ERA is helping customers to identify and understand the risk assessment issues involved with compliance to many CE Marking Directives. Conventionally, these Directives do not always explicitly address the issue of risk assessment, but industrial worker and consumer protection legislation is changing that scenario.

Risk assessment is already a requirement in some CE Marking Directives, such as the Machinery Directive, and is likely to be brought into the revised Low Voltage Directive (LVD) as the first essential requirement when republished in the next few years. Manufacturers and suppliers of products included within the scope of CE Marking Directives need to ensure that appropriate risk assessment is undertaken, to manage compliance throughout the life of their equipment.

Currently many existing CE Marking Directives indicate that authorities are to accept that if a product complies with a relevant harmonized standard then there is a "presumption of conformity" to that Directive. However, newer Directives give risk assessment as the first stage in compliance, and that the safety requirements then to be applied must be based on the actual risks posed by the product in its intended use and foreseeable misuse.
Thus the applicable safety requirements may not necessarily be just the application of harmonised standards (or at least not the current versions of many such standards), and may in fact be a combination of:

	harmonized standards
	non-harmonized standards
	other requirements appropriate to particular risks, often known as "derived safety requirements."

Some harmonized standards (notably some Machinery Directive equipment standards) do include risk assessment requirements, based around those in EN 292 (now being replaced by EN ISO 12100) and EN 1050. Even so, the risks that are identified in these standards may not address all the possible risks from the product. The risks listed in these standards are somewhat prescriptive as opposed to being based on techniques like the widely used 'HAZOPS' approach, which addresses issues from a broader perspective.

In particular, the majority of current LVD harmonized standards do not include explicit risk assessment requirements, and therefore would have to be amended to include them. Given the number and extent of these standards, the work involved would be substantial. The risk assessment will therefore remain the responsibility of product manufacturers for some time to come.

In some situations electronic products may operate, or may cause other equipment to operate, incorrectly. This may cause hazards as a result of electromagnetic compatibility issues, even though the items in question comply with nominally applicable EMC standards. This is particularly relevant when products designed for one environment are to be operated in locations where the EMC environment is considerably different, for example:

	'domestic and light commercial' equipment used adjacent to electrified railway lines and associated systems
	'light commercial' environment areas are located adjacent to high power motor systems (eg. in offices next door to lifts and elevators)
	'industrial' environment equipment located in light commercial areas (eg. small industrial estates adjacent to private housing)

In these situations, EMC-related risks cannot necessarily be addressed merely by compliance with standards, and the required risk assessments must take into account the actual EM interactions that could occur. These situations require suitable combinations of both safety and EMC assessment skills to be applied and call for the use of personnel experienced in both risk areas.

The WEEE and RoHS Directives became EU law last February and are planned to become UK law later this year. WEEE requires producers to pay for disposal of many types of electrical products. RoHS restricts the use of six substances in most of these products and in particular of lead solder. Further environmental legislation, including the Energy using Products (EuP) Framework Directive, is on the horizon concerning the whole life environmental impact of such equipment in terms of the total amounts of energy and materials required to build, operate, maintain, repair and dispose of them. All these requirements are complicated by the current lack of relevant reference standards and methodologies for designers and manufacturers to apply.

John Allen, Compliance Consultant at ERA, explained: "Taken together, these Directives present risk to companies who do not understand them or plan for compliance early enough. Conversely, if approached correctly, they offer an opportunity to increase market share, improve product design and reduce costs. They affect the electrical and mechanical design of products, and steps need to be taken to maximise the opportunities and minimise the risks."

On 21 September 2004, ERA will be running a new 'Regulatory Compliance Management' training course. The event will assist manufacturers, importers and distributors to understand the general legal and CE Marking requirements applicable to their operations. The course programme includes EU Directives and CE Marking, regulatory compliance management strategies and tools for regulatory compliance support.

For further information about this event, please e-mail: events@era.co.uk

About ERA Technology
ERA Technology works at the leading edge of many advanced technologies. The business was founded in 1920 and today provides specialist, high value-added, technology-based services including design and development, testing, assessment and expert advice.

The company has built an international reputation for technical expertise through constant innovation at the leading edge of technology. ERA provides technology-based services across industries such as communications, aerospace, defence, IT, manufacturing, transport, electronics and energy.

ERA Technology is a Chelton Group company, part of Cobham plc.