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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
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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which, when the summary was generated, still provided a presumption of conformity together with references already withdrawn from the OJ.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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- Published: 28 December 2021
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New Machine Regulation 2021: amendments of 20 October 2021
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.
Download Report PDF
- Published: 29 October 2021
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Norme armonizzate Direttiva macchine Ottobre 2021: il File CEM
Importa il File CEM in CEM4, e visualizza tutti i titoli delle norme armonizzate per Direttiva macchine aggiornamento Ottobre 2021
Elenco Norme armonizzate Direttiva macchine 2006/42/CE ad Ottobre 2021, in formato CEM, dei Titoli delle norme armonizzate per la Direttiva macchine 2006/42/CE aggiornato:
Con il file CEM è possibile tenere sotto controllo in CEM4, nell'Archivio normativa, tutte le Norme armonizzate (n. 787), suddivise per CEN/CENELEC/Tipo A/B/C, consultare, gestire direttamente da CEM4 e commentare le stesse.
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Norme armonizzate online
- Published: 15 October 2021
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ISO 7010 Raccolta dei Segnali di sicurezza previsti dalla norma - Ed. 2021 Amd 3
Agosto 2021
Aggiornata la raccolta segnaletica ISO 7010:2019, con altri segnali pubblicati con l'emendamento 3 di luglio 2021:
- Raccolta immagini segnaletica Ed. 7.0 aggiornata con emendamento 3 di luglio 2021
Nuovi Pittogrammi Emendamento A3 Luglio 2021:
E067 - Evacuation mattress
E068 - Lifebuoy with light and smoke
E069 - Person overboard call point
F019 - Unconnected fire hose[/box-info]
ISO 7010:2019
Graphical symbols - Safety colours and safety signs - Registered safety signs
Corrigenda/Amendments:
ISO 7010:2011/Amd 1:2012
ISO 7010:2011/Amd 2:2012
ISO 7010:2011/Amd 3:2012
ISO 7010:2011/Amd 4:2013
ISO 7010:2011/Amd 5:2014
ISO 7010:2011/Amd 6:2014
ISO 7010:2011/Amd 7:2016
ISO 7010:2011/Amd 8:2017
ISO 7010:2011/Amd 9:2018
ISO 7010:2019/Amd 1:2020
ISO 7010:2019/Amd 2:2020
ISO 7010:2019/Amd 3:2021
- Published: 05 September 2021
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Position Paper CEN-CENELEC draft Machinery Regulation July 2021
ID 13933 | 07.07.2021 / In allegato Position paper
Position Paper CEN-CENELEC response to the European Commission’s Public Consultation on the draft Machinery Regulation July 2021
Il 21 aprile 2021, la Commissione Europea (CE) ha adottato la sua proposta di Regolamento Macchine che sostituirà la Direttiva Macchine 2006/42/CE.
Allo stesso tempo, la CE ha avviato una consultazione pubblica per ottenere un feedback sul progetto di regolamento macchine. Con questo documento, CEN e CENELEC forniscono la loro posizione su questa proposta.
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- Published: 07 July 2021
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Sicurezza macchine per imballare EN 415-10
ID 3486 | Rev. 1.0 dell'8.05.2021 / Documento completo allegato
Le misure di protezione contro il rischio derivante dalle parti in movimento delle macchine per imballare in accordo con le norme della serie EN 415-X.
Il Documento, estratto dalla norma armonizzata EN 415-10:2014 Sicurezza delle macchine per imballare Parte 10: Requisiti generali, prende in esame la parte relativa alle misure di protezione contro il rischio derivante dalle parti in movimento.
Il Cap. 4 della EN 415-10 tratta dei pericoli di natura meccanica derivanti dalle parti in movimento (schiacciamento, cesoiamento, taglio, impigliamento, attrito, urto, trascinamento e intrappolamento. Non tutti questi pericoli possono essere eliminati solo tramite l’interruzione dell’alimentazione a causa della gravità o dell’energia accumulata.
Il Cap. 5.2.1 della EN 415-10, oggetto del Documento, analizza i pericoli derivanti dalle parti in movimento e le misure di protezione correlate.
La norma non analizza:
- il rischio derivante dall’utilizzo delle macchine in aree accessibili al pubblico;
- utilizzo della macchine per imballare in atmosfere potenzialmente esplosive;
- pericoli specifici per la salute, la sicurezza o l’igiene associati ai prodotti che possono essere manipolati dalle macchine, ma include consigli generali su tale argomento;
- pericoli che possono essere associati alla messa fuori servizio della macchine per imballare.
La norma tecnica EN 415-10 tratta dei requisiti generali per le macchine per imballare definite dalla EN 415-1 oppure oggetto di un’altra EN 415 specifica.
Norme della famiglia EN 415-X:
UNI EN 415-1:2014 - Sicurezza delle macchine per imballare - Parte 1: Terminologia e classificazione delle macchine per imballare e delle relative attrezzature;
UNI EN 415-2:2001 - Sicurezza delle macchine per imballare - Macchinario per imballare in contenitori preformati rigidi;
UNI EN 415-3:2010 - Sicurezza delle macchine per imballare - Parte 3: Formatrici, riempitrici e sigillatrici;
UNI EN 415-4:1998 - Sicurezza delle macchine per imballare - Pallettizzatori e depallettizzatori EC 1-2006 UNI EN 415-4:1998 - Sicurezza delle macchine per imballare - Pallettizzatori e depallettizzatori;
UNI EN 415-5:2010 - Sicurezza delle macchine per imballare - Parte 5: Macchine avvolgitrici;
UNI EN 415-6:2013 - Sicurezza delle macchine per imballare - Parte 6: Macchine avvolgitrici di pallet;
UNI EN 415-7:2008 - Sicurezza delle macchine per imballare - Parte 7: Macchine per imballaggi multipli;
UNI EN 415-8:2008 - Sicurezza delle macchine per imballare - Parte 8: Macchine reggiatrici;
UNI EN 415-9:2010 - Sicurezza delle macchine per imballare - Parte 9: Metodi di misurazione del rumore per macchine per imballare, linee d imballaggio e relative attrezzature, grado di accuratezza 2 e 3;
UNI EN 415-10:2014 - Sicurezza delle macchine per imballare - Parte 10: Requisiti generali.
Per la trattazione completa dell’argomento è necessario consultare la norma tecnica EN 415-10.
La EN 415-10 è una norma tecnica di tipo C ed è armonizzata per la direttiva macchine 2006/42/CE.
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- Published: 11 June 2021
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Proposal for a Regulation of the European Parliament and of the Council on machinery products
Update 20.10.2021 / Proposal 2021 Regulation machinery products
EC, 20.10.2021
In attachment:
- 2021/0105/COD Emendament Proposal Regulation machinery 2021
- COM(2021) 202 - Proposal for a Regulation of the European Parliament and of the Council on machinery products
- COM(2021) 202 ANNEX - Annex to the Proposal for a Regulation of the European Parliament and of the Council on machinery products
- SWD(2021) 82 - Impact assessment
- SWD(2021) 83 - Executive summary of the Impact assessment
The Machinery Directive (hereafter ‘MD’) establishes a regulatory framework for placing machinery on the Single Market, based on Article 114 of the TFEU (the approximation of laws. The general objectives of the MD are to: i) ensure free movement of machinery within the internal market; and ii) ensure a high level of protection for users and other exposed persons. The MD follows the ‘new approach’ principles of EU legislation. It is intentionally written to be technology neutral, which means that it lays down the essential health and safety requirements (hereafter ‘safety requirements’) to be complied with, without prescribing any specific technical solution to comply with those requirements. The choice of the technical solution is a prerogative of manufacturers, which leaves space for innovation and new design development.
During the REFIT evaluation of the directive, all interested parties confirmed it is an essential piece of legislation although it identified a necessity to improve, simplify and adapt the MD to the needs of the market. Some Members of the European Parliament’s expressed their support to the revision of the Machinery Directive. In particular, by ‘taking the legislation’ to the XXI century and promoting innovation for the EU economy.
As part of the Commission Work Programme 2020 under the priority ‘A Europe fit for the Digital Age’, the revision of the product safety Directive 2006/42/EC on Machinery (MD) contributes to the digital transition and to the strengthening of the Single Market. Indeed, regarding new technologies and their impact on safety legislation, the Commission has published in February 2020 a White Paper on Artificial Intelligence accompanied by a ‘Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics’. The Report, which has conducted an analysis of the impact of new technologies and the challenges they pose to Union safety legislation, concluded that the current product safety legislation contains a number of gaps that need to be addressed, in particular, among other, in the Machinery Directive. This is even more relevant for a sustainable recovery from the COVID pandemic, since the machinery sector is an essential part of the engineering industry and one of the industrial mainstays of the EU economy.
In view of dealing with the elements highlighted in the evaluation and developed in the impact assessment report of the machinery directive5, as well as responding to the Commission policy objectives on digitalization, this proposal expects to tackle the following problems:
Problem 1: The MD does not sufficiently cover new risks originating from emerging technologies.
In order to boost the trust in digital technologies, 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.
There are several aspects that need to be addressed within this problem. The first one relates to the potential risks that originate from a direct human-robot collaboration as the collaborative robots (co-bots) that are designed to work alongside human and employees are exponentially increasing. A second source of potential risk originates from connected machinery. A third area of concern lies with the way software updates affects the ‘behaviour’ of the machinery after its placing on the market. A fourth concern relates to the ability of manufacturers to conduct a full risk assessment on machine learning applications before the product is placed on the market. Finally, as far as the autonomous machines and remote supervisory stations, the current MD foresees a driver or an operator responsible for the movement of a machine. The driver may be transported by the machinery or may be accompanying the machinery, or may guide the machinery by remote control, but does not consider the possibility of no driver, and sets up no requirements for autonomous machines.
Problem 2:
(i) Legal uncertainty due to a lack of clarity on the scope and definitions; and
(ii) possible safety gaps in traditional technologies.
The MD needs greater legal certainty in its scope and definitions, which generated some difficulties for manufacturers to understand the correct legal framework they should apply.
Some overlaps or inconsistencies with other EU specific legislation were identified. With respect to the definitions set by the Directive, the definition of 'partly completed machinery' raised a number of concerns particularly centred at the borderline with the definition of 'machinery' and the definition of ‘machinery’ has been clarified. Besides, there is a need to clarify the exclusion of means of transport and to reinforce the coherence of the exclusion of some products covered by the Low Voltage Directive 2014/35/EU when those products integrate a Wi-Fi function.
Furthermore, it is a common practice that machines placed on the market are modified in order for example to add a function or improve the performance. The problem is that if the machine suffers a substantial modification, without the manufacturer’s agreement, may be not in conformity any longer with the essential health and safety requirements. The current MD does not address this situation.
There are a number of requirements on traditional technologies not related to new technologies that were identified either as not clear or safe enough, or as too prescriptive and potentially hindering innovation. These requirements are related to installation of lifting appliances, slow speed lifts, seating, protection against hazardous substances, overhead power lines and vibration from portable handheld and hand guided machinery.
Problem 3: Insufficient provisions for high risk machines.
The third party conformity assessment is considered by some Member States and stakeholders more adapted to address the high risks stemming from certain groups of machines.
Another problem is that the current list of high-risk machines in Annex I was elaborated 15 years ago, and the market has much evolved since then. It is necessary to remove machines no longer considered high risk and/or introducing new ones (such as machinery embedding AI systems, which fulfil a safety function).
Problem 4: Monetary and environmental costs due to extensive paper-based documentation.
The MD requires manufacturers to provide the necessary machinery information, such as instructions. To ensure that every machine user has access to the instructions, providing a printed version was considered as the most viable option. Since then, however, the use of the internet and digital technologies has increased. The requirement to provide printed versions increases the costs and administrative burdens for economic operators and has a negative impact on the environment. However, it must be also considered that some users are less digitally savvy, there is a lack of internet access in certain environments and the digital manual might not match the version of the product.
Problem 5: Inconsistencies with other pieces of Union product safety legislation.
The New Legislative Framework is a package of measures aimed at brought together all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of industrial products with the requirements adopted to protect the various public interests and for the proper functioning of the single market. A main objective of the Commission is to bring product harmonisation legislation in line with the reference provisions of Decision 768/2008/EC. While the Machinery Directive is already a New Approach directive, it is not yet aligned to the NLF.
The lack of MD’s alignment to the NLF creates inconsistencies with other EU product legislation.
Problem 6: Divergences in interpretation due to transposition.
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.
Furthermore, there have been delays in the transposition of the Directive in some Member States.
Fonte: EC
- Published: 21 April 2021
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Stima del rischio ISO/TR 14121-2 p. 6.4 Punteggio numerico - Esempio e scheda
ID 13083 | 12.03.2021 / Documento di esempio e scheda applicazione in allegato
La norma ISO/TR 14121-2 (Rapporto Tecnico) Sicurezza del macchinario Valutazione del rischio Parte 2: Guida pratica ed esempi di metodi, fornisce una guida pratica per l'esecuzione della valutazione del rischio per il macchinario in conformità alla EEN ISO 12100 e descrive diversi metodi e strumenti per ogni fase del processo. Fornisce esempi di differenti misure che possono essere utilizzate per ridurre il rischio ed è destinata ad essere utilizzata per la valutazione del rischio di una estesa varietà di macchinari in termini di complessità e di potenziale di danno.
I suoi utilizzatori previsti sono le persone coinvolte nella progettazione, installazione o modifica del macchinario.
Nel Documento è illustrato uno dei metodi riportati nella
ISO/TR 14121-2, il “
Punteggio Numerico” (
p. 6.4), con esempio / scheda di valutazione del rischio e processo di riduzione del rischio per una Macchina formatrice a mandrino verticale, in cui l'identificazione dei pericoli è limitata, in questo esempio, alla fase di utilizzo e, in particolare, alla messa a punto e al funzionamento della macchina.
Nel rapporto tecnico ISO/TR 14121-2, nell’esempio relativo la macchina formatrice, viene usato il metodo grafico. In questo documento, allo stesso esempio viene applicato un metodo a punteggio numerico usando i parametri riportati al capitolo 2.
Metodi di Stima del Rischio ISO/TR 14121-2
Nella ISO/TR 14121-2 sono illustrati 4 metodi per la Stima del rischio:
1. Matrice del rischio (6.2)
2. Grafico del rischio / Metodo grafico (6.3)
3. Punteggio numerico (6.4)
4. Metodo ibrido (6.5)
Si ricorda che la EN ISO 12100 demanda all'uso dei metodi illustrati nella ISO/TR 14121-2 (anche se non armonizzata) per la valutazione dei rischi relativi alle macchine:
"EN ISO 12100
...
Scopo e campo di applicazione ...L’uso pratico di diversi metodi per ogni fase della valutazione del rischio è descritto nell’ISO/TR 14121-2".
Figura 0 - ISO/TR 14121-2 Metodi di Stima del rischio
...
Vedi il Documento
- Published: 06 April 2021
- Hits: 8867
