In April, the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) concluded that there was "reason for concern" about estimated exposures of the phthalate DINP to toddlers chewing soft PVC toys. It was less concerned about exposures to a second phthalate, DEHP.
Consumer Affairs Commissioner Emma Bonino subsequently failed by one vote to win support from her fellow Commissioners for an emergency ban on the sale of toys containing phthalates. But they agreed to prepare a Directive setting limits on toys' phthalate content, and authorised Member States to curb sales of PVC toys if migration levels were shown to exceed the SCTEE's proposed limits (ENDS Reports 280, pp 30-31 , 281, p 49 ).
Disappointed that the Commission had not ruled out Member State bans, the toy and chemical industries shifted their hopes to a study commissioned by the Dutch Health Ministry. But this, too, failed to provide a robust defence of the plasticisers when it was published in September (ENDS Report 284, p 34 ).
Meeting in November, the SCTEE examined the Dutch study and others and repeated its view that the margin of safety for DINP raised some concern. But it added that DEHP now raised "clear concern" as well. Exposure to phthalates from other sources would increase the concern, it said, but the magnitude of such exposure is uncertain.
The margin of safety (MOS) for DINP relative to the no observed adverse effect level of 15mg/kg/day was increased substantially from 8.8 to 75. However, it still raised some concern because it is less than the normal safety margin of at least 100.
DEHP raised more concern than before because its MOS was recalculated at 19, much lower than the original margin of 67, and because the critical effect of testicular damage was judged to be of greater relevance to humans than the previously used key effect of kidney and liver damage. The MOS for the other phthalates under examination - DNOP, DIDP, BBP and DBP - were not of concern.
Ms Bonino is likely to renew her attempts to get agreement for an emergency ban on toys for children under three which contain DINP and DEHP in the light of the new advice. The Consumer Affairs Directorate will also assess alternatives such as adipates and citric acid esters - already used in PVC blood bags and other medical devices.
Greenpeace and the European consumers' organisation BEUC were quick to call for an emergency ban. "Consumers will not tolerate a policy process that requires substantial evidence of death and disease before public health action is justified," said BEUC. "What makes this situation so obscene is that children, toddlers and babies are deliberately being placed at risk by toy manufacturers, who have executed a systematic campaign of mis-information."
The toy and plasticiser industries criticised the SCTEE's conclusions on two main grounds. Firstly, they said it ignored a study commissioned by phthalate producer Aristech that would have given an MOS of 440 for DINP rather than 75. And secondly, the results of experiments with rodents do not apply to humans, who have far fewer cell receptors susceptible to peroxisome proliferation which can lead to liver and kidney damage.
The industries also pointed out that DEHP is "very rarely" used in toys and "virtually not at all" in items designed to be put in the mouth by toddlers. However, Greenpeace has found toys, including teethers, with concentrations of 10-35% in the USA and the EC.
Meanwhile, in November the Canadian Health Ministry issued a warning that DINP posed a health risk to small children because of scientific evidence linking it to kidney and liver damage. Parents were advised to dispose of products designed for sucking, such as soft teethers or rattles, and offered a list of products known not to contain DINP.
The Ministry is working with retailers to identify and remove products from their shelves, and has asked manufacturers of other soft PVC toys to find a safe substitute over the next six months. It is also investigating the use of DINP in other children's products.
Later in November, the Mexican Health Ministry decided to stop imports of soft PVC toys and to withdraw them from the market while it gathered further information.
At the same time, American toy retailing giant Toys "R" Us announced it was withdrawing teethers and other "direct-to-mouth" PVC products which contain phthalate plasticisers from its 1,500 stores worldwide. The company said it made the decision because of "some manufacturers' decisions to phase out of product combined with conflicting reports on the safety of phthalates raised concerns among customers." It is awaiting results from tests being conducted by the US Consumer Product Safety Commission and "other regulatory agencies" before it decides whether to follow Mattel and phase out phthalates (ENDS Report 284, p 34 ).
Greenpeace called on the company to withdraw all soft PVC toys for children under three and criticised it for backtracking on a commitment last year to remove all soft PVC toys from the shelves in both Austria and the Netherlands. According to the environmental group, toy producers Lego, Brio and Rubbermaid have already adopted PVC-free policies, while several US firms have recently announced phthalate phase-outs in teething toys - including Safety First, the First Years Inc and Gerber Products.
Italian toy producer Artsana, the third biggest in Europe and owner of the Chicco brand, has also announced it is phasing out the use of soft PVC in products for children under three, replacing it with polyethylene and ethylene vinyl acetate. Hasbro, the second largest global producer, has yet to take any action.