The Countdown is on
The new Machinery Directive 2006/42/EC
By Prof. Dr. Thomas Klindt, Munich Office
Dear Reader, The production and sale of machinery require lead time. There is therefore not much time left until the new Machinery Directive 2006/42/EC comes into force. The recently amended Machinery Regulation which is its German equivalent, implements the new rules coming into force in a little over one year. Machinery manufacturers, the electrical industry and component suppliers must by the end of 2009 prepare all contracts, internal procedures, documentation and technical training for this change - which will take place overnight. Purchasing, tendering, goods inward checks and contract management must be adapted in good time in advance. Not only within their own company must market participants already today face up to the new regulation. In transactions, a feeling for whether the target company fulfils all the requirements of technical and legal compliance - or whether the potential acquisition can lead to difficulties - must be developed. This must be remembered in the due diligence. In this Newsletter, we would like to give you access to the new law on machinery construction. You will see that many of the rules are of fundamental significance, and many have very detailed effects. For many companies, knowledge of these details will be essential for the avoidance of errors leading to liability. For comprehensive advice on the matter, we are at your disposal. Prof. Dr. Thomas Klindt _____________________________
_____________________________
----------------------------------
| The new EC Machinery Directive comes into force on Tuesday, 29 December 2009, 00:00 hours in the entire EU jurisdiction. Apart from in the 27 EU Member States (see inset below) it will also apply in the states which voluntarily have so far applied the EC Machinery Directive, namely, in addition to the EEA states Norway, Iceland and Liechtenstein, Switzerland and probably also Turkey. Machinery, and safety components which after that date do not fully comply with the new EC Machinery Directive 2006/42/EC will be illegal in all these states their sale cannot therefore be legally conducted. First Group: Manufacturers of complete Machines For the manufacturers of complete machines, the EC Machinery Directive 2006/42/EC provides various changes. They must appoint a company CE officer as responsible person to the supervisory authorities for the technical documentation according to Annex VII of Directive 2006/42/EC and must be resident in the EU. Since the authorities in practice will understand the authorization referred to also as responsibility, this provision - and this is new - imposes a demand on the personnel policy organization of the company. The task of the internal company contact person will be to provide in response to official CE requests the entire technical documentation reasonably adequate to the questions, rapidly and with the correct content. This in turn implies that the technical documentation with all its statutory components is available at any time correctly and completely. Careful Documentation Companies should therefore not save at the wrong end with regard to documentation. In the case of accidents, complaints or other events, the demand for the technical documentation is one of the first official measures. Companies which can then provide the technical documentation only incompletely or not at all, arouse doubts as to the legal conformity of the goods supplied. Foreseeable Misuse With a change to the wording of the principles of safety integration (cf. Annex I No. 1.1.2 of Directive 2006/42/EC), the idea of foreseeable misuse is now granted a prominent place in the design and instruction process of machine construction. The new Machinery Directive states as follows: "Machinery must be designed and constructed so that it is fitted for its function and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof ". Foreseeable misuse is already known in product liability as the extension of the safety requirements to be taken into account by the manufacturer - and consequently as potentially dangerous for industry. From the point of view of the manufacturer, it is unfortunately often not possible to ascertain what misuse the user may foreseeably make, not to mention ascertaining such misuse in a binding manner. It is therefore all the more important that communication and intelligent exchange between the design, technical editing, after sales and maintenance departments be intensified with the objective that possible methods of misuse become known at an early stage and observed at users. There is only to be one original user instruction document It is also new that, in principle, one original instruction must exist, i.e. instructions for which the manufacturer or the authorized person undertakes responsibility. If there is none such, in particular because the appliance is imported from outside Europe, the importer must ensure a translation of the entire original instruction into the language(s) of the country of use. The translation must be marked as "translation of the original instructions". For EU importers, this could involve the risk of costs - e.g. translation costs - which must be taken into account in their calculations.More intensive Market Surveillance The new Machinery Directive 2006/42/EC intensifies market surveillance. The EU Commission in its New Legislative Framework coming parallel into force, expressly demands intensification of state controls and the improvement of communication between the European market surveillance authorities - the latter also on grounds of competitive equality. Manufacturers of machines will have to adjust to a more intensive checking of compliance with safety regulations. Second Group: Manufacturers of partly completed machinery The manufacturers of partly completed machinery face significant changes due to the new Machinery Directive. The former Machinery Directive (in force since 1989) makes only passing reference to partly completed machinery. A manufacturer's declaration was required which had only to contain a prohibition on operation and nothing more. With the new Machinery Directive 2006/42/EC, the obligations of the manufacturer of partly completed machinery are considerably expanded from the point of view of design, instruction and documentation. Declaration of Incorporation A manufacturer's declaration is no longer demanded but instead a declaration of incorporation (cf. Annex II B Directive 2006/42/EC) the content of which is comprehensive and manifold. The declaration of incorporation must state what safety requirements of Directive 2006/42/EC have been applied and complied with. In addition, it must be stated whether other CE Directives (e.g. in the area of EMV or ATEX) have been complied with In addition, manufacturers of partly completed machinery must undertake in the declaration of incorporation to provide the authorities of EU Member States on request with certain documents. The medium (e.g. e-mail) by which the requested documents are intended to reach the authorities must be stated. New Form of Documentation The new Directive provides for a completely new form of documentation in the case of partly completed machinery. The documents described as relevant technical documentation (Annex VII B of Directive 2006/42/EC) must make clear what requirements of the Machinery Directive apply to the relevant partly completed machinery and whether they have been complied with. The technical file must, inter alia, comprise the following: a general description of the machinery, the overall drawing of the machinery and drawings of the control circuits, documentation on risk assessment. From the risk assessment documentation (cf. inset below) it must also be evident what procedure was followed. In addition, Annex VII B of the Directive contains regulations for testing of components and fittings to determine whether by its design or construction they are capable of being assembled and put into service safely. The relevant reports and results should be included in the technical file. The technical file must be available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery. It is unmistakably clear that all this means extensive changes for the document management of manufacturers or partly completed machinery - in particular because up to the present time they simply had no such obligations. The new Machinery Directive establishes for them a genuinely new legal obligation. The manufacturers of partly completed machinery are expressly permitted to provide the assembly instructions in one EU language - it must not necessarily be the language of the country of assembly. The language of the assembly instructions of partly completed machinery can therefore be freely chosen from among the EU languages - unlike the instructions in the case of completed machinery. | Third Group: Manufacturers of Components The former Machinery Directive applied already to certain components; the new Machinery Directive, however, contains stricter requirements of which additional suppliers must also take note. Manufacturers of safety components, lifting accessories, chains, ropes and webbing and removable mechanical transmission devices should take particular note of the new regulations. All these components are now equated with actual machines. The same formal and material requirements as for completed machines therefore apply to them. That means: the basic safety and health requirements (Annex I of the Directive) are to be observed and a Declaration of Conformity according to Annex II A of the Directive is to be prepared. In addition, a CE marking is to be attached and the user instructions must be in the language of the user's country (Annex I 1.7.4 of the Directive). In addition, the technical documentation in accordance with Annex VII A of the Directive is to be prepared and available if an authority demands to inspect it. The documentation must also contain a risk assessment according to DIN EN ISO 12100 (cf. below). Individual Components A safety component in the meaning of the Machinery Directive is a component "which serves to fulfill a safety function, which is independently placed on the market, the failure and/or malfunction of which endangers the safety of persons and which is not necessary in order for the machinery to function or for which normal components may be substituted in order for the machinery to function." The phrase in italics is new. A list of such components, not, however, to be understood as exhaustive, is contained in Annex V to the Directive. In particular, manufacturers of the kinds of products listed there should read the new Machinery Directive very carefully (cf. left inset). Lifting accessory means "a component or equipment not attached to the lifting machinery allowing the load to be held, which is placed between the machinery and the load or on the load itself or which is intended to constitute an integral part of the load and which is independently placed on the market. Slings and their components are also regarded as lifting accessories". The terms chains, ropes and webbing are practically self-explanatory. They must, however, of course - according to the definition in the Directive - have been designed and constructed "for lifting purposes as part of lifting machinery or lifting accessories". Other chains, ropes and webbing for other uses are not covered by the Machinery Directive. Removable mechanical transmission device means a removable component for transmitting power between self-propelled machinery or a tractor and another machine. Fourth Group: Manufacturers of Electrical and Electronic Products The limits to the application of the low-voltage Directive 2006/95/EC are intended, by the new Machinery Directive, to be easier to identify. To date, a rather unclear rule based vaguely on the degree of danger applied. The actual attribution was left to each manufacturer. European industry solves the problem of demarcation in practice more or less plausibly, for example, in connection with white goods. The new Machinery Directive excludes certain electrical and electronic products if these products fall under the low-voltage Directive 2006/95/EC (see inset below). The purpose of this provision is a mutually exclusive application of one or other Directive. In addition, high-voltage equipment such as controlling devices or transformers are not coered by the scope of application of the Directive 2006/42/EC. Manufacturers of these electrical products must therefore concern themselves with the exclusion criteria and a clear internal attribution. Old Friends: What Safety Requirements remain unchanged? The following aspects - unchanged - belong to the significant mandatory and officially monitored regulations: Risk Assessment The danger analysis has changed its name and is now called - in accordance with international standard terminology - risk assessment. This does not change anything in substance since DIN EN ISO 12100 is based on international standards. The intended use must be stated as before. All dangers associated with that use of the machine must be identified. The manufacturer must design and construct the machine taking account of the results of the risk assessment. And, in particular, it remains that the risk assessment must be conducted prior to or, at the latest, parallel to the design process, not subsequently. Machines without risk assessment continue to be unthinkable from the point of view of the Machinery Directive. Form follows Danger The obligation to comply with basic safety and health requirements continues to apply (cf. Annex 1.1 of the Directive), in particular, the principles for integration of safety. Form follows danger applies. Machines are so to be designed that their design is safe. Technical protection measures such as warnings or instructions for use can only be subordinate safety measures. This hierarchy is repeatedly emphasized by courts in product liability law. This area is subject to many problems - which not least play a role in liability cases. Conformity Declaration The conformity declaration continues to be necessary for machinery. It has also still to be signed. Language of the Original Instructions While it is clarified for instructions that an original version must exist, the provision on language remains unchanged. The instructions must be in the official language of the Member State in which the machine is placed on the market and/or taken into operation. General contractual agreements on one (allegedly) language understandable to all, for example, English, continues therefore not to be admissible. The opposite applies, however, as an exception, if maintenance instructions for experts instructed by the manufacturer are concerned. Obligation of Technical Documentation The obligation of technical documentation remains unchanged in Annex VII of the Directive (previously Annex V). The technical documentation can be demanded by the authorities and must be preserved for at least 10 years after the day of manufacture of the machinery (in the case of series manufacture, from the day of the manufacture of the last unit). Risk: Product Liability Litigation Non-compliance with the provisions of the Machinery Directive involves undertaking considerable risks. In product liability litigation, the courts deduce from infringement of the safety requirements of the Machinery Directive a failure to achieve the safety standards in product liability law - this is mostly proved in detail by an expert report. There are already many judgments in this sense. Compliance with the requirements of the Machinery Directive is a protection not only against official measures of market surveillance but also minimizes the risks in product liability. Sit back: For whom is that all irrelevant? Some technical industrial branches remain unaffected by the new EC Machinery Directive. Their products are expressly excluded.
|
To read this newsletter in pdf format |
©Nörr Stiefenhofer Lutz 9/2008
