Commission adopts Communication
on Precautionary Principle
Brussels,
2 February 2000
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 Wallström, 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 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.
