Introduction In 1997, Greenpeace opened up a new front in its campaign against polyvinyl chloride (PVC), raising concerns about the safety of phthalate esters in children’s toys. Despite the defeat—by one vote—in the European Commission of a measure to ban phthalates in certain children’s toys in 1998, many toy retailers and manufacturers are eliminating phthalates and PVC from their products. Although eclipsed by media coverage of genetically modified foods, the debate over phthalates in toys has all the hallmarks of a classic scientific controversy: conflicting accounts of scientific ‘facts’ fought out in public by a plethora of experts.Superficially about science, most controversies are less concerned with scientific facts and more about politics and the democracy of decision-making.The current phthalate controversy in Europe began in Denmark. In April 1997 Danish authorities approached the European Commission with concerns about the levels of phthalates being released from teething rings made in China for a company called Chicco- Artsana. Although the manufacturer withdrew the products from sale in Europe, the issue revealed the absence of a validated method for testing phthalate migration.As a result—and in response to lobbying by Greenpeace and the toy industry—the Commission asked its Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) to evaluate the evidence. CSTEE evaluation The CSTEE met five times during 1998, examining the amount of phthalate esters in toys, data on leaching from toys, exposure to phthalates from other sources as well as their toxicity.In its review of the literature, the CSTEE found that DEHP causes liver cancer in rats and mice, but via a pathway that is less relevant in humans. It also noted that DEHP caused reproductive effects, including testicular atrophy, embryo toxicity and teratogenicity. Other phthalate esters produce a similar pattern of effects, and there is some evidence that BBP has oestrogenic effects in vitro.1 In April 1998 the CSTEE concluded that for two phthalate esters—DINP and DEHP—estimated safety margins were below 100, and the safety margin of 8.8 for DINP ‘gave cause for concern’.However, when the CSTEE met again in November 1998, results were available from Dutch and Austrian tests on the release of DINP and DEHP into saliva in human volunteers, plus results from tests by the US Consumer Product Safety Commission (CPSC) laboratory.These data gave a more reassuring picture of the amount of phthalates leached from toys when sucked, but the CSTEE said: ‘The revised margin of safety (MOS) values are 75 for DINP and 19 for DEHP, respectively. The MOS for DINP raises some concern as it is less than the previously recommended safety margin of at least 100.The MOS for DEHP raises clear concern.’2 Its November 1998 opinion concluded: ‘The CSTEE recommends that an interlaboratory comparison exercise be carried out in order to document the reproducibility of Phthalate esters in children’s toys— calls for product substitution Becky Allen examines a current public safety controversy Phthalate esters Phthalate esters have been widely used since the 1940s, especially as plasticisers in vinyl products to make them soft and flexible.Examples include the following: l butyl benzyl phthalate (BBP) l diisononyl phthalate (DINP) l dibutyl phthalate (DBP) l di-2-ethyl hexyl phthalate (DEHP) l di-n-octyl phthalate (DNOP) l diiso-decyl phthalate (DIDP) The phthalate esters causing the most concern as regards toxicity are DEHP and DINP.Baby chewing PVC teething ring containing phthalates F EAT U R E C G G102 Green Chemistry August 1999Green Chemistry August 1999 G103 F E AT U R E C G could attempt to make phthalates in PVC more immobile, switch to plasticisers other than phthalate esters, or replace PVC altogether.Although recent Indian work suggests that surface-modification techniques using sodium sulfide might prevent phthalate migration,3 previous attempts to lock phthalates into PVC have resulted in loss of flexibility. Alternative plasticisers include adipates and citrates, although less is known about their toxicity and mobility in PVC. The third option is replacing PVC with other materials such as polyolefins.Metallocene polyolefins, thermoplastic elastomers and ethylene vinyl acetate are identified as interim substitutes for PVC in toys in a report commissioned from the University of Massachusetts by Greenpeace.4 But despite being safer and cost-competitive, industry currently lacks the will to change, the report says. ‘Rather than spending resources on only assessing the risks of phthalate plasticiser in PVC toys, attention should focus on which alternatives can be developed and selected to replace PVC in toys,’ says the report.It also points to new technologies such as thin wall injection moulding and gas assisted injection moulding as a way forward. However, in the long term the report says the toy industry should abandon plastics based on petrochemicals altogether.The report concludes: ‘Advancements in biodegradable plastics hold hope for the future production of toys that are more sustainable through their life cycle.’ Recent developments Dutch migration test validated5 On 31 May 1999 it was announced that the so-called ‘Dutch Migration Test’, which can be used to measure the the Dutch laboratory method to measure phthalate release from PVC toys.Studies performed in order to shed light on the issue of buccal absorption of phthalates should be carried out. The CSTEE further recommends that additional studies be carried out in order gain more insight as to the total time children are mouthing PVC toys.’ Calls for a ban Despite the narrow defeat in the European Commission of measures to ban phthalates in toys in 1998, several member states—as well as toy manufacturers and retailers—have taken action, and in December 1998 the US CPSC asked industry to find substitutes for phthalates in products for children under three.Although not recommending a ban, the CPSC said there were ‘several areas of uncertainty where additional scientific research is needed’.As a precaution while more scientific work is done, the CPSC requested industry to remove phthalates from soft rattles and teethers. By early 1999, companies including Hasbro, Mattel and Toys-R-Us stopped using phthalates in teethers and rattles or removed phthalate-containing products from their shelves. Although Greenpeace has presented such moves as another victory in its war against PVC, industry bodies including the US Chemical Manufacturers’ Association (CMA) Phthalate Esters Panel say that adverse effects in animals exposed to phthalates only occur at ‘extremely high doses’ and that DEHP, about which the CSTEE expressed most concern, is rarely used in children’s toys.‘Countries that are banning phthalates are not acting in accordance with the scientific evidence,’ says the CMA.Product substitution Amid the heat and light of the debate over phthalate toxicity, less is being said about alternatives to phthalates in PVC, or alternatives to PVC itself in children’s toys. According to Maurits Bruggink of the Toy Industries of Europe: ‘An unfortunate consequence has been the announcement by some companies that they will use alternative raw materials, not because their products are unsafe but simply because of pressure.In the end it will be the consumer who will suffer, not only from lack of choice, but also because many raw materials are far less well understood.’ Manufacturers that decide to address consumer concerns about the safety of phthalates have several choices. They Phthalates on the Web For further information on phthalates, especially in PVC toys, see the following websites: l http://www.greenpeace.org/ -comms/pvctoys/ l http://www.vinyltoys.com l http://www.phthalates.com l http://www.vinylinfor.org l http://www.ecpi.org and links therefrom.Soft plastic toys often end up in children’s mouths ‘A Greenpeace report concludes that the toy industry should abandon plastics based on petrochemicals’US panel confirms safety of phthalates6 An independent expert panel convened by the American Council on Science and Health (ACSH) announced on 22 June its conclusion that phthalates are safe for use in toys and medical devices.The 17-member panel, chaired by the former US Surgeon General Dr C. Everett Koop, reviewed a wide variety of published and unpublished scientific literature from the US, Canada and Europe to evaluate potential health risks from DEHP and DINP.The conclusions were that DEHP and DINP are not carcinogenic nor do they have other harmful effects at levels to which people are exposed, casting doubt on the extrapolations which have been made in the past from animal studies to human health. On toys, the panel recommends further studies to expand knowledge of children’s exposure, but states clearly its view that ‘DNIP in toys is not harmful for children who use these toys normally.’ The controversy goes on The conclusions of the ACSH report have been welcomed by the European Council for Plasticisers and Intermediates.But Greenpeace and other organisations do not accept the panel’s findings and claim that there is sufficient doubt about the risks involved to ban the controversial materials.They will therefore continue their campaign to ban PVC and phthalates. G104 Green Chemistry August 1999 F E AT U R E C G migration of the phthalate plasticiser DNIP from toys etc. has been successfully validated in trials organised by the TNO Nutrition and Food Research Institute in the Netherlands, and carried out in 6 laboratories in Germany, the Netherlands and the UK; it was expected that the test could be also validated for other phthalates.The test could be used to ensure that toys and childcare items, intended to be put in the mouths of children under 3 years old, conform to the migration limits suggested by CSTEE. Whether EU Member States, including the Netherlands, adopt the Dutch test method still has to be decided. Any EU-wide agreement may have to follow collaborative trials being conducted by the EU Joint Research Centre (JRC) at Ispra in Italy.The JRC is believed to be looking at a number of methods, including one similar to that of the Dutch that has been developed by the Laboratory of the Government Chemist in the UK and which is also currently undergoing interlaboratory testing.Danish regulation of phthalates On the 1 April 1999 the Danish ban on phthalates in toys and baby articles for children under 3 years of age came into force, making it the second European country to enforce such a ban, following Austria which banned them in January 1999. In June 1999 the Danish Government announced a new plan to regulate the use of PVC and phthalates by introducing taxes on both of them—2 Danish Kroner per kg of PVC and 7 Danish Kroner per kg phthalates. In addition the Danish plan covers a range of initiatives which, if fully implemented, would keep PVC away from incineration plants.In recent years Denmark has taken the lead in the regulation of PVC and phthalates, and has found that voluntary agreements between its government and the PVC industry have not worked—hence the proposed legislation.The Danish goal is to reduce the use of phthalates by 50% by the year 2010. ‘A US panel states that DNIP in toys is not harmful for children who use these toys normally’ ‘The Danish goal is to reduce the use of phthalates by 50% by the year 2010’ References 1 CSTEE (1998). Opinion expressed at the CSTEE third plenary meeting, Brussels, 24 April 1998. 2 CSTEE (1998). Opinion expressed at the CSTEE third plenary meeting, Brussels, 26–27 November 1998. 3 A. Jayakrishnan and S. Lakshmi. Immobile plasticiser in flexible PVC. in Nature, 17 December 1998, 396, 638. 4 University of Massachusetts/ Greenpeace (1999). A review of the availability of plastic substitutes for soft PVC in toys. 5 For information on the Dutch Migration Test see http://www.ecpi.org/pressreleases/ pr990531.htm 6 For information on the ACSH Panel findings see http://www.acsh.org