EU Risk Assessments

Laboratory ResearchThe five main phthalate plasticisers, DINP, DIDP, DEHP, BBP and DBP have all undergone comprehensive European Union Risk Assessments conducted under European Union Regulation 793/93. This legislation, which is now replaced by the new EU chemicals legislation REACH, sets out a framework for the evaluation of the risks to human health and the environment from substances.

Under the Regulation 793/93, substances were prioritised for risk assessment on the basis of their production volumes. For each prioritised substance, experts from one national government volunteered to draft the European Union's assessment of the substance.

In each case the rapporteur country worked with other national experts, industry and third parties to collate data and draft an assessment in the form of a draft risk assessment report.

This comprehensive assessment of all existing scientific evidence examined the properties of the respective phthalates, the levels at which the substance may cause adverse effects and the worse case scenarios of exposure.

This assessment of exposure examined both regional exposure levels and exposure via routes such as consumer articles. The draft report was then agreed by consensus with technical experts from all European Union national governments.

Scientific review

The Risk Assessment Report was then peer-reviewed by the European Union's highest source of independent scientific advice at that time, the Scientific Committee on Toxicity, Ecotoxicity and the Environment, which gives its opinion to the European Commission on the quality of the risk assessments.

Conclusions of the Reports

On the basis of the Risk Assessment Report, national experts either recommended that there was no need to adopt any further measures than those currently in place to protect human health or the environment, or they proposed measures to be taken to reduce the risk.

The conclusions were agreed by European Union national governments and the European Commission and were subsequently published in the Official Journal of the European Union and on the European Commission's Joint Research Centre website.

OECD

The Risk Assessment Reports are also presented to the Organisation for Economic Co-operation and Development as a contribution to the Chapter 19, Agenda 21 goals for evaluating chemicals, agreed at the United Nations Conference on Environment and Development, held in Rio de Janeiro in 1992.

The risk assessment reports, summary reports and the announcements in the EU Official Journal are available on the following web pages: