CE Marking is a legal requirement for Machinery supplied after January 1995 into the European Economic Area. The software allows the Essential Health and Safety Requirements (EHSR) of the current Machinery Directive 2006/42/EC to be addressed, and a comment made to define whether the equipment complies or not. If it complies, the comment should be positive, and explain how it complies, a photograph can be added to show compliance.
If the equipment does not comply to the EHSR, then a risk assessment should be carried out. When the process is complete, and all risk assessments signed off and completed, then the equipment can have the CE marking attached and a Declaration of Conformity issued.
The Europa website has a Machinery Directive page where the current Machinery Directive 2006/42/EC can be freely downloaded, the Guidance Document freely downloaded, and a list of current Harmonised Standards to the Directive. This is updated approximately four times per year.
HSE also provide guidance on what is an assembly of machines.
When is a machine, not a machine?
When it is a partly completed machine…
CE marking of machinery has been with us since 1993, so it is concerning that many machinery users and manufacturers still don’t do it properly. The original machinery directive was significantly modified at the end of 2009. Machinery supplied since then should comply with the current Machinery Directive 2006/42/EC, which defines machinery 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,’
‘assemblies of machinery … or partly completed machinery … which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,’
It goes on to define partly completed machinery as
‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, forming machinery to which this Directive applies;’
The difference is that machinery must carry CE marking, partly completed machinery must not.
A robot is a partly completed machine, as it has to be integrated into other machinery to carry out its functions. The hazards need to be addressed by the integrator, rather than the robot manufacturer. Something like a conveyor could be either a machine, or a partly completed machine. If it is supplied with controls, and just needs connecting to a power source, then it is a machine and should carry CE marking. If it is controlled by the system it is being incorporated into, it should not carry the CE marking.
When purchasing a standalone machine that works on its own, that does not require any other equipment to feed it, and does not need any other communication with other equipment, it should carry CE marking and be supplied with a Declaration of Conformity and an Instruction Manual.
If a machine is purchased that cannot work on its own, one that needs other equipment to work with it, that needs inter-connection, it should be considered as partly completed machinery. CE marking should not be applied, and a Declaration of Incorporation and assembly instructions should be supplied. The equipment must not be used until the complex assembly of machines has been CE marked, and is safe.
End users need to understand what their responsibilities are when ordering machines, as they have a duty to ensure that the equipment being supplied has been CE marked correctly. It is not enough to assume the manufacturer is doing it correctly, the end user should be checking that the equipment is safe, and the documentation is correct.
Under the Provision and Use of Work Equipment Regulations (PUWER), Regulation 10 specifies ‘Every employer shall ensure that an item of work equipment conforms at all times with any essential requirements … in which these Regulations apply …’
CE marking is a process that must be followed, to ensure that machinery meets the Essential Health and Safety Requirements, (EHSR’s) of the Machinery Directive. The manufacturer of the individual machinery should be checking their machinery to ensure it meets the EHSR’s and recording the information in a Technical File, along with risk assessments, drawings, calculations and any other information to ensure that the machinery meets the EHSR’s and is safe.
If a new machine is being created from a complex assembly of machines, it still needs to go through the CE marking process, a Technical File created, hazards created by linking the machines assessed and reduced or removed, adequate instructions provided for the assembly (not just individual manuals), and a Declaration of Conformity issued when the equipment is safe.
The end user has no legal right to see the Technical File for purchased equipment, and often, it won’t exist in a hard copy form, but end users should be requesting to visit the suppliers premises and review the Technical File, to ensure that items such as an EHSR report, adequate risk assessments, and other reasonable information, actually exists. If the manufacturer won’t allow any such inspection, then consider whether that supplier is the best one to use. Don’t expect the manufacturer to supply a copy of the Technical File, there is too much information, and some of it will have intellectual property rights.
Manufacturers are also in a difficult position, because many purchasers are aware that CE marking is a requirement, and want to see it on the machine, and the documentation. They often don’t understand that it is a criminal offence to apply CE marking where it should not be, and pressure is applied on sales people within manufacturing organisations to provide what the customer wants to see, whether it is correct or not.
When machines are linked together to create a production line or complex assembly, the person assembling the line has the responsibility for the CE marking, and should create a Technical File, address the EHSR’s, carry out risk assessments and ensure that the machines, and the interfaces between machines are safe and compliant. The person responsible for this could be the end user, a prime contractor or someone appointed to take the responsibility. The contract should define who will be responsible for the CE marking of the assembly. If it isn’t addressed, the end user will probably end up having the responsibility, and it may be missed in the commissioning process.
There are many things that need to be considered, for example, how safety functions are connected on a number of machines, how the emergency stop system works, how interlocks work, and how to ensure that the complex assembly is safe to use. This requires discussions and design reviews with users, designers and integrators to develop a functional safety specification. There are European Normative standards (EN standards) that should be followed to ensure the functional safety of the equipment is assessed correctly, then validated. This results in a report that should be part of the Technical File, but the end user should also be provided with. This is important, as if the equipment gets modified in the future, this validation may need to be reviewed and reassessed. Similarly, individual machines require the same information to be available. Compliance with these standards usually requires experienced electrical engineers who understand the basics of functional safety.
End users should also be considering items such as consistency of control colours. It is a little known fact that within the Electrical Standard EN 60204-1, (section 10), the preferred colour for a Start control is White, the preferred colour for Stop is Black. Many machines come with Green Start and Red Stop, which is acceptable within the standard, however where there is a complex assembly of machines, consistency should be applied across the system. End users also need to ensure that machinery across their sites have consistent colours, especially where operators often use different machines. Consideration should also be given to makes of components for maintenance consistency, types of guard fixings, to ensure operators aren’t provided with tools that allow them to dismantle parts of the machinery they shouldn’t have access to.
The person responsible for CE marking the complex assembly needs to consider such items as maintenance. An individual machine may be accessible for maintenance, but when there are hoppers, gantries and other equipment in the area, then maybe access isn’t as easy as the original manufacturer intended, meaning that additional access platforms may need to be added. Consideration needs to be given to how to get tools, spare parts and components to the areas where they are needed. If access is by a ladder then it is difficult to get tools and equipment up them safely, maybe better access needs to be provided so they can be lifted by forklift truck, or overhead crane. If there is room for stairs, they should be provided.
If the Essential Health and Safety Requirements are addressed for each machine and assembly of machines, then all of these items, and more, should be identified, and the design should ensure that the equipment is safe to use and maintain.
It is important that someone is allocated this responsibility within the contract, and that the correct documentation is provided. As a start, it helps if the end user knows what to look for in the documentation.
A partly completed machine should come with a Declaration of Incorporation to the Machinery Directive, the only European Directive a Declaration of Incorporation is used with. This is a legal document, the equipment should be identifiable, by model, type, serial number, name and address of manufacturer, this information should be repeated on the machine plate, so it is obvious which machine the Declaration applies to. This should be a document supplied with the machine, not a download from a website. A list of the EHSR’s that have been addressed should be listed on the Declaration of Incorporation, along with the name and address of the responsible person, the name should be printed, and a signature shown. The name and address of the person responsible for compiling the Technical File should also be on the Declaration. This person should be based in Europe, so that the authorities can access the Technical File if required. There should be a statement specifying that the equipment must not be used until the equipment it is being incorporated into, complies with all applicable EHSR’s.
When a machine, or complex assembly of machines has been installed and made safe with all risk assessments signed off, a Declaration of Conformity should be issued. This should list all Directives applied, should have all information to identify the machinery or complex assembly of machines, should list any Standards applied. The responsible person should sign and date the Declaration, the name and job title should be printed, as should the name and address of the person responsible for compiling the Technical File. The Declaration on the Declaration of Conformity should state that the machinery identified complies with all relevant Essential Health and Safety Requirements applicable. Finally the CE marking should be applied.
In conclusion, CE marking to the Machinery Directive is something that should be considered from the start of the project, the Essential Health and Safety Requirements and Risk Assessments are a key part to CE marking, if they are not addressed, it is likely things will be missed. Contracts need to specify where responsibility lies, and don’t assume because a company is large, that they are doing it right… Buyer or seller.