Manufacturers and Importers
What if I manufacture and/or import substances > 1 tonne per year?
If you are a manufacturer/importer and you manufacture and/or import substances into the EU in quantities greater than 1 tonne per year, you may have to register that substance. In order to reduce animal testing and costs for industry, registrants of the same substance are required to jointly submit information on the hazardous properties of a substance and its classification, and they may also, if they agree, jointly submit the chemical safety report (CSR only required for >10 tonnes per year) . The information is to be submitted by one lead registrant on behalf of the others; the other joint registrants must submit other information individually, such as their company details, and production volumes. However, manufacturers and importers are allowed to opt out of joint registration arrangements if this would result in excessive cost, if they disagree with the lead registrant on the interpretation of information, or if disclosure of confidential information would cause substantial commercial damage.
For phase-in substances, a system is established to help registrants find other registrants with whom they can share data and get an overview about which studies are available. Those who have pre-registered the same substance become part of the Substance Information Exchange Forum (SIEF) for that substance.