PARENT SESSION

5B a - RA: Ranking and Chemical Specific
Hall 6
8:30 AM - 12:30 PM, Tuesday, 29 April 2003
Co-chair: Loonen, H.¹, McCarty, L.², ^{1 2}

(TU6/1) Major changes in the revised EU TGD for risk assessment and its use under REACH.

Loonen, Helene¹, de Bruin, Jack¹, Hansen, Bjorn¹, Kaland, Toralf², Paya Perez, Ana¹, ¹ European Chemicals Bureau, Ispra, Italy² Norwegian Pollution Control Authority, Oslo, Norway

ABSTRACT- The EU Technical Guidance Document (TGD) for the risk assessment of new and existing chemicals has been revised to accommodate recent scientific and technical developments and to address the practical experiences gained with the risk assessment of industrial chemicals. The revision was done through a number of working groups with participation of experts from the EU Member states, Industry and NGO's. Revisions have been made in a wide variety of areas. Major changes include the new guidance for the risk assessment of biocidal active substances, and new guidance for marine risk assessment including a PBT assessment. Furthermore changes were made to the environmental exposure assessment, the ecotoxicological effects assessment and the testing strategy. For the environmental exposure assessment the guidance was expanded with respect to the use of measured environmental concentrations, estimation of emissions during the later stages of the life cycle (during service life of articles and waste disposal), and assessment of "unintentional" sources. Major changes in the ecotoxicological effects assessment include the guidance on the use of statistical extrapolation techniques and expanded guidance for the derivation of the PNEC for sediment, the terrestrial environment and top predators. Whereas most of the revisions result in expanded guidance, other changes may have a direct impact on either the PEC or PNEC and hence on the outcome of the risk assessment. Special attention will be given to these minor changes with direct impact on the outcome of the risk assessment. Furthermore the use of the TGD principles under the new chemicals policy (REACH) will be discussed.

Key words: technical guidance document, risk assessment