Since 1993, the ConformiteEuropeene (CE) mandatory mark has signified conformance with legal andtechnical directives put forth by the European Union (EU). This CE mark hasserved as an entry stamp for many industrial products and services certifyingthat the producer of the product or service complies with health, safety,and/or environmental requirements. Altogether, there are around 25 directivesrequiring the CE mark certifying such areas as: safety, machinery, low-voltageequipment, terminal equipment, and electromagnetic compatibility.

Many manufacturers understandand comply with existing CE marking, but not all manufacturers are fully aware,and many more are not prepared, to conform with the looming new MachineryDirective set to become effective on December 29, 2009. Manufacturers mustunderstand that there are significant changes from the current directive,Machinery Directive 89/392/EEC to the new directive, Machinery Directive2006/42/EC.

For manufacturers planning tocompete with machinery sales into the European marketplace, it will beessential to become well versed in the new requirements and follow up withaction plans for product compliance.

Machinery Directive: What's New

The evolving requirementsstipulated by the new Machinery Directive provide users and suppliers ofmachinery with guidelines for prevention of serious injury.

Some key changes include:

Process of Risk Assessment - Machine manufacturers are obligated to complete a riskassessment that is now defined within the directive as an iterative process ofhazard identification, risk estimation, hazard elimination or risk reduction.

Safety system requirements - Machine designers are obligated to design controlsystems in such a way that a fault in the hardware or software of the controlsystem and/or reasonably foreseeable human error does not lead to hazardoussituations.

Harmonized standards - The standard governing the design and implementationof the safety related parts of control systems on machinery (EN 954-1) becomesobsolete on December 29, 2009. Machine builders must use EN ISO 13849 or EN/IEC62061 to achieve compliance with the new directive.

Administrative and Assessment Procedures - New assessment procedures are defined for machineslisted in Annex IV of the directive and for "partly completed machines". Formanufacturers of Annex IV machines self-certification is now possible.

Machine builders outside the EU - Machine builders outside the EU must authorize aperson who must be established in the Community to compile the technical filefor the machine. Machine builders without an operation in the EU can appoint an"Authorized Representative".

Structural changes to the newMachinery Directive expand language to include more detailed instruction,dictate changes in essential requirements, provide greater scope underadministrative procedures, and even review definitions of machinery.

For example, under 3.1.3 ControlSystems and Devices, the obligations on machine control system designers aremore explicitly and in some cases more stringently defined. In the main theserequirements restate with clarity that a failure of or any other cause in amachine control system should not lead to a hazardous situation. However therequirement to consider "foreseeable human error" is new. The design of thesafety system must be considered in a manner where machine operators do notbenefit or gain incentive from bypassing safety systems. Recognizing advancesin technology the new directive introduces the obligation to consider controlsystems and protective devices to automatically prevent start-up if it detects aperson in a danger zone.

Or, under 3.3.1. Boundarywith Low Voltage Directive, the interpretation of the "Low Voltage Directive"("LVD") and the existing "Machinery Directive" resulted in the unintentionalexclusion from the machinery directive of machines on which it could be claimedthat the hazards were primarily electrical. In certain cases such aninterpretation resulted in only the LVD being applied. This "loophole" is nowclosed by specifically listing in the new MD the electrical and electronic productswhich are covered by the LVD as opposed to the new Machinery Directive.

In addition to final productsor services, assemblies of machines such as robot cells and production linesalso fall under obligations of the new Machine Directive.

Clearly, the new MachineDirective provides meaningful expansion to existing requirements. Manufacturersmust heed the expanded changes and ensure their products and services fullycomply with the significantly more stringent standards.