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.
|