Abstract

This report describes the initial hazard and risk assessment process for new substances at the National Institute of Public Health and Environmental Protection (RIVM) in the Netherlands. This assessment pertains to both man and the environment and is performed within the framework of the European Community (EC) Directive 79/831/EEC and the ensuing Dutch Chemical Substances Act. The report is restricted to the assessment of substances on the basis of the tests required at a market or production volume up to 100 tonnes per year or 500 tonnes cumulative. It has been written as a reference guide for those involved in the hazard and risk assessment process at RIVM in the first place, but also for the risk managers responsible for the regulation and the overall dossier evaluation of new substances, and for others interested in this subject, e.g. industry, non-governmental organizations and the public at large. Step by step the essential elements of the hazard and risk assessment process are discussed: organizational aspects, data requirements, the determination of the acceptability of the data received, the scientific evaluation of the test methods and results, the exposure assessment, the comparison of exposure and toxicity data, and the uncertainty analysis. The report also discusses requirements for further testing following the initial assessment and concludes with a summary of recent and relevant developments in the European Community within the field of the assessment of new substances.