[ 20 October 2003 ]

Experts confirm no general risk to human health from the Plasticiser DEHP

EU Risk Assessment comes a stage closer to conclusion

EU member state experts have confirmed that the health of people in general is not being endangered by the use of one of the world’s most commonly used plasticisers, di(2-ethylhexyl) phthalate (DEHP).

The experts, representing all 15 EU member states at a technical meeting⁽¹⁾ held in Italy to discuss the EU risk assessment for DEHP, agreed that the exposure of the general population is well below (at least 700 times) levels at which their health might be put at risk. Therefore no risk reduction measures are needed for the general population.

Their decision was based on a number of biomonitoring studies (studies that actually monitor the levels in people of chemicals and their breakdown products) undertaken in both Europe and the United States.

“It was very heartening that the decisions were taken on the basis of sound science”, said Director of the European Council for Plasticisers and Intermediates, Dr David Cadogan. “It also clearly reflects the recognition that, when looking at the likely risks of chemical substances, biomonitoring studies  are superior to the use of worst case exposure estimates and mathematical models that have previously been favoured” he said.

The meeting of the member state experts concludes the technical discussions of the EU risk assessment for DEHP. An amended draft now has to be prepared by the Swedish rapporteur before it goes for approval from the EU Article 15 Committee.

“We are very pleased that the safe use of DEHP has been further confirmed”, said Dr Cadogan.

The only areas where the rapporteur is likely to ask for measures to be taken to reduce risk now relate to:

• The use of DEHP in children’s toys – but as DEHP is not used in toys intended to be put in the mouth, the risk is only theoretical
• Possible exposure of workers in factories - but in most cases adequate precautions are already being taken. “Nevertheless we will certainly ensure that customers are made aware of the necessities,” said Dr Cadogan.
• Some localised environmental exposure near to factories – but localised emissions can be governed by emission controls.
• Medical devices – but in October 2002 the European Union’s Scientific Committee on Medicinal Products and Medical Devices has published an Opinion on the use of DEHP in medical devices saying that it can make no recommendations to limit its use.

DEHP is widely used today to make polyvinyl chloride (PVC) flexible in a broad range of everyday applications from flooring to life-saving medical devices.

(1) EU Technical Meeting III / 2003 held in Ispra, Italy, September 16 to 19 2003

                                                                  – Ends –

For further information please contact:

Tim Edgar
European Council for Plasticisers and Intermediates
Avenue E Van Nieuwenhuyse 4,
B-1160 Brussels, Belgium

Telephone: 0032 2 676 7363
Mobile: 0032 475 37 66 93

• To download pdf version of this press release please click here.