2021/0105(COD) Regulation on machinery products
Next event: Draft final act 2023/06/14
Lead committee dossier:
Next event: Draft final act 2023/06/14
Progress: Awaiting signature of act
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | IMCO |
ŠTEFANEC Ivan ( EPP)
|
MALDONADO LÓPEZ Adriana ( S&D),
HAHN Svenja ( Renew),
CORMAND David ( Verts/ALE),
CAMPOMENOSI Marco ( ID),
FIDANZA Carlo ( ECR),
KONEČNÁ Kateřina ( GUE/NGL)
|
| Committee Opinion | EMPL |
VIND Marianne ( S&D)
|
Konstantinos ARVANITIS ( GUE/NGL),
Elżbieta RAFALSKA ( ECR),
Stefania ZAMBELLI ( ID),
Sara SKYTTEDAL ( PPE)
|
Lead committee dossier:
Legal Basis:
TFEU 114
Legal Basis:
TFEU 114Subjects
Events
2023/06/14
CSL - Draft final act
Documents
2023/05/22
EP/CSL - Act adopted by Council after Parliament's 1st reading
2023/04/18
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 595 votes to 7, with 30 abstentions, a legislative resolution on the proposed for a regulation of the European Parliament and of the Council on Machinery products.
The European Parliament's position adopted at first reading under the ordinary legislative procedure amends the Commission's proposal as follows:
Subject matter
This Regulation lays down health and safety requirements for the design and construction of machinery, related products and partly completed machinery to allow them to be made available on the market or put into service while ensuring a high level of protection of the health and safety of persons, in particular consumers and professional users, and, where appropriate, of domestic animals and property, and, where applicable, of the environment. It also establishes rules on the free movement of products within the scope of this Regulation in the Union.
In order to ensure that the scope of this Regulation is sufficiently clear, a distinction should be made between machinery, related products and partly completed machinery. Moreover, related products should be understood as comprising interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices, which are all products within the scope of this Regulation.
Scope of application
The purpose of this Regulation is to address the risks stemming from machinery function and not from the transport of goods, persons or animals. Consequently, this Regulation should not apply to means of transport by air, on water and on rail networks although it should still apply to the machinery mounted on those means of transport.
Means of transport by road that are not yet covered by a specific Union legal act should be regulated by this Regulation except in respect of risks that might arise from circulation on public roads. This means that vehicles, including e-bikes, e-scooters and other personal mobility devices that are not subject to EU type approval under Regulation (EU) No 167/2013 of the European Parliament and of the Council or Regulation (EU) No 168/2013 of the European Parliament and of the Council or approval under Regulation (EU) 2018/858 of the European Parliament and of the Council(10) are covered by this Regulation.
Protection of persons during installation or use of machinery or related products
Member States may lay down requirements to ensure that persons, including workers, are protected when installing or using machinery or related products, provided that such rules do not allow for the modification of machinery or a related product in a way that is not compatible with this Regulation.
List of products
The new Regulation changes the structure of the list of machinery or products, which is set out in Annex I of the Commission proposal. Machinery and related products falling under the categories listed in Annex I, Part A and Part B should be subject to specific conformity assessment procedures . The European Commission, after consulting the relevant stakeholders, should adopt delegated acts to update this list of products.
The Commission should assess the seriousness of the inherent potential risk presented by a category of machinery or related products for the purpose of determining whether to add that category of machinery or related products to Annex I or to withdraw that category of machinery or related product from Annex I.
When conducting the assessment, the Commission should consider the following elements:
- indications of harm that have been caused in the past by machinery or related products which have been used for their intended use or following any reasonably foreseeable misuse;
- information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission;
- information about known accidents and serious ‘close calls’, including the characteristics of those accidents or ‘close calls’;
- data on accidents or damage to health caused by the machinery or related product for at least the preceding four years.
A category of machinery or related product should be included in Annex I, Part A, if, according to the assessment and taking into account the available information, it presents a serious inherent potential risk, and if certain conditions are fulfilled.
Common technical specifications
The Commission should adopt implementing acts laying down common specifications for the essential health and safety requirements of the Regulation, provided that it respects the role and functions of the standardisation organisations, as an exceptional fall back solution to facilitate the fulfilment of the manufacturer's obligation to comply with those requirements, where the standardisation process is blocked or where there is a delay in establishing appropriate harmonised standards. If such a delay is due to the technical complexity of the standard in question, the Commission should take this into account before contemplating the establishment of common specifications. The Commission should involve relevant stakeholders in the process.
Instructions
The new Regulation strikes a balance between digital and paper documentation. Manufacturers should ensure that machinery or related products are accompanied by the instructions and information set out in Annex III. The instructions should be provided in digital format . These instructions and information must clearly describe the product model to which they correspond.
When the instructions for use are provided in digital format, the manufacturer should make them accessible online during the expected lifetime of the machinery or related product and for at least 10 years after the placing on the market of the machinery or related product. However, at the request of the user at the time of the purchase, the manufacturer should provide the instructions for use in paper format free of charge within one month .
The instructions for use, the safety information and the information set out in Annex III should be in a language which can be easily understood by users, as determined by the Member State concerned, and shall be clear, understandable and legible.
Documents
2023/03/01
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2023/01/25
CSL - Coreper letter confirming interinstitutional agreement
Documents
2023/01/25
EP - Text agreed during interinstitutional negotiations
Documents
2022/06/06
EP - Committee decision to enter into interinstitutional negotiations confirmed by plenary (Rule 71)
2022/05/18
EP - Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 71)
2022/05/05
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on the Internal Market and Consumer Protection adopted the report by Ivan ŠTEFANEC (EPP, SK) on the proposal for a regulation of the European Parliament and of the Council on machinery products.
The committee recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure be amended as follows:
Subject matter and scope
Member stated that the 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 Union consumers and professional operators .
The following should be excluded from the scope of the Regulation:
- vehicles which have as their only objective the transport of goods, persons or animals by air, water or rail except for machinery mounted on those vehicles;
- motor vehicles and their trailers, as well as systems, components and separate technical units, parts and equipment designed and constructed for such vehicles, which fall within the scope of application of Regulation (EU) 2018/858, except for machinery mounted on those vehicles;
- motor vehicles intended exclusively for competition.
Machinery mounted on two- or three-wheel vehicles and quadricycles as well as on agricultural and forestry tractors should be covered by Regulation (EU) 2018/858.
Clarification of definitions
The report proposed to clarify certain definitions, such as ‘safety component’, ‘substantial modification’ and ‘manufacturer’, and suggested adding new definitions, namely ‘machine and related products’, ‘safety function’, ‘technical documentation’ and ‘lifetime’, to make the scheme more understandable.
Members also considered it necessary to make a clearer distinction between the definitions that apply to ‘partly completed machinery’ and those that apply to other categories of machinery and related products.
High-risk machinery and related products
Members proposed to replace the term ‘high-risk machinery and related products’ with ‘ categories of machinery and related products subject to the specific conformity assessment procedure ’ (Annex I, Part A).
The Commission could adopt delegated acts to amend Annex I, after consulting the relevant stakeholders, by adding a new machine or related product to the list of categories of machinery and associated products in Annex I, or by removing a machine or related product from that list. Where a new machine or related product is added to the list in Annex I, the Commission should ensure that economic operators have sufficient time to comply with their obligations under the Regulation.
Machinery and related products which present a risk to human health taking into account their design, intended purpose and any foreseeable use would be added to the list of categories of machinery and related products in Annex I.
A machinery product that is established as posing a risk to human health should be included in the list of categories of machinery products in Annex I, Part A, if at least one of the following conditions is fulfilled:
- no harmonised standards or technical specifications covering all the relevant essential health and safety requirements exist for the category of the machinery product in question;
- residual risks due to shortcomings of protective measures exist and information communicated to the Commission in accordance with paragraph 4 demonstrates a recurrence of serious or fatal accidents or damage to health in relation with these residual risks;
- statistics on accidents referred to in paragraph 4 demonstrate either shortcomings in the relevant harmonised standards or technical specifications or a recurring incorrect application of the relevant harmonised standards or technical specifications;
- the degree of uncertainty of the potential risk related to new types of machinery or technologies.
A machine or related product that is found to present a risk to human health and that does not fulfil any of these conditions should be included in the list of categories of machinery and related products in Annex I, Part B.
Partly completed machinery
Partly completed machinery should only be made available on the market if it complies with the relevant essential health and safety requirements set out in Annex III, and if the manufacturer has declared this to be the case in the EU Declaration of Incorporation.
Documents
All relevant technical documentation, assembly instructions and declarations should be available in paper form or electronically and, where electronic, should be accessible throughout the life cycle of the machinery or related product.
Presumption of conformity of machinery and related products
If harmonised standards covering the essential health and safety requirements set out in Annex III are developed and references to these standards are published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, the relevant technical specifications should no longer apply.
Procedure applicable at national level
Where the market surveillance authorities of a Member State have sufficient reason to believe that a machine or related product does not comply with the requirements set out in the Regulation or presents a risk to the health or safety of persons and, where appropriate, domestic animals or to property and, where applicable, the environment, they should carry out an evaluation in relation to the machinery product concerned covering all relevant requirements laid down in this Regulation.
Where the relevant economic operator does not take corrective action referred to in the Regulation, within the specified period or where the non-compliance or the risk persists, the market surveillance authorities should ensure that the machinery product concerned is withdrawn or recalled, or that making available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly without delay.
Deadlines and transitional arrangements
The report proposes to extend the deadline for repealing Directive 2006/42/EC from 30 to 48 months after the date of entry into force of the new Regulation. Member States should not prevent the making available on the market of machinery that has been placed on the market in accordance with Directive 2006/42/EC before the date of application of the Regulation.
The deadline for the Commission to submit its first report on the evaluation of the Regulation would be extended from 54 to 72 months. Lastly, the date of application of the regulation has been postponed from 30 to 48 months after its entry into force.
Documents
2022/05/03
EP - Vote in committee, 1st reading
2022/05/03
EP - Committee decision to open interinstitutional negotiations with report adopted in committee
2022/03/08
EP - Committee opinion
Documents
2021/12/01
EP - VIND Marianne (S&D) appointed as rapporteur in EMPL
2021/11/10
EP - Amendments tabled in committee
Documents
2021/10/20
EP - Committee draft report
Documents
2021/06/10
CZ_CHAMBER - Contribution
Documents
2021/06/07
EP - Committee referral announced in Parliament, 1st reading
2021/05/27
EP - ŠTEFANEC Ivan (EPP) appointed as rapporteur in IMCO
2021/04/22
EC - Document attached to the procedure
Documents
2021/04/22
EC - Document attached to the procedure
Documents
2021/04/22
EC - Document attached to the procedure
Documents
2021/04/21
EC - Legislative proposal published
Details
PURPOSE: to improve and adapt the existing Machinery Directive to the new needs of the market and risks origination from emerging technologies.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: as part of the Commission Work Programme 2020 under the priority ‘A Europe fit for the Digital Age’, the Commission plans to revise the Machinery Directive (‘the MD’, Directive 2006/42/EC). This revision contributes to both the digital transition and to the strengthening of the single market.
In order to boost the trust in new digital technologies such as direct human-robot (co-bot) collaboration, connected machinery, 3D printers, the MD needs to provide legal certainty as regards those technologies, existing gaps could hinder a level playing field for manufacturers, which would impact the efficiency of the MD.
The fact that the current machinery legislation is a Directive leaving Member States to choose the means to comply with the legislative objectives, has led to different interpretations of the MD provisions creating legal uncertainty and lack of coherence throughout the single market.
The Commission suggests that the proposal should take the form of a Regulation as this would better ensure that Member States do not impose national technical requirements that go beyond the safety requirements laid down in Annex I of the current Directive and/or contradict those safety requirements.
CONTENT: this draft regulation proposed by the Commission responds to market needs by bringing greater legal clarity to the current provisions, simplifying the administrative burden and costs for companies by allowing digital formats for documentation and adapting conformity assessment fees for SMEs, while ensuring coherence with the EU legislative framework for products.
The proposed new regulation will ensure the safe integration of artificial intelligence (AI) systems into machines and thus encourage innovation.
Specific provisions of the proposal
Scope and definitions
While the scope of the proposed regulation remains the same, the definition of safety component has been clarified to include non-physical components such as software. There is also a new definition of substantial modification to ensure that machinery, placed on the market and/or put into service, that suffers substantial modifications is in conformity with the essential health and safety requirements in Annex III.
Exclusions
The exemption of the means of transport on road is extended beyond the Union type approval legislation to increase the legal certainty. The reason is to prevent that vehicles not covered by that legislation are covered by default by the machinery legislation, as this legislation is not meant to regulate risks other than those stemming from the machinery function (such as sawing, excavating, etc.), and not the risks exclusively related to its transport function of persons or goods.
High-risk machinery
The proposal sets up classification rules for high-risk machinery empowering the Commission to adopt delegated acts to adapt the list of high-risk machinery in Annex I. This list is obsolete and needs to be adapted to the technical progress and new type of machinery presenting high risks such as machinery with Artificial Intelligence ensuring safety functions.
Obligations of economic operators
The proposal incorporates obligations for manufacturers, importers and distributors to be aligned with the New Legislative Framework Decision.
Conformity assessment
The proposal keeps the manufacturer internal check option for machinery that is not classified as high risk. However, for high-risk machinery, considering that Annex I will be adapted to the technological progress when needed and the NLF alignment, only third-party certification will be accepted, even when manufacturers apply the relevant harmonised standards.
Notified bodies
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and for the confidence of all interested parties in the New Approach system. Therefore, the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State.
Documents
Documents
- Draft final act: 00006/2023/LEX
- Decision by Parliament, 1st reading: T9-0097/2023
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE742.409
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: GEDA/A/(2023)000924
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2023)000924
- Text agreed during interinstitutional negotiations: PE742.409
- Committee report tabled for plenary, 1st reading: A9-0141/2022
- Committee opinion: PE703.051
- Amendments tabled in committee: PE699.191
- Committee draft report: PE697.614
- Contribution: COM(2021)0202
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SEC(2021)0165
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2021)0082
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2021)0083
- Legislative proposal published: COM(2021)0202
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SEC(2021)0165
- Document attached to the procedure: EUR-Lex SWD(2021)0082
- Document attached to the procedure: EUR-Lex SWD(2021)0083
- Committee draft report: PE697.614
- Amendments tabled in committee: PE699.191
- Committee opinion: PE703.051
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2023)000924
- Text agreed during interinstitutional negotiations: PE742.409
- Draft final act: 00006/2023/LEX
- Contribution: COM(2021)0202
Activities
- Ivan ŠTEFANEC
Plenary Speeches (1)
Votes
Machines et équipements - A9-0141/2022 - Ivan Štefanec - Accord provisoire - Am 180 #
2023/04/18 Outcome: +: 595, 0: 30, -: 7
The Left
NI| Amendments | Dossier |
| 455 |
2021/0105(COD)
2021/11/10
IMCO
338 amendments...
Amendment 101 #
Proposal for a regulation Title 1 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on machinery
Amendment 102 #
Proposal for a regulation Recital 6 a (new) (6a) Notes that it is in the public interest to harmonise the environmental standards for powering some of the relevant machinery products, such as electrical bicycles. Calls on the Commission to explore in cooperation with the manufactures the possibility of a unique charger for electrical bicycles placed on the market, with the view to ensure common health and safety requirements for charging across the EU.
Amendment 103 #
Proposal for a regulation Recital 10 (10) Where there is a possibility that the machinery products will be used by a consumer, that is to say, a non-professional operator, the manufacturer should take account of the fact that the consumer does not have the same knowledge and experience with handling machinery products in the design and construction of the products and consider the safety impact. The same applies where a machinery product is normally used to provide a service to a consumer. While consumers do not necessarily purchase machinery products, machinery products are still being used by them.
Amendment 104 #
Proposal for a regulation 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
Amendment 105 #
Proposal for a regulation Recital 15 (15) Since the purpose of this Regulation is to address the risks stemming from the machinery function and not the transportation function of goods or persons, it should not apply to vehicles
Amendment 106 #
Proposal for a regulation 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
Amendment 107 #
Proposal for a regulation Recital 16 (16) Household appliances intended for domestic use which are not electrically operated furniture, audio and video equipment, information technology equipment, office machinery, low-voltage switchgear and control gear and electronic motors fall within the scope of Directive 2014/35/EU of the European Parliament and of the Council21 and should therefore be excluded from the scope of this Regulation with the exception of mechanical safety of those appliances, which should be part of this Regulation. Some of those products are progressively incorporating Wi-Fi functions, e.g. washing machines, and are therefore covered by Directive 2014/53/EU of the European Parliament and of the Council22 as radio equipment. Those products should also be excluded from the scope of this Regulation. __________________ 21 Directive 2014/35/EU of the European
Amendment 108 #
Proposal for a regulation Recital 16 (16) Household appliances intended for domestic use which are not electrically operated furniture, audio and video equipment, information technology equipment, office machinery, low-voltage switchgear and control gear and electr
Amendment 109 #
Proposal for a regulation Recital 17 (17) The evolution of the machinery sector has resulted in the growing use of digital means and software plays a more and more important role in the machinery design. Consequently, the definition of machinery should be adapted. In this respect, machinery missing only the upload of a software intended for the specific application of the machinery should fall under the definition of machinery and not under the definition of partly completed machinery if the safe use of this machinery does not depend on this software. Furthermore, the definition of safety components should cover not only physical devices but also digital devices. In order to take into account the increasing use of software as a safety component, software that performs a safety function and is placed independently on the market
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
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
Amendment 112 #
Proposal for a regulation Recital 24 (24) In the machinery sector, around 98 % of the companies are small or medium sized enterprises (SMEs). In order to
Amendment 113 #
Proposal for a regulation Recital 29 (29) The manufacturer
Amendment 114 #
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
Amendment 115 #
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,
Amendment 116 #
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,
Amendment 117 #
Proposal for a regulation Recital 31 (31) It is essential that, before drawing up the EU declaration of conformity, the manufacturer
Amendment 118 #
Proposal for a regulation Recital 34 (34) When placing machinery products
Amendment 119 #
Proposal for a regulation 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 120 #
Proposal for a regulation Recital 45 (45) The list of
Amendment 121 #
Proposal for a regulation 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.
Amendment 122 #
Proposal for a regulation Recital 45 a (new) (45a) Nevertheless, provisions set out in Articles 5(1) and 21(2) of this Regulation should only apply to AI systems with a self-determining and evolving behaviour during normal operation. On the contrary, these provisions should not apply to conventional software incapable to learn or evolve, and programmed only to execute certain automated functions of machinery products.
Amendment 123 #
Proposal for a regulation 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 124 #
Proposal for a regulation Recital 45 a (new) (45a) Nevertheless, provisions set out in Articles 5(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 125 #
Proposal for a regulation Recital 46 a (new) Amendment 126 #
Proposal for a regulation Recital 50 (50) Manufacturers
Amendment 127 #
Proposal for a regulation Recital 50 (50) Manufacturers should be responsible for
Amendment 128 #
Proposal for a regulation Recital 56 (56) Conformity assessment bodies frequently subcontract parts of their
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
Amendment 130 #
Proposal for a regulation Recital 76 a (new) (76a) The harmonised standards relevant to this Regulation should take into account the United Nations Convention on the Rights of Persons with Disabilities1a __________________ 1a Endorsed by "Council Decision of 26 November 2009 concerning the conclusion, by the European Community, of the United Nations Convention on the Rights of Persons with Disabilities"
Amendment 131 #
Proposal for a regulation 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 (d) lifting accessories, including lifting appliances whose speed is not greater than 0.15 m/s’;
Amendment 133 #
Proposal for a regulation Article 2 – paragraph 1 – point d (d) lifting accessories; including lifting appliances whose speed does not exceed 0.15 m/s’;
Amendment 134 #
Proposal for a regulation Article 2 – paragraph 1 – point g a (new) (ga) specific equipment for use in fairgrounds or amusement parks;
Amendment 135 #
Proposal for a regulation Article 2 – paragraph 1 – point g a (new) (ga) non type approved road vehicles including pedal cycles with pedal assistance;
Amendment 136 #
Proposal for a regulation Article 2 – paragraph 1 – point g a (new) (ga) equipment to be used in fairgrounds or amusement parks;
Amendment 137 #
Proposal for a regulation 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) (gb) vehicles which have as their objective the transport of goods or persons by road, not covered by Regulation (EU) No 168/2013;
Amendment 139 #
Proposal for a regulation Article 2 – paragraph 1 – point g b (new) (gb) vehicles which have as their objective the transport of goods or persons by road, not falling within the scope of application of Regulation (EU) No 168/2013;
Amendment 140 #
Proposal for a regulation Article 2 – paragraph 2 – point b Amendment 141 #
Proposal for a regulation Article 2 – paragraph 2 – point b Amendment 142 #
Proposal for a regulation Article 2 – paragraph 2 – point b Amendment 143 #
Proposal for a regulation Article 2 – paragraph 2 – point e Amendment 144 #
Proposal for a regulation Article 2 – paragraph 2 – point e (e) vehicles which have as their only objective the transport of goods, animals or persons by
Amendment 145 #
Proposal for a regulation Article 2 – paragraph 2 – point e (e) vehicles which have as their only objective the transport of goods, or
Amendment 146 #
Proposal for a regulation Article 2 – paragraph 2 – point e (e) vehicles which have as their only objective the transport of goods or persons by
Amendment 147 #
Proposal for a regulation Article 2 – paragraph 2 – point f (f) two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that
Amendment 148 #
Proposal for a regulation Article 2 – paragraph 2 – point f (f) two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles,
Amendment 149 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry
Amendment 150 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry
Amendment 151 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry
Amendment 152 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry vehicles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that
Amendment 153 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry vehicles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that
Amendment 154 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry
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;
Amendment 156 #
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;
Amendment 157 #
Proposal for a regulation Article 2 – paragraph 2 – point g b (new) (gb) motor vehicles exclusively intended for competition;
Amendment 158 #
Proposal for a regulation 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) (gc) assemblies of CE marked pressure equipment within the meaning of Directive 2014/68/EU;
Amendment 160 #
Proposal for a regulation Article 2 – paragraph 2 – point m – point i (i) household appliances intended for domestic use which are not electrically operated furniture, except for their mechanical safety;
Amendment 161 #
Proposal for a regulation Article 2 – paragraph 2 – point m – point i (i) household appliances intended for domestic use which are not electrically operated furniture, excluding their mechanical safety;
Amendment 162 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 – point d (d) assemblies of machinery referred to in points (a), (b), (c) or partly completed machinery referred to in point (
Amendment 163 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 – point f (f) an assembly as referred to in points
Amendment 164 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 – point f (f) an assembly as referred to in points (a), (b), (c), (d) and (e) missing only the upload of a software intended for its specific application, if the safe use does not depend on this software.
Amendment 165 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 – point f (f) an assembly as referred to in points (a), (b), (c), (d) and (e) missing only the upload of a software intended for its specific application, if the safe use does not depend on this software.
Amendment 166 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) ‘interchangeable equipment’ means a device which, after the putting into service of a machinery product, is assembled with that machinery product by the operator himself or herself in order to change its function or attribute to it a new function, in so far as that equipment is not a tool;
Amendment 167 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘safety component’ means a physical or digital component, including software, of a machinery
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
Amendment 169 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘safety component’ means a physical or digital component, including software, of a machinery product, except partly completed machinery which serves 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 170 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘safety component’ means a physical or digital component, including software, of a machinery
Amendment 171 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 (12) ‘plac
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;
Amendment 173 #
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, excluding partly completed machinery;
Amendment 174 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘artificial intelligence system’ means an artificial intelligence system as defined in Article 3(1) of Regulation (EU) .../... of the European Parliament and of the Council28
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;
Amendment 176 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘substantial modification’ means a
Amendment 177 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen 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, maintenance and repair operations by third parties are not substantial modifications;
Amendment 178 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen by the manufacturer and
Amendment 179 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen by the manufacturer and as a result
Amendment 180 #
Proposal for a regulation Article 3 – paragraph 1 – point 17 (17) ‘manufacturer’ means any natural or legal person who manufactures machinery products or who has machinery products designed or manufactured, and markets those machinery products under his or her name or trademark or who
Amendment 181 #
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 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 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;
Amendment 183 #
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 is placed on the market or put into service to inform the user of the machinery product of the intended
Amendment 184 #
Proposal for a regulation Article 3 – paragraph 1 – point 19 (19) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks with regard to the manufacturer’s obligations under the requirements of this Regulation;
Amendment 185 #
Proposal for a regulation Article 3 – paragraph 1 – point 25 (25) ‘CE marking’ means a marking by which the manufacturer indicates that a machinery product, excluding partly completed machinery, is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
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;
Amendment 187 #
Proposal for a regulation 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 188 #
Proposal for a regulation Article 3 – paragraph 1 – point 29 (29) ‘conformity assessment body’ means a body that performs conformity assessment
Amendment 189 #
Proposal for a regulation Article 3 – paragraph 1 – point 29 a (new) (29a) ‘technical documentation’ means all the elements referred to in Annex IV for the machinery products under this Regulation;
Amendment 190 #
Proposal for a regulation Article 3 – paragraph 1 – point 30 (30) ‘notified body’ means a conformity assessment body notified in accordance with Article 2
Amendment 191 #
Proposal for a regulation Article 5 – title Amendment 193 #
Proposal for a regulation Article 5 – paragraph 1 1. High-risk machinery products listed in Annex I shall be subject to a specific conformity assessment procedure, requiring participation of a notified body as referred to in Article 21(2).
Amendment 194 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 195 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 196 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1a. The Commission shall update Annex I before the date referred to Article 52 to ensure relevant machineries are subject to the specific conformity assessment procedure.
Amendment 197 #
Proposal for a regulation Article 5 – paragraph 2 2. The Commission is empowered to
Amendment 198 #
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
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
Amendment 200 #
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 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 201 #
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
Amendment 202 #
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
Amendment 203 #
Proposal for a regulation Article 5 – paragraph 3 – subparagraph 1 A machinery product shall be included in
Amendment 204 #
Proposal for a regulation Article 5 – paragraph 3 – subparagraph 1 A machinery product shall be included in the list of
Amendment 205 #
Proposal for a regulation Article 5 – paragraph 4 – point d (d) statistics on accidents caused by the machinery product for the preceding four years based, in particular information obtained from the Information and Communication System for Market Surveillance (ICSMS) information, safeguard clauses, Rapid Alert System (RAPEX)
Amendment 206 #
Proposal for a regulation Article 5 – paragraph 4 – point d (d) statistics on accidents caused by the machinery product for the preceding four years based, in particular information obtained from the Information and Communication System for Market Surveillance (ICSMS) information, safeguard clauses, Rapid Alert System (RAPEX) and the Machinery Administrative Cooperation Group reporting and the Pan-European Injury Database.
Amendment 207 #
Proposal for a regulation 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 208 #
Proposal for a regulation Article 5 a (new) Article 5a 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 and public 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 209 #
Proposal for a regulation 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 210 #
Proposal for a regulation Article 8 – paragraph 1 a (new) Amendment 211 #
Proposal for a regulation 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
Amendment 212 #
Proposal for a regulation 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 213 #
Proposal for a regulation 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
Amendment 214 #
Proposal for a regulation Article 10 – paragraph 1 1. When
Amendment 215 #
Proposal for a regulation 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 216 #
Proposal for a regulation Article 10 – paragraph 2 – subparagraph 1 Before
Amendment 217 #
Proposal for a regulation Article 10 – paragraph 3 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity electronically, where relevant, at the disposal of the market surveillance authorities for ten years after the machinery product has been placed on the market. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from the competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III.
Amendment 218 #
Proposal for a regulation Article 10 – paragraph 3 3. Manufacturers shall keep the technical documentation and the EU declaration of conformity, where relevant, at the disposal of the market surveillance authorities for ten years after the machinery product has been placed on the market. Where relevant,
Amendment 219 #
Proposal for a regulation Article 10 – paragraph 6 6. Manufacturers shall indicate their name, registered trade name or registered trade mark, the postal address
Amendment 220 #
Proposal for a regulation Article 10 – paragraph 7 7. Manufacturers shall ensure that the machinery products are accompanied by the instructions and information set out in section 1.7 of Annex III in a language which can be easily understood by end- users and accessible for persons with disabilities in accordance with requirements of Directive (EU) 2019/882 (European Accessibility Act), as determined by the Member State concerned. Such instructions and information shall be clear, understandable, intelligible and legible.
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.
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.
Amendment 223 #
Proposal for a regulation Article 11 – paragraph 2 – introductory part 2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The authorised representative shall have the appropriate financial and organisational means to perform the tasks specified in the mandate. The authorised representative shall provide a copy of the mandate to the competent authority, upon request, in a Union language determined by the competent authority. The mandate shall allow the authorised representative to do at least the following:
Amendment 224 #
Proposal for a regulation Article 11 – paragraph 2 – point a (a) keep the EU declaration of conformity and the technical documentation electronically at the disposal of the national market surveillance authorities for ten years after the machinery product has been placed on the market;
Amendment 225 #
Proposal for a regulation Article 11 – paragraph 2 – point b (b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the machinery product. It could be either in paper or electronic form;
Amendment 226 #
Proposal for a regulation Article 12 – paragraph 2 – subparagraph 1 Before
Amendment 227 #
Proposal for a regulation Article 12 – paragraph 3 3. Importers shall indicate their name, registered trade name or registered trade mark, the postal address
Amendment 228 #
Proposal for a regulation Article 12 – paragraph 4 4. Importers shall ensure that the machinery product is accompanied by the instructions and information set out in section 1.7 of Annex III in a language which can be easily understood by end- users and accessible for persons with disabilities in accordance with requirements of Directive (EU) 2019/882 (European Accessibility Act), as determined by the Member State concerned.
Amendment 229 #
Proposal for a regulation Article 12 – paragraph 8 8. Importers shall, for ten years after the machinery product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available electronically to those authorities. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential health and safety requirements set out in Annex III.
Amendment 230 #
Proposal for a regulation Article 15 – paragraph 1 A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the machinery product shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 10 for the part of the machinery product that is affected by the modification or, if the substantial modification has an impact on the safety of the machinery product as a whole, for the entire machinery product. If a substantial modification that only affects a part the machinery product is carried out by a natural or legal person other than the manufacturer, the importer or the distributor, the manufacturer shall be subject to Article 10 point 1, 3, 7, 8, 10 and fill in the declaration in Annex V for the part that has been changed.
Amendment 231 #
Proposal for a regulation Article 15 – paragraph 1 A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the machinery product in order to put it on the market shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the
Amendment 232 #
Proposal for a regulation Article 15 – paragraph 1 a (new) A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the machinery product for its own use shall be considered a manufacturer for the purposes of this Regulation. They shall have the following obligations with regards to the affected part of the machinery product or for the entire machinery product where the substantial modification has an impact on the safety of the machinery product as a whole: (a) to ensure that the modified part and the machinery product remain in conformity with the essential health and safety requirements set out in Annex III; (b) to draw up the technical documentation referred to in Annex IV that relates to the modification carried out, indicating in particular the date of implementation of the modification and the results of the risk assessment carried out in accordance with the general principles and with section 1.1.2 of Annex III. This documentation must be available to the market surveillance authorities for a period of 10 years after the machinery product has been put into service; (c) to carry out the conformity assessment procedure referred to in Article 21 section 3; (d) to ensure that the instructions provided for in Annex III, section 1.7.4 are updated in view of the substantial modification made to the machinery product.
Amendment 233 #
Proposal for a regulation Article 17 – paragraph 3 Amendment 234 #
Proposal for a regulation Article 17 – paragraph 3 Amendment 235 #
Proposal for a regulation Article 17 – paragraph 3 Amendment 236 #
Proposal for a regulation Article 17 – paragraph 3 – point a Amendment 237 #
Proposal for a regulation Article 17 – paragraph 3 – point a 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;
Amendment 239 #
Proposal for a regulation Article 17 – paragraph 3 – point b Amendment 240 #
Proposal for a regulation Article 17 – paragraph 3 – point b Amendment 241 #
Proposal for a regulation Article 17 – paragraph 3 – point b (b) the Commission has requested one or more European standardisation
Amendment 242 #
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 the re
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
Amendment 244 #
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
Amendment 245 #
Proposal for a regulation Article 17 – paragraph 3 – subparagraph 2 Amendment 246 #
Proposal for a regulation Article 17 – paragraph 3 – subparagraph 2 Amendment 247 #
Proposal for a regulation 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 248 #
Proposal for a regulation Article 17 – paragraph 4 Amendment 249 #
Proposal for a regulation Article 17 – paragraph 4 Amendment 250 #
Proposal for a regulation Article 17 – paragraph 5 Amendment 251 #
Proposal for a regulation Article 18 – paragraph 2 2. The EU declaration of conformity must be able to be filled electronically and 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 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
Amendment 253 #
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
Amendment 254 #
Proposal for a regulation Article 20 – paragraph 1 1. The CE marking shall be affixed visibly, legibly and indelibly to the
Amendment 255 #
Proposal for a regulation Article 21 – paragraph 1 1. In order to
Amendment 256 #
Proposal for a regulation Article 21 – paragraph 1 1. In order to
Amendment 257 #
Proposal for a regulation Article 21 – paragraph 2 – introductory part 2. Where the machinery product is a
Amendment 258 #
Proposal for a regulation Article 21 – paragraph 2 – introductory part 2. Where the machinery product is not a high-risk machinery product listed in Annex I, the manufacturer or the
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;
Amendment 260 #
Proposal for a regulation Article 21 – paragraph 2 – point a (a)
Amendment 261 #
Proposal for a regulation Article 21 – paragraph 2 – point b (b)
Amendment 262 #
Proposal for a regulation Article 21 – paragraph 2 – point b a (new) (ba) Conformity based on full quality assurance (module H) set out in Annex IX;
Amendment 263 #
Proposal for a regulation Article 21 – paragraph 3 3. Where the machinery product is not a
Amendment 264 #
Proposal for a regulation Article 21 – paragraph 3 a (new) 3a. Where, in assessing the compliance of machinery with the essential health and safety requirements set out in Annex III, the manufacturer has applied harmonised standards the references of which have been published in the Official Journal of the European Union, the manufacturer shall use any of the following procedures: (a) the internal production control procedure (module A) set out in Annex VI; (b) EU type-examination procedure (module B) provided for in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII; (c) Conformity based on full quality assurance (module H) set out in Annex IX;
Amendment 265 #
Proposal for a regulation Article 21 – paragraph 4 Amendment 266 #
Proposal for a regulation Article 21 – paragraph 4 a (new) 4a. In assessing the compliance of machinery with the health and safety requirements set out in Annex III, the manufacturer has not applied or has applied only in part harmonised standards the references of which have been published in the Official Journal of the European Union, or when harmonised standards do not exist, machinery shall be submitted with regard to those essential health and safety requirements, to either of the following procedures: (a) the internal production control procedure (module A) set out in Annex VI; (b) EU type-examination procedure (module B) provided for in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII;
Amendment 267 #
Proposal for a regulation Article 22 – title Amendment 268 #
Proposal for a regulation Article 22 – paragraph 1 – introductory part 1. The manufacturer of partly completed machinery
Amendment 269 #
Proposal for a regulation Article 22 – paragraph 2 2. Where relevant, the manufacturer of partly completed machinery or the manufacturer’s authorised representative shall make available to the competent national authority upon its request the
Amendment 270 #
Proposal for a regulation Article 23 – paragraph 1 Member States
Amendment 271 #
Proposal for a regulation Article 25 – paragraph 3 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26. In addition, that body shall have arrangements to cover liabilities arising out of its
Amendment 272 #
Proposal for a regulation Article 26 – paragraph 2 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its
Amendment 273 #
Proposal for a regulation Article 26 – paragraph 4 4. A notifying authority shall not offer or provide any
Amendment 274 #
Proposal for a regulation 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 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 276 #
Proposal for a regulation Article 28 – paragraph 4 – subparagraph 1 A conformity assessment body, its top- level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of a machinery product, that they assess, nor the authorised representative of any of those parties. This shall not preclude the use of a machinery product that is necessary for the operations of the conformity assessment body or the use of a machinery product for personal purposes.
Amendment 277 #
Proposal for a regulation Article 28 – paragraph 4 – subparagraph 2 A conformity assessment body, its top- level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, import, distribution, manufacture, marketing, installation, use or maintenance of machinery products, or represent the parties engaged in those
Amendment 278 #
Proposal for a regulation Article 28 – paragraph 4 – subparagraph 3 A conformity assessment body shall ensure that the
Amendment 279 #
Proposal for a regulation Article 28 – paragraph 4 – subparagraph 3 a (new) The conformity assessment body shall ensure rotation between the responsible personnel carrying out the conformity assessment tasks.
Amendment 280 #
Proposal for a regulation Article 28 – paragraph 5 5. A conformity assessment body and its personnel shall carry out the conformity assessment
Amendment 281 #
Proposal for a regulation Article 28 – paragraph 6 – subparagraph 1 A conformity assessment body shall be capable of carrying out all the conformity assessment
Amendment 282 #
Proposal for a regulation Article 28 – paragraph 6 – subparagraph 2 – point a (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment
Amendment 283 #
Proposal for a regulation Article 28 – paragraph 6 – subparagraph 2 – point c (c) appropriate policies and procedures to distinguish between
Amendment 284 #
Proposal for a regulation Article 28 – paragraph 6 – subparagraph 2 – point d (d) procedures for the performance of conformity assessment
Amendment 285 #
Proposal for a regulation Article 28 – paragraph 6 – subparagraph 3 A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment
Amendment 286 #
Proposal for a regulation Article 28 – paragraph 7 – point a (a) sound technical and vocational training covering all the conformity assessment
Amendment 287 #
Proposal for a regulation Article 28 – paragraph 8 – subparagraph 1 The impartiality of a conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment
Amendment 288 #
Proposal for a regulation Article 28 – paragraph 8 – subparagraph 2 The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment
Amendment 289 #
Proposal for a regulation Article 28 – paragraph 10 10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment
Amendment 290 #
Proposal for a regulation Article 28 – paragraph 11 11. A conformity assessment body shall participate in, or ensure that its personnel responsible for carrying out the conformity assessment
Amendment 291 #
Proposal for a regulation Article 30 – paragraph 3 3.
Amendment 292 #
Proposal for a regulation Article 31 – paragraph 2 2. The application for notification shall be accompanied by a description of the conformity assessment
Amendment 293 #
Proposal for a regulation Article 32 – paragraph 3 – point a (a) full details of the conformity assessment
Amendment 294 #
Proposal for a regulation Article 32 – paragraph 5 – subparagraph 1 The conformity assessment body concerned may perform the
Amendment 295 #
Proposal for a regulation Article 33 – paragraph 2 – subparagraph 1 The Commission shall make publicly available the list of notified bodies including the identification numbers that have been assigned to them and the conformity assessment
Amendment 296 #
Proposal for a regulation Article 36 – paragraph 2 – subparagraph 1 A notified body shall perform its
Amendment 297 #
Proposal for a regulation Article 38 – paragraph 1 – point c (c) any request for information which it has received from market surveillance authorities regarding its conformity assessment
Amendment 298 #
Proposal for a regulation Article 38 – paragraph 1 – point d (d) on request, any conformity assessment
Amendment 299 #
Proposal for a regulation Article 38 – paragraph 2 2. A notified body shall provide other notified bodies carrying out similar conformity assessment
Amendment 300 #
Proposal for a regulation Article 41 – paragraph 4 – subparagraph 1 Where the relevant economic operator does not take
Amendment 301 #
Proposal for a regulation 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 302 #
Proposal for a regulation Article 49 – paragraph 2 – subparagraph 1 Directive 2006/42/EC is repealed with effect from … [
Amendment 303 #
Proposal for a regulation Article 49 – paragraph 2 – subparagraph 1 Directive 2006/42/EC is repealed with effect from … [3
Amendment 304 #
Proposal for a regulation Article 50 – paragraph 1 1. Member States shall not until … [
Amendment 305 #
Proposal for a regulation Article 50 – paragraph 1 1. Member States shall not until … [
Amendment 306 #
Proposal for a regulation Article 50 – paragraph 1 1. Member States shall not until … [
Amendment 307 #
Proposal for a regulation Article 50 – paragraph 1 1. Member States shall not until … [
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 … [
Amendment 309 #
Proposal for a regulation Article 51 – paragraph 1 1. By … [
Amendment 310 #
Proposal for a regulation Article 51 – paragraph 2 – subparagraph 1– point b (b) the conformity assessment procedure applicable to
Amendment 311 #
Proposal for a regulation Article 52 – paragraph 2 It shall apply from … [
Amendment 312 #
Proposal for a regulation Article 52 – paragraph 2 It shall apply from … [
Amendment 313 #
Proposal for a regulation Article 52 – paragraph 2 It shall apply from … [
Amendment 314 #
Proposal for a regulation Annex I – subheading 1 Amendment 315 #
Proposal for a regulation Annex I – point 24 Amendment 316 #
Proposal for a regulation Annex I – point 24 24.
Amendment 317 #
Proposal for a regulation Annex I – point 24 24.
Amendment 318 #
Proposal for a regulation Annex I – point 24 24.
Amendment 319 #
Proposal for a regulation Annex I – point 24 24. Software
Amendment 320 #
Proposal for a regulation Annex I – point 25 Amendment 321 #
Proposal for a regulation Annex I – point 25 25. Machinery embedding AI systems ensuring safety functions, where the safety functions can evolve over time or exhibit non-deterministic behaviour and where the AI systems have not previously been subjected to a conformity assessment.
Amendment 322 #
Proposal for a regulation Annex I – point 25 25.
Amendment 323 #
Proposal for a regulation Annex I – point 25 25.
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.
Amendment 325 #
Proposal for a regulation Annex I – point 25 a (new) 25a. Escalators and moving walks.
Amendment 327 #
Proposal for a regulation Annex I – point 25 b (new) 25b. Cranes with a load moment >150 kNm.
Amendment 328 #
Proposal for a regulation Annex I – point 25 c (new) 25c. Palletisers, depalletisers, pallet wrapping machines.
Amendment 329 #
Proposal for a regulation Annex II – point 18 18. Software of AI systems with self- determining, evolving behaviour or logic during normal operation and ensuring safety function
Amendment 330 #
Proposal for a regulation Annex II – point 18 18. Software of AI systems with self- determining, evolving behaviour or logic during normal operation ensuring safety function
Amendment 331 #
Proposal for a regulation Annex II – point 18 18. Software
Amendment 332 #
Proposal for a regulation Annex II – point 18 18. Software of AI systems ensuring safety functions
Amendment 333 #
Proposal for a regulation Annex III – point 1 – paragraph 1 The manufacturer of a machinery product
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
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
Amendment 336 #
Proposal for a regulation 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 the
Amendment 337 #
Proposal for a regulation 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
Amendment 338 #
Proposal for a regulation 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
Amendment 339 #
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
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
Amendment 341 #
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
Amendment 342 #
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
Amendment 343 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.2 – point e a (new) (ea) The manufacturer shall inform the user about vulnerabilities that might arise and provide remedial measures.
Amendment 344 #
Proposal for a regulation 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
Amendment 345 #
Proposal for a regulation 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 (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 347 #
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)
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)
Amendment 349 #
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
Amendment 350 #
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
Amendment 351 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 1 Amendment 352 #
Proposal for a regulation 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
Amendment 353 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 2 Amendment 354 #
Proposal for a regulation 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 aforementioned hardware component, when relevant for connection or access to software that is critical for the compliance of the machinery product.
Amendment 355 #
Proposal for a regulation 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.
Amendment 356 #
Proposal for a regulation 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.
Amendment 357 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 3 Amendment 358 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 4 Amendment 359 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 5 Amendment 360 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 5 Amendment 361 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point a Amendment 362 #
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
Amendment 363 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point a (a) they can reasonably withstand, where appropriate to the circumstances and the risks, the intended operating stresses and intended
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
Amendment 365 #
Proposal for a regulation 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 366 #
Proposal for a regulation 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
Amendment 367 #
Proposal for a regulation 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
Amendment 368 #
Proposal for a regulation 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
Amendment 369 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point g Amendment 370 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point g Amendment 371 #
Proposal for a regulation 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
Amendment 372 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 6 Amendment 373 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – introductory part 1.3.7. Risks related to moving parts and
Amendment 374 #
Proposal for a regulation 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
Amendment 375 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – point b Amendment 376 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – point b (b) human-machine
Amendment 377 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5 Amendment 378 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5 Amendment 379 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5 Amendment 380 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5 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)
Amendment 382 #
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 d
Amendment 383 #
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 d
Amendment 384 #
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 d
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 d
Amendment 386 #
Proposal for a regulation 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 Amendment 388 #
Proposal for a regulation Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 4 – point a (a) mark on the machinery product
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
Amendment 390 #
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 lifetime of the 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 391 #
Proposal for a regulation Annex III – Part 1 – point 1.7 – point 1.7.4 – paragraph 4 – point c (c)
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 (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
Amendment 393 #
Proposal for a regulation Annex III – Part 1 – point 1.7 – point 1.7.4 – point 1.7.4.2 – point 1 – point w Amendment 394 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – paragraph 1 – point e (e)
Amendment 395 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – introductory part The instructions
Amendment 396 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point a (a) the vibration total value
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 Amendment 398 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point b Amendment 399 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point c (c) the uncertainty of
Amendment 400 #
Proposal for a regulation Annex III – Part 3 – point 3.1 – point 3.1.1 – point b Amendment 401 #
Proposal for a regulation Annex III – Part 3 – point 3.1 – point 3.1.1 – point b a (new) (ba) ‘Driver’ means an operator responsible for the movement of a machine. The driver may be transported by the machinery or may be on foot, accompanying the machinery, or may guide the machinery by remote control.
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
Amendment 403 #
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 shall be designed according to ergonomic principles. Such restraint systems or provision shall not be fitted if they increase the risk.
Amendment 404 #
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 have an ergonomic design and shall not be fitted if they increase the risk.
Amendment 405 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2 Amendment 406 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2 The machine shall not be able to move when the restraint system is not active in case there is a significant risk of tipping or rolling over. A visual
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
Amendment 408 #
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
Amendment 409 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2 A visual
Amendment 410 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2 Amendment 411 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 1 Amendment 412 #
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. This function shall allow the operator to remotely receive information from the machine. The supervisory control function
Amendment 413 #
Proposal for a regulation 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 Amendment 415 #
Proposal for a regulation 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 Autonomous mobile machinery products shall comply with
Amendment 417 #
Proposal for a regulation Annex III – Part 3 – point 3.3 – point 3.3.3 – paragraph 6 – point a (a) it shall move and operate in an enclosed zone fitted with a peripheral
Amendment 418 #
Proposal for a regulation Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 1 Amendment 419 #
Proposal for a regulation Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 1 Amendment 420 #
Proposal for a regulation Annex III – Part 3 – point 3.5 – point 3.5.4 – paragraph 2 Amendment 421 #
Proposal for a regulation 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
Amendment 422 #
Proposal for a regulation 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
Amendment 423 #
Proposal for a regulation Annex III – Part 3 – point 3.6 – point 3.6.3 – point 3.6.3.1 – paragraph 1 – introductory part The instructions
Amendment 424 #
Proposal for a regulation Annex III – Part 3 – point 3.6 – point 3.6.3 – point 3.6.3.1 – paragraph 1 – point a (a) the vibration total value
Amendment 425 #
Proposal for a regulation Annex III – Part 3 – point 3.6 – point 3.6.3 – point 3.6.3.1 – paragraph 1 – point b 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 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
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
Amendment 429 #
Proposal for a regulation Annex III – Part 6 – point 6.2 – paragraph 3 The control devices for the movements referred to in the first paragraph shall be of the hold-to-run type except where the carrier is completely enclosed. If there is no risk of persons or objects on the carrier colliding or falling and no other risks due
Amendment 430 #
Proposal for a regulation Annex IV – Part A – paragraph 2 – point a (a) a complete description of the machinery product
Amendment 431 #
Proposal for a regulation Annex IV – Part A – paragraph 2 – point n Amendment 432 #
Proposal for a regulation Annex V – point 3 3. The address where the machinery product is permanently installed only for
Amendment 433 #
Proposal for a regulation Annex V – point 6 6. The object of the declaration described in point
Amendment 434 #
Proposal for a regulation Annex VII – point 2 Amendment 435 #
Proposal for a regulation Annex VII – point 5 – paragraph 1 The notified body shall draw up an evaluation report that records the
Amendment 436 #
Proposal for a regulation 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
Amendment 437 #
Proposal for a regulation 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
Amendment 438 #
Proposal for a regulation Annex X – paragraph 2 a (new) The assembly instructions are provided by the manufacturer in digital form.
source: 699.191
2022/01/24
EMPL
117 amendments...
Amendment 100 #
Proposal for a regulation 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 stress and cognitive workload that may be caused by the interaction with the machine shall be adapted to:
Amendment 101 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 4 – point b Amendment 102 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – paragraph 5 Amendment 103 #
Proposal for a regulation Annex III – Part 1 – point 1.5 – point 1.5.1 – paragraph 2 The safety objectives set out in Directive 2014/35/EU shall apply to a machinery product. However, the obligations concerning conformity assessment and the placing on the market
Amendment 104 #
Proposal for a regulation Annex III – Part 1 – point 1.5 – point 1.5.4 – paragraph 1 Errors likely to be made when fitting or refitting certain parts, which could be a source of risk, shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves
Amendment 105 #
Proposal for a regulation Annex III – Part 1 – point 1.5 – point 1.5.13 – paragraph 2 Where a risk cannot be eliminated, the machinery product shall be so equipped that hazardous materials and substances can be contained,
Amendment 106 #
Proposal for a regulation 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
Amendment 107 #
Proposal for a regulation 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 over the entire lifecycle of the machinery product.
Amendment 108 #
Proposal for a regulation 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
Amendment 109 #
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 over the entire lifecycle 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 110 #
Proposal for a regulation 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
Amendment 111 #
Proposal for a regulation Annex III – Part 1 – point 1.7 – point 1.7.4 – point 1.7.4.2 – point 1 – point w Amendment 112 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – introductory part 2.2. PORTABLE HAND-HELD
Amendment 113 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – paragraph 1 – introductory part Portable hand-held
Amendment 114 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – paragraph 1 – point c (c) present no risks of accidental starting
Amendment 115 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – paragraph 1 – point e (e) have a device or a connected exhaust system, with an extraction connection outlet or equivalent system to capture or reduce emissions of hazardous substances. This requirement does not apply where its application would result in
Amendment 116 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – introductory part The instructions shall give the following information concerning vibrations
Amendment 117 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point a (a) the vibration total value
Amendment 118 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point b Amendment 119 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 1 – point c (c) the uncertainty of
Amendment 120 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 2 These values
Amendment 121 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 3 If harmonised standards
Amendment 122 #
Proposal for a regulation Annex III – Part 2 – point 2.2 – point 2.2.1 – point 2.2.1.1 – paragraph 4 The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied,
Amendment 123 #
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 have an ergonomic design and shall not be fitted if they increase the risk.
Amendment 124 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.2 – paragraph 2 The machine shall not be able to move when the restraint system is not active in case there is a significant risk of tipping or rolling over. A visual
Amendment 125 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 1 Amendment 126 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 2 Amendment 127 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 3 Amendment 128 #
Proposal for a regulation Annex III – Part 3 – point 3.2 – point 3.2.4 – paragraph 4 Amendment 129 #
Proposal for a regulation Annex III – Part 3 – point 3.3 – point 3.3.3 – paragraph 6 Amendment 130 #
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 a
Amendment 131 #
Proposal for a regulation Annex III – Part 3 – point 3.3 – point 3.3.3 – paragraph 6 – point b (b) it shall be equipped with devices intended to detect any human, domestic animal or any other obstacle in its vicinity, where those obstacles could give rise to a risk to health and safety of persons or where appropriate of domestic animals or to safe operation of the machinery product.
Amendment 132 #
Machinery, lifting accessories and their components shall be capable of withstanding the stresses to which they are subjected during their life
Amendment 16 #
Proposal for a regulation 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) (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 (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
Amendment 19 #
Proposal for a regulation 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 (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 21 #
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 only foreseeable 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
Amendment 22 #
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,
Amendment 23 #
Proposal for a regulation 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 (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 (39) This Regulation
Amendment 26 #
Proposal for a regulation 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 (40) In the absence of relevant harmonised standards, the Commission should be able to establish technical specifications for
Amendment 28 #
Proposal for a regulation 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
Amendment 29 #
Proposal for a regulation Recital 42 (42)
Amendment 30 #
Proposal for a regulation 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
Amendment 31 #
Proposal for a regulation 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,
Amendment 32 #
Proposal for a regulation Recital 45 a (new) (45a) Nevertheless, the provisions laid down in Articles 5(1) and 21(2) of this Regulation should be applied only to AI systems capable of self-determination and evolving during normal operation. By contrast, they should not be applied to conventional software that is not capable of learning or evolving and is programmed solely to make machinery products perform certain automated functions.
Amendment 33 #
Proposal for a regulation 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
Amendment 34 #
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-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
Amendment 35 #
Proposal for a regulation 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
Amendment 36 #
Proposal for a regulation 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.
Amendment 37 #
Proposal for a regulation Recital 76 a (new) (76 a) The harmonised standards relevant to this Regulation take into account the United Nations Convention on the Rights of Persons with Disabilitities 1a (UN CRPD) and if the standards do not take the UN CRPD into account, manufacturers would have to explain why;
Amendment 38 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation lays down requirements for the design and construction of machinery products to allow the making
Amendment 39 #
Proposal for a regulation Article 2 – paragraph 1 – point d (d) lifting accessories, including lifting appliances whose speed does not exceed 0.15 m/s’;
Amendment 40 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry vehicles, 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
Amendment 41 #
Proposal for a regulation Article 2 – paragraph 2 – point g (g) agricultural and forestry
Amendment 42 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 – point f (f) an assembly as referred to in points (a), (b), (c), (d) and (e) missing only the upload of a software intended for
Amendment 43 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 a (new) (1 a) When machinery contains embedded software, preinstalled or installed subsequently, the latter shall be considered as an integrated part of the machinery;
Amendment 44 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 Amendment 45 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘substantial modification’ means a modification of a machinery product, by physical or digital means after that machinery product has been placed on the market or put into service, which is not foreseen 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. Maintenance and repair operations by third parties are not substantial modifications;
Amendment 46 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1 a. European Injury Database 1.The Commission shall establish and coordinate a European Injury Database, that covers all type of injuries caused by products and machinery placed or made available on the Union market; 2.The market surveillance authorities of Member States shall register the injury data to the database, in compliance with Union and national rules on data protection; 3. The Commission shall establish a common methodology for data collection and oversight the registration of data made by market surveillance authorities;
Amendment 47 #
3. 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 48 #
Proposal for a regulation Article 5 – paragraph 4 – point d (d) statistics on accidents caused by the machinery product for the preceding four years based, in particular information obtained from the Information and Communication System for Market Surveillance (ICSMS) information, safeguard clauses, Rapid Alert System (RAPEX)
Amendment 49 #
Proposal for a regulation 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 applies only to artificial intelligence systems with self- determining behaviour or logic which are capable of evolving during normal operation, so as not to compromise the safety of the machinery product as a whole.
Amendment 50 #
Proposal for a regulation Article 17 – paragraph 3 Amendment 51 #
Proposal for a regulation 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 52 #
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
Amendment 53 #
Proposal for a regulation 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 54 #
Proposal for a regulation Annex I – point 24 24.
Amendment 55 #
Proposal for a regulation Annex I – point 24 24. Software ensuring safety functions
Amendment 56 #
Proposal for a regulation Annex I – point 24 a (new) 24 a. Safety component with fully or partially evolving behaviour or logic.
Amendment 57 #
Proposal for a regulation Annex I – point 25 Amendment 58 #
Proposal for a regulation Annex I – point 25 25. Machinery embedding
Amendment 59 #
Proposal for a regulation Annex I – point 25 a (new) 25 a. escalators and moving walks;
Amendment 60 #
Proposal for a regulation Annex II – point 18 18.
Amendment 61 #
Proposal for a regulation Annex III – point 1 – introductory part 1. The manufacturer of a machinery product
Amendment 62 #
Proposal for a regulation Annex III – point 1 – paragraph 1 – introductory part By the iterative process of risk assessment and risk reduction referred to in the first subparagraph, the manufacturer
Amendment 63 #
Proposal for a regulation 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
Amendment 64 #
Proposal for a regulation Annex III – point 1 – paragraph 1 – point d (d) estimate the risks, taking into account the severity of the possible injury or damage to health, including mental health, and the probability of its occurrence;
Amendment 65 #
Proposal for a regulation Annex III – point 1 – paragraph 1 – point f (f) eliminate the hazards or sufficiently reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).
Amendment 66 #
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
Amendment 67 #
Proposal for a regulation Annex III – point 3 3. The essential health and safety requirements laid down in this Annex are mandatory
Amendment 68 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.1 – paragraph 1 – point a (a) ‘hazard’ means a potential source of injury or damage to health, including mental health;
Amendment 69 #
Proposal for a regulation 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 the reasonably foreseeable conditions
Amendment 70 #
Proposal for a regulation 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 the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of protective measures shall be to eliminate any risk throughout the foreseeable life
Amendment 71 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.2 – point b – introductory part (b) In selecting the most appropriate methods, the manufacturer
Amendment 72 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.2 – point e (e)
Amendment 73 #
Proposal for a regulation 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 74 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.5 – paragraph 2 During the transportation of the machinery product
Amendment 75 #
Proposal for a regulation 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
Amendment 76 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point c (c)
Amendment 77 #
Proposal for a regulation 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 78 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point d (d)
Amendment 79 #
Proposal for a regulation 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
Amendment 80 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point e (e) adapting the human-machinery product interface to the foreseeable characteristics of the operators, including with respect to a machinery product with intended
Amendment 81 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.6 – paragraph 1 – point f Amendment 82 #
Proposal for a regulation 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)
Amendment 83 #
Proposal for a regulation 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 84 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.7 – paragraph 1 The operating position shall be designed and constructed in such a way as to avoid any risk due to exhaust gases
Amendment 85 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.7 – paragraph 3 Where appropriate, the operating position shall be fitted with an adequate cabin designed, constructed
Amendment 86 #
Proposal for a regulation 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
Amendment 87 #
Proposal for a regulation 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
Amendment 88 #
Proposal for a regulation 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
Amendment 89 #
Proposal for a regulation Annex III – Part 1 – point 1.1 – point 1.1.9 – paragraph 2 A hardware component for connection 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, where relevant and feasible, collect evidence of a legitimate or illegitimate intervention in the hardware component where. This requirement does not include detection of hardware manipulation.
Amendment 90 #
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
Amendment 91 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point a (a) they can reasonably 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 92 #
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
Amendment 93 #
Proposal for a regulation 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
Amendment 94 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point f Amendment 95 #
Proposal for a regulation Annex III – Part 1 – point 1.2 – point 1.2.1 – paragraph 2 – point g (g) recording of data on the safety related
Amendment 96 #
Proposal for a regulation 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
Amendment 97 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.2 – paragraph 4 Where a risk of rupture or disintegration remains despite the measures taken, the parts concerned shall be mounted, positioned
Amendment 98 #
Proposal for a regulation Annex III – Part 1 – point 1.3 – point 1.3.7 – introductory part 1.3.7. Risks related to moving parts
Amendment 99 #
Proposal for a regulation 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
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Joint Declaration on EU legislative priorities for 2023 and 2024New
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2023-02-18Show (1) Changes | Timetravel
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2023-02-11Show (2) Changes | Timetravel
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https://www.europarl.europa.eu/RegData/commissions/imco/lcag/2023/01-25/IMCO_LA(2023)000924_EN.pdf
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https://www.europarl.europa.eu/RegData/commissions/imco/inag/2023/01-25/IMCO_AG(2023)742409_EN.pdf
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2023-02-08Show (3) Changes | Timetravel
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2022-12-05Show (5) Changes | Timetravel
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2022-07-29Show (5) Changes | Timetravel
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2022-07-28Show (5) Changes | Timetravel
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2022-07-14Show (3) Changes | Timetravel
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2022-06-20Show (2) Changes | Timetravel
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https://www.europarl.europa.eu/doceo/document/A-9-2022-0141_EN.html
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https://www.europarl.europa.eu/doceo/document/A-9-2022-0141_EN.html
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2022-06-07Show (6) Changes | Timetravel
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| procedure/Legislative priorities |
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| procedure/subject/2.10.03 |
Standardisation, EC/EU standards and trade mark, certification, compliance
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| procedure/subject/3.40.08 |
Mechanical engineering, machine-tool industry
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| procedure/subject/4.15.15 |
Health and safety at work, occupational medicine
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| procedure/subject/4.60.04.02 |
Consumer security
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2022-06-01Show (14) Changes | Timetravel
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Standardisation, EC/EU standards and trade mark, certification, compliance
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Mechanical engineering, machine-tool industry
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| procedure/subject/4.15.15 |
Health and safety at work, occupational medicine
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| procedure/subject/4.60.04.02 |
Consumer security
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2022-03-11Show (1) Changes | Timetravel
| docs/6/docs/0/url |
https://www.europarl.europa.eu/doceo/document/EMPL-AD-703051_EN.html
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2021-12-17Show (1) Changes | Timetravel
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2021-11-25Show (1) Changes | Timetravel
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https://www.europarl.europa.eu/doceo/document/IMCO-AM-699191_EN.html
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Preparatory phase in ParliamentNew
Awaiting committee decision |
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2021-06-08Show (3) Changes | Timetravel
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European Economic and Social Committee
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2021-05-31Show (1) Changes | Timetravel
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2021-05-11Show (1) Changes | Timetravel
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