European Commission  [Printer-friendly version]
February 2, 2000

EUROPEAN UNION'S COMMUNICATION ON THE PRECAUTIONARY PRINCIPLE

[Rachel's introduction: The European Commission (EC) is the
environmental agency of the European Union (EU). In 1992, the EU
included the precautionary principle in its founding document, the
Treaty on the European Union, also known as the Maastricht Treaty.
In early 2000 the EC adopted a "Communication on the use of the
precautionary principle," reprinted below, which spelled out how the
principle would be applied in environmental decisions.]

The European Commission has today adopted a Communication on the use
of the precautionary principle. The objective of the Communication is
to inform all interested parties how the Commission intends to apply
the principle and to establish guidelines for its application. The aim
is also to provide input to the on-going debate on this issue both at
EU and international level. The Communication underlines that the
precautionary principle forms part of a structured approach to the
analysis of risk, as well as being relevant to risk management. It
covers cases where scientific evidence is insufficient, inconclusive
or uncertain and preliminary scientific evaluation indicates that that
there are reasonable grounds for concern that the potentially
dangerous effects on the environment, human, animal or plant health
may be inconsistent with the high level of protection chosen by the
EU. Today's Communication complements the recently adopted White Paper
on Food Safety and the agreement reached in Montreal this week-end on
the Cartagena Protocol on Bio-safety.

The Communication also qualifies the measures that may be taken under
the precautionary principle. Where action is deemed necessary,
measures should be proportionate to the chosen level of protection,
non-discriminatory in their application and consistent with similar
measures already taken. They should also be based on an examination of
the potential benefits and costs of action or lack of action and
subject to review in the light of new scientific data and should thus
be maintained as long as the scientific data remain incomplete,
imprecise or inconclusive and as long as the risk is considered too
high to be imposed on society. Finally, they may assign responsibility
-- or the burden of proof -- for producing the scientific evidence
necessary for a comprehensive risk assessment. These guidelines guard
against unwarranted recourse to the precautionary principle as a
disguised form of protectionism.

Today's Communication was presented to the Commission by Mr Erkki
Liikanen, Enterprise and the Information Society Commissioner, Mr
David Byrne, Health and Consumer Protection Commissioner, and Ms
Margot Wallstrom, Environment Commissioner. It is a follow-up to
President Romano Prodi's speech to the European Parliament on 5
October 1999.

The Communication recalls that a number of recent events have
undermined the confidence of public opinion and consumers because
decisions or absence of decisions were not supported by full
scientific evidence and the legitimacy of such decisions was
questionable.

The Commission has consistently striven to achieve a high level of
protection, inter alia in the environmental and human, animal and
plant health fields. It is the Commission's policy to take decisions
aimed to achieve this high level of protection on a sound and
sufficient scientific basis. However, where there are reasonable
grounds for concern that potential hazards may affect the environment
or human, animal or plant health, and when at the same time the lack
of scientific information precludes a detailed scientific evaluation,
the precautionary principle has been the politically accepted risk
management strategy in several fields. Although the precautionary
principle is not explicitly mentioned in the EC Treaty except in the
environment field, the Commission considers that this principle has a
scope far wider than the environment field and that it also covers the
protection of human, animal and plant health.

The Communication makes it clear that the precautionary principle is
neither a politicisation of science or the acceptance of zero-risk but
that it provides a basis for action when science is unable to give a
clear answer. The Communication also makes it clear that determining
what is an acceptable level of risk for the EU is a political
responsibility. It provides a reasoned and structured framework for
action in the face of scientific uncertainty and shows that the
precautionary principle is not a justification for ignoring scientific
evidence and taking protectionist decisions.

The horizontal guidelines established in this Communication will
provide a useful tool in the future for taking political decisions in
this regard and will contribute to legitimate decisions taken when
science is unable to assess completely the risk rather than decisions
based on irrational fears or perceptions. Thus, one of the objectives
of the Communication is to clearly describe the situations in which
the precautionary principle could be applied and determining the scope
of measures taken in this respect. It will therefore help ensuring the
proper functioning of the Internal Market as well as a high level of
protection and predictability for consumers and economic operators
located in the EU and elsewhere.

COMMUNICATION FROM THE COMMISSION ON THE PRECAUTIONARY PRINCIPLE

SUMMARY

1. The issue of when and how to use the precautionary principle, both
within the European Union and internationally, is giving rise to much
debate, and to mixed, and sometimes contradictory views. Thus,
decision-makers are constantly faced with the dilemma of balancing the
freedom and rights of individuals, industry and organisations with the
need to reduce the risk of adverse effects to the environment, human,
animal or plant health. Therefore, finding the correct balance so that
the proportionate, non-discriminatory, transparent and coherent
actions can be taken, requires a structured decision-making process
with detailed scientific and other objective information.

2. The Communication's fourfold aim is to:

** outline the Commission's approach to using the precautionary
principle,

** establish Commission guidelines for applying it,

** build a common understanding of how to assess, appraise, manage and
communicate risks that science is not yet able to evaluate fully, and

** avoid unwarranted recourse to the precautionary principle, as a
disguised form of protectionism.

It also seeks to provide an input to the ongoing debate on this issue,
both within the Community and internationally.

3. The precautionary principle is not defined in the Treaty, which
prescribes it only once -- to protect the environment. But in
practice, its scope is much wider, and specifically where preliminary
objective scientific evaluation, indicates that there are reasonable
grounds for concern that the potentially dangerous effects on the
environment, human, animal or plant health may be inconsistent with
the high level of protection chosen for the Community.

The Commission considers that the Community, like other WTO members,
has the right to establish the level of protection -- particularly of
the environment, human, animal and plant health, -- that it deems
appropriate. Applying the precautionary principle is a key tenet of
its policy, and the choices it makes to this end will continue to
affect the views it defends internationally, on how this principle
should be applied.

4. The precautionary principle should be considered within a
structured approach to the analysis of risk which comprises three
elements: risk assessment, risk management, risk communication. The
precautionary principle is particularly relevant to the management of
risk.

The precautionary principle, which is essentially used by decision-
makers in the management of risk, should not be confused with the
element of caution that scientists apply in their assessment of
scientific data.

Recourse to the precautionary principle presupposes that potentially
dangerous effects deriving from a phenomenon, product or process have
been identified, and that scientific evaluation does not allow the
risk to be determined with sufficient certainty.

The implementation of an approach based on the precautionary principle
should start with a scientific evaluation, as complete as possible,
and where possible, identifying at each stage the degree of scientific
uncertainty.

5. Decision-makers need to be aware of the degree of uncertainty
attached to the results of the evaluation of the available scientific
information. Judging what is an "acceptable" level of risk for society
is an eminently political responsibility. Decision-makers faced with
an unacceptable risk, scientific uncertainty and public concerns have
a duty to find answers. Therefore, all these factors have to be taken
into consideration.

In some cases, the right answer may be not to act or at least not to
introduce a binding legal measure. A wide range of initiatives is
available in the case of action, going from a legally binding measure
to a research project or a recommendation.

The decision-making procedure should be transparent and should involve
as early as possible and to the extent reasonably possible all
interested parties.

6. Where action is deemed necessary, measures based on the
precautionary principle should be, inter alia:

** proportional to the chosen level of protection,

** non-discriminatory in their application,

** consistent with similar measures already taken,

** based on an examination of the potential benefits and costs of
action or lack of action (including, where appropriate and feasible,
an economic cost/benefit analysis),

** subject to review, in the light of new scientific data, and capable
of assigning responsibility for producing the scientific evidence
necessary for a more comprehensive risk assessment.

Proportionality means tailoring measures to the chosen level of
protection. Risk can rarely be reduced to zero, but incomplete risk
assessments may greatly reduce the range of options open to risk
managers. A total ban may not be a proportional response to a
potential risk in all cases. However, in certain cases, it is the sole
possible response to a given risk.

Non-discrimination means that comparable situations should not be
treated differently, and that different situations should not be
treated in the same way, unless there are objective grounds for doing
so.

Consistency means that measures should be of comparable scope and
nature to those already taken in equivalent areas in which all
scientific data are available.

Examining costs and benefits entails comparing the overall cost to the
Community of action and lack of action, in both the short and long
term. This is not simply an economic cost-benefit analysis: its scope
is much broader, and includes non-economic considerations, such as the
efficacy of possible options and their acceptability to the public. In
the conduct of such an examination, account should be taken of the
general principle and the case law of the Court that the protection of
health takes precedence over economic considerations.

Subject to review in the light of new scientific data, means measures
based on the precautionary principle should be maintained so long as
scientific information is incomplete or inconclusive, and the risk is
still considered too high to be imposed on society, in view of [the]
chosen level of protection. Measures should be periodically reviewed
in the light of scientific progress, and amended as necessary.

Assigning responsibility for producing scientific evidence is already
a common consequence of these measures. Countries that impose a prior
approval (marketing authorisation) requirement on products that they
deem dangerous a priori reverse the burden of proving injury, by
treating them as dangerous unless and until businesses do the
scientific work necessary to demonstrate that they are safe.

Where there is no prior authorisation procedure, it may be up to the
user or to public authorities to demonstrate the nature of a danger
and the level of risk of a product or process. In such cases, a
specific precautionary measure might be taken to place the burden of
proof upon the producer, manufacturer or importer, but this cannot be
made a general rule.