The new Machinery Directive came into force across Europe on December 29th of 2009, and in Italy will be in effect from 06/03/2010. The changes made are numerous: we shall limit ourselves to list the most relevant and to explain in more detail what we Feedback deserve a proper interpretation.
The most important new features are:
- Scope and Definitions
• Extending the scope also to lifting accessories (which are already bearing the CE marking) and chains, ropes and slings, thereby introducing certification procedures for these components not provided for in existing legislation;
• Introduction of "quasi-machines";
• Extending the scope to lifts construction (currently excluded from the Machinery Directive is that the Lift Directive) and the elevators with speeds up to 0.15 m / s;
• Extending the scope to portable cartridge where the cartridge is not a direct action on the part, such as nail guns, guns for slaughter or to mark (currently excluded as considered as firearms);
• Reformulation of the exclusions from the purpose of all means transport in general, taking also into account risks covered by specific directives on agricultural tractors (2003/37/EC) and on the vehicles included in the scope of Directives 70/156/EEC and 2002/24/EC;
• Introduction of 'list of products falling within the scope of the Low Voltage Directive and therefore excluded from the Machinery Directive;
• Changing the definition of machine which now refers also to machines lacking the motor
• Introduction of a new definition for the safety component and an annex with a list of them and updated guidance.
- Procedures for certification
• Affixing the CE marking also for the safety components, devices and removable mechanical transmission chains, ropes and straps;
• Obligation to bring in the technical documentation pertaining to the risk assessment carried out in design of the machine, demonstrating the procedure followed (although not explicitly required by existing directives, the technical files always provide a more complete summary of the arguments that led the choice of technical solutions on the basis of risk assessment. But this is no longer sufficient and need to bring back all the procedure followed in a systematic and detailed documentation that follow the appropriate methods);
• Changes to Annex IV, such as the exclusion of internal combustion engines used to power machines underground work, the exclusion of machines for the manufacture of pyrotechnics, the inclusion of units
logic with security features (previously only included those for two-hand control) and the inclusion of all protective devices designed to detect persons (previously included only those EHS);
• Termination of the obligation to submit the technical file with a Notified Body certification for manufacturers that produce the cars in Annex IV in conformity with the harmonized
• Introduction of opportunities for manufacturers, for machines in Annex IV, to operate under the "full quality assurance", ie according to a quality system for design, manufacture, final inspection and testing, approved by a Notified Body as an alternative to other procedures for certification required by the Directive now in force;
• Introduction of an end, after five years, the validity of the type examination certificates issued by notified bodies.
- Annex I
• With regard to amendments to Annex I, we shall refer to the most relevant in a separate paragraph of the text that follows.
- Miscellaneous
• Introduction of specific measures regarding the "potentially dangerous machines" (they are not machines that can compromise the safety of people, and these would then be withdrawn from the market with the procedures of the safeguard clause, but the machines are that could be dangerous as technically similar to those withdrawn from the market or because constructed on the basis of harmonized rules considered not to meet the essential safety requirements of the Directive). For such machines, the Commission may adopt specific measures to prohibit or restrict their placing on the market or subject to special conditions;
• Imposing more stringent constraints for notified bodies and the Member States to notify them;
• Introduction of sanctions "effective, proportionate and dissuasive" Member States should take in respect of breaches of national standards transposing the Directive.
New definition of "machine" itself
For a correct reading of the text of the new direttiva occorre evidenziare che ogni qualvolta viene citato il termine “macchina” ci si riferisce a tutti i prodotti inclusi nello scopo della Direttiva con l’esclusione delle quasi-macchine, alle quali sono dedicate articoli e/o clausole specifiche, ovvero disposizioni e procedure diverse.
La nuova definizione di macchina, propriamente detta, è: “insieme equipaggiato o destinato ad essere equipaggiato di un sistema di azionamento diverso dalla forza umana o animale diretta, composto di parti o di componenti, di cui almeno uno mobile, collegati tra loro solidamente per una applicazione ben determinata”.
A completamento di questa definizione base sono state aggiunte quattro appendici che includono anche le macchine complex and the hand-operated equipment for lifting weights. The second of these appendices is particularly relevant because the definition also includes machines that are not complete as long as representing a "ready to be installed and can only work if mounted on a vehicle or installed in a building or a building" , solving issues on many machines (eg cranes designed for mounting on trucks that are currently not considered as machinery).
The big news however is the inclusion of the machines sold without the engine or, more generally, without a separate drive system "which, the second most common interpretations may also include the transmission system, including ancillary equipment such as brakes and parts of the system of monitoring them closely related. This may facilitate, for example, users who prefer to have a homogeneous storage engine to facilitate maintenance of their machines, but introduces important new challenges. For machines sold without a system of its own shares, in fact, the responsibility, now its the only manufacturer, are likely to be diluted among several entities, such as the manufacturer of the car, the engine manufacturer, suppliers, users and / or assemblers the final machine ready for use. Basta pensare alla pratica impossibilità del fabbricante di garantire i livelli di rumorosità e di vibrazione, l’efficacia del sistema di controllo completo, o i tempi di arresto e/o di frenatura. Il costruttore, comunque, dovrà indicare nelle istruzioni tutte le caratteristiche del sistema di azionamento da installare sulla macchina.
Considerazioni sulle quasi-macchine
Esse sono definite come “insiemi che costituiscono quasi una macchina ma che, da soli, non sono in grado di garantire un’applicazione ben determinata. Un sistema di azionamento (drive system) è una quasi-macchina. Le quasi-macchine sono unicamente destinate ad essere incorporate o assemblate ad altre macchine o altre quasi-macchine o apparecchi to constitute machinery covered by this Directive. "
They must not be CE marked and procedures are different from those for other products covered by the Directive. Even the records be produced shall be denominated in a different way, to avoid confusion.
The manufacturer of such machinery, before placing on the market, should develop:
the "relevant documentation" (other than "technical documentation" provided for machines);
the "declaration of incorporation" (other than "declaration of conformity provided for machines);
" instructions assembly "(other than a notice provided for machines).
States, under the supervision of the market, take all appropriate measures to ensure that such machinery can be placed on the market only if they meet the requirements of the Directive that concern, but do not apply to them the strict procedures which safeguard clauses, which are provided exclusively for cars.
A greater clarification, one could say that we have introduced a new opportunity for manufacturers of these products without going too over the duties and control procedures. In Directive 98/37/EC, the manufacturers of machines that are not complete, for ad essere assemblate con altre macchine per formare una macchina propriamente detta, devono solamente dichiarare questa destinazione dei loro prodotti (dichiarazione di cui all’Allegato II - B). La nuova Direttiva offre invece ai costruttori delle “quasi macchine” che soddisfano uno o più requisiti essenziali di sicurezza dell’Allegato I, la possibilità di dichiarare la loro rispondenza ai requisiti soddisfatti. In questo modo tali prodotti avranno un valore aggiunto sul mercato in quanto, per i rischi relativi ai requisiti soddisfatti, offrono maggiori garanzie al fabbricante della macchina finale che li utilizza.
Due concetti però devono essere chiari:
• il fabbricante della quasi-macchina è libero to determine under which satisfy the essential safety requirements, and then declare to be met, with the consequent obligations arising from the compilation of relevant technical documentation. The requirements of Annex I, in fact, are not mandatory for such machinery, but they apply only to machines, that is, to finished products.
• For the purposes of the procedures under the safeguard clauses are responsible for the complete machine is, and remains, who issues the declaration of conformity and affix the CE marking, namely the manufacturer of the machine.
Amendments to Annex I Annex I, which contains the essential health and safety standards for the machines is not cambiato in modo sostanziale, salvo che per la necessaria introduzione dei requisiti da applicare ai nuovi prodotti immessi nello scopo, quali i prodotti cosmetici e farmaceutici, gli ascensori da cantiere e gli ascensori con velocità inferiore a 0,15 m/sec, le macchine portatili per fissaggio ed altre macchine ad impatto.
E’ stata mantenuta, per quanto possibile, la struttura esistente e la numerazione delle varie clausole per non creare difficoltà ai fabbricanti, che altrimenti avrebbero dovuto modificare i programmi già impostati per la predisposizione dei fascicoli tecnici. Questa soluzione, molte volte, è andata a scapito dell’organicità della trattazione.
Sono state aggiunte alcune definizioni e sono stati change some terms, adjusting as much as possible to those used in the harmonized standards, and then consolidated the common language in recent years among security workers.
The part relating to the content of the instruction manual has been completely reorganized and rewritten. It is currently very comprehensive and provides valuable guidance for manufacturers.
E 'was given more emphasis to the procedure for risk assessment, as well as concepts related to ergonomics in expressing a more comprehensive and complete the principles of the relationship between man and machine.
The part relating to control systems has been completely renovated, making it more organic, but without practically intact the principles expressed in the current directive. Has introduced several requirements which take account of operational needs and safety of some types of machines such as vending machines, and machines by remote control, today more and more popular. E 'introduced the concept of "arrest operation" that is a stop that, for operational reasons, do not cut off the supply of the actuators.
Regarding the emergency stop was made clear the concept that it is a measure of additional protection to be installed in addition to security measures required, not replace them.
Regarding the choice of protection against i rischi dovuti agli elementi mobili di trasmissione è stato introdotto l’obbligo, qualora la valutazione del rischio lo richieda, di usare ripari di tipo B (interbloccati con bloccaggio del riparo) come per gli elementi mobili che partecipano alla lavorazione. Questa modifica avrà influenza sulla normativa, rigidamente impostata sui dettami della Direttiva attuale.
Importanti sono i cambiamenti dei requisiti supplementari di cui alle parti 4 e 6 relative alle “operazioni di sollevamento” ed al “sollevamento di persone”. Queste parti sono state completamente riformulate e ristrutturate per tenere conto dell’introduzione nello scopo della direttiva degli ascensori da cantiere e degli ascensori con velocità inferiore am / 0.15 sec.
do not describe all the changes. We'll just provide the key to understanding these two parties and make a few comments.
Part 4, which in the current Directive only refers to the lifting of loads in the new text of the Directive also applies to the lifting of persons. With this extension, however, one might wonder what it's more the later part 6, which was intended to refer to the lifting of persons.
The key to understanding the two parties is as follows: Part 4 refers to the lifting of persons or things, but just thinking about the dangers faced by people working outside the machines in question, while Section 6 mainly refers the dangers faced by people in the use of machines for their handling.
We proposed to integrate the two sides, or at least numbered. E 'prevailed, however, the principle not to change too much the structure of the present Directive.
Remarkable was the difficulty in developing and reorganizing the two parts because of the wide range of machines to which they relate, and the result is not entirely satisfactory in our opinion.
FINAL CONSIDERATIONS The current directive has created many problems in its application, so that the standing committee responsible for advising on the joint is made impossible to answer all questions received.
The text of the new Directive is certainly more comprehensive, giving a response to many questions, but introduces new issues and other concerns.
It 'still in the process of drafting a guide prepared by a working group of the European Commission which also participates in an official ISPESL representing government departments.
Source: ISPESL
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