Technical guidance document chemical risk assessment

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. 

It is not possible to achieve "adequate control" of the risks of persistent, bioaccumulative chemicals. The fact that traditional risk assessment cannot reasonably be applied to such chemicals, and that a revised PBT (persistent, bioaccumulative, toxic) assessment is necessary, is explicitly recognised in the EU s Technical Guidance Document for risk assessment. Their intrinsic properties mean that there is a high risk of exposure at sometime during the lifecycle of the chemical or the article that contains it. Even small releases, if they are continuous, can result in significant exposures. This is why we see significant and, in some cases, escalating levels of brominated flame retardants, nonylphenols and other persistent chemicals in breast milk, umbilical cord blood and human tissue. 

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

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

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. 

ECB. 2003a. 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. Part II. Environmental risk assessment. Ispra (IT) European Commission-Joint Research Centre, Institute for Health and Consumer Protection, European Chemicals Bureau (ECB), Chap 3, Appendix 1. 

The annex V of Directive 67/548/EEC, in the EU document, OECD guidelines for testing method for chemicals, addressing three areas of concern (i) determination of physical-chemical properties (ii) methods for determining effects on human health and (iii) methods for environmental effects. Annex lA of Directive 93/67/EEC is involved with the risk assessment of potential toxic effects concerning human health. The technical guidance document on risk assessment published by the European Commission [4], is involved with human health assessment. Analysis of hazard identification and dose-response assessment is based on the following key points ... 

ICCA - International Council of Chemical Associations, ICCA Responsible Care Report 2008, Brussels 2008 ECB — European Chemicals Bureau, Technical Guidance Document on Risk Assessment of Chemical Substances following European Regulations and Directives, European Communities, Ispra April 2003... 

According to the Technical Guidance Document (TGD) for risk assessment of new and existing chemical substances (EC 2003), smdies conducted with human volunteers are strongly discouraged as they are problematic from an ethical point of view and results from such smdies should be used only in justified cases (e.g., tests which were conducted for the authorization of a medical product or when effects in already available human volunteer smdies with existing substances have been observed to be more severe than deduced from prior animal testing). However, the potential differences in sensitivity of human smdies and smdies in animals should be taken into account in the risk assessment, on a case-by-case basis. 

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. 

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. 

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). 

Several steps have been taken towards a more harmonised methodology within the more general area of risk assessment of chemicals. The EU has proposed a number of principles for assessment of risks to man and the environment in directive 93/67/EEC (EC 1993) as well in the Technical guidance documents in support of directive 96/67/EEC on risk assessment (EC 2003), to further common practices in risk assessment. A harmonisation of national exposure limits is to be expected, since the EU sets both binding and indicative OELs for each member state to consider in its national regulations. However as noted by Vincent (1998) a full international harmonisation of OELs is unlikely and may not even be the most... 

Multi-criterion analysis is a decision-making tool for qualitative weighting of aggregated impact assessment indicators. Further information is available in the OECD Technical Guidance Document on the use of Socio-economic Analysis in Chemical Risk Management Decision-Making [510]. 

Considering European legislation, the first drafts of the Technical Guidance Document describing the risk assessment of industrial chemicals (1993-1994), and the first Guidance Documents on the environmental risk assessment of pesticides, including the publication of the technical annex of Directive 91/414/ EC (1996), represent some European milestones in the field of environmental risk assessment. 

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 (Part I, n, III and IV). The European Commission Luxembourg European Commission. The white paper on Chemical Strategy, COM (2001) 88. European Commission Luxembourg... 

The safe management of chemicals in the EU is based on the stepwise approach illustrated in Figure 23-3. In April 1996 a Technical Guidance Document was pub-lished to provide guidance on the risk assessment of both notified substances (as required under Commission Directive 93/67/EEC) and existing substances (under EC Regulation No. 1488/94) This guidance document deals with the risk assessment for human health and the environment, and covers also the use of (quantitative) structure-activity relationships. Of particular importance for the outcome of the risk assessment are the emission scenario documents, especially with respect to the default values, which will he applied if experimental data are not available. 

From the data presented in Table 2, and by following the approach recommended in the EU Technical Guidance Document for the Risk Assessment of New Notified and Existing Chemicals, Predicted No Observed Effect Concentrations (PNECs) can be obtained by applying uncertainty factors on the NOECs. The resulting PNECs are as follows TEQ with factor of 10 = 30 pg/L or with factor of 2 on microcosm = 75 pg/L MTEA with factor of 10 = 300 pg/L factor of 2 on microcosm = 750 pg/L PDQ with factor of 10 = 100 pg/L DEQ with factor of 100 (two chronic studies but not on the most sensitive species, algae) = 6.8 pg/L. 

In keeping with its mission and nonprofit status, TERA provides a limited amount of free technical assistance to government and nonprofit organizations. This may include brief reviews of documents, guidance over the telephone, or a written review of an assessment done by the organization. TERA also develops educational materials on health risks of chemicals and risk assessment methods. 

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