REACh is based on the principle of self-regulation. Chemicals can only be produced (used) if there is sufficient information available about its property (physical, toxicity, environmental influence etc.). REACh makes industry bear most responsibilities to manage the risks posed by chemicals and provide appropriate safety information to their users.
In parallel, it foresees that the European Union can take additional measures on highly dangerous substances, where there is a need for complementing action at EU level. All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which shall be submitted to the Agency.
Manufacturers and importers must provide their downstream users with the risk information they need to use the substance safely. This will be done via the classification and labelling system and Safety Data Sheets (SDS), where needed. Furthermore, a Chemical Safety Report (CSR) is required for all chemical substances that are manufactured - or imported - in volumes over ten tonnes per year. The larger the quantity, the more properties have to be evaluated.
Risk estimates of applications are only required for products containing substances classified as hazardous and if they are listed in the Safety Data Sheet. For products not classified as hazardhous no detailed information on application is required. |
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