EU Risk Assessments
Under the EU Risk Assessment
Procedure (Council Regulation (EEC) 793193 of 23 March 1993)
numerous chemicals and substances in everyday use are 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.
Five phthalates, commonly used as plasticisers in PVC, have
undergone or are currently undergoing an EU assessment to determine
whether they pose any risk to human health or the environment.
However, because of the overwhelming amount of scientific research
which has repeatedly demonstrated that they pose no significant
risk, it is not expected that there will be grounds for any
recommendations which are not already covered by the health and
safety advice given by the producers.
The risk assessments on three of the five phthalates have
already been completed and two of them - those for diisononyl
phthalate (DINP) and diisodecyl phthalate (DIDP) - show no
risks to human health or the environment for any current use.
The European Commission published its findings in the EU
Official Journal on April 13 2006, confirming the outcome of a risk
assessment involving more than 10 years of extensive scientific
evaluation by EU regulators.
Following the recent adoption of EU legislation with the regard
to the marketing and use of phthalates in toys and childcare
articles, the risk assessment conclusions clearly state that there
is no need for any further measures to regulate the use of DINP and
DIDP (please see press
release)
The 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.
"After such a resounding regulatory approval from the European
Union, downstream users can continue to use DINP and DIDP with the
utmost confidence" said Dr David Cadogan, Director of the European
Council for Plasticisers and Intermediates (ECPI). "Once the REACH
legislation enters into force, the conclusions of the risk
assessments and the body of research that underpin them will be of
great assistance to both producers and users of these
substances."
The full technical reports are also available:
For further information on these two phthalates please refer to
the DINP
Information Centre and the DIDP Information Centre. You can also see
the advertisements and advertorials which have been placed in specialist
media by the European Council for Plasticisers and
Intermediates.
The third risk assessment, for dibutyl phthalate (DBP), shows
some potential risk to plants in the vicinity of processing sites
and possibly to workers through inhalation. But in both cases,
simple measures can be implemented wherever they do not
already exist.
(For further information on DBP please refer to
the DBP
Information Centre)
DEHP and BBP assessments are still open
The risk assessments for di-2-ethylhexyl phthalate (DEHP) and
butylbenzyl phthalate (BBP) remain open as scientific data is still
being considered. However, it is expected that both will be
completed early in 2006 and the conclusions for all five risk
assessments will be published in the EU Official
Journal shortly afterwards.
Responsibility is with EU member states
The responsibility for undertaking such assessments is entrusted
to individual EU member states which make recommendations to the
European Commission on any control measures they feel should be
implemented in order to limit any risk that could exist. However,
any such recommendations have to be ratified by a majority vote of
a committee comprised of member state representatives.
The plasticiser industry is committed to the principles of the
worldwide 'Responsible Care' initiative and therefore, throughout
the evaluation process, the European Council for Plasticisers
and Intermediates (ECPI) and its members have given the EU
risk assessment process their full support. ECPI has also ensured
that all the relevant data and scientific studies have been made
available.
'ECPI and its members welcome the EU's rigorous assessment which
we believe will both confirm the scientific research which has been
carried out and allay any misplaced fears that may exist,' said
ECPI Director, Dr David Cadogan.
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