4. The Proposed EC Biocides Directive — a contentious use of risk comparisons

The draft Directive on biocides sets up a harmonised system of control over the placing on the EC market of a wide range of products - from household detergents to industrial rodenticides and anti-fouling agents - based on an assessment of the risks they pose to human health and the environment. A revised proposal incorporates an annex containing a framework of common principles upon which member states can base decisions to authorise products (EC, 1995).

One proposal in the Directive that has provoked intense opposition is "comparative assessment". The debate is significant because the Biocides Directive would be the first to enshrine this concept. The Directive would allow the inclusion of an active ingredient to be refused "if there is another active substance ... for the same product type or another method of control exists, which in the light of scientific or technical knowledge presents significantly less risk to health or the environment." The principle of substitution based on comparative analysis has long been supported by the Scandinavian States. At the Environment Council in December 1994, seven Member States - Belgium, Denmark, Germany, Austria, the Netherlands, Finland and Sweden - entered a statement in the minutes asserting their belief that "by comparative assessment as proposed in the Commission proposal ... it is possible to reach a high level of protection of the environment and health respecting the economic and practical consequences for the user." The French and the UK oppose such comparative assessment.

The Swedish Experience

In Sweden a review of all biocides on the market was initiated in 1990. Products for particular applications are assessed simultaneously, enabling regulators to take a holistic view on the comparative risks of substances and their impact of their withdrawal from the market. Sweden recognises the limitations of comparative assessment. The differences in risk must be significant to make a comparison justified, and comparative assessment cannot be used where a substance poses less risk in one area but the alternatives pose less risk in others. The Swedish recognise that the economic and practical costs to the user must be considered.

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