An extensive European Commission scientific study has found that the phthalate plasticizers used most widely to soften PVC pose no human health and environmental risks and their use requires no new regulation.
The decision is the latest in an extended debate in Europe over the safety of phthalates. Manufacturers hope the new findings will influence regulators' position on the materials under a new European chemical safety program known as REACH (Registration, Evaluation and Authorization of Chemicals).
The risk-assessment study, launched more than 10 years ago, covers five phthalates. Work was concluded last month on three: diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and dibutyl phthalate (DBP).
Study findings, published April 13 in the EC's official journal, found that the chemicals are safe to use as plasticizers in a range of applications including PVC flooring, clothing, cosmetics and medical products.
The EC has gone back and forth on phthalates' safety. In 1999, the region banned all three materials from baby toys. Although a later report said the materials were safe, the commission's Scientific Committee on Toxicity, Ecotoxicity and the Enviroment overruled that finding and made the ban permanent.
The ban arose from widespread fears that phthalates are harmful to human health, causing cancer or disrupting the hormone systems of children. The latest study does not reverse that ban.
Still, the EU findings were welcomed warmly by the plasticizer industry in Europe. Although the phthalates cannot be used in baby toys, officials hope the study means that the phthalates will continue to be permitted in other applications.
``After such a resounding regulatory approval from the EU, downstream users can continue to use DINP and DIDP with the utmost confidence,'' David Codo-gan, director of the European Council for Plasticisers and Intermediates of Brussels, Belgium, said in a news release.
He added that the study conclusions and the research behind them ``will be of great assistance to both producers and users'' under the EC's anticipated REACH chemicals registration legislation.
Greenpeace has lobbied heavily to ban phthalates. Greenpeace spokeswoman Katharine Mill was unavailable for comment. However, she told Chemistry World magazine that ``the [commission's] opinion accepts that there are divergent scientific views.'' She added that Greenpeace is in favor of a ``general prohibition'' of PVC to ``avoid all the other problems associated with the production and disposal'' of the material.
The EC study did recommend some lesser actions. In the case of DBP, the latest study found some risk to the health of some plant workers and recommended measures to limit their exposure from inhalation and ``repeated dermal exposure arising from aerosol forming activities.''
In addition, it referred to some potential atmospheric risk near manufacturing sites. The study recommended EU governments lay down conditions and emission limits for production permits.
Reports on two other phthalates, di(2-ethylhexyl) phthalate (DEHP) and butylbenzyl phthalate (BBP), are expected in the first half of this year.