PARENT SESSION

(05-09) A Pragmatic Risk Assessment Approach .

Feijtel, Tom^*,1, Comber, Mike², Holt, Martin³, Jacobi, Sylvia⁴, Koch, Volker⁵, Lecloux, André⁶, Money, Chris⁷, Penman, Mike⁷, Veenstra, Gauke⁸, De Rooij, Christ⁹, ¹ Procter & Gamble, Eurocor, Strombeek-Bever, Belgium² AstraZeneca, Brixham, United Kingdom³ ECETOC, Brussels, Belgium⁴ Degussa, Hanau-Wolfgang, Germany⁵ Clariant, Sulzbach am Taunus, Germany⁶ Eurochlor, Brussels, Belgium⁷ ExxonMobil, Machelen, Belgium⁸ Shell, London (Waterloo), United Kingdom⁹ Solvay, Brussels, Belgium

ABSTRACT- Industry fully supports the objectives of the EU White Paper i.e. protection of human health and environment, and agrees with the Commission's proposal to develop a risk-based decision framework. The success for the implementation of any pragmatic risk-based approach will largely depend on the ability to focus resources on the chemicals of concern and the generation of appropriate data. The need for data should be proportional to the needs of the risk assessment and should allow for the minimisation of animal testing, such that only tests essential for decision-making on use and control are conducted. Although the entire process is complex and several issues need to be considered in more detail, ECETOC has developed an initial concept for a transparent, flexible and pragmatic approach for Risk Assessment. The general concept starts from the premise that pending on the degree of hazard and exposure, different information requirements will be needed to demonstrate safe and responsible production and use. This approach allows low hazard or low volume/exposure substances of no concern to be put aside without the need for executing a risk assessment, and then focus can and will be placed on substances and exposure scenarios of concern. This presentation will cover both the general elements as well as some practical illustrations of the concept.

Key words: Environment, Risk assessment, Human health, Exposure