DEHP risk assessment conclusion delayed
EU chemicals regulators have delayed finalising a comprehensive risk assessment that could have a huge impact on the commercial future of the phthalate DEHP, a PVC softener used in applications such as floor coverings, and medical bags and tubes.
Meeting in Arona, Italy, last week, member state experts postponed a decision to agree on the maximum concentration of DEHP that can be ingested without risk to human health. The phthalate is a toxin known to harm mammalian reproductive systems.
Sweden\'s national chemical watchdog, Kemi, which drafted the risk assessment under the EU existing substances programme, says intake should be limited to 3.7 milligrams per kilogram of body weight per day (mg/kg/d). Its stance is based on the \"no observed adverse effect level\" (Noael) found in a 1997 study known as Poon.
Since DEHP has been detected in breast milk and some foods at background concentrations higher than this, accepting Kemi\'s proposal as the reference point for risk management intervention would mean stronger controls and perhaps a ban on DEHP manufacture to reduce levels in the environment. It would also call into question its use in a wide range of medical applications.
But phthalate manufacturers are pushing for the risk assessment to be amended after two new studies showed Noaels up to 30 times greater than the Poon study. Accepting their conclusions instead would \"effectively minimise concerns\" over DEHP\'s effect on humans and lift the threat to the substance, industry lobby Ecpi said on Friday.
Ecpi welcomed the postponement, which it said would give member states more time to consider the new studies. The first, funded by German chemical giant Basf and known as Schilling, produced a Noael of 113 mg/kg/d.
Last month, the EU\'s scientific toxicology committee, the Cstee, praised the Schilling study but backed Kemi\'s use of Poon as the reference point. But Ecpi says that a second study just published by Wolfe et al confirms the figure found by Schilling and could tip the balance in its favour.
Though no formal conclusions have yet emerged, Environment Daily understands that only Norway and Denmark backed Sweden at the meeting. Other member states, including France and Germany, said they needed more information before reaching a decision. National authorities have been given four weeks to consult and submit their final positions to the European chemicals bureau, which oversees the programme.
* Meanwhile, in a paper prepared for last week\'s meeting and seen by Environment Daily, Kemi partially accepts Cstee criticism of its risk assessment of the environmental effects of DEHP (ED 22/02/02). The conclusion that there was no danger to the environment from DEHP in sediments and soils would be revised, it said. But it insisted that Cstee concerns that DEHP could be \"biomagnified\" were \"not an issue\".
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