Threat of EC ban on phthalates in toys recedes, but Directive looms

The threat of immediate EC restrictions on the sale of soft PVC toys has faded after Consumer Affairs Commissioner Emma Bonino failed to win support for the move from her colleagues in May. But European Commissioners have agreed to prepare a Directive on the use of phthalate plasticisers in PVC products after a scientific committee concluded that there was "reason for concern" about the effects of the compound most widely used in soft PVC toys on children's health.

The controversy over the risks posed by phthalate migration from soft PVC toys or teethers likely to be sucked or chewed by young children has been running since last summer. Retailers in Denmark, Belgium, the Netherlands and Germany received official requests to withdraw such products following phthalate migration tests (ENDS Report 272, pp 24-28 ).

Last October, the European Commission asked its Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) to establish a working group to assess the health impact of PVC toys containing phthalate plasticisers, to set phthalate migration limits, and to agree a common test method for measuring migration levels which replicates the chewing of such toys by babies.

In February, the European Council for Plasticisers and Intermediates (ECPI) rubbished the group's exposure data after its initial report declared that "the information contained in the present opinion is enough for it to be published as such and eventually to warrant action" (ENDS Report 277, p 29 ).

Alarmed at the turn of events, the international toy industry stepped up its lobbying efforts. In February, the US Ambassador in Brussels wrote to the Commission to argue against any curbs on soft PVC toys. Internal notes sent by the US Department of Commerce to embassies in the EC warned that "a ban in Europe undermines the goals of free trade" and could result in "enormous loss of trade in these and similar products."

In March, the Spanish Government made a formal request to the Commission for restrictions on soft PVC toys. The request was made under the 1992 Directive on product safety, which enables the Commission to propose immediate bans on products if it considers they pose a "serious and immediate health risk."

The scope and objectives of a Directive on phthalates are presently unclear, but it will be proposed as an internal market measure, possibly under the 1992 Directive. Some Member States are already preparing measures against phthalates. Austria has drafted legislation on a ban on toys containing some phthalates, while Denmark has taken measures on certain toys and has urged the Commission to take similar action. In May, Sweden announced proposals to ban phthalates in PVC toys for children under three (see pp 45-46 ).

The CSTEE published its final opinion in April. For two phthalates, DINP and DEHP, this estimated that the margin of safety between intakes and no observed adverse effect levels was below 100 - namely 8.8 and 67, respectively. While the safety margin for DINP gave reasons for concern, the Committee was less concerned about the estimated level of DEHP exposure because humans appear to be less sensitive towards the chemical's critical effects.

Since concern about phthalates first arose two years ago, it has tended to focus on the oestrogenic effects displayed in cell assays by two members of the group - BBP and DBP.

However, the Committee's report barely mentions possible oestrogenic effects, highlighting instead the ability of phthalates to induce peroxisome enzyme production in the liver of rats and mice - a process which can lead to liver cancers - as the most important potential risk to humans.

DINP is the phthalate most commonly used in toys, and for some years has been replacing DEHP. According to official research in the UK, 28 of 29 PVC teethers tested in 1996 contained DINP, compared with ten out of 27 in 1991. The number containing DEHP declined from 13 to one in the same period.

Following publication of the Committee's opinion, a joint statement from the PVC, phthalate and toy industries said that it had "confirmed no basis for restrictions on PVC toys" because it "does not state - or even imply - any immediate or serious risk." According to the three industries, "the overwhelming mass of evidence is that phthalates are entirely safe for human health." A recent information leaflet on soft PVC toys published by the trade association Toy Industries of Europe said there is no evidence of a carcinogenic risk from phthalates.

The industries are pinning their hopes on a Dutch study using human adult volunteers which "will provide a more comprehensive assessment of human exposure to phthalates in toys." The results will be compared with in vitro extraction methods in order to arrive at a standardised method, and could result in a modification of the Committee's opinion.

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