Categories 8 and 9 in the WEEE Directive covering medical, and monitoring and control equipment are currently excluded from the scope of the RoHS Directive but it is the intention of the European Commission to bring these categories within scope if possible. Dr Paul Goodman provides an overview of progress on the study being carried out by ERA for the EC to provide the data to establish if this is possible.

Article 6 of the RoHS Directive (2002/95/EC) requires the European Commission to present proposals for including categories 8 and 9 equipment in the scope of the RoHS Directive. This statement implies that there is a clear intention to include these categories at some time in the future and the European Commission has asked ERA to review these categories (see press release). This investigation will provide the data and information that the Commission will need to prepare proposals which will be submitted to the European Parliament and Council who will act in co-decision to amend the RoHS Directive if appropriate.

The scope of the ERA review is very broad as all aspects of category 8 and 9 equipment are being investigated. This includes determining the quantity of these products placed on the EU market annually and the quantities of RoHS restricted substances that they contain, and determining why these substances are used and what alternatives are currently available. Where no substitute is available, exemptions will need to be considered although it is clear that a long list of new exemptions would not be acceptable.

The impact of inclusion of these categories in the scope of RoHS on manufacturers and users needs to be assessed. Many manufacturers of category 8 and 9 products are already carrying out trials using lead-free solders but changing to “lead-free” is not straightforward for producers of some types of equipment. The increased rate of component obsolescence currently being experienced by many manufacturers is a cause for concern, as these obsolete components will usually contain lead. Category 8 and 9 product manufacturers can currently use these parts but would not be able to if they are within the scope of RoHS. Where category 8 or 9 products are re-designed every 3 – 5 years this a less serious problem, but many category 8 and 9 products are sold in relatively small numbers and designs may remain unchanged for 10 years and more.

Reliability is important for many types of products within these categories. Premature failure of medical equipment could at worst be fatal but there is always a risk to patients if unexpected breakdowns occur. For example, interruption of cancer treatment, which must be carried out according to a pre-set plan, could affect the chances of a full cure. Monitoring and control equipment is also used in safety critical applications, for example smoke and carbon monoxide detectors are relied on to prevent deaths from fires and poisoning respectively. The potential implications on reliability will therefore need to be carefully considered.

Many types of category 8 and 9 products must be re-qualified if even small changes are required as a result of RoHS and this can be both time consuming and expensive.

Scope is another issue that will need to be clarified. Many manufacturers are unclear whether their products are within the scope of WEEE and RoHS. Also, some manufacturers are finding that WEEE scope is being interpreted differently in different EU Member States. This is very confusing for manufactures but, as WEEE is an Article 175 Directive, this some variation between EU States is permissible. RoHS, however, is an Article 95 Directive (single market) and so scope and its interpretation should be the same in all EU States.

The impact on innovation has also been highlighted. The effect of RoHS is that researchers and designers do not consider using the RoHS restricted materials for new products and this clearly restricts the options available and, in certain cases, could prevent the development of new and better technology in the future as most manufacturers would avoid these materials. Requesting exemptions will not be an option in most cases as this is both slow and uncertain. The implications of this restriction in innovation are potentially serious. For example, advances in medical technology clearly improve health and the ability to cure illness but restricting the choice of materials that could be used could potentially limit these improvement. It is impossible today to predict what new discoveries would be made in the next 20 or 30 years if researchers were free to use all possible materials.

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