() The new European Technical Guidance Document on Risk Assessment and its use under REACH.
Loonen, H.1, Hansen, B.G.H.2, Bruijn, J.1, Paya-Perez, A.1, Kaland, T.3, Munn, S.1, 1 European Chemicals Bureau - European Commission, Ispra, Italy2 DG Environment - European Commission, Brussels, Belgium3 Norwegian Pollution Control Authority, Oslo, Norway
ABSTRACT- The EU Technical Guidance Document (TGD) on the risk assessment of chemical substances is the official reference for the preparation of comprehensive risk assessment reports following the current EU legislation. The TGD 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 coordinated by the European Chemicals Bureau and with participation of experts from the EU Member states, Industry and NGO's. Revisions have been made in a wide variety of areas. The major revisions in the chapter on environmental risk assessment include new emission scenarios, release estimations and predictive models for the elimination processes. In particular new approaches to estimate the releases to the environment from products with a long life-time and via waste disposal have been introduced. The strategy for the effects assessment for sediment and soil organisms has been improved as well as the section on risks of chemicals through food-chain accumulation. New guidance is given for calculating the PNEC using statistical extrapolation techniques. An entire new approach was developed with experts from OSPAR on how to perform a risk assessment for the marine environment. This section includes a PBT assessment, which is particularly developed to take into account the high uncertainty in predicting reliable exposure and/or effect concentrations hampering quantitative risk assessment. 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 (sometimes-small) changes with direct impact on the outcome of the risk assessment. Furthermore the use of the TGD principles under the new European chemicals policy (REACH) will be discussed.
Key words: chemicals legislation, risk assessment