Consumer Exposure Scenarios Under Reach

Abstract

TS1-10 Abstract: Exposure assessment under REACH is one of the most important prerequisites for risk assessment. If, for example, exposure can be excluded, then toxicologic tests can be skipped or reduced. The exposure will be assessed by the companies, often having no experience with risk assessment procedures. Therefore, the approaches for exposure assessment must be simple, easy to understand, and quickly to be performed. The basis for exposure assessments are standard generic exposure scenarios (ES). In the current EU technical guidance document, some general rules have been laid down. However, neither harmonization nor development of standard approaches for defining ES occurred. Also, a number of different definitions and interpretations of what is meant by an ES exists. In the first phase of the REACH Implementation Project 3.2, an attempt has been made to develop a definition that covers all the requirements of an ES: “An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.” On this basis, a tiered approach has been developed for applying ES. However, the practical implementation of ES into the assessment must be developed as well as a documentation system serving as a library of the different types of ES. Consumer exposure has to focus the use of consumer products and its control by risk management measures. In the tiered approach, the first step is to characterize an ES very roughly. This generic scenario is following a worst case concept. It considers conservative assumptions as well as a simple model. Under these conditions, the estimates of the assessment will reveal an overestimation. Generic ES may cover a greater range of products, they may be defined for similar situations, eg, releases of the same substance from different types of products. A proposal was made to compile those similar scenarios as “use and exposure categories.” If, by using such broad generic scenarios and categories, a risk can be excluded, then no further evaluation is needed. In the case in which a risk cannot be excluded, the assessment must be refined and the ES has to be focused to particular uses by taking data that describe the use more realistically and a respective model as well. As a platform for exchanging information about ES, the database “EIS-Chemrisks” was developed in which stakeholders can store ES dossiers by using a standardized format and to initiate a stakeholders’ dialogue.