Initial assessment of the hazards and risks of new chemicals to man and the environment

Abstract This paper 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 present paper is restricted to the assessment of the hazards of new substances on the basis of the base set, i.e. tests required at a market or production volume up to 100 tonnes per year or 500 tonnes cumulative. Step by step the essential elements of the hazard 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 and the comparison of exposure and toxicity data. Requirements for further testing following the initial assessment are also discussed.