Technical guidance document European

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

Technical Guidance Document 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, European Commission, 1996. 

Finally, in the risk characterization step, the PEC/PNEC quotient that defines the risk of the substance in the environment is calculated. If the quotient (PEC/PNEC) is less than 1, the substance do not present risk to the environment. More information is available in the European Commission Technical Guidance Document on Risk Assessment [3] and in the United States Environmental Protection Agency s Guidelines for Ecological Risk Assessment [6]. 

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. 

Institute for Health and Consumer Protection (2003) Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances Commission Regulation (EC) No 1488/94 on risk assessment for existing substances Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market... 

This chapter uses the formal EU risk assessment methodology laid down in the European Commission Regulation (1488/94) and follows closely the principles of the technical Guidance Document [1] of the Existing Substances Regulation (793/93). 

Institute for Health and Consumer Protection - European Chemicals Bureau Technical Guidance Document on Risk Assessment, European Communities 2003 Ibid., Part 1, p. 10... 

EC (1996) Technical guidance document in support of the Commission directive 93/67EEC on risk assessment for new notified substances and Commission regulation 1488/94 EEC on risk assessment for existing chemicals. Brussels, European Commission. 

ECB (2003) Technical Guidance Document on Risk Assessment, European Chemicals Bureau, Ispra. 

The appropriateness of the risk assessment methodology in accordance with the Technical Guidance Documents for new and existing substances for assessing the risks of nanomaterials, European Commision, Scientific Committee on Emerging and Newly-Identified Health Risks,... 

European Commission. 1996. Technical guidance documents in support of Directive 93/67/ EEC on risk assessment of new notified substances and regulation (EC) No. 1488/94 on risk assessment of existing substances (Parts I, II, III, and IV). No. CR-48-96-001, 002, 003, 004-EN-C. Luxembourg Office for Official Publications of the European Community, 739 p. http //ecb.jrc.it/DOCUMENTS/TECHNICAL GUIDANCE DOCUMENT/EDITION l/tgdpart4.pdf (accessed December 28, 2007). 

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. 

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

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 ... 

Technical Guidance Document and Water Framework Directive approaches EU member state, North American, and other international approaches) and the way in which they are implemented (e.g., mandatory pass or fail probabilistic, e.g., 95th percentiles or tiered risk assessment frameworks). Soil and water standards were considered, as were values for the protection of human health and the natural environment. The focus was on European regulatory frameworks, although expert input was sought from other jurisdictions internationally. Chemical standards for aquatic (water and sediment) and terrestrial (soil and groundwater) systems were the main focus for the meeting. This workshop built on, and included some participants from, a 1998 SETAC workshop Re-evaluation of the State of the Science for Water-Quality Criteria Development (Reiley et al. 2003). 

An emission factor is defined as a constant that relates the intensity of an activity to an emission (OECD 2002a). Emission factors can be used to estimate releases from nearly any source that generates emissions with a strong proportional dependence on the extent. Emission factors are used for specific cases where no release information is available, or if the release is only given for 1 specific compartment. The complementary release estimates can be obtained using the OECD approach or from the European Technical Guidance Document (ECB 2003a). The release of a chemical to an environmental compartment a is calculated as... 

EC. 2003. Technical guidance document on risk assessment. Ispra (IT) European Chemicals Bureau (ECB), Institute for Health and Consumer Protection, European Commission, Joint Research Centre. 

---