Assessing risks--challenges posed by the European general product safety directive.
The concept of risk appears in a prominent way in the recently revised European Directive on General Product Safety (GPSD). Risk assessment is therefore an important tool for the success of the Directive; the question is how risk assessment should be carried out in a systematic manner in order to meet the aims of the Directive. In this paper, the references in the GPSD concerning the concept of risk are reviewed and compared with reported problems in European risk assessment. Existing guidelines for risk assessment are examined in order to determine what factors determine the consistency of the outcome. This leads to recommendations for a process that could be followed in order to make risk assessment successful in the context of the GPSD. On the basis of existing guidelines for risk assessment, criteria are formulated with which methods of risk assessment should comply. A stepwise process is proposed in order to develop a common method of risk assessment that can be applied in Europe to support the GPSD. The requirements for risk management in the new GPSD are rather abstract and lack specification, both for producers and for enforcement authorities. The Directive further refers to the need to develop non-binding guidelines in due course. Sources of different outcomes of the risk assessment process are outlined in this paper as well as possibilities to achieve a more consistent basis for decision, more uniformity and transparency. These are essential conditions if one wishes to avoid both undue trade barriers and unsafe products on the market. A leading role for the European Commission seems necessary to make sure that the intentions of the GPSD are accomplished.
van Aken
Dirk
D
Consumer Safety Institute, P.O. Box 75169, 1070 AD Amsterdam, The Netherlands.
D000056:Accident Prevention; D003257:Consumer Product Safety / Q000592:standards*; D005062:European Union; D019983:Guideline Adherence / Q000592:standards; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D017064:Process Assessment, Health Care / Q000592:standards; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000592:standards*