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 (Commission Communication C/2008 34/1 and Commission Recommendation L 33/8).
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 was requested 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).
In February 2008, the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published an Opinion in which they said there is reason for some concern for prematurely born male neonates although follow-up studies after high DEHP exposures in neonates do not indicate there is an effect of DEHP on the development of the human male reproductive system. They said that some other patient groups with relatively high DEHP exposures, including male foetuses of pregnant women may also result in some risk. But they point out that as it may be difficult to obtain the same functionalities in certain medical devices as with those made of PVC plasticised with DEHP, the risk and benefits of using alternatives should be carefully evaluated on a case by case basis. For more information please see the section on highly exposed patients.
Possible environmental risk to river basins: to be addressed through the use of Environmental Quality Standards (which already exist for DEHP).
The full DEHP risk assessment report can be downloaded from this website:
- Download from this website
Please note the full risk assessment report is a large document (588 pages / 3.12mb). Therefore, it may take some time to download.