Machinery Directive 2006/42/EC Closing of "loopholes" through ...

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Dannecker / Ostermann: Loopholes in the Machinery Directive 2006/42/ECWhat does this mean with respect to therisk assessment?Under public law the buyer of machinery(including machine plants) / partlycompleted machinery has no right todemand the handover of the seller's riskassessment. It is intended as part of thetechnical file only for examination by theauthorities.In individual cases, e.g. with complexplants where the plant owner as "in-housemanufacturer" has to evaluate theCE conformity of given interfaces or insituations where existing plants aremodified, however, it is quiteunderstandable that the buyer demandsthe handover of the risk assessment ofmachinery / partly completed machinery.This can only be agreed upon by privatelaw within the scope of the supplycontract. In view of the private autonomy,the contract parties have the possibility todefine the subject of supplies andservices.Example of a contract clause:"The documents to be handed over by theSeller shall also include the riskassessment in accordance with theGeneral Principles of Annex I of theMachinery Directive 2006/42/EC for themachinery / partly completed machinery tobe supplied."Without such an "agreement on condition",however, the buyer has no entitlement toclaim the handover of the risk assessment.Alternatively it can be agreed, for example,that the machinery owner / buyer canexamine the manufacturer's / seller's riskassessment at his company premisesinstead of the handover. In both casesagreement on an obligation to confidentialhandling of the manufacturer's technicalsolutions is justified, as it isunquestionable that this constitutes knowhowof the manufacturer / seller that is notyet in the public domain and is thereforeworthy of protection.When does the conformity documentationhave to be handed over?The Machinery Directive prescribes inArticle 5 (1) that the EC declaration ofconformity must be handed over to theowner / user together with the machinerywhen it is placed on the market or put intoservice. While the time of placement ontothe market or putting into service ofindividual machines generally raises noquestions, this is often seen as a complexprocess of long duration in the case ofmachine plants, as the "trial operation" bythe plant manufacturer is regularly carriedout after the end of the erection work, i.e.the machine plant is adjusted, run in, etc.The trial operation by the plantmanufacturer is, however, regularlycharacterised in that the machine plantdoes not yet satisfy the demands of theMachinery Directive in all respects, inparticular Annex I, as e.g. guards have notyet been fitted, covers have to be removedagain, etc. An issue of the EC declarationof conformity and the attachment of theCE marking is not yet admissible at thispoint, so that this does not represent a"placement on the market". This trialoperation consequently takes place on amachine plant that is still in themanufacturing phase. The trial operationat this time is therefore subject to theoccupational safety provisions under theresponsibility of the plant manufacturer.The machine plant must satisfy theprotection goals of Annex I MachineryDirective only at the time of placement onthe market or of putting into service. Likewith a single machine this is a "point intime" and not a "period of time.There is therefore a need for clarificationof the "safety-related", i.e. the point atwhich the plant manufacturer's trialoperation has been concluded, themachine plant satisfies the public lawrequirements such as the MachineryDirective and the machine plant can beplaced on the market or put into service.Private law measures can be taken here,e.g. in the form of a commissioningprotocol to be signed by both contractparties in which the owner / buyer not onlyconfirms that e.g. the mechanical function8
Dannecker / Ostermann: Loopholes in the Machinery Directive 2006/42/ECof the machine plant is assured or e.g. theproduction over a 24-hour period ofoperation has been successfullydemonstrated, but also that the machineplant satisfies the public law requirementsof the Machinery Directive ("CEacceptance"). From this point in time, theowner / buyer is responsible in accordancewith Article 4(2) of the Directive2009/104/EC for ensuring that this safetylevel is not infringed during the furtheroperation of the machine plant.Example of a contract clause in thecommissioning protocol:"With the commissioning of the subject ofsupply, it shall be placed at the Buyer'sdisposal for the first time for its intendeduse. The Buyer confirms that at this timethe subject of supply satisfies the safetyand health protection requirements of theMachinery Directive 2006/42/EC and ofthe other relevant European directives ofthe Community and therefore functionsand can be operated safely."This does not preclude the necessity forfurther contractual provisions, e.g. on thequality of the machine plant over andabove this "safety-related transfer ofperils". The "CE acceptance" musttherefore not necessarily constitute a"quality acceptance" at the same time.This can and will as a rule take place later,e.g. when the product-specificperformance values of the machine planthave been demonstrated, e.g. in the formof test or guarantee runs. The advantageof such a split acceptance is that after the"CE acceptance", the owner can producewith the plant from a public law point ofview because it is "safe".Points of particular note for partlycompleted machinery1. Declaration of incorporation instead ofEC declaration of conformitySince 29.12.2009, certain manufacturer'sobligations in accordance with Article 5 (2)and Article 13 Machinery Directive applyalso to "partly completed machinery" asdefined in Article 2 g) Machinery Directive.In particular a special procedure (not aconformity assessment procedure) inaccordance with Article 13 in conjunctionwith Annex VII B Machinery Directive hasto be carried out which includes also thedrawing up of a risk assessment. Thedeclaration of incorporation in accordancewith Annex II Part 1 Section B MachineryDirective to be drawn up and handed overto the buyer, however, requires themanufacturer only to indicate whichfundamental requirements of theMachinery Directive in the sense of theprotective goals of Annex I MachineryDirective are applied and fulfilled. Themanufacturer of the partly completedmachinery can therefore limit himself inthe declaration of incorporation toindividual safety and health protectionrequirements which in his view areapplicable to the partly completedmachinery.For the buyer, however, who integratesthe partly completed machinery into acomplete machine, or assembles ittogether with other machinery or partlycompleted machinery, it is often importantthat the manufacturer of the partlycompleted machinery confirms that thisconforms to all the safety and healthprotection requirements in the sense ofAnnex I Machinery Directive relevant andapplicable to the partly completedmachinery up to the interfaces indicated inthe documentation.This can be achieved in that themanufacturer of the partly completedmachinery undertakes contractually toissue an "extended declaration ofincorporation" 8 in which he certifiesprecisely this statement.In this way the buyer who installs thispartly completed machinery in the finalmachine / plant receives a high degree oflegal security.8 See www.maschinenrichtlinie.de “ErweiterteEinbauerklärung”9
Page 1 and 2: Klaus Dannecker, LawyerVoith GmbH,
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