European Union Directive guidance documents

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. 

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 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. 

---