From the Health & Safety Day held in 2001, a number of questions were raised, the answers to which are below. The HSE appreciates that these may not be complete in all cases and in certain circumstances may need to be addressed on an individual basis either by your Local Health & Safety Officer of the HSE. You can forward your individual concerns via the PMMDA - see Contact Us Page.

Schedule 4 to the Supply of Machinery (Safety) Regulations (SM(R)R) includes injection and compression moulding machines with manual loading or unloading. Manual loading can be equated to manual feeding. In the context of these machines does this refer to loading polymer and unloading product?

Yes. However note that even where polymer is loaded into a hopper by hand, this may not be considered "manual loading" of the machine i.e. where loading from the hopper into the machine is automatic and there is no risk if the machine starts up. However in this case the machine is still a schedule 4 machine if it is unloaded manually.

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Following on from the above, if the machine is loaded automatically and a robot arm unloads the product, does this mean it is not a Schedule 4 machine?

Correct. Provided the above comprises the total machine i.e. no provision for manual feed without changing the machine. As a general rule if the machine can easily revert to use manually with minimum effort, HSE's view it that it remains a Schedule 4 machine.

It is common in the industry to add vacuum hopper loaders to injection moulding machines and/or pick and place robots to remove finished product. This is encouraged to reduce manual handling risk. It can take place either at the time of purchase of the injection moulding machine (IMM) or at some point during its life. In answering the questions below both these circumstances have been considered

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In adding this equipment/machinery to a Schedule 4 machine, what are the implications for the supplier/user and do they turn to the approved body (who maybe in another country) at any point? IMM's may or may not be built in accordance with BS EN201.

The loader and robot may be specifically designed for this type of injection moulding or similar machine, or may be a general design with no specific application, In the latter case, they are not machines and so cannot be issued with a Declaration of Incorporation. The former can.

If the IMM is not modified in any substantial way (e.g. removal of protection devices/guards: interface with electronics etc) and could still be used manually with minimum effort, it is considered the machine remains a Schedule 4 machine. However, the whole complex machine is subject to SM(S)R and needs CE marking etc. The Essential Health and Safety Requirments (EHSRs) of the individual machines need not be re-assessed provided modifications have not affected that area, e.g. if the control circuit or guarding of drives have not been modified the original CE procedure for that machine is sufficient. Schedule 4 requirements do not have to be complied with provided this assembly of machines results in automatic feed and unload. If it doesn't then the whole will need to go through the Schedule 4 procedures and the responsible person (who will be determined by reference to the definition of responsible person in each case) has a choice of Approved Body. They do not need to go to the Approved Body who dealt with the IMM - although there may be a cost advantage as they will have all the etc.  

NOTE: if the robot and feeds have not been CE marked (because they are general machines with no specific application) the EHSRs relevant to there operation will need to be addressed by the responsible person, which may be the user, if they are putting the assembly of machines together. Where the hopper loader and robot have a particular application they will/should be CE marked.

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Should a Declaration of Incorporation or Conformity be given for the hopper loader or robot?

See above - it depends on whether it has been manufactured for specific or general applications. If it is a machine and is sold to operate with the IMM (i.e. will not be used independently) then a Declaration of Incorporation should be issued. If it has no specific application or is not complete i.e.does not have all the actuators, control and power circuits) it is not a machine and so cannot be CE marked or issued with a Declaration of Incorporation.

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Who should be appointed to take on the role of dealing with a modified machine?

The responsible person has ultimate responsibility. They should ensure a competent person e.g. a suitable engineer - either from inside or outside the company ensures that EHSRs are complied with. Where a Schedule 4 machine is involved an Approved Body does not need to be involved unless significant modifications are to be made to the IMM and it can still operate in manual mode.

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It is correct that unlike Section 6 of the Health & Safety at Work Act, the Supply of Machinery (Safety) Regulations don't accommodation requires for safeguards to be left off if a user request supply of a machine without them?

Yes, the exception ebing that if the supplied unit is a machine (see definition) but the user does not want all the guards and other safety devices fitted as they intend to combine it with other equipment/machines, they could ask for a Declaration of Incorporation from the supplier (i.e. no CE mark) and use the information from the supplier on how it meets the relevant EHSRs as part of their Declaration of Conformity for the whole unit.

Essential Health & Safety Requirement 1.6.2 requires there to be access to operating position and servicing points.

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What is the responsibility on the UK based supplier where an IMM is supplied into the UK and it has a hopper feed which is not accessible from the floor and yet safe means of access hasn't been supplied?

Is it any different for a granulator where no access is provided to the feed opening?

In both cases access should have been supplied, the nature will depend on the frequency and mode of access e.g. for infrequent access a ladder may suffice but for routine access, especially if carrying materials, stairs would be needed with hand rail etc.

Responsibility for failure to comply with the EHSRs will depend on the particular circumstances. If the UK supplier is not the responsible person (i.e. first supply, or manufacture is elsewhere in the EU/EEA) then the responsibility on the UK supplier is to supply safe equipment and on the user to ensure the EHSRs have been complied with. In both cases it may be possible to argue that the defect was not apparent to the user or supplier (e.g. electrical control circuit was faulty), but in this case they should have known the access arrangements were unsafe (if there were no/poor means of access0. the breaches are under SM(S)R Regulations 11(2) (supplier who is not the responsible person) and the Provision and Use of Work Equipment Regulations 10(1) (user).

So the duty on the supplier is to ensure the equipment is safe, i.e. has proper access. However, the responsible person (i.e. manufacturer/first supplier in EU) has primary duty to meet the EHSRs under SM(S)R. However this cannot be used as an excuse to use unsafe machines. In practice HSE will ask the responsible person to correct the machine and similar machines in the EU and circulate this information to other member states. If it is a blatant breach, HSE may take enforcement action. HSE may also take action on the supplier in the UK if fault should have been seen (as in this case). if it is a significant risk HSE may also issue a Notice on the user to prevent use until the fault is corrected.

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What are the duties on a conveyor supplier when they supply a conveyor at the same time as the supply of a granulator which may be from another supplier or imported directly by the user?

This depends on the integration of the two machines and intention of the manufacturer.

If the two have been supplied independently and neither need major modification in order to work together, neither supplier has additional duties other than those they should have already complied with under SM(S)R for the individual item of machines. Declarations of Conformity for both should be issued.

However, a Declaration of Incorporation should be issued where the manufacturer builds the machine with the intention that it is incorporated into, or assembled with, a larger machine, i.e. cannot function as intended independently of the larger assembly. In other words, to fulfill its intended function, the machine needs to be incorporated into another relevant machines. Irrespective of which Declaration procedure the machines comes under, the relevant EHSRs have to be met.

In the case of a small conveyor for incorporation into a larger assembly, it may not initially require guards for the head and tail drums, but electrical hazards should be addressed by the conveyor manufacturer and appropriate precautions taken to reduce such risks.

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What are the duties on the conveyor supplier when supply is after the original supply of the granulator?

This will depend on the "agreement" but we would expect the supplier to enquire as to use and give advice. With respect to other legal provisions, the situation has not changed, e.g. it will be the user if they fit the machines together etc, who will take on the role of ensuring the EHSRs are met and issuing a Declaration of Conformity for the whole machine. They need to only address those EHSRs that have not been adequately covered in any CE Declaration of Conformity or Incorporation issued by the individual machine manufacturer.

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