EU Risk Assessment confirms no general risk to human health from DEHP

The European Union has confirmed that DEHP poses no general risk to human health. The summary of a comprehensive European risk assessment, involving nearly 15 years of extensive scientific evaluation by EU regulators, was published in the EU Official Journal on February 7 2008.

The assessment demonstrates that DEHP poses no risk to the general population and that no further measures need to be taken to manage the substance in any of its key end-use applications. This confirms an earlier opinion of member state experts and an opinion from the EU Scientific Committee for Toxicity, Ecotoxicity and the Environment (CSTEE) adopted in 2004.

The only areas of possible risk identified in the assessment relate to:

  • The use of DEHP in children's toys: Under regulations introduced in January 2007 DEHP is no longer permitted in toys and childcare articles in the EU.
  • Possible exposure of workers in factories: But adequate precautions are already taken based on occupational exposure limit values.
  • Some localised environmental exposure near to factories: The European Union will finalise measures relating to emissions controls from converters plants during 2008.
  • The use of DEHP in certain medical devices: An EU Scientific Review is being undertaken to determine whether there may be any risk from the use of DEHP in certain medical applications (children and neonates undergoing long-term blood transfusion and adults undergoing long-term haemodialysis). However, in October 2002 the European Union's Scientific Committee on Medicinal Products and Medical Devices published an Opinion on the use of DEHP at that saying that it could make no recommendations to limit its use.
  • Possible environmental risk to river basins: to be addressed through the use of Environmental Quality Standards (which already exist for DEHP).

The EU Risk Assessment procedure

Under the EU Risk Assessment Procedure (Council Regulation (EEC) 793193 of 23 March 1993) various chemicals and substances in everyday use have been scrutinised and scientifically evaluated on a regular basis by the European Commission (CEC) in consultation with EU member states.

It is a well-defined and rigorous procedure during which scientific data and research from a wide range of sources is evaluated by national scientific institutes and qualified bodies.

Di-2-ethylhexyl phthalate (DEHP) was among five phthalates, commonly used as plasticisers in PVC, which have undergone an EU assessment to determine whether they pose any risk to human health or the environment.

These rigorous EU risk assessments, which include a high degree of conservatism and built-in safety factors, have been carried out under the strict supervision of the European Commission and provide a clear scientific evaluation on which to judge whether or not a particular substance can be safely used.

The full DEHP risk assessment report can be downloaded from this website or from the European Chemicals Bureau:

Please note this is a very large document (588 pages / 3.12mb) and may therefore take some time to download.