Abstract

This report is a continuation of the description of 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 first report (no. 679102006) was 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 (level O or base set level). The present publication pertains to the post base set assessment, specifically on the basis of tests required at market volumes of 100 to 1000 tonnes per year or 500 to 5000 tonnes cumulative (level 1). Step by step the essential elements of the hazard and risk assessment process are discussed in so far these have not yet been dealt with in the earlier report. These elements include 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 requirements for further testing following the level 1 assessment.