ABSTRACT

Manufacturers or importers (MIs) assess and document in a chemical safety assessment (CSA) that (1) risks arising from the manufacture/import of substance are adequately controlled during manufacture and MI use(s) and (2) others further down the supply chain can adequately control the risks. Registration requires that producers and importers of articles complete a CSA. Person(s) preparing CSAs are competent person(s) with appropriate experience who have received appropriate training, including refresher training. CSAs address all identied substance uses, and a manufacturer’s CSA also addresses substance manufacture. The CSA considers (1) the substance use on its own (including major impurities and additives), in a mixture, and in an article, as dened by the identied uses, and (2) all stages of the life cycle comparing potential adverse effects with known or reasonably foreseeable exposures, taking into account implemented and recommended risk management measures and operational conditions. This chapter further outlines CSA production steps.