this file
Contents
1. the supply of each machine with a correct declaration of conformity the presence of the user s manual that contains all large elements provided for by the applicable directivels in the original language with if necessary translation into the language s of the country of destination the absence of striking risks or designations of non conformity that can be observed without consulting the technical construction file in the event that the machine appears in annex V of the Machinery Directive possibly an appropriate intervention by a notified body for the domain involved YOU ARE CONSTRUCTING A MACHINE FOR YOUR OWN USE In principle the obligations concerning CE marking apply in full to everyone who builds a machine for his own use or who incorporates machinery and or parts of machines into another machine for his own use In addition to the obligations as manufacturer of the machine you must naturally also comply with the rules that are directed towards the machine user employer See our Practical Guide Work equipment machinery Vincotte Vincotte DO YOU NEED HELP IN APPLYING THE MACHINERY DIRECTIVE External helo can be obligatory for machinery of annex IV In addition external input can be the solution in the absence of sufficient manpower if you yourself are too still developing the necessary expertise for commercial reasons You can approach VINCOTTE for expert and efficient2. a z n Ti This guide is intended for machine builders including those who build machinery for their own use designers engineering consultants assemblers importers sellers or distributors of machinery interested machine users Why this guide The compulsory CE marking on machinery opens the doors of Europe to you In exchange for this the European regulations lay certain obligations on you The CE marking on machinery indicates conformity with all applicable European directives or with their transposition into national law that require such marking Logically it is the Machinery Directive that contains the most specific requirements for machinery Nevertheless conformity with the Machinery Directive is not necessarily sufficient and for many machines other directives will also have to be followed So particularly when one first becomes acquainted with this issue the situation can come over as reasonably complex Taking into account and in the light of the experience with revised Machinery Directive 2006 42 EC VINCOTTE has produced for you this revised edition of the Practical Guide Machinery published for the first time in 1994 and since then distributed in many thousands of copies Naturally the practical experience obtained in the meantime has also been worked into this new edition Our intention is in short in a practical and straightforward way to set out the various steps that are necess
3. This reference must be understood as a reference to Directive 84 500 EEC Regulation EC no 1935 2004 and Directive 2002 72 EC Directive 87 404 EEC relating to simple pressure vessels The Simple Pressure Vessels Directive applies for hazards regarding pressure to pressure vessels within its scope that are built in series and that are built into or connected with machinery If simple pressure vessels that have already been put on the market are built into a machine then the machine manufacturer s technical file must contain documents that confirm the conformity of the pressure vessels with the Simple Pressure Vessels Directive Requirement 3 1 2 of annex of the Machinery Directive covers the risk of breakage during use of parts when this risk is not covered by the specific Directive 23 24 Directive 90 396 EEC relating to appliances burning gaseous fuels This Directive applies to appliances burning gaseous fuels that are used for cooking heating hot water production refrigerating lighting or washing including fan assisted gas burners and to equipment for such appliances The Directive also applies for the hazards covered thereby to appliances within its scope that are built into machinery If appliances burning gaseous fuels that have already been placed on the parket are built into machinery then the documents with regard to the conformity with this Directive must be added to the machine manufacturer s t
4. and or the evaluation of the quality systems and the supervision of the application of these systems They can be designated for one or more categories of the machinery named in annex V The criteria for designating the bodies are laid down in annex X The Member States notify to the EU Commission and the other Member States what bodies they have designated and for what specific interventions The bodies are assigned an identification number by the Commission Although the designation of the notified bodies and the supervision of their operation is national there is in contrast to the external services for technical checking no territorial limitation to the competency of the bodies and for the compulsory interventions the manufacturer can call on any body notified for the technical field The declarations or reports supplied are valid in all countries of the EEA Vin otte is a notified body for most machinery of annex IV 17 18 The CE marking and the identification plate on the machine Article 16 and annex III directives bear the CE C marking according to the depicted model This CE label is not supplied by an official body it must be put by the manufacturer or his authorised representative visibly legibly and indelibly in the immediate vicinity of the name of the manufacturer or his authorised representative and using the same technique on each machine A clear link is therefore crea
5. conferring a presumption of conformity and so among other things simplifying the drawing up of the technical file see below they after all give a description of the state of the technique This means also that if the manufacturer uses solutions other than those set out in the relevant standardis he is nevertheless still expected to be able to demonstrate that with this solution a level of safety is attained comparable with the level obtained when the standard is applied The harmonised standards for the application of the Machinery Directive are divided into three levels A basic standards that apply to all machinery basic concepts terminology and design principles B generic or general standards that deal with specific safety aspects B1 or safety provisions B2 that are relevant for a whole series of machines C machine standards for the safety of specific machinery or groups of machines The European standards are indicated by the letters EN or EN ISO for standards drawn up in conjunction with ISO followed by a number and the year of issue e g EN ISO 13857 2008 These standards are also included in the catalogue of the national standards institutions possibly translated and their European references are preceded by the national identification letters for Belgium NBN without the content being changed by this The A and B standards are also called horizontal standards the C
6. help in just about all aspects of both the application of the Machinery Directive and the CE marking on machinery Our long experience and our approach among other things periodically assessed in the context of our accreditation as notified body for the Machinery Directive and various other directives are our guarantee of the quality of this help Typical examples of assistance are nterventlon as a notified body for most machinery of annex V EC type examination complete quality assurance system Voluntary certification of the conformity in cases in which the intervention of a notified body is not mandatory Exploratory study of the application of the CE marking in a project applicable directives and situating the equipment within these directives the various obligations the relevant standards etc Help in the design concerning application of the essential requirements and the relevant standards Help in drawing up the user information Help in the conformity assessment procedure technical file EC declaration of conformity markingl declaration for partly completed machinery Help in drawing up the purchase order for partly completed machinery and or in assessing the conformity guarantees received from the manufacturer Information about legislation and standards and the interpretation of these Supervision of the coordination of projects for incorporating into another machine or complex installa
7. standards vertical The most efficient starting point in the study of the conformity of a machine is if itis available the appropriate standard of the C type Logically it is the manufacturer s duty to ensure that the people charged with the design and the construction of machinery have access to the current version of the relevant harmonised standards and have a clear understanding of the role and the importance of these standards For the aspects that are not covered by harmonised standards where possible other references will have to be sought such as European design standards prEN national and international standards specialist literature Logically preference will be given to references that reflect the best state of the technique such as is experienced at present in Europe Of course use of these do not automatically give a presumption of conformity For special problems for which there is insufficient competence within the company it would be appropriate to call in external specialists in the domain involved 10 The technical file demonstrating the conformity Annex VII Basic ideas about the technical file for machinery Before placing machinery on the market and or putting it into service the manufacturer shall ensure that a technical file is available This technical file has to comply with the provisions of annex VII section A of the Machinery Directive article 5 1 It must demonstrate that the des
8. technical file For machinery described in Annex IV Possible application of the special procedures for assessment of conformity Putting the CE marking and other information on each machine The drawing up of an EC declaration of conformity to be supplied with each machine ine 14 18 18 oO dm Yu Oa gt Vincotte Machinery in the scope of the Machinery Directive articles 1 and 2 The following types of equipment fall within the scope of the Machinery Directive referred to further in this guide as machinery machinery in the strict sense defined as an assembly fitted with or intended to be fitted with a drive system other than directly applied human or animal effort consisting of linked parts or components at least one of which moves and which are joined together for a specific application The latter means that the machine itself must be usable in practice must have a practical function Under the entity machinery in the strict sense fall also assemblies of machinery or of machinery and partly completed machinery which in order to achieve the same end are arranged and controlled so that they function as an integral whole machines missing only the components to connect it on site or to sources of energy and motion machinery ready to be installed and able to function as it stands only if mounted on a means of transport or installed in a build
9. the Machinery Directive then these obligations rest on each person who places on the market or puts into service the machine vvithin the EEA See p 28 The natural or legal person vvho builds machinery for their own use The obligations of the manufacturer of the machine also apply to those who build machinery for their own use without the intention to place them on the market See among other things p 28 The vision of this guide In view of the relative complexity of the rules concerning CE marking for machinery and their comprehensive applicability itis not possible to discuss in detail in a few pages and in a conveniently laid out manner all the possible scenarios that can arise VVhen dravving up this gulde a fairiy extensive discussion of the application of the Machinery Directive to a standard machine vvas decided upon supplemented bya summary of the interfaces of the Machinery Directive with a number of other directives as they were applicable at the time when this text was drawn up The reader must however be aware that not all details or specific situations vvith respect to the application of the CE marking are covered in this approach and that in case of doubt the text of the law is prevailing Note This guide always refers to the European directives although they for their end user are strictly speaking legally valid by transposition into the national legislation of the EU Member States For Belgium the tr
10. the documentation of the risk assessment from which the procedure followed appears with inclusion of the following information A list of the essential health and safety requirements which apply to the machine involved and the description of the protective measures implemented to eliminate identified hazards or to reduce risks and when appropriate the indication of the residual risks associated with the machinery For the risk analysis the manufacturer must go through the following steps Define the limits of the machines Check what hazards and hazardous situations may be caused s Estimate the risks Assess the risks so as to decide on the need for arisk reduction or otherwise Eliminate the hazards or reduce the risks It is important that a good construction file in a systematic and credible way and with sufficient profundity demonstrates the conformity of the machine model with the essential requirements of the directive For a credible demonstration of the conformity with the applicable requirements tests can be used among other things The results of these tests are included in the construction file When a type C standard is applied the required tests will normally be stated in the standard Vincotte Vincotte If in the design and construction of the machine use is made of a harmonised type C standard the compilation of above mentioned essential element becomes a lot simpler in
11. with meat and material with similar physical characteristics or the following types 4 1 sawing machinery with fixed blade s during cutting having a fixed or reciprocating movement bed or support for the workpiece 4 2 sawing machinery with blade s assembled on a carriage with reciprocating motion 5 Combined machinery or the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics 6 Hand fed tenoning machinery with several tool holders for woodworking 7 Hand Ted vertical spindle moulding machinery for working with wood and material with similar physical characteristics 8 Portable chainsaws for woodworking Vincotte Vincotte 10 11 dE 13 14 Lo 16 18 Presses including press brakes for the cold working of metals with manual loading and or unloading whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm s Injection or compression plastics moulding machinery with manual loading or unloading Injection or compression rubber moulding machinery with manual loading or unloading Machinery for underground working of the following types 12 1 locomotives and brake vans 12 2 hydraulic povvered roof supports Manually loaded trucks for the collection of household refuse incorporating a compression mechanism Removable mechanical transmi
12. ansposition of the directives discussed here takes place generally in line with the execution decrees of the law of 9 February 1994 concerning the safety of products and services Since this concerns totally harmonised legislation the importance of the national transposition is limited in practice to the rules for supervising and curbing infringements The Belgian transposition of the revised Machinery Directive 2006 42 EC can be found in the Royal Decree of 12 August 2008 Belgian official journal of 1 October 2008 The amendment relating to the machinery for pesticide application 2009 127 EC is to be found in the Royal Decree of 13 August 2011 Belgian Official Gazette 7 9 201 Vin otte Vincotte YOU ARE A MANUFACTURER Steps for the application of the Machinery Directive to a machine Establishing whether the equipment is a machine and whether it comes within the scope of the Machinery Directive Design and construction of the machine in conformity with the applicable essential technical requirements of the directives and the state of the art In this context also the drawing up of a global users manual Compilation and keeping available for the authorities and or the notified body of a technical file that demonstrates conformity of the machine with the Directive When manufacturing a series establishing the measures for the conformity of all machinery of the series with the model dealt with in the
13. ary in order to place on the market or put into service a machine in Europe 1 Directive 2006 42 EC came into force 29 December 2009 It replaces Directive 98 37 EC Vincotte Vincotte To whom does the Machinery Directive apply The manufacturer Put simply one can say that this is the person who takes responsibility for the conformity of the machine with the Machinery Directive and puts his name on it This could for example be a design consultant or the apparent manufacturer who purchases machinery in order to place it on the market under his own name A person vvho alters nevv machinery to place it on the marketor bring it into use in principle also has the obligations of the manufacturer See p 5 and follovving The authorised representative The natural or legal person that is authorised in vvriting by the manufacturer to performall or part of the obligations and formalities intended in the Machinery Directive on his behalf For this directive the authorised person must be established in the EU the Community in practice in the European Economic Area or EEA the EU plus Norway Iceland and Liechtenstein A particular type of authorised person or company is one that is authorised to put together the technical file See p 27 The importer machinery from outside the EEA and the seller or distributor within the EEA VVhen neither the manufacturer nor the authorised person observe the obligations of
14. d to the authorities in response to areasoned request and in some cases for machinery of annex V to the notified body The Machinery Directive also does not provide that the technical file must be supplied with the machine The file does not in principle have to be permanently present in material form particular drawings can e g be held in a drawings archive in electronic form or on paper t also does not have to be located within the territory of the EEA t must however be possible for the person who is authorised to do this in the EC declaration of conformity to assemble it and make it available within a reasonable time frame The file must be drawn up in one or more of the official languages of the EEA So it can e g be in Danish but not in Japanese An exception to this is the original instructions for use a copy of which must be contained in the file The file must not necessarily contain all the detailed information about the manufacture of parts used unless knowledge of them is indispensable for checking the conformity with the essential requirements Vincotte 9 mun o t 2 14 Additional obligations for machinery of annex IV Article 12 3 and 12 4 The machinery of annex IV For the assessment of conformity of most machinery namely that which is not named in annex V of the Machinery Directive the prescribed procedure is that of an internal check of
15. e technical construction file the informing of the authorised representative of every change that the manufacturer makes in the machine onthe assumption that the authorised representative acts as importer or distributor the distribution of the costs incurred if the manufacturer appoints additional distributors or importers For the obligations on the technical level we refer to the previous chapters 27 28 YOU ARE AN IMPORTER OR SELLER The CE marking has the advantage that at present the legal requirements concerning the design and construction of machinery are identical in all countries of the EEA As an importer or seller you are nevertheless advised to consider a number of elements In the first instance it is important for you not to conclude any agreements for the supply of machinery without being certain that this machinery will have the CE marking and an EC declaration of conformity f not you run the risk of yourself being landed with some of the problems n principle you could then naturally consider acting as authorised representative as discussed above If the manufacturer guarantees that his machinery comply with the applicable European directives then it would be advisable to display reasonable prudence principally in connection with the following aspects the presence of a correct CE marking and an identification plate on each machine bearing the name and address of the manufacturer
16. ear in the Lifts Directive are applicable The Machinery Directive also applies to lifts that are excluded from the scope of the Lifts Directive insofar as they are not also excluded from that of the Machinery Directive Directive 2000 9 EC relating to cableway installations designed to carry persons On the basis of article 3 of the Machinery Directive the latter is not applicable to cableway installations designed to carry persons that fall within the scope of the Cableways Directive The Machinery Directive is on the other hand applicable to some of the cableways excluded from the scope of the Cableways Directive for example cableways exclusively for goods and cableways for agriculture mining or industrial use Other installations excluded from the scope of the Cableways Directive are also excluded from 2 in principle this overview only gives references to the basic directives not to any Directives that amend these basic directives 3 Overview based on the draft commentary on the Machinery Directive 2006 42 EC Vincotte Vincotte that of the Machinery Directive for example as means of transport for transport over water and over railway tracks Directive 94 9 EC concerning equipment and protective systems intended for use in potentially explosive atmospheres ATEX 100 Directive The ATEX 100 Directive applies for the explosion risk to machinery intended to be used in a potentially explosive env
17. echnical file Appliances that are intended specifically for use In industrial processes and are used in industrial companies fall outside the scope of the Directive and so are subject to the Machinery Directive if they fall within its scope or are built into machinery The Machinery Directive also applies to appliances burning gaseous fuels with moving parts that fall within the scope of the Gas Appliances Directive for hazards that are not covered by the latter Directive Directive 97 23 EC concerning pressure equipment The Pressure Equipment Directive applies for hazards that are the result of pressure to the pressure equipment within its scope that forms part of or is connected with machinery If pressure equipment that has already been placed on the market is built into machinery then the documents with regard to the conformity with this Directive must be added to the machine manufacturer s technical file Requirement 3 1 2 of annex of the Machinery Directive covers the risk of breakage during the use of parts when this risk is not covered by the specific Directive Pressure equipment that falls under category at the highestx amp that is built into machinery within the scope of the Machinery Directive is excluded from the scope of the Pressure Equipment Directive So in this case the Machinery Directive applies in full to such equipment Directive 89 106 EC concerning construction products The Constructio
18. f the model so in fact of one type unit while the manufacturer or his authorised representative must naturally guarantee the conformity of each unit supplied In case of series manufacture the technical file must therefore in addition to the construction file for the conformity of the model contain a description of the internal measures that have been used to make sure that all copies of the machine remain in conformity with the provisions of the directive In other words It concerns the measures whose purpose is to keep the manufactured machinery identical to the model for which the file was drawn up Although not obligatory the ideal approach to this obligation relies on a certified quality system EN ISO 9000 In the absence of such a system the manufacturer will have to work out its own measures that ensure a comparable result In conjunction with this in practice the problem also arises with the evolution of the model change of suppliers small changes in the design etc On the one hand the retention period must be respected for the construction file for the original model on the other hand the most important thing is that each change must be covered by a supplement to the file or for fundamental changes by a new version of the file 11 12 Some additional rules for the technical file The file does not have to be systematically made available to one or another inspection body it only has to be submitte
19. he machinery or hazards involved in addition to the requirements of the first chapter So for example in addition to chapter 1 a mobile elevator platform will have to comply with chapters 3 4 and 6 The division of annex is as follows General principles 1 Essential health and safety requirements 2 Supplementary requirements for the food industry machinery for cosmetics or the pharmaceutical industry hand held and or hand guided machinery portable fixing tools and other riveting tools machinery for working wood and material with similar physical characteristics and machinery for assembled with other machinery See further for the special rules for this machinery pesticide application 3 Supplementary requirements to offset hazards due to the mobility of machinery 4 Supplementary requirements to offset hazards due to lifting operations 5 Supplementary requirements for particular machinery intended for underground work 6 Supplementary requirements regarding the hazards due to the lifting of people The manufacturer will in line with his risk assessment have to establish what essential requirements are applicable to his machinery and whether these are complying in the correct way with defendable solutions This assessment is greatly simplified to the extent that the machine is designed and built in conformity with the harmonised standardis The essential requirements of the Machinery Directive and the harm
20. heck of design and manufacture according to annex VIII so without intervention of a notified body The EC type examination for machinery of annex IV This is the procedure according to annex IX by which a notified body establishes and declares that a representative model of the machine intended in annex V the type complies with the provisions of the Machinery Directive The manufacturer must apply for this examination to a single notified body of his choice He must in doing this make available one specimen of the type for examination together with his technical file Upon a positive result of the examination the notified body supplies a declaration of EC type examination to the applicant On the basis of this declaration the manufacturer must then draw up for each machine his own declaration of conformity the declaration of EC type examination is limited to the type The declaration of EC type examination must be stored by both parties for 15 years Every 5 years the notified body must evaluate the validity of the declaration and possibly extend the duration of validity The manufacturer must ensure that the machine complies with the state of the technique He must inform the notified body of all changes made to the type so that the body can judge whether the declaration remains valid From its side the notified body must inform the manufacturer of all important changes that can have consequences for the val
21. idity of the declaration The procedure for complete quality assurance This is the procedure for assessing the conformity of machinery intended in annex IV by means of a system for complete quality assurance according to annex X The quality system must refer to the design the manufacture the final check and the testing of the machine In doing this the notified body must evaluate and approve the quality system and monitor the way in which it is applied The manufacturer must apply for the evaluation of his quality system to a single notified body of his choice With his application he must make available the documentation of his quality system as well as the technical file for one model of each of the categories of machinery stated in annex V that he wants to manufacture Here too conformity of the quality system with the relevant harmonised standard gives a presumption of conformity The notified body conducts periodic checks to monitor the way the manufacturer maintains Vincotte Vincotte and operates the quality system These periodic checks must be scheduled in such a way that after each period of three years all parts of the system have been checked The notified body can furthermore make unannounced visits to the manufacturer The notified body Notified bodies are designated by the Member States to perform the compulsory interventions on machinery of annex IV under 2006 42 EC the EC type examination
22. ign a declaration of conformity for the assembled whole to agree by contract thatthe manufacturer as much as possible declares conformity with all essential n many cases machinery is assembled or complex installations are tailor made by the user starting with purchased machinery or partly completed machinery The responsibility for the project can then for example rest on the client the supplier of part of the basic machinery an engineering consultant etc The status of a being an assembly is subject to compliance with the following criteria the assembly serves a common purpose such as the manufacture of a specific product the assembled machines are functionally connected in such as way as to create potential risks so arisk assessment is required for the whole assembly the assembly has a common control system requirements for which fulfilment does not depend on the assembly or building in and that the manufacturer supplies a user s manual that as much as possible deals with all aspects of bringing the partly comple ted machine into service Compliance with all essential requirements that are not included in the declaration of incorporation must obviously be guaranteed by the purchase of the partly completed machinery he purchase of a partly completed machine is therefore never the end of the story In general for the application of the Machinery Directive the assembly must be treated as a norma
23. ign and construction of a model of the machine comply with the requirements of the Machinery Directive To the extent that this is necessary for the assessment of the conformity it must also provide an insight into the design manufacture and operation of the machine The technical file must be made available to the competent authorities of the Member States for at least ten years following the date of manufacture of the machinery or in the case of series manufacture of the last unit produced Not making the file available after a properly justified request from the authorised national authorities can be sufficient reason for doubt about the conformity of the machine with the essential requirements of the directive Next to the use by the authorities as the basis for assessing the conformity the technical file as discussed further must also be submitted to the notified body for machinery of Annex V in the case of an EC type examination according to annex X and if the procedure for complete quality assurance is used according to annex xX The construction file with respect to the conformity of the model The elements that must be present in the model s construction file are summed up in point A 1 a of annex VII Apart from a number of other elements such as information about the machine a copy of the instructions for use and the EC declaration of conformity an essential element of the construction file is undoubtedly
24. in accidents as the consequence of defects in the product objective liability of the manufacturer Naturally the correct application of the Machinery Directive will indeed reduce the chance of an accident and thereby the likelihood of a damages claim YOU ARE THE MANUFACTURER S AUTHORISED REPRESENTATIVE Acting as the machine manufacturer s authorised representative assumes the following elements anexpress agreement with the manufacturer regarding the obligations of the manufacturer that will be fulfilled by the authorised representative the authorised representative is established in the EEA the contracted obligations in the context of the application of the Machinery Directive are performed by the authorised representative The role of authorised representative means the acceptance of an important responsibility Therefore we advise any interested parties to take some elementary precautions before committing themselves to this role These precautions consist particularly in establishing precisely in writing the rights and obligations of each of the two parties Depending on the nature and the extent of the tasks delegated by the manufacturer among other things the following aspects will have to be looked at in the contract the execution of possible technical modifications to the machine if these are necessary for conformity the supply of the necessary technical documents for the compilation of th
25. ing or a structure for example a mobile crane or a gantry crane machinery exclusively powered by direct human effort but intended for lifting loads interchangeable equipment that is intended to be assembled by the user with a machine or tractor and thereby change its function or attribute a new function safety components that are independently placed on the market so not incorporated in a machine and are intended by their manufacturer to fulfil a safety function in machinery These are components that are not necessary for the normal operation of the machine or that can be replaced by normal components in order for the machinery to function Annex V of the Directive contains a non limitative list of safety components lifting accessories components or equipment not attached to the lifting machinery allowing the load to be held which are placed between the machinery and the load or on the load itself or which are intended to constitute an integral part of the load and which are independently placed on the market slings and their components are also regarded as lifting accessories chains ropes and webbing chains ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories removable mechanical transmission devices removable component for transmitting power between self propelled machinery or a tractor and another machine by joining them at the fi
26. ironment including the electrical equipment of this machinery In this case the manufacturer of the machine will have to draw up an EC declaration of conformity with the Machinery Directive and the ATEX 100 Directive The reference to the specific community directives in essential requirement 1 5 7 of annex of the Machinery Directive must be understood as areference to the ATEX LOO Directive The ATEX 100 Directive is not applicable to zones within a machine where a potentially explosive environment can exist and neither to an explosion risk that exists under other than atmospheric conditions In this case the hazards will be covered by essential requirement 1 5 7 of the Machinery Directive For machinery already on the market a machinery manufacturer can incorporate into the machine ATEX appliances protective systems or components against the explosion risk In that case the EC declaration for the machine does not have to refer to the ATEX Directive but the declarations of conformity of the appliances systems or components is to be included in the machinery manufacturer s technical file Directive 84 500 EEC Regulation EC No 1935 2004 Directive 2002 72 EC relating to materials and articles intended to come into contact with foodstuffs The requirement 2 1 1 a of annex l isa reminder that materials that are intended to come into contact with foodstuffs have to comply with the directives concerned
27. ives The drawing up of a technical file according to annex VII B This file is somewhat comparable to that for machinery but specifically demonstrating the conformity is limited to those essential requirements that are stated by the manufacturer in his declaration as being fulfilled The supply of the partly completed machine with a declaration of incorporation according to annex II 1 B In addition to the earlier ban on putting into use which remains among other things it is specific to this declaration that the manufacturer must state what essential requirements of the Machinery Directive have been applied and complied with and moreover that he undertakes to give the required relevant information about the partly completed machine to the authorities 19 m Xo R ee ee le 1 ON Vincotte The supply with the partly completed machine of assembly instructions to ensure correct assembly These instructi ons must be drawn up in an official langu age of the EEA that is acceptable to the purchaser The declaration of incorporation and the assembly instructions must be included in the technical file for the assembled machine So although the obligations of the manufactu rer of the partly completed machine have been extended to an important extent it remains important for the purchaser who will have to s
28. l machine in which someone will have to act as manufacturer with responsibility for the conformity for compiling the technical file drawing up and signing the overall declaration of conformity affixing the CE marking etc In such situations the client is advised to pay attention in particular to the need o establish at the start of the project who will be manufacturer in the sense of the Directive Jo the extent to which the conformity of the purchased or partly completed machinery is guaranteed the work of the final manufacturer can be simplified Particular attention must be paid to this in purchasing partly completed machinery see above Relation between the Machinery Directive and other directives Below are stated a number of EU directives that can be important for machinery 3 At the same time the principal relation between these directives and the Machinery Directive is also stated briefly Directive 2006 95 EC relating to electrical equipment designed for use within certain voltage limits Low Voltage Directive Pursuant to article 1 2 k of the Machinery Directive this directive may therefore be used in place of the Machinery Directive for particular electrical machinery such as household appliances that are intended for private use Electrical low voltage equlpment from other machinery must on the basis of the essential requirement 1 5 1 of annex of the Machinery Directive comply with
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30. mpleted More information may be required when the machine is intended to be used In a potentially explosive environment or other information that is necessary for safe use When a component of the machine has to be moved with hoisting or lifting equipment while it is in use the weight of this component must also be stated Some of the type C standards contain provisions concerning this additional information machine into the language area concerned t is worth noting that the same language require ments apply for the manual that has to be provided with the machine This declaration naturally concerns the machine in the condition in which it is placed on the market The manufacturer or his autho rised representative must retain the original declaration until at least 10 years after the last date of manufacture of the machine Details of the content of the EC declaration of conformity are given in annex l 1 A of the Machinery Directive Vincotte Vincotte The EC declaration of conformity must in addition to conformity with the provisions of the Machinery Directive declare conformity with the other applicable directives If a notified body is involved for a machine of annex V the declaration must also contain information about the notified body and in EC type examinations the number of the EC type examination declaration New in the revised Machinery Directive 2006 42 EC is that the declaration mu
31. n Products Directive applies in addition to the Machinery Directive to machinery intended to form an enduring part of buildings or constructed works Such as powered gateways doors windows blinds and screens systems for ventilation and air conditioning This Directive is only applicable however to products for which a harmonised technical specification is available Directive 97 68 EC amended relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non road mobile machinery This Directive applies to the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non road mobile machinery within its scope Vincotte 1 26 Engines installed in non road mobile machinery must bear the marking intended in article 6 and described in section 3 of annex of the Directive but this Directive does not have to be mentioned in the declaration of conformity with the Machinery Directive The machine manufacturer s technical file will however contain the documents with regard to the conformity of the engine installed in the machine with the Directive Directive 1999 5 EC on radio equipment and telecommunications terminal equipment This Directive applies to the radio equipment within its scope that is built into machinery such as radio control If radio and telecommunicati
32. on equipment that has already been placed on the market is built into machinery then the technical file of the machine manufacturer must contain the documents with regard to the conformity of this equipment with the Directive t should be noted that the safety of remote control systems is subject to the Machinery Directive Directive 2000 14 EC relating to the noise emission in the environment by equipment for use outdoors This Directive applies regarding emission of noise to machinery intended for use outdoors that falls within its scope The last paragraph of requirement 1 7 4 2 u of annex of the Machinery Directive specifies that the requirements of Directive 2000 14 EC regarding measuring the sound pressure or sound power level are applicable to the machinery within its scope and that in that case the corresponding provisions of the requirement no longer apply Directive 2002 95 EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment RoHS The RoHS Directive applies to electrical and electronic equioment of the categories 1 2 3 4 5 6 7 and 10 of annex A in Directive 2002 96 EC WEEE Some of the products of these categories can also fall within the scope of the Machinery Directive such as for example categories 1 large household appliances not intended for domestic use 6 electrical and electronic tools 7 powered equipment for sport and leis
33. onised standards Typical of the New Approach directives for the free movement of products are the requirements for design and construction of the products formulated as fundamental or as inthe revised Machinery Directive 2006 42 EC essential requirements The Intention in doing this is that the legal requirements remain limited to generally formulated objectives that indicate the results to be achieved without imposing the technical solutions though this does not detract from some of the requirements being fairly concrete and specific Vincotte Vincotte The details of interpretation and application of the fundamental requirements are left to those involved with nevertheless a legally regulated preference for the use of the harmonised European standards in the form of alegal presumption of conformity with the corresponding essential requirements While some of the essential requirements are limited to a couple of lines of text their application is supported by one or more standards that take up a considerable volume As for other directives the list of the harmonised standards that give a presumption of conformity with the essential requirements of the Machinery Directive is published periodically in the Official Journal of the European Union Although not mandatory the harmonised European standards thus play an important role in the application of the New Approach directives apart from their use
34. rst fixed bearing When it is placed on the market with the guard it shall be regarded as one product In addition the following elements must be taken into account article 1 2 of the Machinery Directive contains a list of exceptions to the scope machinery that is excluded from the scope pursuant to article 3 directives that cover particular hazards more specifically have priority over the Machinery Directive See further Interfaces with other directives The Machinery Directive also applies to part y completed machinery that can not accomplish a particular application independently in the past called machinery intended to be incorporated into machinery or The essential health and safety requirements Annex The essential health and safety requirements of the Machinery Directive The machinery to which the Machinery Directive is applicable must answer to the essential safety and health requirements relating to the design and construction of machinery which constitute the subject of annex of the directive This annex is divided into six chapters preceded by some important General principles The first chapter formulates in a general way the various requirements and is applicable to all machinery The others deal in a more specific way with the additional health and safety requirements for particular special types of machinery or for particular hazards These additional requirements apply to t
35. ssion devices including their guards Guards for removable mechanical transmission devices Vehicle servicing lifts Devices for the lifting of persons or of persons and goods involving a hazard or falling from a vertical height of more than three metres Portable cartridge operated fixing and other impact machinery Protective devices designed to detect the presence of persons Energy operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9 10 and 11 Logic units to ensure safety functions Roll over protective structures ROPS Falling object protective structures FOPS 15 16 The conformity assessment procedures for machinery of annex IV Formachinery that completely complies with the recommendations of the harmonised European type C standards that cover the whole application of the directive to the machine the manufacturer has the choice of three possibilities lo get a EC type examination of the machine and the file performed he procedure for a complete quality assurance according to Annex X the machinery is completely built according to harmonised standards that cover the complete application of the relevant essential requirements to the machine then the manufacturer has in addition to the procedures described above also the option of following the same procedure as for machinery not specified in annex V namely the internal c
36. st contain the name and address in the EEA of Obligations for partly completed machinery Article 13 In the directive 98 37 EC as amended by 98 79 EC partly completed machinery was defined as machinery intended to be Incorporated into machinery or assembled with other machinery except where it can function Independently The legal obligations of the manufacturer of such machinery were limited to supplying it with a declaration the essential element of which was a ban on putting it into use before the whole machine into which it was built or the other machine into which it was incorporated was brought into conformity with the provisions of the directive The basic definition of such machinery that can not function independently has not changed substantially but the revised directive 2006 42 EC speaks of partly completed machinery At the same time the obligations for placing partly completed machinery on the market have been extended They include in broad terms the following the person who is authorised to draw up the technical file In addition it must mention the place and date on which the declaration was made The person who accepts the duty of signing the declaration should if he himself is not responsible for designing and constructing the machine at least check that there is a reasonable likelihood confirmed by a correct file that the machine complies with the essential requirements of the direct
37. ted between the manufacturer and the CE marking All machinery must as an external sign of conformity with all applicable When machinery of annex V has passed the complete quality assurance procedure then the CE marking must be followed by the identification number of the notified body involved In addition to the CE marking at least the following information must be put on each machine The declaration of conformity Annex l 1 A and II 2 Every machine when placed on the market and or put into service must be accompanied by an EC declaration of conformity drawn up by the manufacturer or his authorised representative The original declaration must be drawn up in one or more official language s of the EEA When an original declaration in the official language or languages of the country of destination is lacking a translation of the original declaration into that language or languages must be provided by the manufac turer or his authorised representative or possibly by the person who introduces the The company name and the complete address of the manufacturer and where applicable his authorised representative The designation of the machine i e the usual name for the machine category to which the specific machine model belongs Designation of series or type The serial number if any The year of construction that is to say the year in which the manufacturing process was co
38. that case it is sufficient after establishing that the machine falls within the scope of the standard to give a description of the way in which the provisions of the standard are used In some cases the standard does not cover the complete application of the Machinery Directive to the machine This can then be established on the one hand in the description of the applicability in the standard and on the other hand in the informative annex that indicates the connection between the provisions of the standard and the directive usually referred to with two letters beginning with Z7 In such cases additional action is of course necessary for the essential requirements that are not covered Deviations from the standard must also be defended more extensively In the event that the manufacturer does not wish to make use of the relevant harmonised standard or if there is no appropriate standard the case for the defence can for example be based on the list of essential requirements n that case the defense of the conformity will normally demand greater effort and in such cases the standard will still have to be used as reference for the state of the technique see above The best approach will be if there is a tyoe C standard to follow this as much as possible or in any case to use it as reference Additional obligations in case of series manufacture Basically the construction file for a machine deals with the conformity o
39. the manufacture of the machinery which is known as self certification without the compulsory intervention of third parties However additional rules apply for the assessment of conformity of machinery that is mentioned in annex V Categories of machinery to which one of the procedures referred to in Article 12 3 and 4 must be applied 1 Circular saws single or multi blade for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics or the following types 1 1 sawing machinery with fixed bladels during cutting having a fixed bed or support with manual feed or the workpiece or with a demountable energy feed 1 2 sawing machinery with fixed blade s during cutting having a manually operated reciprocating saw bench or carriage 1 3 sawing machinery with fixed blade s during cutting having a built in mechanical feed device for the workpieces with manual loading and or unloading 1 4 sawing machinery with movable blade s during cutting having mechanical movement or the blade with manual loading and or unloading 2 Hand fed surface planing machinery for woodworking 3 Thicknessers for one side dressing having a built in mechanical feed device with manual loading and or unloading for woodworking 4 Band saws with manual loading and or unloading for working with wood and material with similar physical characteristics or for working
40. the technical requirements of the Low Voltage Directive but not with its obligations regarding assessment of conformity so the Low Voltage Directive does not have to be mentioned in the EC declaration of conformity Directive 88 378 EEC on the safety of toys On the basis of article 3 of the Machinery Directive the latter is not applicable to machinery that falls within the scope of the Toys Directive Directive 89 686 EEC relating to personal protective equipment PPE On the basis of article 3 of the Machinery Directive the latter is not applicable to machinery that falls within the scope of the PPE Directive Directive 93 42 EEC concerning medical devices amended by 2007 47 EC On the basis of article 3 of the Machinery Directive the latter is not applicable to machinery that falls within the scope of the Medical Devices Directive Hereby it should be noted that article 3 of the amended Medical Devices Directive specifies that all relevant essential requirements of the Machinery Directive that do not appear in the Medical Devices Directive are applicable Directive 95 16 EC concerning lifts On the basis of article 3 of the Machinery Directive the latter is not applicable to lifts and safety components that fall within the scope of the Lifts Directive Hereby it should be noted that section 1 1 of annex of the Lifts Directive specifies that all relevant essential requirements of the Machinery Directive that do not app
41. tions 29 o ars pm On e gt Vincotte WHERE TO FIND MORE INFORMATION Particular directives or Official Journals of the EU for example looking up the consolidated text in one of the EU languages searching by the basic directive number www eur lex europa eu The most recently published Official Journals of the EU VVVVVV eur lex europa eu The text of the New Approach directives the lists of the associated harmonised standards plus the link to the specific sites for particular directives VVVVVV eC europa eu On the specific sites there are also usually any guides to the application of the directive links to the lists of notified bodies etc Belgian legislation Belgian Statute Book or specific legislation including the Belgian transposition of directives www just fgov be www economie fgov be To order standards www nbn be Standards can also be inspected at the Standardisation Bureau NBN Brabanconnelaan 29 1000 Brussels Services provided by Vincotte www vincotte be Vin otte is at your service for all questions about legislation obligations and evaluations on CE marking for machinery Contact our Product Managers Machinery Marc Vanderhaeghe EO4 7079025 E mvanderhaeghe vincotte be Koen Chielens 1 0479 790118 E kchielens vincotte be For certification Annex IV machinery Koen Chielens 1 0479 790118 E kchielens vincotte be Reproduction allowed with c
42. ure and 10 automatic dispensers The restrictions of the RoHS Directive regarding the use of dangerous substances apply to such products Directive 2004 108 EC relating to electromagnetic compatibility The EMC Directive applies in addition to the Machinery Directive to machinery that contains electrical or electronic equipment and that is capable of causing electromagnetic disturbances or the performance of which is susceptible to being affected by such disturbances The Directive covers aspects of EMC with regard to the operation of the machine The Machinery Directive deals with the immunity of machinery regarding electromagnetic disturbances of importance for safety transmitted by radiation or along conductors Vincotte Vincotte Directive 2005 32 EC regarding ecodesign for energy using products The Energy using Products Directive establishes a framework for requirements regarding the ecodesign of industrial products The measures to be applied in this context can be applicable to machinery or to equipment intended for building into machinery Note Directive 85 374 EEC amended by 1999 34 EC concerning the liability of the manufacturer for defective products is not directly related with for example the Machinery Directive n contrast to the Machinery Directive the transposition of which comes under criminal law this Directive comes under civil law It regulates the compensation of the victim
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