industry and environment - DTIE

Chemicals management
The precautionary principle and EU chemicals policy
Mary Taylor, Safer Chemicals Campaign, Friends of the Earth Europe, Friends of the Earth,
26-28 Underwood Street, London N1 7JQ, United Kingdom (maryt@foe.co.uk)
In order to protect the environment, the precautionary approach shall
be widely applied by States according to their capabilities. Where there
are threats of serious or irreversible damage, lack of full scientific certainty
shall not be used as a reason for postponing cost-effective measures
to prevent environmental degradation.
Principle 15 of The Rio Declaration on Environment and Development (1992)
The EC Treaty has incorporated the precautionary principle since 1992
(Treaty of Maastricht), although without defining it in any detail. Its incorporation
into the Treaty is highly significant and should set the stage for
environmental protection measures to be undertaken quickly, before
“absolute proof” of harm is evident.
In 1999 the Council of Ministers adopted a Resolution urging even more
determination to be guided by the principle, further emphasizing acceptance
of its place in EU policy and law. As noted by the European Commission,
“applying the precautionary principle is a key tenet of [Community]
policy”. 1 It is recognized that the precautionary principle applies in both
environmental and health spheres. 2
The precautionary principle in the Treaty
Community policy on the environment shall aim at a high level of protection
taking into account the diversity of the situations in the various
regions of the Community. It shall be based on the precautionary principle
and on the principles that preventive action should be taken, that
environmental damage should as a priority be rectified at source and
that the polluter should pay.
Maastricht Treaty (now the Amsterdam Treaty, Art 174(2)), 1992
However, putting the precautionary principle into practice is conceptually
and politically challenging. In 2000 a Communication from the European
Commission attempted to set out an approach and guidelines for
using and applying the principle. 3 This was partly in response to accusations
of “arbitrary” decision-making, since use of the precautionary principle
is regarded by some non-EU countries – the US in particular – as
restricting trade. There is also potential for conflict even between EU countries
if there is no common acceptance of how to interpret the principle.
A key argument for the Commission was that World Trade Organisation
rules incorporate the precautionary principle, 4 recognizing the “independent
right” of countries “to determine the level of environmental or health
protection they consider appropriate.”
The Commission’s paper has turned out to be controversial. The Commission
has proposed that risk assessment and management is central to
the concept and that invoking the principle has to start with a scientific
evaluation, albeit one which should be explicit about any uncertainties.
Intrinsic hazardous properties alone should not trigger the principle,
according to the Commission. Given the problems with risk assessment
(which needs both hazard and exposure information) in chemicals regulation,
environmentalists viewed this as a weak start.
The Commission also noted that precautionary action should be based
on cost-benefit analysis, with the proviso that non-economic factors could
be taken into account. But it is feared that this may turn to the advantage
of economic short-term interests that can quantify their costs more easily.
Sweden has argued that it should be about cost-effectiveness and not costbenefit
analysis, 5 which accords more with environmentalists’ views. Principle
15, in our view, should be interpreted as finding the cost-effective way
to take action once the decision to act has been taken, and not about using
cost-benefit analysis to decide whether to act or not.
Precaution and the chemicals policy debate
Debate about the precautionary principle is very pertinent to current discussions
on the regulation of chemicals. In many ways, much current chemicals
policy in the EU is the antithesis of the precautionary principle and
concerns about the current lack of regulation. Our ignorance about most
chemicals in use, and worries about a number of synthetic chemicals being
found in human tissue, have led the European Commission to produce legislative
proposals.
The historic and unregulated production of chemicals means that we
have all grown up in a society that produces and uses thousands of chemicals
in an almost infinite variety of ways. Our world is made up of chemicals
– so much so that the European chemical industry employs 1.7 million
people and produced over EUR 500 billion worth of chemicals in 2002.
The industry is making much use of impact assessments to try to show the
harm to industry that new regulations will bring. Yet the vast majority of
chemicals (aside from certain groups such as medicinal products, pesticides
and newly registered chemicals) have never had basic safety assessments
undertaken. Their use has been taken for granted and, in general, manufacturers
have not been required to provide safety data for the 100,000
chemicals that were known to exist and catalogued back in 1981.
We are exposed to probably hundreds of synthetic chemicals every day.
Hazardous chemicals can be found in all sorts of household goods – clothes,
cosmetics, PCs, even toys. Chemicals do not sit still forever in these products.
We are exposed directly in some uses (such as shampooing hair), or
and environmental monitoring. If all toxicity
studies are negative, use of the substance may be
considered (Figure 7).
For substances with low persistence and potential
for bioaccumulation (non-PB) we propose a
tiered testing system in which production volume
and results from previous tests determine further
test requirements and risk management decisions.
This system includes five parallel pathways for
tiered testing (Hansson and Rudén 2004):
1. general acute toxicity;
2. general sub-acute to chronic toxicity;
3. reproductive toxicity;
4. mutagenicity;
5. ecotoxicity.
Here we will briefly outline the principles of
this system, using the tests for general (acute) toxicity
as an example (Figure 8).
Data on sensitizing properties and acute toxicity
are essential in risk assessment. For a company
that is considering using a chemical substance, this
is the most elementary information that it needs
to obtain from the supplier. Without this information,
it is impossible to determine what measures
are needed to ensure safe handling at the
company’s own workplace and what safety-related
information should be passed on to costumers.
Therefore, in our proposed system in vivo testing
for skin and eye irritation and for skin sensitization
are mandatory for non-PB substances with a
production volume of 1 tonne per year, and the
same applies to test data that enable an estimation
of acute systemic toxicity. Substances with a production
volume of less than 1 tonne per year
should either be submitted to these tests or be classified
and labelled as insufficiently investigated.
We are well-aware of the shortcomings of the
current test methods for acute mammalian toxicity.
We emphasize the need to replace these tests
with new ones. Development and validation of
methods that reduce the need for animal testing
should be highly prioritized. The usefulness of any
new test method should be evaluated in the light
of the surprisingly low accuracy of the harmonized
classifications of acute systemic toxicity based on
data obtained with current test methods (Rudén
and Hansson 2003).
For substances that are acutely toxic we propose
additional testing of general toxicity, primarily in
the form of a 28-day toxicity study. This should
also be required for all substances with a produc-
16 ◆ UNEP Industry and Environment April – September 2004