Summary report of the open public consultation on the Evaluation of the Machinery Directive 2006/42/EC
15.09.2017
The open public consultation ran from 22 September to 16 December 2016. It was conducted in the context of the evaluation of the Machinery Directive.
This summary report takes stock of the contributions and presents preliminary trends that emerge from them, focusing on the quantitative aspects of the consultation input.
Objectives of the consultation
The objective of the consultation was to collect input on the performance of the Machinery Directive since it became applicable, in 2009.
The questions in the survey were organised by five evaluation areas:
- Relevance - the extent to which the original objectives of the Machinery Directive are still relevant to the needs of the machinery market, including manufacturers and users. The two main objectives of the Directive relate to facilitating the functioning of the internal market for machinery, and ensuring a high level of safety of machinery;
- Effectiveness - the extent to which the two objectives of the Directive were achieved (and factors preventing this);
- Coherence - the extent to which the Directive is coherent with other legislation;
- Efficiency - the extent to which the two objectives of the Directive were achieved at a reasonable cost;
- EU added value - the extent to which the European Directive adds value as compared to what could have been achieved at Member State level.
Respondents were free to contribute to whichever sections or questions they wanted to and also to complement with a position paper.
The Commission is analysing the various contributions to the online consultation, which will feed into a full synopsis report, planned to be published on Europa website for machinery by the end of 2017.
This online consultation is part of a broader dialogue process in which the Commission is consulting stakeholders. It will proceed to a wrap-up of the entire structured dialogue and draw conclusions on these issues, notably if a revision is necessary or not.
Dalla Versione CEM4 4.8.9 di Ottobre 2017 è modificato il Report di Valutazione del rischio RESS/Pericoli per l’inserimento del valore numerico/grafico della riduzione del rischio in riferimento alle matrici di stima del metodo ibrido ISO/TR 14121-2:2012 p. 6.5 confrontato tra la stima del rischio iniziale e finale/residuo.
Quadro Stato VR: Quadro generale Stato Valutazione dei Rischi (*)
Update news 08.2017
Report "Quadro complessivo Stato VR" / "RA Complete Summary" *
Metodo di Valutazione dei Rischi: Classico / Classic Tool
Dalla Rel. 4.5.3 di CEM4, per facilitare la comprensione immediata della Valutazione dei Rischi, è stato predisposto un nuovo Report “Quadro complessivo stato VR”, con il quale, oltre alla già presente visualizzazione a video dello stato dell’analisi in corso, Applicabilità/Conformità, con i valori impostati ed i controlli in anteprima di CEM4, è possibile stampare/esportare lo stato complessivo della VR in poche pagine, ed avere un quadro sintetico dell’andamento/stato della Valutazione dei Rischi, senza procedere forzatamente a tutta la stampa/esportazione.
Il Valore “PASS SCHEDA VR”, è il valore che indica, secondo la Valutazione effettuata, se la Scheda VR è PASS di Conformità e il Requisito in valutazione è “normativamente conforme” (Compliance).
Version to CEM4 Rel 4.6.4, adds an important feature of the Update of Harmonized Standards.
It will be so prepared and maintained a file of Update Standards type "CEM" (Version 1.0), with which we can provide an update desynchronized type of "Rules CEM" by an update of the type "software exe" to CEM4 .
With the Update Standards, you can update the DB with data retrieval of the standards used in the management of the Risk Assessment in "Presumption of Conformity" there by guaranteeing a better standards control over the raw data.
The Technical Standards Harmonized EN for the Machinery Directive 2006/42/EC, subdivided into type A/B/C (EN CEN ) and CENELEC EN Uncategorized, have been renovated in readability in an organic way, and in this form, as Communication from the Commission on June 09, 2017.
Harmonised standards Machinery Directive Communication Last 9 June 2017 are on our site page's www.cem4.eu:
Changelog:
- 1.1.8 EN ISO 10326-1 - Mechanical vibration - 1.5.9 EN ISO 10326-1 - Mechanical vibration
Evaluation Trial Version free for 30 days, complete with all the features, at the end trial period, you can activate the product by purchasing a license.
With the Update rules standards, you can update the database of the standards used in the management of the Risk Assessment in "Presumption of Conformity".
Attention! With importing the CEM Update Standards will be updated to reference standards (qualifications and possible description) that underlie each EHSR, the rules already present will be overwritten, but the references will be maintained on existing documents prepared importing the file.
Harmonised Standards Machinery Directive See online
Com 2018/C 092/01 09 March 2018
Commission communication in the framework of the implementation of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC
(Publication of titles and references of harmonised standards under Union harmonisation legislation)
Aggiunto nella Versione 4.8.6 (Maggio 2017) il metodo di Valutazione dei Rischi, "EN ISO 12100 Standard"
Dalla Versione 4.8.6 di CEM4 (19 Maggio 2017) è stato aggiunto un altro metodo di Valutazione dei Rischi, chiamato "EN ISO 12100 Standard" (2017), che ha la medesima struttura del metodo "EN ISO 12100", ma con selezione solo di determinati campi considerati essenziali, la scheda seguente ne illustra le differenze:
ebookDirettiva macchine e norme armonizzate consolidato 2017
Testo consolidato Direttiva macchine e norme armonizzate 2017 - tutte le modifiche e rettifiche dal 2009 al 2014 e norme tecniche armonizzate in vigore 2017 disponibile EPUB/PDF.
Il testo tiene conto delle seguenti modifiche e rettifiche dal 2006 al 2017:
3. Rettifiche: Rettifica, GU L 76 del 16.3.2007, pag. 35 (2006/42/CE)
4. Recepimento Decreto Legislativo 27 Gennaio 2010 n. 17(GU n. 41 del 19 febbraio 2010) "Attuazione della direttiva 2006/42/CE, relativa alle macchine e che modifica la direttiva 95/16/CE relativa agli ascensori"
Since Version 4.7.0 CEM4, in addition to the classic update mode "Update", has introduced a further mode of the software update "Patch" (Build Versions), only in autoupdate directly from software, to read changes or quick fixes anomalies software/regulations to CEM4; patches will consequently packaged versions in "Update".
Patch 22.2017 (4.8.8 Build 1), fix:
- 0002588: [Documentation] Added requirements for custom reports - 0002653: [Fix] Automatic translation: migration from Microsoft Datamarket to Azure Cognitive Services - 0002655: [Fix] Added option inside machinery property window to enable or disable assessment with custom schemes
Guide to application of the Machinery Directive 2006/42/EC
Edition 2.1 - July 2017 (Update of 2nd Edition)
The Guide updated Edition 2.1 is intended to be a living document, edited and updated with new guidance once approved by the Machinery Working Group. It will be made available in other EU languages, but only the English version will be checked by the Commission. Therefore, in case of doubt, the English version should be taken as the reference. The Guide can be downloaded and is presented in a printable format. The text of the Directive is presented in boxed red italic type - the comments follow in black type.
The Guide has been prepared with the help of an Editorial Group and this Update of the 2nd Edition has been carried out by an external consultant and the Commission, assisted by some of the members of the Editorial Group. The Commission4 wishes to warmly thank the members of the Editorial Group both for the huge amount of work they have carried out as well as for the efficient, constructive and cooperative spirit in which the drafts have been prepared. In parallel to the work of the Editorial Group, a Machinery Core Group established by Orgalime, including representatives of the main sectors of machinery manufacturing, has provided invaluable input from the industry. The drafts prepared by the Editorial Group have been submitted to the Member States and stakeholders for comments. The Commission would also like to thank all those who have made comments. We have tried to take them into account as far as possible.
Con il file CEM puoi avere sotto controllo in CEM4, nell'Archivio normativa, tutte le Norme armonizzate (n. 763), suddivise per CEN/CENELEC/Tipo A/B/C, consultare, gestire direttamente da CEM4 e commentare le stesse.
This Version adds a new risk assessment method called "EN ISO 12100Standard".
The "EN ISO 12100 Standard" method, selectable in the "Machine Properties", allows a "VRQ" Risk Assessment with reduced fields with respect to the "EN ISO 12100 extended" method, so are 3 possible risk assessment methods:
1. Classic EHSRs 2. EN ISO 12100 (extended) 3. EN ISO 12100Standard
Since Version 4.7.0 CEM4, in addition to the classic update mode "Update", has introduced a further mode of the software update "Patch" (Build Versions), only in autoupdate directly from software, to read changes or quick fixes anomalies software/regulations to CEM4; patches will consequently packaged versions in "Update".
Patch 20.2017 (4.8.5 Build 3), fix:
- 0002583: [Print report] Fixed view error for field "CEN" into report "Requirements text" for check lists. - 0002586: [Home] Small changes to the style - 0002584: [Home] Topnav: added user commands dropdown. Sidebar: added user profile picture
First and foremost always check the applicability of the machine to other Directives of the "New Approach" which provide for CE marking:
- Dir 2006/95/EC "Low Voltage" (including) - Dir 2004/108/EC "Electromagnetic Compatibility" (almost always) - Other eg ATEX , PED , etc., and import the relevant requirements (see Administration standards), proceed to the Risk Assessment (see Risk Assessment customized ) and bring in the EC Declaration of Conformity.
For each machine, you must specify the following information, in order:
1 . Master Data Company (Manufacturer); 2 . Data of the Project to which the machine (defined for example as a series of models, machine families, orders, etc.); 3 . Technical specifications of the machine.
Through the tree structure of the archive in the main window, the user can work on documents needed to administer the requirements of the Machinery Directive: make a Risk Assessment on RESS of the Machinery Directive Risk Assessment on Technical Regulations/Requirements, draft the EC declaration of conformity, organize the Technical Construction File, locate the data plate bearing the CE marking, etc.
Steps 1 and 2 describe the procedure to insert a New Company and a New Project.
Step 3 illustrates the procedure to insert a New Machine.
Each company can have multiple projects and each project can contain multiple machines in turn.
Each machine has its ownCEM4 Homesummary and a tree structure that represents theTechnical File.
In this section you will be treated just inserting New Machines. For more information on other management functions ( move, copy , delete, etc. . ) Refer to the " Advanced" or the user manual of the product
After starting the software, the main screen isCEM4 Home, composed of the elements shown in the screenshot below.
- On the left side, the module archive and standards, with tree structures for navigation within the database.
- To the right of the work area, in which are shown the information home, newer machines, Legislation, Administration, News, external links.
Regulation (EU) 2023/1230 of the European parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC.
All the Communications of the harmonized standards published since 2014. The application of the harmonized standards is "Presumption of Conformity" to compliance with the RESS of Annex I of the Machinery Directive 2006/42/EC.
Report consultation Evaluation Machinery Directive 2006 42 EC
