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January 16, 2014

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Beware the CE Mark: it’s no guarantee of safety

 

Equipment used in the EU has been CE Marked since 1995. It’s supposed to be a sign of quality and safety, but that’s not always the case.

Phil Chambers BSc CMIOSH, Strategic Safety Systems Ltd

Some people facetiously say that CE stands for “Check Everything”.  Unfortunately, there is some truth in this.  While the intention is to indicate that the equipment meets certain safety standards, there is no absolute assurance that this is so.

CE Marking applies to all equipment supplied for first time use in the EU after 1 January 1995.  The organisation that introduces the machine into the EU is accountable for the process.  Normally, this would be the manufacturer, but agents or importers would be accountable for equipment that originates outside the EU.

Though we normally think of the process as being applied to new machines, it also applies to old machines if they were introduced into the EU after January 1995. Similarly, though it is intended to ease trading, it applies even if the equipment is for self-use. This is particularly tough on companies who produce specialised equipment to use themselves and would never sell it onwards.

So who polices CE Marking? The short answer is nobody. Apart from specific machinery listed in Schedule Two Annex IV of the regulations, there is no organisation that either certifies the machine, or licenses the supplier as being able to certify their machine. There are some good reasons why this should be so, but be aware that you are essentially trusting on the supplier on their word. Unfortunately, there is great variation in the knowledge and abilities of different suppliers and a CE label is no indication that the machine is safe.

Where does the buck stop?

It is the employer who has the final accountability for ensuring that the equipment is safe. Take the case of the London Borough of Tower Hamlets vs. HSBC Bank plc. The printing operations of HSBC bought a brand new Spanish press, which was CE Marked and which they believed to be safe. There was an accident and HSBC were prosecuted; the manufacturer was not.

The legislation driving this is the Machinery Directive, or the Supply of Machinery (Safety) Regulations, which enacts the directive in the UK.

According to the Regulations, the manufacturer must:

1.     design and build the equipment so that it complies with appropriate Essential Health
and Safety Requirements (EHSRs) and Harmonised European Standards (HESs);

2.     assess the equipment for conformity with EHSRs and HESs;

3.     be able to compile a technical file proving conformance;

4.     draw up a declaration of conformity and affix the CE mark to the equipment. 

Where the equipment is part of an assembly, step four is slightly different.

What goes wrong?

In my experience, the key problems arise from the appropriate EHSRs and HESs not being followed. The key points to look for are:

1. Gross non-conformities

On a machine I viewed recently, there was a finger crush point (capable of causing injuries requiring amputation) right next to a handle, scissor lifts had no protective edge trips and could shear a foot, a platform was of insufficient length and had incomplete guard rails and there was insufficient fixed guarding.  None of these were difficult or expensive to control and one is rather puzzled as to why they had not been controlled at source.

2. Minor non-conformities

Some of the standards include requirements which have the best of intentions but may be difficult to incorporate.  In other cases, compliance with the standard may actually increase the risk.  These need to be assessed and the supplier should state where exceptions have been made.

3. Lack of awareness

An example I see quite often arises from how the safety related control system works.  A typical fault is not following EN 13849 Safety Related Parts of Control Systems. Unfortunately, this is not structured in a way that makes it easy to follow.  

What tends to happen is that people fit high reliability interlocks and then use them as an input to the PLC, which is therefore outside the control of the high integrity system. The arrangement is not precluded by EN 13849, but the supplier must go to some lengths to prove that this arrangement is safe. Surely everyone has experienced computer crashes or situations where programs freeze and one can anticipate situations where the safety functions are suspended because the software is busy elsewhere. I actually know of an injury that was caused by just this situation.  An easier and far better arrangement is to have the safety related control system downstream of the PLC.

What should the purchaser do?

The purchaser needs to take two main actions:

1. Include clear specifications in your order, including statements that the safety related control system must be downstream of the PLC. One company that I work with has a set of specifications to which the supplier must adhere. You might consider a clause where you hold back final payment until it has been checked and any faults corrected.

2. Be aware that when equipment arrives, the presence of the CE mark does not necessarily mean it is safe.  You must carry out a thorough risk assessment. Where there are major faults, then you could take this up with the supplier; they are the ones who should supply equipment which is fit for purpose.

 

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Martin WhiteWayne JonesRussell loveridgeJavierDavid Dyer Recent comment authors
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Javier
Javier

I fully agree with what the article highlights and would propose the Machinery Directive be amended to read that the manufacturer shall make available to the purchaser a copy of the technical file or if trade secret or confidentiality issues are at a stake have an independent body certifying compliance.

Prevention-through-design is paramount.

Russell loveridge
Russell loveridge

May be this is a wake up call –

CE marking is a declaration by the producer that in their opinion the product meets the requirements and so can be sold within the EU. Not all CE marked products have the involvement of an independent certification body, and those that do may only have a low level of attestation.

Maybe a more appropriate meaning of CE is Caveat emptor – buyer beware!

Wayne Jones
Wayne Jones

The HSE should review the regulations, standards and guidance available and update it into simple formats for purchaers to abide by and to assist them in determining what their purchasing poilicies cover. I think simplified information would also assist installers, particularly where machinery is linked or integrated…how many would be fooled by the control systems not being downstream of the PLC ?

Alex Howard
Alex Howard

Hmm! So, as I understand it, ignore what CE is supposed to signify and ensure that your specification and your risk assessment is robust enough to make the item ‘safe to use’.

I do like the advice about retention of final payment until any faults discovered are remediated. I shall be passing this article onto some of my procurement personnel

Bob Bowman
Bob Bowman

See this – there are many other references to the ”other CE’ if you Google. Anyone got an opinion?

http://www.icqc.co.uk/en/china-export.php

David Dyer
David Dyer

My business purchased a circular saw for cutting steel bar to length from a UK company who imported the product from China, via Germany. The machine arrived on the Monday with inadequate interlocks, free access to the blade, no protection from crush injuries on the load table to name but a few of the uncontrolled hazards. It took some fabrication and a week of not only the time of the supplier but mine and the Engineering Mangager to put things right. The CE mark and certificate of conformity was signed off in Germany, was for a different product with a… Read more »

Martin White
Martin White

The major point that the article misses is that the end user (HSBC in the example) has the obligation to carry out a PUWER assessment before first use, and at regular intervals afterwards. It would have been most likely PUWER (or perhaps offences under the Health and Safety at Work Act) rather than contravention of the Machinery Directive or non conformance with EU standards.