BETA

64 Amendments of Dita CHARANZOVÁ related to 2021/0105(COD)

Amendment 110 #
Proposal for a regulation
Recital 19
(19) Where machinery products pose risks that are addressed by the essential health and safety requirements set out in this Regulation but are also wholly or partly covered by other more specific Union legislation, this Regulation should not apply to the extent that those risks are covered by that other Union legislation. In other cases, machinery products may pose risks that are not covered by the essential health and safety requirements set out in this Regulation. For example, machinery products incorporating a Wi-Fi function or an artificial intelligence system may pose risks not addressed by the essential health and safety requirements set out in this Regulation, as this Regulation does not deal with risks specific to such systems. For artificial intelligence systems, the specific Union legislation on artificial intelligence should apply, since it contains specific safety requirements for high-risk artificial intelligence systems that pose significant risks to the health and safety or fundamental rights of persons. In order to avoid incoherence with regard to the type of conformity assessment and to avoid introducing requirements to perform two conformity assessments, those specific safety requirements should however be checked as part of the conformity assessment procedure set out in this Regulation. The essential health and safety requirements set out in this Regulation should in any case be applied in order to ensure, where applicable, the safe integration of the artificial intelligence system into the overall machinery, so as not to compromise the safety of the machinery product as a whole.
2021/11/10
Committee: IMCO
Amendment 111 #
Proposal for a regulation
Recital 21
(21) The evolution of the state of the art in the machinery sector has an impact on the classification of high-risk machinery products that potentially pose a high risk. In view of properly reflecting all high-risk machinery products potentially posing a high risk, criteria should be established for the assessment by the Commission of which machinery products should be included in the listAnnex I of thigh risk machinery productss Regulation, containing the list of machinery products that potentially pose a high risk.
2021/11/10
Committee: IMCO
Amendment 113 #
Proposal for a regulation
Recital 29
(29) The manufacturer or the manufacturer’s authorised representative should also ensure that a risk assessment is carried out for the machinery product, which the manufacturer wishes to place on the market. For this purpose, the manufacturer should determine which of the essential health and safety requirements that are applicable to the machinery product and in respect of which measures must be taken to address the risks that the machinery product may present. Where the machinery product integrates an artificial intelligence system, the risks identified during the risk assessment should include those risks that may appear during the machinery product’s lifecycle due to an intended evolution of its behaviour to operate with varying levels of autonomy. In this respect, where the machinery product integrates an artificial intelligence system, the risk assessment for the machinery product should consider the risk assessment for that artificial intelligence system that has been carried out pursuant to Regulation (EU) .../... of the European Parliament and of the Council23 . __________________ 23 + OJ: Please insert in the text the number of the Regulation contained in document ….
2021/11/10
Committee: IMCO
Amendment 118 #
Proposal for a regulation
Recital 34
(34) When placing machinery products on the market, the importer should indicate on the machinery product his or her name, registered trade name or registered trade mark, the e-mail address and the postal address at which he or she can be contacted. Exceptions should be provided for in cases where the size or nature of the machinery product does not allow it. This includes cases where the importer would have to open the packaging to put his or her name and address on the machinery product.
2021/11/10
Committee: IMCO
Amendment 120 #
Proposal for a regulation
Recital 45
(45) The list of high-risk machinery in Annex IV 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.
2021/11/10
Committee: IMCO
Amendment 126 #
Proposal for a regulation
Recital 50
(50) Manufacturers should bare responsible for certifying the conformity of their machinery products with this Regulation. Nevertheless, for certain types of machinery products that have a higher risk fto make sure that a conformity assessment of their machinery products is carried out in actcor, a stricter certification procedure requiring participation of a notified body should be requireddance with this Regulation.
2021/11/10
Committee: IMCO
Amendment 129 #
Proposal for a regulation
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-riskAnnex I 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 atwith expert levels and stakeholders. 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.
2021/11/10
Committee: IMCO
Amendment 155 #
Proposal for a regulation
Article 2 – paragraph 2 – point g a (new)
(ga) motor vehicles and their trailers as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that are approved according to Regulation (EU) No 2018/858, except for machinery mounted on those vehicles;
2021/11/10
Committee: IMCO
Amendment 158 #
Proposal for a regulation
Article 2 – paragraph 2 – point g b (new)
(gb) motor vehicles exclusively intended for competition;
2021/11/10
Committee: IMCO
Amendment 159 #
Proposal for a regulation
Article 2 – paragraph 2 – point g c (new)
(gc) assemblies of CE marked pressure equipment within the meaning of Directive 2014/68/EU;
2021/11/10
Committee: IMCO
Amendment 168 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
(3) ‘safety component’ means a physical or digital component, including software, of a machinery which servesproduct, except partly completed machinery, which is designed or intended to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endangers the safety of persons but which is not necessary in order for the machinery to function or may be substituted by normal components in order for the machinery to function;
2021/11/10
Committee: IMCO
Amendment 172 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
(13) ‘putting into service’ means the first use, for its intended purpose, in the Union, of a machinery product except for partly completed machinery;
2021/11/10
Committee: IMCO
Amendment 175 #
Proposal for a regulation
Article 3 – paragraph 1 – point 16
(16) ‘substantial modification’ means a modification of a machinery product, except for partly completed machinery, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer and as a result of which the compliance of the machinery product with the relevant essential health and safety requirements may be affected. A substantial modification is given if the remaining risk is increased by the modification of the machine under the application of all necessary protective measures;
2021/11/10
Committee: IMCO
Amendment 182 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18
(18) ‘instructions for use’ means the information provided by the manufacturer when the machinery product, except for partly completed machinery, is placed on the market or put into service to inform the user of the machinery product of the intended purpose and the proper use of that machinery product as well as information on any precautions to be taken when using or installing the machinery product, including information on the safety aspects;
2021/11/10
Committee: IMCO
Amendment 186 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28
(28) ‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to machinery products, except for partly completed machinery, have been fulfilled;
2021/11/10
Committee: IMCO
Amendment 191 #
Proposal for a regulation
Article 5 – title
High-risk mMachinery products referred to in Annex I
2021/11/10
Committee: IMCO
Amendment 194 #
Proposal for a regulation
Article 5 – paragraph 1
1. High-risk mMachinery products listed in Annex I shall be subject to a specific conformity assessment procedure, as referred to in Article 21(2).
2021/11/10
Committee: IMCO
Amendment 199 #
Proposal for a regulation
Article 5 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 45 to amend Annex I in view of technical progress and knowledge or new scientific evidence by including in the list of high-riskAnnex I machinery products a new machinery product or withdrawing an existing machinery product from that list, pursuant to the criteria laid down in paragraphs 3 and 4.
2021/11/10
Committee: IMCO
Amendment 203 #
Proposal for a regulation
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. 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.
2021/11/10
Committee: IMCO
Amendment 221 #
Proposal for a regulation
Article 10 – paragraph 10 a (new)
10a. Manufacturers shall provide users with information on security-related updates and identified cyber risks in a timely and reliable manner.
2021/11/10
Committee: IMCO
Amendment 222 #
Proposal for a regulation
Article 10 – paragraph 10 b (new)
10b. Manufacturers shall ensure access to stable and ongoing technical support over the normal lifetime of a machinery product, if its safety depends on software.
2021/11/10
Committee: IMCO
Amendment 238 #
Proposal for a regulation
Article 17 – paragraph 3 – point a
(a) no reference to harmonised standards covering the relevant essential health and safety requirements is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no candidate standard is expected to be published;
2021/11/10
Committee: IMCO
Amendment 243 #
Proposal for a regulation
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 in the standardisation procedure or the request has cannot been accepted by any of the European standardisation organisations due to problems that cannot be solved.
2021/11/10
Committee: IMCO
Amendment 252 #
Proposal for a regulation
Article 18 – paragraph 2
2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annexes VI, VII, VIII and IX and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the machinery product is placed on the market or is made available on the market.
2021/11/10
Committee: IMCO
Amendment 257 #
Proposal for a regulation
Article 21 – paragraph 2 – introductory part
2. Where the machinery product is a high-risk machinery product listed in Annex I, the manufacturer or the manufacturer’s authorised representative and the person who has carried out a substantial modification to the machinery product shall apply one of the following procedures:
2021/11/10
Committee: IMCO
Amendment 259 #
Proposal for a regulation
Article 21 – paragraph 2 – point -a (new)
(-a) the internal production control procedure (module A) set out in Annex VI;
2021/11/10
Committee: IMCO
Amendment 263 #
Proposal for a regulation
Article 21 – paragraph 3
3. Where the machinery product is not a high-risk machinery product listed in Annex I, the manufacturer or the manufacturer’s authorised representative and the person who has made a substantial modification to the machinery product shall apply the internal production control procedure (module A) set out in Annex VI.
2021/11/10
Committee: IMCO
Amendment 268 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
1. The manufacturer of partly completed machinery or the manufacturer’s authorised representative shall, before placing partly completed machinery on the market, ensure that the following documents are drawn up in paper or digital form:
2021/11/10
Committee: IMCO
Amendment 302 #
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1
Directive 2006/42/EC is repealed with effect from … [3048 months after the date of entry into force of this Regulation].
2021/11/10
Committee: IMCO
Amendment 306 #
Proposal for a regulation
Article 50 – paragraph 1
1. Member States shall not until … [4260 months after the date of entry into force of this Regulation] impede the making available on the market of machinery which was placed on the market in conformity with Directive 2006/42/EC before … [the date of entry into force of this Regulation]. However, Chapter VI of this Regulation shall apply mutatis mutandis to such machinery instead of Article 11 of that Directive, including machinery for which a procedure has already been initiated under Article 11 of Directive 2006/42/EC as from … [the date of entry into force of this Regulation].
2021/11/10
Committee: IMCO
Amendment 308 #
Proposal for a regulation
Article 50 – paragraph 2
2. EC type-examination certificates and approval decisions issued in accordance with Article 14 of Directive 2006/42/EC shall remain valid until … [4260 months after the date of entry into force of this Regulation], unless they expire before that date.
2021/11/10
Committee: IMCO
Amendment 309 #
Proposal for a regulation
Article 51 – paragraph 1
1. By … [5472 months after the date of entry into force of this Regulation] and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public.
2021/11/10
Committee: IMCO
Amendment 310 #
Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 1– point b
(b) the conformity assessment procedure applicable to high-risk machinery products listed in Annex I.
2021/11/10
Committee: IMCO
Amendment 312 #
Proposal for a regulation
Article 52 – paragraph 2
It shall apply from … [3048 months after the date of entry into force of this Regulation].
2021/11/10
Committee: IMCO
Amendment 314 #
Proposal for a regulation
Annex I – subheading 1
HIGH-RISK MACHINERY PRODUCTSCategories of machinery products to which one of the procedures referred to in Article 5 and 21 must be applied
2021/11/10
Committee: IMCO
Amendment 319 #
Proposal for a regulation
Annex I – point 24
24. Software ensuring safety functions, including AI system, including AI systems, fulfilling safety functions.
2021/11/10
Committee: IMCO
Amendment 324 #
Proposal for a regulation
Annex I – point 25
25. Machinery embedding AI systems ensuring safety functions, if these AI systems have not already been subjected to a conformity assessment.
2021/11/10
Committee: IMCO
Amendment 331 #
Proposal for a regulation
Annex II – point 18
18. Software ensuring safety functions, including AI system, including AI systems, fulfilling safety functions.
2021/11/10
Committee: IMCO
Amendment 334 #
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
By the iterative process of risk assessment and risk reduction referred to in the first subparagraph, the manufacturer or his or her authorised representative shall:
2021/11/10
Committee: IMCO
Amendment 335 #
Proposal for a regulation
Annex III – point 2
2. The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery product in question when it is used under the conditions foreseen by the manufacturer or his or her authorised representative or in foreseeable abnormal situations. However, the principles of safety integration established in section 1.1.2 and the obligations concerning marking of machinery products and instructions referred to in sections 1.7.3 and 1.7.4 apply in all cases.
2021/11/10
Committee: IMCO
Amendment 340 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.2 – point e
(e) A machinery product shall be designed and constructed in such a way that it is possible for the user to test the safety functions, and t where applicable. The machinery product shall be supplied with all the special equipment and accessories, and where appropriate, with the description of specific functional test procedures, essential to enable it to be tested, adjusted, maintained and used safely.
2021/11/10
Committee: IMCO
Amendment 348 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 point f
(f) adapting a machinery product with intended fully or partially evolving behaviour or logic that is designed to operate 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.
2021/11/10
Committee: IMCO
Amendment 359 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 5
The machinery product shall collect evidence of a legitimate or illegitimate intervention in the software or a modification of the software installed on the machinery product or its configuration.deleted
2021/11/10
Committee: IMCO
Amendment 364 #
Proposal for a regulation
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 a hazardous situation;
2021/11/10
Committee: IMCO
Amendment 372 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 6
For autonomous mobile machinery products, the control system shall be designed to perform the safety functions by itself as set out in this section, even when actions are ordered by using a remote supervisory function.deleted
2021/11/10
Committee: IMCO
Amendment 381 #
Proposal for a regulation
Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5
The machinery product with fully or partially evolving behaviour or logic that is designed to operate with varying levels of autonomy shall be adapted to respond to people adequately and appropriately (verbally through words or nonverbally through visual or audio signals, 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.
2021/11/10
Committee: IMCO
Amendment 385 #
Proposal for a regulation
Annex III – Part 1 – point 1.6 – point 1.6.2 – paragraph 2
In the case of machinery into which persons shall enter for operation, adjustment, maintenance or cleaning, the machinery accesses shall be dimenesiogned and adapted for the use of rescue equipment in such a way that a timely rescue of the persons is guaranteedin a way that takes emergency rescue into account.
2021/11/10
Committee: IMCO
Amendment 389 #
Proposal for a regulation
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 4 – point c
(c) be presented in a format that makes it is possible for the end user to download the instructions throughout the expected lifetime of the machinery product and save them on an electronic device so that he or she can access them at all times, in particular during a breakdown of the machine. This requirement also applies to a machinery product where the instruction manual is embedded in the software of the machinery product. General principles for the drafting of instructions
2021/11/10
Committee: IMCO
Amendment 397 #
Proposal for a regulation
Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point b
(b) the mean value of the peak amplitude of the acceleration from repeated shock vibrations, to which the hand-arm system is subjected;deleted
2021/11/10
Committee: IMCO
Amendment 402 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 1
Where there is a risk that operators or other persons transported by the machinery may be crushed between parts of the machinery and the surroundings should the machinery roll or tip over, in particular for machinery equipped with a protective structure referred to in section 3.4.3 or 3.4.4, the machinery shall be designed or equipped with a restraint system so as to keep the persons in their seats or in the protective structure, without restricting movements necessary for operations or movements relative to the structure caused by the suspension of the seats. Such restraint systems or provision shall not be fitted if they increase the risktake ergonomic principles into account and must not be fitted if they increase the risk. When the restraint system is not activated, the machine shall be prevented from moving if there is a considerable risk of rolling or tipping over.
2021/11/10
Committee: IMCO
Amendment 407 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2
A visual or audible signal shall be provided at the driving position alerting the driver when the driver is in the driving position and not using the restraint system is not active.
2021/11/10
Committee: IMCO
Amendment 411 #
Proposal for a regulation
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. ThisWhen a supervisory control function is needed as a protective measure on autonomous mobile machinery products, that function shall allow thbe osperator to remotely receive information from the machine. Tcific to its autonomous operation. Where the supervisory control function shall only allow actions to stop and to start remotely the machine. 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 operationalows a remote action from the operator, the function shall be designed in such a way that that action does not increase any risk.
2021/11/10
Committee: IMCO
Amendment 413 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 2
The information the driver receives from the machine when the supervisory control function is active shall enable the driver to have a complete and accurate view of the operation, movement and safe positioning of the machine in its travel and working area.deleted
2021/11/10
Committee: IMCO
Amendment 414 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 3
This information shall alert the driver of the occurrence of unforeseen or dangerous situations present or impending, which require driver’s intervention.deleted
2021/11/10
Committee: IMCO
Amendment 415 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 4
If the supervisory control function is not active, the machinery shall not be able to operate.deleted
2021/11/10
Committee: IMCO
Amendment 416 #
Proposal for a regulation
Annex III – Part 3 – point 3.3 – point 3.3.3 – paragraph 6 – introductory part
Autonomous mobile machinery products shall comply with anyone or both of the following conditions:
2021/11/10
Committee: IMCO
Amendment 426 #
Proposal for a regulation
Annex III – Part 3 – point 3.6 – point 3.6.3 – point 3.6.3.1 – paragraph 1 – point b
(b) the mean value of the peak amplitude of the acceleration from repeated shock vibrations, to which the hand-arm system is subjected;deleted
2021/11/10
Committee: IMCO
Amendment 427 #
Proposal for a regulation
Annex III – Part 4 – point 4.1 – point 4.1.3 – paragraph 1
When lifting machinery or lifting accessories are placed on the market or are first put into service, the manufacturer or his or her authorised representative shall ensure, by taking appropriate measures or having them taken, that the machinery or the lifting accessories which are ready for use — whether manually or power- operated — can fulfil their specified functions safely.
2021/11/10
Committee: IMCO
Amendment 428 #
Proposal for a regulation
Annex III – Part 4 – point 4.3 – point 4.3.1 – paragraph 1
Each length of lifting chain, rope or webbing not forming part of an assembly shall bear a mark or, where this is not possible, a plate or irremovable ring bearing the name and address of the manufacturer or his or her authorised representative and the identifying reference of the relevant certificatedeclaration of conformity.
2021/11/10
Committee: IMCO
Amendment 430 #
Proposal for a regulation
Annex IV – Part A – paragraph 2 – point a
(a) a complete description of the machinery product and of its intended use;
2021/11/10
Committee: IMCO
Amendment 432 #
Proposal for a regulation
Annex V – point 3
3. The address where the machinery product is permanently installed only for lifting machinery products for lifting persons from one level of a building to another level installed in a building or a structure:
2021/11/10
Committee: IMCO
Amendment 433 #
Proposal for a regulation
Annex V – point 6
6. The object of the declaration described in point 45 is in conformity with the relevant Union harmonisation legislation:
2021/11/10
Committee: IMCO
Amendment 434 #
Proposal for a regulation
Annex VII – point 2
2. EU type-examination shall be 2. carried out by assessment of the adequacy of the technical design of the machinery product through examination of the technical documentation, plus examination of a physical or digital specimen of the machinery product that is representative of the production envisaged (production type).
2021/11/10
Committee: IMCO
Amendment 438 #
Proposal for a regulation
Annex X – paragraph 2 a (new)
The assembly instructions are provided by the manufacturer in digital form.
2021/11/10
Committee: IMCO