EC approach to environmental risk assessment of new substances

The Directive which lays down the principles for the assessment of the risks to man and the environment of new chemical substances specifies four distinct stages in a risk assessment: hazard identification, dose (concentration)-response (effect) assessment, exposure assessment and risk characterization. The central principle is that risk is dependent upon the likely extent of exposure to a substance as well as its inherent hazardous properties. An assessment should lead to one (or more) of four conclusions: that a substance is of no immediate concern, that risk reduction recommendations should be made, that additional information should be obtained immediately or that additional information should be obtained at a later stage. Additional information can be used to revise an assessment and to confirm indications of a given risk.