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
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 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
Reproduced from LM issue 114, October 1998