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Machinery CE marking: beware the pitfalls

28 February 2016

While CE marking may appear to be one of the simpler European Union requirements to get right, it is in fact one of the most misunderstood. Neil Dyson reports.

It is a common assumption that if machinery has the CE marking, no further action on the purchaser’s part is required, but the CE marking is not proof of machinery safety. Likewise those manufacturing machinery often assume that if its component parts carry the CE marking, then the entire machine complies with CE marking requirements – this is not the case.

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. The DoC is a formal statement that a machine complies, and it must be signed by the responsible person within the organisation. As the responsible person and signatory, they may be subject to prosecution if the equipment is found not to comply. 

The DoC must include the name and address of the manufacturer (or their authorised representative); a description of the product, including type, model and any other information that clearly relates the equipment to the Declaration; reference to the standards applied, and identification of the signatory.

Technical file
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:
ia list of the essential health and safety requirements (EHSRs) which apply to the machinery,
iithe 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”.

Changes to machinery
The existing DoC may become invalid if any substantial changes are made to machinery. This could include upgrades to existing machines. Even if the machinery was originally compliant with CE marking when it was first purchased and put into service, any changes could necessitate a new CE marking conformity assessment. 

But how do you know if the modifications that you have made will be considered substantial by the regulatory authorities? There are two key areas of guidance to help you.

The first is the UK’s Health & 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. These include the following instances:

- 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 is 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.

Many assume that if each individual electrical or electronic component in a machine carries the CE marking to the EMC Directive, then the entire machine will also meet EMC requirements. However, that is not necessarily the case. 

Consider a variable speed drive that produces a level of electromagnetic interference about half of that acceptable under the regulations. Clearly, there is no problem in stating that this drive complies with the regulations. However, if you put four of those drives on a machine, is it reasonable to assume that the machine complies with the regulations, simply because each of the drives is compliant? The machine may be compliant, especially if measures to control EMC have been incorporated in its design, but the point is that it cannot be assumed to be compliant.

Machine builders that assume that all that they have to do to meet the requirements of the EMC Directive is to use components that carry CE marking are following a dangerous route. As there is no shortcut to achieving compliance with the EMC Directive in order to meet legislative requirements and ensure safety, machines must be thoroughly tested. 

End-user protection
The Provision and Use of Work Equipment Regulations 1998 (PUWER) applies to all equipment regardless of its age, including equipment that carries the CE marking. It describes what an employer needs to do to protect employees in the workplace. It is the employer’s responsibility to ensure that all machinery meets the requirements of the Machinery Directive and PUWER.

End-user companies should therefore undertake as risk assessment before new machinery is used. 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 or PUWER. Software has been designed for machinery compliance risk management, taking much of this headache away, but it is essential that it is the latest version that reflects current legislation. 

Getting it right
The CE marking is a visible sign that a machine comes with all the relevant standards and Directives. It is therefore vital that machinery manufacturers, builders and owners understand how to apply the vast range of possible relevant standards and directives to machinery. This will ensure both compliance and the saleability of equipment destined for the European market. 

Neil Dyson is with TÜV SÜD Product Service

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