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Events

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
2021/04/22
   EC - Document attached to the procedure
2021/04/22
   EC - Document attached to the procedure
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

  • 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
  • Contribution: COM(2021)0202
AmendmentsDossier
455 2021/0105(COD)
2021/11/10 IMCO 338 amendments...
source: 699.191
2022/01/24 EMPL 117 amendments...
source: 704.618

History

(these mark the time of scraping, not the official date of the change)

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type
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body
EP
events/4/summary
  • 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.
procedure/Legislative priorities/1
title
Joint Declaration 2022
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docs/6/docs/0/url
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  • 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.
procedure/Legislative priorities
  • title: Joint Declaration 2021 url: https://oeil.secure.europarl.europa.eu/oeil/popups/thematicnote.do?id=2066000&l=en