Poisonous dummies

The scares over 'toxic' toys and toys in sweets and cereals confirm that, post-BSE, food regulation has become a Euro obsession. Bill Durodié reports

Environmentalist and consumer protection groups have been lobbying the European Commission for a total ban on the use of phthalates (organic compounds used to soften PVC) in plastic items liable to be placed in a child's mouth- notably numerous toys, teething dummies, and bathtime rubber ducks. When in July the Commission decided instead simply to invite member states to check products against new safety margins proposed by its Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), there were complaints about Brussels going soft on the dangers of chewy PVC.

The lobbyists need not worry. The outcome will be much the same as a formal ban. In the cautious climate which now exists in the scientific and business worlds, no member state, manufacturer or retailer will sensibly choose to go against the new recommendation.

The BSE debacle has prompted a sea change in the way the Commission examines all issues concerning safety. Shocked into action by the biggest food and health panic of recent times, hardly a single speech by president Jacques Santer since has failed to refer to the need for new measures. While the jury is still out in determining possible links between bovine spongiform encephalopathy (BSE), and its transmission to humans in the form of new variant Creutzfeldt-Jakob disease (nvCJD), the Commission's public health and consumer protection services have been reorganised accordingly anyway. These developments, allowing for faster and tougher responses to perceived problems, food-related or otherwise, will have far-reaching implications long after the last suspect beef herd is destroyed.

The potential for action in fields relating to human health protection, consumer protection and the environment was already contained within articles in the Treaty on European Union (Maastricht Treaty). The BSE crisis then acted as a catalyst for a new article within the Amsterdam Treaty last year, further expanding the Commission's remit. The consumer policy directorate at the Commission, only created in 1995, has been expanded to take on health protection matters; its staff has recently been tripled.

A Multidisciplinary Scientific Committee set up in 1996 to deal with BSE was replaced in June 1997 by a Scientific Steering Committee with a far broader mandate, and 131 leading European scientists (from over 1000 who applied) coopted to sit on its various subcommittees. At the same time a series of key documents were produced laying down the new hard line on consumer health and food safety matters.

Notably, the Commission established a Rapid Alert System and Risk Assessment Unit, and overtly adopted the 'precautionary principle' as the basis of its approach to all matters. The new reports even suggested that 'there may be demands...to go further in the area of the health protection measures than the scientific evidence suggests is necessary', referring to the new systems variously as 'farm to fork', 'plough to plate', 'stable to table', or any other alliterated or rhyming A-Z that could indicate how all-encompassing the new measures are intended to be. When the Commission issued its 'Green Paper on the general principles of food law in the European Union', the Consumer Committee's own response proposed applying the precautionary principle 'even where there is no known scientific uncertainty'.

However, far from heralding a new era of direct legislatory interference from Brussels, it would appear that the Commission has grown more circumspect in the application of its new powers. Lacking the nerve to stick its finger into every pie, the Commission increasingly prefers to let others determine the agenda. As Financial Times columnist Lionel Barber recently observed, 'today, Brussels is using peer pressure and voluntary codes of conduct to encourage minimum standards of compliance'.

The new panic-inspired methods of regulating the food industry are well illustrated by the Committee on Product Safety Emergencies, which led the initial investigation into phthalates. In 1997 this body had also investigated the risks associated with mixing unwrapped non-food articles with food products, typically toys in chocolate eggs, crisps and cereal packets. Although it did not result in a ban, the committee declared a 'serious and immediate risk to health' from the outset. EU member states were required to review their existing procedures, and reams of scientific and statistical documents were produced. The result was to place manufacturers and retailers on the defensive, regardless of the quality of the evidence.

The panic had been triggered by two (non-fatal) incidents involving children choking on parts of toys contained in food, after which Belgium banned such products by royal decree in May 1997. But choking fatalities are fortunately rare, and when they do occur it is not usually toys that children choke on. Research commissioned by the UK Department for Trade and Industry in 1996 showed that 84 per cent of cases related to food products themselves. Among the non-food items on which children choke, coins form the largest single category. Cotton wool, conkers, stones, silver foil, tissue paper, even a child's dummy and half a penicillin tablet have proved fatal. Very few incidents have ever involved toys.

The world is full of small objects which could hypothetically cause death by choking. Legislating on the matter would prove futile as well as being irrational. But in the current climate of self-restraint, the food industry has proved willing to take action anyway, while consumer groups continue to lobby for even tighter restrictions, such as already exist in the USA. Last October, Nestlé withdrew its magic chocolate ball containing Disney characters from sale in America, even before any ruling as to whether it satisfied the stringent US food and drug regulations.

The research into phthalate toxicity, of which almost 100 papers were presented to the committee, also makes a far from convincing case for restriction. Experiments on rats to determine the 'no observed adverse effect level' (NOAEL) produce variations as great as three orders of magnitude. Nevertheless, true to the precautionary approach, the worst results are then multiplied by a further uncertainty factor of 100 to determine acceptable limits for humans.

In April and June this year the CSTEE issued an opinion paper and 'answers to questions' on phthalate 'migration' from toys and dummies. Both indicate human insensitivity to the hepatic peroxisome proliferation induced by feeding phthalates to rodents in determining the NOAEL, and taken to be an indicator of potential carcinogenic effects. While more sensitive changes, such as increased liver or kidney weights, are now taken as the critical endpoints, there is no evidence as to the applicability of such results to humans. Reproductive abnormalities, highlighted by campaigners against the products, do not appear in rodents at doses any less than 10 times the NOAEL.

The CSTEE documents also accept that 'the intake from toys may not be the major source', indicating that for at least one such compound, food products give us almost 90 per cent of our daily dosage. A recent UK Ministry of Agriculture, Fisheries and Food information sheet indicated that rather than being caused by plastic containers and packaging, this was more likely to be due to general environmental conditions. Indoor air provided most of the remaining 10 per cent, arising from the significant number of plastic objects and surfaces in our homes.

Due to the lack of uniformity in methodologies used to assess the oral leakage of phthalates from PVC, the Commission and toy industry alike are waiting on the results of a Dutch experiment by adult human volunteers, to revise their official safety margins. This new survey was expected to be considered by the CSTEE at its meeting in September. However, even if significant dispersal is found to occur through salivary contact, the case as to whether phthalates in such doses are detrimental to health would remain to be proven.

It is probable though that no amount of experimentation will determine the outcome of these issues. The Consumer Committee has already declared that even when scientific evidence is available 'too great an emphasis on this may be undesirable from the consumer's point of view'. Indeed the first biannual BSE follow-up report, communicated to the European Parliament in May 1998, went so far as to raise 'the possibility of taking into account minority scientific views'-in other words, of accepting the worst-case scenario regardless of what most scientists say.

When hard facts are replaced by the precautionary principle, the only possible outcome is to adopt the lowest common denominator. As soon as one region, manufacturer or retailer decides to err on the side of safety, then all others will inevitably have to follow. Referring to the lack of any proof that a danger exists, one supermarket chain in Europe has indicated that 'we choose to give our customers the benefit of this doubt'. While consumers now wait for further such doubts to 'benefit' from, it is already clear that the real poisonous dummies in this scenario are not necessarily the plastic teethers which so many are currently seeking to ban.

Bill Durodié is director of the independent research group Objective Europe