Concern about the possible health effects on babies which ingest phthalates by sucking or chewing soft PVC toys or teethers arose last year. The Danish, Dutch and Belgian health authorities responded to the results of phthalate migration tests by asking retailers to withdraw such products from their shelves (ENDS Report 272, pp 24-28 ).
Since then, the German Government has made a similar request to retailers. And the Italian Health Minister has agreed to ask national toy manufacturers to use alternatives to PVC and consider legal controls on phthalates in PVC toys.
In October, the Commission announced that it was appointing a scientific committee to assess the health impact of such toys, to set phthalate migration limits, and to agree a common test method for measuring migration levels which replicates the chewing of PVC toys (ENDS Report 273, pp 26-27 ). The PVC industry urged that no action should be taken until the EC risk assessments currently under way separately on some phthalates were completed, but called for the setting of migration limits "to protect its reputation".
The industry was caught off guard by the speed of events when the SCTEE published its initial opinion in February. Although its final opinion will not be issued until the results of a Dutch human exposure study are published later this year, the Commission said that "the information contained in the present opinion is enough for it to be published as such and eventually to warrant action."
The Committee proposed EC guideline values for extractable amounts of individual phthalates in toys which included a safety margin of at least 100 - and at least 500 for one phthalate, BBP - and which would probably amount to an effective ban.
To assess the health risks involved, the Committee used an exposure dose calculated from the maximum amounts released when a 10cm2 toy is extracted for 12 hours by a model saliva solution under dynamic conditions. For three phthalates - DINP, DNOP and DEHP - the estimated margins of safety between the level at which no adverse effect was observed in animal tests and the potential exposure levels for small children were below the 100-fold margin which is normally applied, standing at 2.7, 62 and 21 respectively. The three phthalates are the same as those found in the greatest quantities in toys by a Greenpeace survey last year. For three others - DIDP, DBP and BBP - the margins were substantially higher.
Phthalate producers have reacted angrily to the Committee's findings. Dr David Cadogan of the European Council for Plasticisers and Intermediates (ECPI) said that the data were "meaningless in that it is based on studies that are non-standardised, non-validated and non-reproducible. Assumptions that a young child would chew on a soft PVC toy for 12 hours non-stop do not reflect reality. The only products likely to be in the mouth for anywhere near that length of time are pacifiers, dummies or soothers - none of which are made from plasticised PVC."
The Committee recognised the uncertainties of assessing actual exposures by applying the model values. But it stressed that the process did not take into account that more than one phthalate can occur in toys, that young children could be more sensitive to the potential effects of phthalates, or that they may be subject to additional exposures by other routes.
PVC producers have put a little distance between themselves and the phthalate manufacturers. "According to ECPI, scientific evidence has shown that phthalates are not harmful to health or the environment," said John Svalander, Director of the European Council of Vinyl Manufacturers. But if the authorities decided that specific plasticisers should not be used for a specific baby product, "we would obviously encourage our customers to use alternatives."
The Committee said that its conclusions may be modified when the results of the Dutch study become available. It added that more extensive testing and evaluation of long-term effects of some phthalates may lead to a revision of the "no observed adverse effect level" values.
Last autumn, Austria announced that it would legislate to ban phthalates in PVC toys for children under three (ENDS Report 274, p 45 ). Danish Environment Minister Svend Auken also announced plans for a ban on phthalates and other hazardous substances in toys, and has since pressed EC Industry Commissioner Martin Bangemann to accept this.