64 Amendments of Dita CHARANZOVÁ related to 2021/0105(COD)
Amendment 110 #
Proposal for a regulation
Recital 19
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.
Amendment 111 #
Proposal for a regulation
Recital 21
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.
Amendment 113 #
Proposal for a regulation
Recital 29
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 ….
Amendment 118 #
Proposal for a regulation
Recital 34
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.
Amendment 120 #
Proposal for a regulation
Recital 45
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.
Amendment 126 #
Proposal for a regulation
Recital 50
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.
Amendment 129 #
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-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.
Amendment 155 #
Proposal for a regulation
Article 2 – paragraph 2 – point g a (new)
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;
Amendment 158 #
Proposal for a regulation
Article 2 – paragraph 2 – point g b (new)
Article 2 – paragraph 2 – point g b (new)
(gb) motor vehicles exclusively intended for competition;
Amendment 159 #
Proposal for a regulation
Article 2 – paragraph 2 – point g c (new)
Article 2 – paragraph 2 – point g c (new)
(gc) assemblies of CE marked pressure equipment within the meaning of Directive 2014/68/EU;
Amendment 168 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
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;
Amendment 172 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
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;
Amendment 175 #
Proposal for a regulation
Article 3 – paragraph 1 – point 16
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;
Amendment 182 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18
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;
Amendment 186 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28
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;
Amendment 191 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Amendment 194 #
Proposal for a regulation
Article 5 – paragraph 1
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).
Amendment 199 #
Proposal for a regulation
Article 5 – paragraph 2
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.
Amendment 203 #
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. 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 221 #
Proposal for a regulation
Article 10 – paragraph 10 a (new)
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.
Amendment 222 #
Proposal for a regulation
Article 10 – paragraph 10 b (new)
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.
Amendment 238 #
Proposal for a regulation
Article 17 – paragraph 3 – point a
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;
Amendment 243 #
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 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.
Amendment 252 #
Proposal for a regulation
Article 18 – paragraph 2
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.
Amendment 257 #
Proposal for a regulation
Article 21 – paragraph 2 – introductory part
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:
Amendment 259 #
Proposal for a regulation
Article 21 – paragraph 2 – point -a (new)
Article 21 – paragraph 2 – point -a (new)
(-a) the internal production control procedure (module A) set out in Annex VI;
Amendment 263 #
Proposal for a regulation
Article 21 – paragraph 3
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.
Amendment 268 #
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
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:
Amendment 302 #
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1
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].
Amendment 306 #
Proposal for a regulation
Article 50 – paragraph 1
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].
Amendment 308 #
Proposal for a regulation
Article 50 – paragraph 2
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.
Amendment 309 #
Proposal for a regulation
Article 51 – paragraph 1
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.
Amendment 310 #
Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 1– point b
Article 51 – paragraph 2 – subparagraph 1– point b
(b) the conformity assessment procedure applicable to high-risk machinery products listed in Annex I.
Amendment 312 #
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
It shall apply from … [3048 months after the date of entry into force of this Regulation].
Amendment 314 #
Proposal for a regulation
Annex I – subheading 1
Annex I – subheading 1
Amendment 319 #
Proposal for a regulation
Annex I – point 24
Annex I – point 24
24. Software ensuring safety functions, including AI system, including AI systems, fulfilling safety functions.
Amendment 324 #
Proposal for a regulation
Annex I – point 25
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.
Amendment 331 #
Proposal for a regulation
Annex II – point 18
Annex II – point 18
18. Software ensuring safety functions, including AI system, including AI systems, fulfilling safety functions.
Amendment 334 #
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
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:
Amendment 335 #
Proposal for a regulation
Annex III – point 2
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.
Amendment 340 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.2 – point e
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.
Amendment 348 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.6 point f
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.
Amendment 359 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 5
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 5
Amendment 364 #
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 a hazardous situation;
Amendment 372 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 6
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 6
Amendment 381 #
Proposal for a regulation
Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5
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.
Amendment 385 #
Proposal for a regulation
Annex III – Part 1 – point 1.6 – point 1.6.2 – paragraph 2
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.
Amendment 389 #
Proposal for a regulation
Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 4 – point c
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
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
Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point b
Amendment 402 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 1
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.
Amendment 407 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2
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.
Amendment 411 #
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
Amendment 413 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 2
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 2
Amendment 414 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 3
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 3
Amendment 415 #
Proposal for a regulation
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 4
Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 4
Amendment 416 #
Proposal for a regulation
Annex III – Part 3 – point 3.3 – point 3.3.3 – paragraph 6 – introductory part
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:
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
Annex III – Part 3 – point 3.6 – point 3.6.3 – point 3.6.3.1 – paragraph 1 – point b
Amendment 427 #
Proposal for a regulation
Annex III – Part 4 – point 4.1 – point 4.1.3 – paragraph 1
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.
Amendment 428 #
Proposal for a regulation
Annex III – Part 4 – point 4.3 – point 4.3.1 – paragraph 1
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.
Amendment 430 #
Proposal for a regulation
Annex IV – Part A – paragraph 2 – point a
Annex IV – Part A – paragraph 2 – point a
(a) a complete description of the machinery product and of its intended use;
Amendment 432 #
Proposal for a regulation
Annex V – point 3
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:
Amendment 433 #
Proposal for a regulation
Annex V – point 6
Annex V – point 6
6. The object of the declaration described in point 45 is in conformity with the relevant Union harmonisation legislation:
Amendment 434 #
Proposal for a regulation
Annex VII – point 2
Annex VII – point 2
Amendment 438 #
Proposal for a regulation
Annex X – paragraph 2 a (new)
Annex X – paragraph 2 a (new)
The assembly instructions are provided by the manufacturer in digital form.