective the transport of goods or persons by road, not covered by Regulation (EU) No 168/2013;
Amendment 141 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
Amendment 143 #
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
Amendment 201 #
Proposal for a regulation
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
A machinery product shall be included in the list of high-risk machinery products in Annex I if it poses a risk to human health taking into account its design and intended purpose and foreseeable use. A machinery product shall be withdrawn from the list of high-risk machinery products in Annex I if it no longer poses such risk. The risk posed by a certain machinery product shall be established based on the combination of the probability of occurrence of harm and the severity of that harm.
Amendment 207 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. A Member State which has concerns about a machinery product being listed or not listed in Annex I shall immediately inform the Commission of its concerns and provide reasons in support thereof. If at least three Member States request to list a new machinery product in Annex I, the Commission shall without delay analyse this request.
Amendment 209 #
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article 6a Pan-European Injury Database 1. A Pan-European Injury Database (IDB), which would cover all types of injuries involving consumer products shall be set up and coordinated by the European Commission. 2. The relevant market surveillance authorities established by the Member States shall contribute to the establishment of the database and deliver injury data to the database, based on a common methodology, comprehensive and in accordance with European and national laws on data protection. 3. The Commission shall support the co-ordination of the collection of data from Member States and the operation of the database.
Amendment 244 #
Proposal for a regulation
Article 17 – paragraph 3 – point b
Article 17 – paragraph 3 – point b
(b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements and there are undue delays for over a year in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations.
Amendment 247 #
Proposal for a regulation
Article 17 – paragraph 3 – subparagraph 2
Article 17 – paragraph 3 – subparagraph 2
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3). The Commission shall also consult relevant stakeholders, especially trade unions and consumer organizations.
Amendment 270 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
Member States mayshall lay down requirements including specific trainings and sufficient resources to ensure that persons, including workers, are protected when installing and using machinery products, provi in ordedr that such rules do not allow for modification of a machinery product in a way that is not compatible with this Regulationo guarantee a high level of protection for EU workers and citizens.
Amendment 301 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. Member States shall lay down the rules on penalties and fines applicable to infringements by economic operators of this Regulation and shall take all measures necessary to ensure that they are enforced. The penalties and fines provided for shall be effective, proportionate and dissuasive and may include criminal penalties for serious infringements. Fines shall amount to at least 3% of the economic operator´s worldwide turnover of the preceding fiscal year for serious breaches of this regulation.
Amendment 311 #
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
It shall apply from … [3024 months after the date of entry into force of this Regulation].
Amendment 338 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.2 – point a
Annex III – Part 1 – point 1.1 – point 1.1.2 – point a
(a) A machinery product shall be designed and constructed so that it is fit for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under threasonably foreseeable conditions foreseen of use but also taking into account any reasonably foreseeable misuse thereof. The aim of protective measures shall be to eliminate any risk throughout the foreseeable lifetime of the machinery product including the phases of transport, assembly, dismantling, disabling and scrapping.
Amendment 344 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – introductory part
Annex III – Part 1 – point 1.1 – point 1.1.6 – introductory part
Under the intended conditions of use, the discomfort, fatigue and physical and psychological stresscognitive workload faced by the operator shall be reduceliminated to the minimum possible, taking into account ergonomic principles such as:
Amendment 345 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – point c
Annex III – Part 1 – point 1.1 – point 1.1.6 – point c
(c) avoiding a machine-determined work rate by allowing its adaptivity;
Amendment 346 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 – point e
Annex III – Part 1 – point 1.1 – point 1.1.6 – point e
(e) 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 with varying levels of autonomy;
Amendment 352 #
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 situa) function.s
Amendment 362 #
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) functions;
Amendment 366 #
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 371 #
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 373 #
Proposal for a regulation
Annex III – Part 1 – point 1.3 – point 1.3.7 – introductory part
Annex III – Part 1 – point 1.3 – point 1.3.7 – introductory part
1.3.7. Risks related to moving parts and psychological stresscognitive workload
Amendment 374 #
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 376 #
Proposal for a regulation
Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – point b
Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – point b
(b) human-machine interaccoexistence in a shared space with direct collaboration.
Amendment 386 #
Proposal for a regulation
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 2
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 2
By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his or her authorised representative may be supplied in only one official language of the Union which the specialised personnel speaks fluently and fully understands.
Amendment 387 #
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
Amendment 412 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 1
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 1
Autonomous mobile machinery products shall have a supervisory control function specific to the autonomous mode. This function shall allow the operator to remotely receive information from the machine. The supervisory control function shall only allow actions to stop and to start remotely the machine and must include a function which would allow the operator to bring the machinery into a secure state. It shall be designed and constructed to allow those actions only when the driver can see directly or indirectly the machine's movement and working area and the protective devices are operational.