Q Taking a simplistic view as a general guideline and conscious that all of our machines are shipped from within the EU with a CE mark is it right to assume that a machine delivered with a proprietary make of robot fitted, designed for use on an injection moulding machine, then only a Declaration of Incorporation is required.

A Yes for the robot but you will need to risk assess the interface issues. You should produce a technical file for the complete machine that will have the Declaration of Incorporation as an addendum. The design and other details needed for the Robot part of the Technical File need not be held by the final manufacturer, but they should be held by the Robot manufacturer.

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Q If a machine has been brought into the UK fully CE compliant and power sockets are then added locally, prior to delivery to the customer, does the machine then need to be re-CE marked and a new Technical File created?

A The Technical File and CE Mark will only apply to the machine with no sockets. The original manufacturer should be contacted with the details (i.e. sockets to EN60204) and agree to add this to his technical file and confirm that the CE mark is still valid - if he will not do this then the person who modified the machine would take on these duties. 

Power supply on machines should comply with EN 60204 "Electrical Parts of Machine"

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Q When a one off item of automation equipment is designed to work in conjunction with a specified injection moulding machine then a "Declaration of Incorporation" is obtained to ensure their equipment is safe and compliance plus a statement that EN 201 has been satisfied. Is it then correct to issue a Declaration of Conformity for the entire cell (automation and moulding machine combined).

A Yes but also see the note above - i.e. Declaration of Conformity will be the "last page" of your addendum.

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Q On a robot / machinery installation who should take responsibility for material handling system if the customer carried out their own installation?

A Any person or body can only be responsible for the safety matters which are within their control. Since the customer is in control of the installation of the material handling system, they are responsible for its safety. Since the machine will not be complete (i.e. become relevant machinery) until the handling system is installed, then the customer must be responsible for the CE Certification.

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Q I understand that where material hoppers necessitate an operator standing above ground level to fill them routinely that the machine manufacturer should supply steps with a hand rail.

1. Is this only above two meters and

2. can HSE quote the applicable European regulation.

A The two metre rule (from foot level) defines "working aloft". However, the Workplace (Health, Safety and Welfare) Regulations not only requires secure fencing where someone might fall 2 metres or more but also at heights less than 2 metres where there are factors which increase the likelihood of a fall (e.g. route close to an edge) or where serious injury may occur. As well as the UK regulations 'Supply of Machinery (safety) Regulations' and 'Provision of Use of Work Equipment Regulations' , the Workplace (Health, Safety and Welfare) Regulations implement the EU Workplace Directive. 

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QWhen supplying a machine with feed access at a height of over 2m should the supplier provided access as currently nobody does.

AYes but the regulations does not say what access should be provided. Often the regularity of access will determine what type of access is needed. You need to look at the type of machine - why access is needed (e.g. feeding or maintenance) and how frequent access is needed. If the area concerned is to be accessed regularly then an access ladder should be provided. For heights above 2m and where the risk assessment suggest it (eg risk of falling into equipment etc) then a hand rails should be provided or possible stairs.  

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QWhen supplying machines with knowledge that access will be needed on a regular basis (tool change and material feed etc) is it not the responsibility of the customer to ensure health and safety regulations are adhered to?

ANo - if you supply a machine with the knowledge that an area will need access on a regular basis then you must supply safe access to that area. The question is whether access is for planned or fault rectification reasons.

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Q Following on from the above question, it is not always clear when supplying a machine with a hopper whether the customer will take this off and replace it with a hopper loader - who is responsible for the CE marking of the modified cell and how does the supplier indemnify themselves against this situation.

A If the customer decided to modify the machine then it is his responsibility to CE Mark it - they have nullified the agreement with supplier and nullified the CE Marking. If a secondary supplier undertakes this modification then it is their responsibility. The original supplier is not responsible unless he has knowledge of the modification in which case they should take responsibility to make the user aware of the situation. The best course of action is to maintain dialogue between all partners. 

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QDo used and refurbished injection moulding machines need to be CE marked?

AThe answer to this question depends upon what is involved in the overhaul since CE marking applies only to "new" machines. If work parts are replaced "like for like" then the original machine has not been changed and a new machine has not been created. In this case any existing safety measures should still be operative and after checking that these measure have not been compromised by the work, the machine may be returned to service.  

If modifications have been made during the overhaul, it is necessary to check whether the changes have altered the safety characteristics of the machine. If this is the case, it is considered that a new machine has been created and risk assessment should be undertaken on the complete machine which should be CE certified/re-certified as appropriate.

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Q If a robot is supplied and installed on an old (pre- CE marked) machine does it require a Certificate of Incorporation?

A By adding or changing anything on an existing machine, it then becomes a "new machine" and will need to be CE Marked, even if it is only for self-use. The HSE would expect the whole cell to be CE Marked by the new component supplier. However it would be unreasonable to expect that company to know all details of the older machine but evidence of a risk assessment having been conducted is necessary. It is considered that if the machine is technically non-compliant but there is strong evidence of consideration for its safe working, then the HSE is unlikely prosecute. 

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Q What is the current legislation covering safety checks for injection moulding machines in a demonstration/trial facility?

A Article 2 of the Machinery Directive allows non-compliance at exhibitions provided that machines are modified to be safe before sale and provided a notice to that effect is displayed near the machine.

On-site working - machine must be risk assessed and safety measure put in place during trials - if safety hazards become apparent during trials, the fact should be noted and the machine modified to be safe. It is reasonably foreseeable that hazards may become apparent during trials, therefore attending personnel must be competent to realise this and to avoid danger by way of their expertise and experience, however, like guarding, expertise can only be used as a safety strategy when no other safety measure are possible.

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Q What are the implications of CE marked machines not meeting the relevant standards.

A On site, the inspector would require the machine to be stopped and either an Improvement Notice or Prohibition Notice will be served as appropriate. The supplier will be asked to withdraw the machine from the market until modification had been made and it was demonstrated to be sale. A HSE report will also be draw up and submitted to the EU Commission and to all EU enforcing authorities- if it is then agreed, it is withdrawn from the whole EU market. Implications are the loss of sales plus a possible group of civil actions for compensation.

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Q I would like a clear, precise explanation of responsibility for integrated equipment.

CE Marking applies at the point of first supply and logically, a machine cannot be supplied until it is put together and therefore able to perform the function for which it is being supplied.

A Where a machine is compiled, perhaps a production facility consisting of several lesser machines "connected together and arranged to function as a whole" (ref Article 1 of the Machinery Directive) then the person who supplies is the integrator. This means that the integrator is responsible for certifying the safety (i.e... CE marking) integrated machines.

Since the integrator may well have had no say in the design or testing of the individual sub=assemblies or constituent machines, he cannot be expected to be an expert with regard to their safety. The integrator's duty is therefore to compile the Technical File by collecting individual Declaration of Incorporation for each integrated machine, to conduct risk assessments to ensure that the way in which he has integrated the machines or sub-assemblies has not introduced hazards, to inspect and test the complete integrated machine, provide user and maintenance handbooks as necessary and to make a Declaration of Conformity.

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Q When a one off item of automation equipment is designed to work in conjunction with a specified injection moulding machine then a "Declaration of Incorporation is obtained to ensure their equipment is safe and compliance plus a statement that EN 201 has been satisfied. Is it then correct to issue a Declaration of Conformity for the entire cell (automation and moulding machine combined).

AYes but also see the note above - i.e. Declaration of Conformity will be the "last page" of your addendum.

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QWhat is the situation regarding the customer's replacing spare parts on a machine which are not recommended by the supplier.

AThe end user is responsible for using equivalent spare parts. If they use parts that are not equivalent they have nullified the CE mark and take on responsibility for the machine - i.e. they should re CE mark it.

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QWhat is the situation regarding the fitting of auxiliary power sockets on machines for the purpose of supplying ancillary equipment and should these be powered through the machine isolator or through a separate supply.

A This subject is dealt with by BS EN 60204 "Electrical Parts of Industrial Machines" and socket outlets fitted to machines should preferably comply with EN60309 "Industrial Plugs and Sockets"" and must supply a voltage not greater than 250v and a current not greater than 16 amps. If socket outlets do not comply with EN60309 they should be clearly marked with their voltage and current rating.

Whether the circuits are wired through the machine's main switch disconnector (isolator) will depend upon the function of the circuit. The following circuits need not be wired through the isolator

lighting circuits for lights needed during maintenance or repair. (note operational lighting is excluded)

plug and socket circuits exclusively for the connection of repair or maintenance tools (e.g.. drills, test equipment etc - note operational equipment power is excluded)

under-voltage protection circuits which are only used for automatic tripping in case of supply failure

circuits supplying equipment which should normally remain energised for satisfactory operation (e.g. temperature controlled measuring devices, product (work in progress) heaters, program storage devices etc).

control circuits for interlocking

It is recommended that the above circuits are provided with their own disconnecting device.

Where the above circuits are not disconnected by the main disconnector:

a permanent label must be placed in close proximity to the disconnector

a permanent label must be placed in close proximity to the expected circuit

a statement must be inserted in the maintenance manual.

All socket outlets must have provisions to ensure the continuity of the protective bonding circuit. All unearthed conductors connected to the socket must be protected against over-current and overload where necessary and separately from the protection of other circuits.

How are CE regulations being applied in other EU member states.

This varies. Italy has some way to go but is improving - they are being driven by their enforcing authority focusing on the multi-nationals. Germany tries but some suppliers do not fully understand the CE process. Generally things get better as you move towards Scandinavia.

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Q Are there any harmonisation discussion going on between EU and other manufacturing countries e.g. USA and Japan?

A No not at present but there are many ISO committees working to produce harmonised standards that will be EU approved as an ISO EN

Are there any existing or standardised compliance processes that suppliers of capital equipment are using successfully to ensure adherence to standards and procedures during installation and commissioning.

There are no universal or standardised compliance procedures. However the Legal

Consultant at the Spring Seminar, Roy Nightingale is the author of a book on the subject of CE Compliance. He also runs training courses and can advise in-company.

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FURTHER INFORMATION AVAILABLE  on the following links

HSE Polymer & Fibres Sector  www.hse.gov.uk/fod/polymer.htm

DTI Guidance Notes on UK Regulations for Machinery http://www.dti.gov.uk/strd/strdpubs.htm

HSE Publication : SUPPLYING NEW MACHINERY 

Available from : HSE BOOKS at P.O.Box 1999, Sudbury, Suffolk, CO10 6FS

Telephone : 01787 881165 Fax : 01787 313995

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