The technical guidance documents

Site-specific modeiiing used the Technical Guidance Document (CEC, 2003) generic modelling used the BUSES model. 

By comparison with the measured data presented above, it can be seen that the local PECs are generally below, or in the order of, the maximum values measured in the aquatic environment. By way of exception, the values reported for methyltins, and in particular dimeth-yltin dichloride, from stabilizer production using the Technical Guidance Document (CEC, 2003) equations are significantly higher than the maximum measured values reported in the environment. 

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). 

The systematic evaluation of substance properties and predictable or actual exposure patterns over the entire life-time of a substance within the scope of risk assessment is as yet a relatively recent instrument, for which harmonised scientific rales were created in the EU for the first time in 1997 in the form of the Technical Guidance Documents (TGD). An essential element in this range of instruments is how to deal with shortcomings in knowledge. Wherever information is missing, standardised worst-case scenarios are conceived taking into account appropriate safety factors . If under these worst-case assumptions a rele-... 

For biocides, the Technical Guidance Document (EC 2003) as well as the Technical Notes for Guidance (TNsG) should be used as a basis for the risk assessment. Further details on these Guidance Documents are available at the ECB Web site (ECB 2006) under the heading Biocides. ... 

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. 

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,... 

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... 

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. 

GES data, including production phases, activities, operational conditions, RMM, and a cross-reference to the Technical Guidance Document (TGD) substance class usage and concentrations. 

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 ... 

International Uniform ChemicaL Information Database 4.2.4 The technical guidance documents... 

In the EU, risk assessment methodologies for human health have been described in the Technical Guidance Documents (TGDs) first published in 1996 and adapted in 2003. Initially these guidance documents were produced to support Commission Directive 93/67/EEC on risk assessment for new notified substances and... 

Each Member State Authority is given the responsibility for a sub-set of the priority substances and must carry out a risk assessment following the Commission Regulation (EC) No. 1488/94 and guidance given in the Technical Guidance Document... 

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