32 Amendments of Carlo FIDANZA related to 2021/0105(COD)
Amendment 115 #
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 thosean appropriate guideline should be developed, in order to correctly evaluate possible further 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 assessmentThe guideline, defining risk assessment procedures for the machinery product including AI, should also take into account the risk assessment (with related terminology and risk levels) for thate 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 123 #
Proposal for a regulation
Recital 45 a (new)
Recital 45 a (new)
(45a) Nevertheless, provisions set out in Articles5(1) and 21(2) of this Regulation should apply only to AI systems with self- determining, evolving behaviour during normal operation. On the contrary, they should not apply to conventional software not capable to learn or evolve and programmed only to execute certain automated functions of machinery products.
Amendment 150 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) agricultural and forestry vehicletractors, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that fall within the scope of application of Regulation (EU) No 167/2013, with the exclusion of machinery mounted on those vehicles;
Amendment 170 #
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 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 181 #
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 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 and how to keep it operating safely and fit for purpose for its whole lifecycle;
Amendment 187 #
Proposal for a regulation
Article 3 – paragraph 1 – point 29
Article 3 – paragraph 1 – point 29
(29) ‘conformity assessment body’ means a body, natural or legal person with technical expertise that performs conformity assessment activities, including calibration, testing, certification and inspection;
Amendment 210 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
Amendment 212 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
Where machinery products contain an artificial intelligence system, to which the essential health and safety requirements of Regulation (EU) …/… apply, this Regulation shall, in relation to that artificial intelligence system, only apply with regard to its safe integration into the overall machinery and only applies to artificial intelligence systems with self- determining, evolving behaviour or logic during normal operation, so as not to compromise the safety of the machinery product as a whole.
Amendment 215 #
Proposal for a regulation
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
1a. Manufacturers shall draw up recycling instructions for the buyer or company using the machine. Responsibility for recycling shall, however, fall to the company and/or users.
Amendment 241 #
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 the re are undue delays quested standard has not been developed within 5 years following the standardisation procedurerequest, on the basis of the complexity and the international context of the proposed standard, or the request has not been accepted by any of the European standardisation organisations.
Amendment 274 #
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
2. A conformity assessment body shall be established under national law of a Member State and have natural or legal personality and technical expertise.
Amendment 275 #
Proposal for a regulation
Article 28 – paragraph 3 – subparagraph 2
Article 28 – paragraph 3 – subparagraph 2
A body belonging to a business association, a professional body or professional federation representing undertakings involved in the design, manufacture, provision, assembly, use or maintenance of machinery products which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a conformity assessment body.
Amendment 300 #
Proposal for a regulation
Article 41 – paragraph 4 – subparagraph 1
Article 41 – paragraph 4 – subparagraph 1
Where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the machinery product being made available on their national market, to withdraw the machinery product from that market or to recall itwithin the specified period or where the non- compliance or the risk referred to in paragraph 1 persists, the market surveillance authorities shall ensure that the machinery product concerned is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly without delay.
Amendment 303 #
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 … [306 months after the date of entry into force of this Regulation].
Amendment 307 #
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 makplacing 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]its repeal. 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 316 #
Proposal for a regulation
Annex I – point 24
Annex I – point 24
24. Software ensuring safety functions, including AI systemThe safety component of software of AI systems with self-determining, evolving behaviour or logic during normal operation and ensuring safety functions.
Amendment 322 #
Proposal for a regulation
Annex I – point 25
Annex I – point 25
25. Machinery embedding AI systems ensuring safety functionsAI systems with self-determining, evolving behaviour or logic during normal operation ensuring safety functions and embedded in machinery.
Amendment 329 #
Proposal for a regulation
Annex II – point 18
Annex II – point 18
18. Software of AI systems with self- determining, evolving behaviour or logic during normal operation and ensuring safety functions, including AI systems.
Amendment 342 #
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 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 349 #
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 if the outcome of the planned action has a safety impact.
Amendment 355 #
Proposal for a regulation
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 2
Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 2
A hardware component relevant for connection or access to software that is critical for the compliance of the machinery product with the relevant health and safety requirements shall be designed so that it is adequately protected against accidental or intentional corruption. The machinery product shall collect evidence of a legitimate or illegitimate intervention in the hardware component.
Amendment 365 #
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 the learning phase, which cannot go beyond the limits addressed in the risk assessment; the safety functions upgrades are part of the limits defined by the manufacturer;
Amendment 367 #
Proposal for a regulation
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point f
Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point f
(f) the tracing log of the data generated in relation to an intervention and ofto modify the versions of safety software ensuring safety functions uploaded after the machinery product has been placed on the market or put into service, is enabled for five years after such upload, exclusively to demonstrate the conformity of the machinery product with this Annex further to a reasoned request from a competent national authority;
Amendment 369 #
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
Amendment 379 #
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
Amendment 384 #
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 guaranteedtaking emergency rescue into consideration.
Amendment 391 #
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 formatprovide in a format over the whole lifecycle of the machinery product and in all the different versions that makes it is possible for the end user to download the instructions 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 392 #
Proposal for a regulation
Annex III – Part 1 – point 1.7 – point 1.7.4 – point 1.7.4.2 – point 1 – point c
Annex III – Part 1 – point 1.7 – point 1.7.4 – point 1.7.4.2 – point 1 – point c
(c) the EU declaration of conformity, or a document setting out the contents of the EU declaration of conformity, showing the particulars of the machinery product, not necessarily including the serial number and the signature, or the internet address where the EU declaration of conformity can be accessed. over the whole lifecycle of the machinery product;
Amendment 409 #
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 orand audible signal shall be provided at the driving position alerting the driver when the restraint system is not active.
Amendment 418 #
Proposal for a regulation
Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 1
Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 1
Amendment 422 #
Proposal for a regulation
Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 2
Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 2
When the risk of contact or electric arc with an energised overhead power line cannot be fully avoidedis relevant during normal operation in terms of exposure to the risks, mobile machinery products shall be designed, constructed and equipped in such a way that all hazards of an electrical nature are prevented or can be preventthe risk of harm is minimized in the event of contact or electrical arc with an energized power line.
Amendment 437 #
Proposal for a regulation
Annex X – paragraph 1
Annex X – paragraph 1
The assembly instructions for partly completed machinery shall contain a description of the conditions, which are to be met to ensure that the partly completed machinery is correctly incorporated in the final machinery product, and a statement that the final machinery product doesshall not compromise health and safety of persons and, where appropriate, domestic animals and property and, where applicable, the environment.