PARENT SESSION

(05-01) Environmental exposure and effects assessment in the new Technical Guidance Document on risk assessment of chemicals.

Payá-Pérez, Ana^*,1, Loonen, Helene², De Bruijn, Jack¹, Pedersen, Finn¹, ¹ EC Joint Research Centre, Ispra (Va), Italy² Chemin des Escassiers, La Bouilladisse, France

ABSTRACT- The evaluation and control of risks of chemical substances occupies a prominent place on the current agenda of the EU Environment Council of Ministers, recognising that "the new chemicals policy must develop streamlined, pragmatic and effective procedures to overcome the present lack of knowledge about the properties, use and exposure of existing substances as well as the slow pace in the development of risk assessment and risk management measures...(Environment Council Conclusions of 7 June, 2001)". The development and harmonisation of risk assessment methods is the key for a successful risk management, therefore the European Chemicals Bureau initiated in year 2000, in co-operation with Member States, CEFIC/ECETOC, NGOs (WWF) and OSPAR (Marine Risk Assessment) the revision of the Technical Guidance Documents (TGD) in support of the Commission Directive 93/67/EEC on risk assessment for new notified substances and the Commission Regulation (EC) 1488/94 on risk assessment for existing substances, and on Directive 98/8/EC concerning the placing of the biocidal products on the market. The revision process is almost finalised, and widely varying aspects of the risk assessment are under discussion, including both aspects from the exposure assessment as well as the ecotoxicological effects assessment. New emission scenarios, release estimations, and predictive models for the elimination processes have been developed. The release to the environment from waste water treatment plants, or via waste disposal have been revised. The new concept on "unintentional" releases has been introduced and guidance given. The strategy for effects assessment for sediment and soil organisms has been improved, and new guidance for the calculation of the Predicted No-Effect Concentration (PNEC) using statistical extrapolation techniques is given. Major challenges were the inclusion of an approach for the risk assessment of biocides. In this paper the main features of the environment risk assessment methodology will be described and discussed.

Key words: new and existing substances, biocides, risk assessment, environment