REACH replaces 40 existing legal acts and creates a single system for all chemical substances. It requires the registration, over a period of 11 years, of chemical substances within the European Economic Area (the 27 EU Member States + Norway, Liechtenstein and Iceland).
The registration process requires manufacturers and importers to generate data for all chemical substances produced or imported into the EU in quantities above one tonne per year. For substances with annual volumes >10 tonnes, the assessment of safe handling (Chemical Safety Assessment-CSA) must be documented in a Chemical Safety Report (CSR).
The registrants must also identify appropriate risk management measures and communicate them to their users.
REACH is a radical step forward in EU chemicals management. The onus has moved from the authorities to industry.
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.
In addition, REACH allows for the further evaluation of substances where there are grounds for concern, and foresees an authorisation system for the use of substances of very high concern (SVHC). This applies to substances that cause cancer, infertility, genetic mutations or birth defects, and to those which are persistent and accumulate in the environment. The Authorisation system will require companies to switch progressively to safer alternatives where suitable alternatives exist. Current use restrictions will remain under REACH.
REACH also ensures that animal testing is kept to the strict minimum and that alternative methods are encouraged.
Text of REACH EU Regulation in EU languages: