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Smoothing out a bumpy road – Practical hints for the preparation of chemical safety assessments for REACH


Harlan Laboratories Ltd., Zelgliweg 1, Itingen 4452, Switzerland

Human health and environmental hazards of chemical substances must be assessed in relation to estimated or measured exposure levels, reported to ECHA and communicated within the supply chain by registrants under the REACH regulation framework. This article gives an overview of the requirements and practical guidance on how to perform the Chemical Safety Assessment (CSA) and appropriately document the outcomes of the assessment in the Chemical Safety Report (CSR).
For substances which are manufactured in or imported to the European economic area (EEA, the 27 EU member states plus Norway, Iceland, Liechtenstein) in annual quantities equal to or greater than 10 tonnes a CSA/CSR is required (see Article 14 of Regulation (EC) No 1907/2006), if the substances have a classification as dangerous, are present in an isolated form and their identified uses result in human and/or environmental exposure.
The technical dossier for the same substance is to be submitted jointly, while companies are allowed to opt out from the joint submission of the CSR. It is expected by many industrial associations that this option will be a ...