European Union technical guidance document

Table 19.4 Summary of the Main Areas Covered by Chapter 4 of the European Union Technical Guidance Document... 

The European Union System for the Evaluation of Substances (EUSES) [8] is the software provided by European Chemical Bureau (ECB) to implement the EU Technical Guidance Documents on Risk Assessment for new notified substances, existing substances, and biocides [3]. The development of EUSES 2.1 was commissioned by the European Commission to the National Institute of Public Health and the Environment (RIVM) of the Netherlands. The work was supervised by an EU working group comprised of representatives of the JRC-European Chemicals Bureau, EU Member States, and the European chemical industry. 

Currently there is relatively little guidance for the use of QSARs to predict the toxicity and fate (especially in the environment) of chemicals. Some guidance is provided within the European Union (EU) where a comprehensive technical guidance document (TGD) was produced to support the Directive on New Substances and the Regulation on Existing Substances (European Economic Community, 1996). This document includes a substantial chapter providing guidance on the use of QSARs in environmental risk assessments. 

Exposure assessment involves the specification of values for parameters, either for direct determination of the exposure or as input for mechanistic or empirical or distribution-based models that are used to fill the exposure scenario with adequate information. Numerical values for exposure parameters are obtained using various approaches, such as the USEPA s Exposure Factors Handbook (USEPA, 1997a), the European Union s (EU) Technical Guidance Document (EU, 2003), the German XProb project (Mekel, 2003) and the European KTL s ExpoFacts (Vuori et al., 2006). 

EU (2005) Work Package 1. Development of the concept of exposure scenarios. General framework of exposure scenarios. Scoping study for technical guidance document on preparing the chemical safety report under REACH, final report. European Union, European Chemicals Bureau (REACH Implementation Project 3.2-1A Lot 1 Commission Service Contract No. 22551-2004-12 FISC ISP BE ... 

The European Union (EU), like the US EPA, supports the use of QSARs for screening new chemicals. The EU s Technical Guidance Document provides extensive guidance for the use of QSARs (see Further... 

EU TGD, 1996 (updated in 2003). Technical Guidance Document in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EC) No. 1488/94 on risk assessment for existing substances. Office of Official publication of the European Union. ISBN 92-827-8011-2. 

EU (2002b) Human exposure to biocidal products. User guidance version 1. Annex 4 in Technical notes for guidance Human exposure to biocidal products—Guidance on exposure estimation. Ispra, European Union, European Chemicals Bureau, 76 pp. (http //ecb.jrc.it/Documents/Biocides/TECHNICAL NOTES FOR GUIDANCE/TNsG ON HUMAN EXPOSURE/Users guidance to Report 2002.doc). 

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