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Report Regulation on Machinery Products on the state of play - 18.11.2021
Brussels, 18 November 2021 (13569/1/21 REV 1)
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I. INTRODUCTION
The European Commission proposal on Machinery Products was transmitted to the European Parliament and to the Council on 22 April 2021. The proposal was presented in the package together with the proposal for the Act on Artificial Intelligence. The two are aligned as the Machinery Products proposal aims to remain future-proof in light of new technologies. As the issue of artificial intelligence represents one of the priorities of the Presidency, the Presidency attributes an important role to the Machinery Products proposal.
The examination of the proposal in the Council Working Party on Technical Harmonisation started on 26 April 2021 under the Portuguese Presidency.
There were all-in-all 12 meeting days until 25 November 2021, eight of them under the Slovenian Presidency. The Commission`s impact assessment was examined with the help of an indicative questionnaire.
II. MAIN ISSUES
In general, the transmission of the Commission’s proposal has been welcomed as timely, necessary and in line with the good inter-institutional practice. Stakeholders have been heard sufficiently by the Commission and the objective of bringing products with digital content into the scope of the machinery regulation has been accepted.
During the discussions at the Working Party level some essential comments were raised.
Terminology regarding machinery/machinery products
The introduction of the term “machinery products” that partly replaces the currently used term “machinery” demands for considerable attention and the topic was addressed in the Working Party meetings on different occasions. Many Member States would prefer to keep the current wording (“machinery”) as they do not see the added value in the introduced changed wording. They claim that market surveillance authorities do not experience difficulties while using the current wording and they believe that the proposed change in wording could limit the clarity of the text and bring translation issues. On the basis of the Member States’ comments an alternative suggestion was formulated by the Commission where the term “machinery” was coupled with the term “machine/s” but such a solution also brought considerable reservations of many Member States particularly due to translation issues.
Exclusion of »vehicles which have as their only objective the transport of goods or persons by public road, air, water or rail network except for machinery mounted on those vehicles" from the scope of the regulation
Member States are very careful with the suggested exclusion particularly from the perspective of the exclusion of small transport vehicles for personal use or light electric vehicles such as escooters, e-bikes that are widely used but could, on the basis of this Proposal, remain unregulated and consequently potentially dangerous for users. Many Member States would therefore like to keep such vehicles in the scope of the Proposal even when road circulation risk is not covered by the Proposal as is the case with the current Machinery Directive. Some Member States also call for the introduction of the transition period until relevant legislation regulating the mentioned type of vehicles is passed.
Empowerment of the Commission to elaborate technical specifications when standards are not available
Member States expressed their support for the primary role of standards and are therefore rather reserved regarding such an empowerment of the Commission particularly in the area where no considerable issues regarding standardisation have been detected. They can potentially agree to a strengthened wording on the issue of such technical specification only representing the final resort option under specific circumstances.
The list of high-risk products in Annex I
Member States and the Commission agree that the mentioned list needs updating but Member States expect this update during the process of adoption of this Proposal while the Commission claims that they do not have enough data to do so but would adapt the list right after the adoption of this Proposal.
Third-party conformity assessment
Linked to the necessity to update the Annex I is also the newly introduced necessity for third-party conformity assessment procedure of high-risk products (use of module B). Such a requirement represents a considerable burden, particularly for SMEs, and some Member States therefore demand for either maintaining the currently relevant option of self-assessment type of conformity assessment (use of module A) or for a considerable adaptation of the Annex I where the high-risk machinery products are listed.
The recurrent issue in the Working Party meetings was also the issue of definitions that need to be properly specified and agreed upon (substantial modification, artificial intelligence) while the issue of alignment with the NLF was consistently addressed.
The Presidency aims to finish the first examination of the Proposal and intends to finalise it by an examination of the essential health and safety requirements of the machinery products in Annex III.
The length and complexity of this Annex will demand for considerable time for its examination.
The Presidency also strives to present the first partial Presidency compromise text of the Proposal.
III. OUTLOOK
The draft report by the rapporteur, Mr Ivan Štefanec (EPP), will be discussed in the Committee on the Internal Market and Consumer Protection (IMCO) of the European Parliament as from November 2021 and the vote on the draft amendments is expected to take place in March 2022. It will thus be for the incoming French Presidency to intensify contacts with the representatives of the European Parliament in order to find compromise solutions that are acceptable both to the Council and the European Parliament with a view to making an agreement at first reading possible.
The Slovenian Presidency thanks the Portuguese Presidency for starting the discussions, all delegations for their contributions to the file, and the European Commission for its collaborative attitude and fruitful comments necessary to improve the text of the proposal.
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Fonte: EC
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- Pubblicato: 25 Gennaio 2022
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Stima del rischio con il metodo SCRAM (SICK)
ID 15490 | 19.01.2022 / Documento completo (EN)
Risk assessment and risk reduction for machinery - Part 3: Conducting risk estimation. Scalable risk analysis and evaluation method (SCRAM)
Fonte: SICK AG - WHITE PAPER 2019-02
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Introduction
Scope
Machine risk assessment consists of a series of steps used to examine the hazards associated with machines and it consists of two stages, namely risk analysis and risk evaluation, as laid out in ISO 12100:2012. Risk analysis comprises three stages: determining the limits of the machine, identifying hazards, and estimating the risk.
After having completed the hazard identification phase, risk estimation is carried out for each identified hazard and hazardous situation. Risk is defined as a combination of the severity of harm and the probability of occurrence of that harm.
According to ISO 12100:2012, the probability of occurrence of harm can be estimated taking into account the frequency and duration of exposure to the hazard, the probability of occurrence of a hazardous event, and the technical and human possibilities to avoid or limit the harm. The combination of the severity of the possible harm with these three probability parameters will be used to estimate risk values which can then be used for comparison purposes. At the last stage of the assessment process, risk evaluation allows decisions on risk reduction measures to be applied to the machine.
The scope of this white paper is to provide a risk estimation methodology that has proved to be robust, and reliable while preventing errors when estimating risks.
Preface
This white paper is part of a series of papers describing the SICK process of risk assessment in combination with risk reduction:
- Part 1: Defining the scope of the risk assessment
- Part 2: Identifying task/hazard pairs
- Part 3: Conducting risk estimation
- Part 4: Integrating protective devices into (existing) control systems
- Part 5: Implementing emergency operations
- Part 6: Carrying out substantial modifications
Risk reduction process
General
All products and systems include hazards and, therefore, some level of risk. However, the risk associated with those hazards shall be reduced to an acceptable or tolerable levela. The iterative process of risk assessment and risk reduction for each task and hazard combination is essential in achieving acceptable risk (level of risk that is accepted in a given context based on the current values of society).
The objective of risk reduction can be achieved by the elimination of significant hazards, or by reducing each of the two elements (separately or simultaneously) that determine the associated risk:
- Severity of harm from the hazard under consideration
- Probability of occurrence of that harm
...
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Directive 2014/34/EU ATEX: List Harmonised standards published in the OJ | 2021
ID 15294| Update 27 December 2021 / List XLS file in IT
In attachment:
List as PDF file - EN
List as XLS file - EN
List as XLS file - IT
Summary of references of harmonised standards published in the Official Journal – Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres
The summary below consolidates the references of harmonised standards published by the Commission in the Official Journal of the European Union (OJ). It reproduces information already published in the L or C series of the OJ as indicated in columns (2), (5) and/or (7). It contains all references which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.
The Commission services provide this summary for information purposes only. Although they take every possible precaution to ensure that the summary is updated regularly and is correct, errors may occur and the summary may not be complete at a certain point in time. The summary does not as such generate legal effects.
This summary was generated on 31 August 2021
Fonte: EC
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- Pubblicato: 28 Dicembre 2021
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Nuovo Regolamento macchine 2021 / Pubblicati in data 20 Ottobre 2021 emendamenti al Draft di Aprile 2021
ID 14845 | 29.10.2021 / Report emendamenti allegato
Gli emendamenti, prevedono modifiche alla Proposta di nuovo regolamento macchine di Aprile 2021 (2021/0105(COD), in particolare inerenti:
- definizione più chiara delle quasi-macchine;
- precisazioni sul ruolo del rappresentante autorizzato (già ‘mandatario’ nella direttiva 2006/42/CE);
- modifica di " macchine ad alto rischio" in " macchine potenzialmente ad alto rischio"
- indicazioni sugli obblighi per la messa in servizio delle macchine;
- mantenere la possibilità per i fabbricanti di utilizzare anche la procedura di controllo interno della produzione (modulo A) di cui all'allegato VI per i macchinari potenzialmente ad alto rischio,
- precisazioni sulla documentazione in formato digitale;
- data entrata in vigore spostata da 30 a 48 mesi dalla pubblicazione
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2021/0105(COD) 20.10.2021
Draft Report on the proposal for a regulation of the European Parliament and of the Council on Machinery products (COM(2021)0202 – C9-0145/2021 – 2021/0105(COD))
Committee on the Internal Market and Consumer Protection
EXPLANATORY STATEMENT
The Machinery Directive 2006/42/EC establishes a regulatory framework for placing machinery on the Single Market, ensuring its free movement and a high level of protection for users and other persons exposed to machinery products.
On 21 April 2021, the Commission put forward a proposal to revise the Machinery Directive.
The proposed revision came 15 years after the adoption of the Machinery Directive, currently in force, reflecting the Commission Work Programme 2020 under the priority ‘A Europe fit for the Digital Age’. In parallel, the Commission proposed a new Artificial Intelligence Act, with the main goal to reflect the change of the digital transition and the impact of new technologies on the Union product safety legislation.
As the machinery sector is an essential part of the engineering industry and one of the industrial pillars of the EU economy, the Rapporteur finds it very important to consider changes to its legislative framework with due care in order to secure sustainable recovery from the COVID-19 crisis while enabling innovation and new design development, and to keep European producers and designers competitive at the global level playing field.
The Rapporteur welcomes the Commission proposal for a Regulation on machinery products and fully supports its alignment with the New Legislative Framework (NLF) as it brings coherence with the other legislative acts on products safety and horizontal transparency. The Rapporteur also supports the conversion of the Directive into a Regulation as it facilitates uniform application across all EU Member States and therefore the free movement of goods.
While preparing the draft report, the Rapporteur carried out a broad consultation with stakeholders, listening to views and needs of the manufacturers, notified bodies and consumers, and, in addition discussing the proposal with the Commission. On that basis, the Rapporteur proposes the following main changes to the Commission proposal.
1. Scope and definitions
The Rapporteur proposes clarifying the scope, in particular with regard to the exclusion of motor vehicles from the Regulation. In addition, the Rapporteur proposes clarifications of several definitions, such as ‘safety component’ ‘substantial modification’ and ‘manufacturer’, and suggests new definitions on ‘machinery product’, ‘safety function’, ‘technical documentation’ and ‘lifecycle’ in order to contribute to the clearer understanding of the
enacting provisions.
Since the Regulation applies to ‘machinery products’ which, according to the Commission proposal, cover also ‘partly completed machinery’, the Rapporteur considers it important to make a clearer distinction between the definitions applying to ‘partly completed machinery’ and those applying to other categories of machinery products.
This distinction should also be made in respect of the requirements for machinery products in general and those for ‘partly completed machinery’, and in respect of the obligations, including (conformity) assessment procedures, of economic operators.
2. High-risk machinery products
The Rapporteur proposes that the term ‘high-risk machinery products’ be replaced by ‘potentially high-risk machinery products’ throughout the text as he considers that machinery products placed nowadays on the market do not present a high risk by default but only in certain situations.
In addition, in respect of the Commission empowerment to adopt delegated acts to amend Annex I listing potentially high-risk machinery products, the Rapporteur proposes that such delegated acts should not apply earlier than 36 months after their entry into force, so that manufacturers have enough time to adapt their design and production.
The Rapporteur emphasised in the report that machinery products should comply with the essential health and safety requirements when placed on the market or put into service.
Finally, in Annex III the rapporteur specified that the remote control for supervisory control function for autonomous operations should be implemented only as an option, ensuring that the remote actions do not increase the level of risk.
3. Conformity assessment of potentially high-risk machinery products
The Rapporteur proposes to keep the possibility for the manufacturers to use also the internal production control procedure (module A) set out in Annex VI for potentially high-risk machinery products, as he is not convinced that there are enough arguments for removing this option, while keeping in mind both the safety of machinery products and the machinery sector competitiveness and flexibility for innovation. In addition, keeping the possibility of using the internal production control procedure is of particular importance for SMEs.
Moreover, the Rapporteur believes that manufacturer’s authorised representative should not have a mandate for ensuring conformity assessment for machinery products or to be responsible for preparing technical documentation. The manufacturer should be the only responsible for these tasks, in line with the provisions of NLF.
4. Commission empowerment to adopt technical specifications
In respect of the Commission proposal to be able to exceptionally adopt implementing acts establishing technical specifications for the essential health and safety requirements in case of absence of harmonised standards, the Rapporteur proposes that such technical specifications do not apply should harmonised standards be developed in the future. Also, the Rapporteur believes that technical specifications could be drafted by the Commission only if European standardisations organisations have not delivered harmonised standards 3 years after the standardisation request.
5. Documentation
All relevant technical documentation, assembly instructions and declarations should be provided in digital or paper form and, if provided digitally, should be accessible during the whole lifecycle of the machinery product.
6. Market surveillance
The Rapporteur clarifies the rights of Member states’ market surveillance authorities and duties of economic operators in case where a machinery product does not comply with the requirements in this Regulation or poses a risk. While doing that, he strives to align the provisions on market surveillance with the Market Surveillance Regulation (EU) 2019/1020.
7. Deadlines and transitional provisions
The Rapporteur proposes extending the deadline for the repeal of Directive 2006/42/EC from 30 to 48 months after the date of entry into force of the new Regulation. In line with that, the transitional period has been extended from 42 to 60 month, as well, and the deadline for the Commission to present its first report on the evaluation of the Regulation from 54 to 72 months.
Finally, the date of application of the Regulation was postponed from 30 to 48 months after its entry into force.
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- Pubblicato: 29 Ottobre 2021
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