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CE marking misconceptions

CE marking misconceptions

It is a common assumption in industry that if machinery has the CE marking, no further action on the purchaser’s part is required. However, the CE marking is not proof of machinery safety, and while it appears to be one of the most simple European Union (EU) requirements to get right, it is in fact one of the most widely misunderstood, as Neil Dyson of TUV SUD Product Service explains.

As most machinery owners are aware, before any item of machinery can be legally placed on the market in the EU, it must bear the CE marking to show compliance. By applying the CE marking and providing the associated EU Declaration of Conformity (DoC), a manufacturer or importer of machinery is confirming that a machine meets the requirements of all applicable EU Directives. It is therefore essential that machinery end-users understand their supplier’s responsibility in order to ensure compliance with machinery CE marking requirements.

The DoC is a formal statement that a machine complies with applicable directives and standards. It must be signed by the responsible person within the organisation and that signatory may be subject to prosecution if the equipment is found not to comply. The DoC must include:

  • Name and address of the manufacturer (or their authorised representative)
  • Description of the product – including type, model and any other information that clearly relates the equipment to the Declaration 
  • Reference to the standards applied
  • Identification of the signatory 

An essential element in a machinery manufacturer demonstrating that CE marking requirements have been met is the production of a technical construction file (TCF), which must conform to the provisions set out in the Machinery Directive. 

Annex VII of the Machinery Directive states, in paragraph 1(a), that the TCF must now include “documentation on risk assessment” demonstrating the procedure followed, including:

i. a list of the essential health and safety requirements (EHSRs) which apply to the machinery,

ii. the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery.

In addition, EHSR 1.1.2 states “machinery must be designed and constructed so that it is fitted for its function, taking into account foreseeable misuse” and “the aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery.” 

The Work Equipment Directive, which is implemented in the UK by the Provision and Use of Work Equipment Regulations 1998 (PUWER), applies to all equipment regardless of its age.

A risk assessment should therefore be completed before new machinery is put into operation. Any problems can then be rectified with the machinery manufacturer, so that they, or the machinery owner, no longer run the risk of prosecution under the Machinery Directive of PUWER. Software has been designed for machinery compliance risk management, taking much of this headache away, but must be the latest version that reflects current legislation. 

Any substantial changes to machinery, such as upgrades or if it is interlinked with other equipment as part of an assembly, may make the existing DoC invalid. This could therefore necessitate a new conformity assessment, even if the machinery was originally compliant with CE marking when it was first purchased and put into service. 

There are two key areas of guidance to help machinery end-users identify if the modifications they have made will be considered substantial by the regulatory authorities. The first is the Health and Safety Executive, which outlines the different situations involving modifications to machinery where the requirements of the Machinery Directive are likely to apply and action must be taken:

  • Machinery is modified so much that it should be considered as ‘new’ machinery. 
  • Machinery refurbishment with a different safety package. 
  • An existing assembly of machines is modified. 
  • Machinery modified before it is first put into service. 

A second reference guide is the CEOC International document ‘Modification of Machinery in Service – Guide for Inspection’, which gives clear guidance on what constitutes a ‘non substantial’ and a ‘substantial’ modification.

In order to carry the CE marking and comply with the Machinery Directive, any machine that has EMC sensitive electrical or electronic components must meet the requirements of the EMC Directive (2004/108/EC).

The only machines that are not subject to conformity assessment with the essential requirements of the EMC Directive are fixed installations. Often the presumption is that if machinery is screwed to the floor it can be considered a fixed installation. However, if such a machine, or assembly of machines into a production line, is moved and modified at any time, it ceases to become a fixed installation. 

It is therefore very rare that something that is presumed to be a fixed installation actually is and we regularly see this misunderstanding when we make site visits. A best practice approach would be to err on the side of caution and conduct onsite pre-compliance EMC tests for machinery, even if it could possibly fall within the fixed installation definition. 

The CE marking is a visible sign that a machine comes with all the relevant standards ad Directives. It is therefore vital that machinery owners understand both their responsibilities and those of their machine’s manufacturer. 

While understanding how to apply the vast range of standards and directives is complex, it is essential to get right to ensure that the CE marking is correctly applied. Without it, machinery owners could be facing the risk of prosecution or their employees injured by non-compliant machinery.

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