Technical Guidance Document

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. 

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

Technical Guidance Document (CEC, 2003) calculations lead to significantly higher results than those derived using BUSES. This is mainly due to the assumption that local air emissions will enter the wastewater stream — which is not applied to the BUSES calculations. 

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. 

CEC (2003) Technical guidance document on risk assessment 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... 

U.S. EPA, Technical Guidance Document Final Covers on Hazardous Waste Landfills and Surface Impoundments, EPA/530-SW-89-047, U.S. Environmental Protection Agency, Washington, DC, July 1991. 

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. 

EUSES is a useful model for chemicals outside the domain of the persistent, non-dissociating substances of intermediate lipophilicity. Due to the high complexity of the model, it is lacking in transparency on the other hand, the performance of the model is characterized as a good compromise between complexity and practicability. In order to adapt the model to different assumptions or assess the uncertainty, it is necessary to use the EU TGD2003 Spreadsheet version 1.24 of April 2008. This spreadsheet aims to represent the algorithms described in the 2003-version of the EU Technical Guidance Document, as implemented in EUSES 2.0.3. 

Risk Assessment Technical Guidance Document (a. 16), which will presumably apply to registration under REACH. The adequacy of each test can be defined by two basic elements ... 

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). 

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. 

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-... 

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

This risk assessment follows the framework set out in the Commission Regulation (EC) 1488/94 (EC 1994) and implemented in the detailed Technical Guidance Documents (TGD) on Risk Assessment for New and Existing Substances (EC 2003). 

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. 

In addition, the EU Technical Guidance Document (EC 2003), Chapter 3.5, deals with toxicokinetics. 

Source Modihed from EC, 2003. Technical guidance document. Available at http /ecb.jrc.it/tgd... 

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