EU Risk Assessments
Five phthalate plasticisers (US: plasticizers), DINP, DIDP, DEHP, BBP and DBP have been subject to comprehensive European Union Risk Assessments conducted under European Union Regulation 793/93. This legislation, which has now been replaced by the EU chemicals legislation REACH, sets out a framework for the evaluation of the risks which substances may pose to human health and the environment.
Under the EU Regulation 793/93, the risk assessments for substances were prioritised according to production volumes. For each prioritised substance, experts from one national EU government volunteered to draft its assessment. In each case the rapporteur country worked together with other EU Member States experts, industry and third parties to collate data in order to draft a risk assessment report. The European Chemicals Bureau coordinated the risk assessment process.
Following this, Risk Assessment Reports were peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment, which is the European Union’s highest source of independent scientific advice, giving its opinion to the European Commission on the quality of risk assessments.
Conclusions of the Reports
After analysing the Risk Assessment Report, national experts either maintained that no further measures to protect human health or the environment were necessary, or proposed measures to be taken to reduce any risks determined by the report.
For DINP and DIDP, the Risk Assessment Reports concluded that no further risk reduction was necessary (with the exception of stating for DIDP that if it was to be used for toys and childcare articles which can be placed in the mouth then restrictions would be required re: risk of mild liver effects seen in rodents at high doses). In addition the risk assessment reports concluded that no classification and labelling are required for DINP and DIDP.
For DEHP, BBP and DBP the classification as reproductive agents (Category 2 DSD equivalent to Category 1B CLP) was confirmed and various recommendations for risk reduction to protect human health and the environment were made.
National EU governments and the European Commission agreed upon the conclusions which were subsequently published in the Official Journal of the European Union and on the European Commission’s Joint Research Centre website.
The EU Risk Assessment Reports were also presented to the Organisation for Economic Co-operation and Development as a contribution to Chapter 19 of the 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 announcements in the EU Official Journal are available on the following web pages: