Outline on risk assessment programme of existing substances in the European Union.

Various programmes have been developed by national and international organisations to improve chemical safety of existing substances. The European Union Programme came into force on 4 June 1993. This programme gives a legal requirement that the manufacturer or the importer has to deliver data on substances produced or imported. The risk assessment process in the EU provides that every member state formally selects priority substances. To perform the risk characterisation for a priority substance, exposure assessment and the dose (concentration)-response (effect) assessment are conducted. Comparing the information on exposure to the effects identified by a hazard identification of the substance the risk assessor has to decide whether there is or there is no need for further information or testing or whether there is need for limiting the risks. The draft risk assessment report is sent to the OECD as European contribution to the programme on existing substances for discussion with OECD-member countries. A final decision on the substance is performed by the member states of the European Union.