EU Risk Assessments

Laboratory ResearchUnder 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.