Safe or sorry

The idea of allowing manufacturers to certify their own products as safe seems an odd concept to many people. The system does work, however, and with the appropriate checks and balances, forms the basis of the well known and respected CE Marking.

The CE Mark is the cornerstone of product standards in the European Union and serves a number of roles. It acts as a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection laws. It is also a form of passport for the product, as it is illegal to sell product in Europe which does not carry the CE Mark. It also allows free movement of the product in Europe.

But the vast majority of CE-Marked products have never been seen by an official government inspector. Most are simply declared by their manufacturers as conforming to the relevant standards and placed on the market in a process known as self-certification. How safe is this and can such products really be trusted by the buyer of industrial machinery?

CE Marking

To obtain the right to put the CE Mark on its products, a manufacturer must first decide which of the many European Directives apply to it. For instance, an electrically driven pump will need to comply with the Machinery Directive, the Low Voltage Equipment Directive, the Electro-Magnetic Compatibility (EMC) Directive, and possibly the Explosive Atmospheres (ATEX) Directive.

Certain categories of equipment, such as pressure vessels, must be certified by a Notified Body - a government or private testing house recognised by the EU. This is both expensive and time consuming, and most products can follow the self-certification route to compliance with the Directives.

The various Directives specify what are termed 'essential requirements' - the broad expectations that the EU demands. For example, the ATEX Directive states that: 'The materials used for the construction of equipment and protective systems must not trigger off an explosion, taking into account foreseeable operational stresses.'

In assessing the prototype product, the manufacturer should carry out a risk assessment of the design, to determine if there is a risk of it creating a hazard that would see it failing to meet the essential standards. To design out these hazards, the manufacturer needs to refer to the relevant European EN standards. These give the approved methods of meeting the requirements.

For example, the Machinery Directive demands that a pump should not injure people during its normal operation. The EN294 standard will give details of the approved aperture sizes in a grill covering the cooling fan that will prevent people getting their fingers into the pump.

Does self-certification work?

Once the maker is satisfied that the product conforms to all relevant regulations, he can attach the CE Mark sticker and place the product on the market. But will the manufacturer actually carry out these tests?

The answer is we must trust them to do so. Certification and conforming to the Directives is a legal obligation, just as we are all bound to abide by the law in our private lives. We don't have a policeman watching our every move, but we still abide by the law because there are serious legal consequences if we don't. But what guarantees does the buyer have that the product is really up to scratch?

As well as CE Marking, the manufacturer must supply a Declaration of Conformity and a manual with each product. The Declaration of Conformity is a vital document that details which Directives the product conforms to, the standards it is based on and the name and address of the manufacturer. It ensures that the buyer can see exactly what the product is intended to do, and what it cannot do.

Also, it is signed by a named individual who will be held legally responsible for any accident caused by the product while it is being used in the approved manner. No responsible person facing the prospect of a hefty fine or jail term would sign such a document if they were not entirely sure that it was correct and legitimate.

Few people realise that self-certification has been the norm in the UK for a long time. In the days before Declarations of Conformity were required, there was no clear delineation of responsibilities and manufacturers and purchasers could become embroiled in lengthy disputes about what standards the product conformed to and who was responsible for any additions or alterations to the purchased item. The Declaration of Conformity may be the single biggest improvement in UK product safety standards.

Improving safety

The manufacturer must also maintain a Technical File on the product, which must be submitted to the Health and Safety Executive on demand. The Technical File contains details of risk assessments carried out, details of designs, calculations and tests performed and any relevant test certificates. In the event of an accident, the HSE uses the Technical File to see whether the manufacturer has done what he should to make the design safe.

The HSE has tended to advise against taking the CE Marking as sole proof, recommending that companies check for themselves that the product has been properly tested. This need not mean doing all the relevant checks again, but buyers also have a responsibility for safety. They should check the Declaration of Conformity, something that many people don't even realise they have, and familiarise themselves with the Directives it lists and the standards they refer to.

Knowing how the product was designed, and what its limitations are, will help the buyer when he comes to draw up his own risk assessment.

Few companies would want to see the introduction of compulsory third party testing for all products, with all its attendant expense and bureaucracy. Self-certification works and it is in manufacturers' interests to ensure that it does.

Martin Keay advises on safety matters for Reed Exhibitions, whose TOTAL 2004 show, which will cover self-certification, will be held at the NEC from 29 March - 1 April 2004. The exhibition combines Eurochem, Interphex, Pakex and the PPMA Show.