Communication from the Commission on the precautionary principle
Date: 2000-02-02
Institutions: European Commission
Subjects: EU environmental policy, environmental protection, environmental risk prevention, industrial hazard

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 2.2.2000
COM(2000) 1 final

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.

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.

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.

3.

4.

2

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.

3

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.

these measures. Countries that

Assigning responsibility for producing scientific evidence is already a common
consequence of
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.

4

Table of Contents

1.

2.

3.

4.

5.

Introduction .................................................................................................................7

The goals of this communication.................................................................................. 8

The precautionary principle in the European Union...................................................... 8

The precautionary principle in international law......................................................... 10

The constituent parts of the precautionary principle.................................................... 12

5.1.

Factors triggering recourse to the precautionary principle..................................... 13

5.1.1.

Identification of potentially negative effects................................................ 13

5.1.2.

Scientific evaluation ................................................................................... 13

5.1.3.

Scientific uncertainty .................................................................................. 13

5.2. Measures resulting from reliance on the precautionary principle........................... 15

5.2.1.

The decision whether or not to act .............................................................. 15

5.2.2.

Nature of the action ultimately taken........................................................... 15

6.

Guidelines for applying the precautionary principle. .................................................. 15

6.1.

Implementation .................................................................................................... 15

6.2. The triggering factor ............................................................................................ 16

6.3. The general principles of application .................................................................... 17

6.3.1.

Proportionality............................................................................................ 17

6.3.2.

Non-discrimination..................................................................................... 18

6.3.3.

Consistency ................................................................................................ 18

6.3.4.

Examination of the benefits and costs of action and lack of action .............. 18

6.3.5.

Examination of scientific developments...................................................... 19

5

6.4. The burden of proof.............................................................................................. 20

7.

CONCLUSION.......................................................................................................... 21

ANNEX I ............................................................................................................................. 22

• The legislative texts

• Case law

• Policy orientations

ANNEX II............................................................................................................................ 25

ANNEX III .......................................................................................................................... 28

6

1.

INTRODUCTION

A number of recent events has shown that public opinion is becoming
increasingly aware of the potential risks to which the population or their
environment are potentially exposed.

Enormous advances in communications technology have fostered this growing
sensitivity to the emergence of new risks, before scientific research has been
able to fully illuminate the problems. Decision-makers have to take account of
the fears generated by these perceptions and to put in place preventive measures
to eliminate the risk or at least reduce it to the minimum acceptable level. On 13
April 1999 the Council adopted a resolution urging the Commission inter alia
" to be in the future even more determined to be guided by the precautionary
principle in preparing proposals for legislation and in its other consumer-
related activities and develop as priority clear and effective guidelines for the
application of this principle". This Communication is part of the Commission's
response.

The dimension of the precautionary principle goes beyond the problems
associated with a short or medium-term approach to risks. It also concerns the
longer run and the well-being of future generations.

A decision to take measures without waiting until all the necessary scientific
knowledge is available is clearly a precaution-based approach.

Decision-makers are constantly faced with the dilemma of balancing the
freedoms and rights of individuals, industry and organisations with the need to
reduce or eliminate the risk of adverse effects to the environment or to health.

correct balance

Finding the
so that proportionate, non-discriminatory,
transparent and coherent decisions can be arrived at, which at the same time
provide the chosen level of protection, requires a structured decision making
process with detailed scientific and other objective information. This structure is
provided by the three elements of risk analysis: the assessment of risk, the
choice of risk management strategy and the communication of the risk.

Any assessment of risk that is made should be based on the existing body of
scientific and statistical data. Most decisions are taken where there is sufficient
information available for appropriate preventive measures to be taken but in
other circumstances, these data may be wanting in some respects.

Whether or not to invoke the Precautionary Principle is a decision exercised
where scientific information is insufficient, inconclusive, or uncertain and where
there are indications that the possible effects on the environment, or human,
animal or plant health may be potentially dangerous and inconsistent with the
chosen level of protection.

7

2.

THE GOALS OF THIS COMMUNICATION

The aim of this Communication is to inform all interested parties, in particular
the European Parliament the Council and Member States of the manner in which
the Commission applies or intends to apply the precautionary principle when
faced with taking decisions relating to the containment of risk. However, this
general Communication does not claim to be the final word - rather, the idea is
to provide input to the ongoing debate both at Community and international
level.

This Communication seeks to establish a common understanding of the factors
leading to recourse to the precautionary principle and its place in decision
making, and to establish guidelines for its application based on reasoned and
coherent principles.

The guidelines outlined in this Communication are only intended to serve as
general guidance and in no way to modify or affect the provisions of the Treaty
or secondary Community legislation.

Another objective is to avoid unwarranted recourse to the precautionary
principle, which in certain cases could serve as a justification for disguised
protectionism. Accordingly the development of international guidelines could
facilitate the achievement of this end. The Commission also wishes to stress in
this Communication that, far from being a way of evading obligations arising
from the WTO Agreements, the envisaged use of the precautionary principle
complies with these obligations.

It is also necessary to clarify a misunderstanding as regards the distinction
between reliance on the precautionary principle and the search for zero risk,
which in reality is rarely to be found. The search for a high level of health and
safety and environmental and consumer protection belongs in the framework of
the single market, which is a cornerstone of the Community.

The Community has already relied on the precautionary principle. Abundant
experience has been gained over many years in the environmental field, where
many measures have been inspired by the precautionary principle, such as
measures to protect the ozone layer or concerning climate change.

3.

THE PRECAUTIONARY PRINCIPLE IN THE EUROPEAN UNION

The Community has consistently endeavoured to achieve a high level of
protection, among others in environment and human, animal or plant health. In
most cases, measures making it possible to achieve this high level of protection
can be determined on a satisfactory scientific basis. However, when there are
reasonable grounds
the
environment or human, animal or plant health, and when at the same time the
available data preclude a detailed risk evaluation, the precautionary principle has
been politically accepted as a risk management strategy in several fields.

for concern that potential hazards may affect

To understand fully the use of the precautionary principle in the European
Union, it is necessary to examine the legislative texts, the case law of the Court

8

of Justice and the Court of First Instance, and the policy approaches that have
emerged.

Legal Texts

The analysis starts with the legal texts which explicitly or implicitly refer to the
precautionary principle (Annex I, Ref. 1).

At Community level the only explicit reference to the precautionary principle is
to be found in the environment title of the EC Treaty, and more specifically
Article 174. However, one cannot conclude from this that the principle applies
only to the environment (Annex I, Refs. 2 and 3). Although the principle is
adumbrated in the Treaty, it is not defined there.

Like other general notions contained in the legislation, such as subsidiarity or
proportionality, it is for the decision-makers and ultimately the courts to flesh
out the principle. In other words, the scope of the precautionary principle also
depends on trends in case law, which to some degree are influenced by
prevailing social and political values.

However, it would be wrong to conclude that the absence of a definition has to
lead to legal uncertainty. The Community authorities' practical experience with
the precautionary principle and its judicial review make it possible to get an
ever-better handle on the precautionary principle.

Case law

The Court of Justice of the European Communities and the Court of First
Instance have already had occasion to review the application of
the
precautionary principle in cases they have adjudicated and hence to develop case
law in this area. (see Annex I, Refs. 5, 6 and 7)

Policy orientations

Policy orientations were set out by the Commission in the Green Paper on the
General Principles of Food Safety and the Communication of 30 April 1997 on
Consumer Health and Food Safety, by Parliament in its Resolution of 10 March
1998 concerning the Green Paper, by the Council in its Resolution of 13 April
1999 and by the Joint Parliamentary Committee of the EEA (European
Economic Area) in its Resolution of 16 March 1999 (Annex I, Refs. 8-12).

Hence the Commission considers that the precautionary principle is a general
one which should in particular be taken into consideration in the fields of
environmental protection and human, animal and plant health.

Although the precautionary principle is not explicitly mentioned in the
Treaty except in the environmental field, its scope is far wider and covers
those specific circumstances where scientific evidence is insufficient,
inconclusive or uncertain and there are indications through preliminary
objective scientific evaluation that there are reasonable grounds for concern
that the potentially dangerous effects on the environment, human, animal or

9

plant health may be inconsistent with the chosen level of protection .

4.

THE PRECAUTIONARY PRINCIPLE IN INTERNATIONAL LAW

At international level, the precautionary principle was first recognised in the
World Charter for Nature, adopted by the UN General Assembly in 1982. It was
subsequently incorporated into various
international conventions on the
protection of the environment. (cf. Annex II).

This principle was enshrined at the 1992 Rio Conference on the Environment
and Development, during which the Rio Declaration was adopted, whose
principle 15 states that: “in order to protect the environment, the precautionary
approach shall be widely applied by States according to their capability. Where
there are threats of serious or irreversible damage,
full scientific
certainty shall not be used as a reason for postponing cost-effective measures to
prevent environmental degradation”. Besides, the United Nations' Framework
Convention on Climate Change and the Convention of Biological Diversity both
the
refer to the precautionary principle. Recently, on 28 January 2000, at
Conference of the Parties to the Convention on Biological Diversity,
the
Protocol on Biosafety concerning the safe transfer, handling and use of living
modified organisms resulting from modern biotechnology confirmed the key
function of the Precautionary Principle (see Annex II).

lack of

Hence this principle has been progressively consolidated in international
environmental law, and so it has since become a full-fledged and general
principle of international law.

The WTO agreements confirm this observation. The preamble to the WTO
Agreement highlights the ever closer links between international trade and
environmental protection1. A consistent approach means that the precautionary
in these agreements, notably in the
principle must be taken into account
Agreement on Sanitary and Phytosanitary Measures (SPS) and in the Agreement
on Technical Barriers to Trade (TBT), to ensure that this general principle is
duly enforced in this legal order.

Hence, each Member of the WTO has the independent right to determine the
level of environmental or health protection they consider appropriate.
Consequently a member may apply measures, including measures based on the
precautionary principle, which lead to a higher level of protection than that
provided for in the relevant international standards or recommendations.

1

"The parties to this agreement ... recognising that their relations in the field of trade and
economic endeavour should be conducted with a view to raising standards of living, ensuring full
employment and a large and steadily growing volume of real income and effective demand, and expanding
the production of and trade in goods and services, while allowing for the optimal use of the world's
resources in accordance with the objective of sustainable development, seeking both to protect and
preserve the environment and to enhance the means for doing to in a manner consistent with their
respective needs and concerns at different levels of economic development ..."

10

The Agreement on the Application of Sanitary and Phytosanitary Measures
(SPS Agreement) clearly sanctions the use of the precautionary principle,
although the term itself is not explicitly used. Although the general rule is that
all sanitary and phytosanitary measures must be based on scientific principles
and that they should not be maintained without adequate scientific evidence, a
derogation from these principles is provided for in Article 5 (7) which stipulates
that: “in cases where relevant scientific evidence is insufficient, a Member may
provisionally adopt sanitary or phytosanitary measures on the basis of available
international
pertinent
organizations as well as from sanitary or phytosanitary measures applied by
other Members. In such circumstances, Members shall seek to obtain the
additional information necessary for a more objective assessment of risk and
review the sanitary or phytosanitary measure accordingly within a reasonable
period of time.”

including that

information,

from the

relevant

Hence, according to the SPS Agreement, measures adopted in application of a
precautionary principle when the scientific data are inadequate, are provisional
and imply that efforts be undertaken to elicit or generate the necessary scientific
data. It is important to stress that the provisional nature is not bound up with a
time limit but with the development of scientific knowledge.

The use of the term “more objective assessment of risk” in Article 5.7 infers that
a precautionary measure may be based on a less objective appraisal but must
nevertheless includes an evaluation of risk.

The concept of risk assessment in the SPS leaves leeway for interpretation of
what could be used as a basis for a precautionary approach. The risk assessment
on which a measure is based may include non-quantifiable data of a factual or
qualitative nature and is not uniquely confined to purely quantitative scientific
data. This interpretation has been confirmed by the WTO’s Appellate body in
the case of growth hormones, which rejected the panel’s initial interpretation
that the risk assessment had to be quantitative and had to establish a minimum
degree of risk.

The principles enshrined in Article 5.7 of the SPS must be respected in the field
of sanitary and phytosanitary measures; however, because of the specific nature
of other areas, such as the environment, it may be that somewhat different
principles will have to be applied.

International guidelines are being considered in relation to the application of the
Precautionary Principle in Codex Alimentarius. Such guidance in this, and other
sectors, could pave the way to a harmonised approach by the WTO Members, to
drawing up health or environment protection measures, while avoiding the
misuse of
the precautionary principle which could otherwise lead to
unjustifiable barriers to trade.

In the light of these observations, the Commission considers that, following the
example set by other Members of the WTO, the Community is entitled to
prescribe the level of protection, notably as regards the environment and human,
animal and plant health, which it considers appropriate. In this context, the
Community must respect Articles 6, 95, 152 and 174 of the Treaty. To this end,

11

reliance on the precautionary principle constitutes an essential plank of its
policy. It is clear that the choices made will affect its positions at international
and notably multilateral level, as regards recourse to the precautionary principle.

Bearing in mind the very origins of the precautionary principle and its
growing role in international law, and notably in the agreements of the
World Trade Organisation, this principle must be duly addressed at
international level in the various areas in which it is likely to be of
relevance.

Following the example set by the other members of
the
Commission considers that the Community is entitled to prescribe the level of
protection, notably as regards environmental protection and human, animal
and plant health, that it considers appropriate. Recourse to the precautionary
principle is a central plank of Community policy. The choices made to this
end will continue to influence its positions at international level, and notably
at multinational level, as regards the precautionary principle.

the WTO,

5.

THE CONSTITUENT PARTS OF THE PRECAUTIONARY PRINCIPLE

An analysis of the precautionary principle reveals two quite distinct aspects: (i)
the political decision to act or not to act as such, which is linked to the
factors triggering recourse to the precautionary principle; (ii) in the affirmative,
how to act, i.e. the measures resulting from application of the precautionary
principle.

There is a controversy as to the role of scientific uncertainty in risk analysis, and
notably as to whether it belongs under risk assessment or risk management. This
controversy springs from a confusion between a prudential approach and
application of the precautionary principle. These two aspects are complementary
but should not be confounded.

The prudential approach is part of risk assessment policy which is determined
before any risk assessment takes place and which is based on the elements
described in 5.1.3; it
is therefore an integral part of the scientific opinion
delivered by the risk evaluators.

On the other hand, application of the precautionary principle is part of risk
management, when scientific uncertainty precludes a full assessment of the risk
and when decision-makers consider that the chosen level of environmental
protection or of human, animal and plant health may be in jeopardy.

The Commission considers that measures applying the precautionary principle
belong in the general framework of risk analysis, and in particular
risk
management.

12

5.1.

Factors triggering recourse to the precautionary principle

The precautionary principle is relevant only in the event of a potential risk, even
if this risk cannot be fully demonstrated or quantified or its effects determined
because of the insufficiency or inclusive nature of the scientific data.

It should however be noted that the precautionary principle can under no
circumstances be used to justify the adoption of arbitrary decisions.

5.1.1.

Identification of potentially negative effects

Before the precautionary principle is invoked, the scientific data relevant to the
risks must first be evaluated. However, one factor logically and chronologically
precedes the decision to act, namely identification of the potentially negative
effects of a phenomenon. To understand these effects more thoroughly it is
necessary to conduct a scientific examination. The decision to conduct this
examination without awaiting additional information is bound up with a less
theoretical and more concrete perception of the risk.

5.1.2.

Scientific evaluation

A scientific evaluation of the potential adverse effects should be undertaken
based on the available data when considering whether measures are necessary to
protect the environment, the human, animal or plant health. An assessment of
risk should be considered where feasible when deciding whether or not to
invoke the precautionary principle. This requires reliable scientific data and
logical reasoning, leading to a conclusion which expresses the possibility of
occurrence and the severity of a hazard's impact on the environment, or health of
a given population including the extent of possible damage, persistency,
reversibility and delayed effect. However it
is not possible in all cases to
complete a comprehensive assessment of risk, but all effort should be made to
evaluate the available scientific information.

Where possible, a report should be made which indicates the assessment of the
existing knowledge and the available information, providing the views of the
scientists on the reliability of the assessment as well as on the remaining
uncertainties. If necessary, it should also contain the identification of topics for
further scientific research.

Risk assessment consists of four components - namely hazard identification,
hazard characterisation, appraisal of exposure and risk characterisation (Annex
III). The limits of scientific knowledge may affect each of these components,
influencing the overall level of attendant uncertainty and ultimately affecting the
foundation for protective or preventive action. An attempt to complete these
four steps should be performed before decision to act is taken.

5.1.3.

Scientific uncertainty

Scientific uncertainty results usually from five characteristics of the scientific
method : the variable chosen, the measurements made, the samples drawn, the
models used and the causal relationship employed. Scientific uncertainty may

13

also arise from a controversy on existing data or lack of some relevant data .
Uncertainty may relate to qualitative or quantitative elements of the analysis.

A more abstract and generalised approach preferred by some scientists is to
separate all uncertainties into three categories of – Bias, Randomness and True
Variability. Some other experts categorise uncertainty in terms of estimation of
confidence interval of the probability of occurrence and of the severity of the
hazard’s impact.

issue is very complex and the Commission launched a project
This
“Technological Risk and the Management of Uncertainty” conducted under the
auspices of the European Scientific Technology Observatory. The four ESTO
reports will be published shortly and will give a comprehensive description of
scientific uncertainty.

Risk evaluators accommodate these uncertainty factors by incorporating
prudential aspects such as :

–

–

–

–

–

relying on animal models to establish potential effects in man;

using body weight ranges to make inter-species comparisons;

adopting a safety factor in evaluating an acceptable daily intake to account
for
the magnitude of this factor
depends on the degree of uncertainty of the available data;

intra- and inter-species variability;

not adopting an acceptable daily intake for substances recognised as
genotoxic or carcinogenic;

adopting the "ALARA" (as low as reasonably achievable) level as a basis
for certain toxic contaminants.

Risk managers should be fully aware of these uncertainty factors when they
adopt measures based on the scientific opinion delivered by the evaluators.

However, in some situations the scientific data are not sufficient to allow one to
apply these prudential aspects in practice, i.e. in cases in which extrapolations
cannot be made because of the absence of parameter modelling and where
cause-effect relationships are suspected but have not been demonstrated. It is in
situations like these that decision-makers face the dilemma of having to act or
not to act.

Recourse to the precautionary principle presupposes:

– identification of potentially negative effects resulting from a phenomenon,

product or procedure;

– a scientific evaluation of the risk which because of the insufficiency of the data,
their inconclusive or imprecise nature, makes it impossible to determine with
sufficient certainty the risk in question.

14

5.2.

Measures resulting from reliance on the precautionary principle

5.2.1.

The decision whether or not to act

In the kind of situation described above - sometimes under varying degrees of
pressure from public opinion - decision-makers have to respond. However,
responding does not necessarily mean that measures always have to be adopted.
The decision to do nothing may be a response in its own right.

The appropriate response in a given situation is thus the result of an
eminently political decision, a function of the risk level that is "acceptable" to
the society on which the risk is imposed.

5.2.2. Nature of the action ultimately taken

The nature of the decision influences the type of control that can be carried out.
Recourse to the precautionary principle does not necessarily mean adopting final
instruments designed to produce legal effects that are open to judicial review.
There is a whole range of actions available to decision-makers under the head of
the precautionary principle. The decision to fund a research programme or even
the decision to inform the public about the possible adverse effects of a product
or procedure may themselves be inspired by the precautionary principle.

It is for the Court of Justice to pronounce on the legality of any measures taken
by the Community institutions. The Court has consistently held that when the
Commission or any other Community institution has broad discretionary
powers, notably as regards the nature and scope of the measures it adopts,
review by the Court must be limited to examining whether the institution
committed a manifest error or misuse of power or manifestly exceed the limits
of its powers of appraisal.

Hence the measures may not be of an arbitrary nature.

Recourse to the precautionary principle does not necessarily mean adopting
final instruments designed to produce legal effects, which are subject
to
judicial review.

6.

GUIDELINES FOR APPLYING THE PRECAUTIONARY PRINCIPLE.

6.1.

Implementation

When decision-makers become aware of a risk to the environment or human,
in the event of non-action may have serious
animal or plant health that
consequences, the question of appropriate protective measures arise. Decision-
makers have to obtain, through a structured approach, a scientific evaluation, as
complete as possible, of the risk to the environment, or health, in order to select
the most appropriate course of action

15

The determination of appropriate action including measures based on the
if
precautionary principle should start with a scientific evaluation and,
necessary, the decision to commission scientists to perform an as objective and
complete as possible scientific evaluation. It will cast
light on the existing
objective evidence, the gaps in knowledge and the scientific uncertainties.

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.

6.2.

The triggering factor

Once the scientific evaluation has been performed as best as possible, it may
provide a basis for triggering a decision to invoke the precautionary principle.
the desired level of
The conclusions of this evaluation should show that
protection for the environment or a population group could be jeopardised. The
conclusions should also include an assessment of the scientific uncertainties and
a description of the hypotheses used to compensate for the lack of the scientific
or statistical data. An assessment of the potential consequences of inaction
should be considered and may be used as a trigger by the decision-makers. The
decision to wait or not to wait for new scientific data before considering possible
measures should be taken by the decision-makers with a maximum of
transparency. The absence of scientific proof of the existence of a cause-effect
relationship, a quantifiable dose/response relationship or a quantitative
evaluation of the probability of the emergence of adverse effects following
exposure should not be used to justify inaction. Even if scientific advice is
supported only by a minority fraction of the scientific community, due account
should be taken of their views, provided the credibility and reputation of this
fraction are recognised.2

The Commission has confirmed its wish to rely on procedures as transparent as
possible and to involve all interested parties at the earliest possible stage3. This
will assist decision makers in taking legitimate measures which are likely to
achieve the society’s chosen level of health or environmental protection

An assessment of the potential consequences of inaction and of the
uncertainties of the scientific evaluation should be considered by decision-
makers when determining whether to trigger action based on the
precautionary principle.

All interested parties should be involved to the fullest extent possible in the

3

2 cf The WTO Appellate Body report on hormones, paragraph 124 : « In some cases, the very existence of
divergent views presented by qualified scientists who have investigated the particular issue at
hand, may indicate a state of scientific uncertainty »
A considerable effort has already been made notably as regards public health and the
environment. As regards the latter, the Community and the Member States have demonstrated the
importance they attach to access to information and justice by signing the Aarhus Convention of
June 1998.

16

study of various risk management options that may be envisaged once the
results of the scientific evaluation and/or risk assessment are available and
the procedure be as transparent as possible.

6.3.

The general principles of application

The general principles are not
limited to application of the precautionary
principle. They apply to all risk management measures. An approach inspired by
the precautionary principle does not exempt one from applying wherever
possible these criteria, which are generally used when a complete risk
assessment is at hand.

Thus reliance on the precautionary principle is no excuse for derogating from
the general principles of risk management.

These general principles include:

•

•

•

•

•

proportionality,

non-discrimination,

consistency,

examination of the benefits and costs of action or lack of action

examination of scientific developments.

6.3.1.

Proportionality

The measures envisaged must make it possible to achieve the appropriate level
of protection. Measures based on the precautionary principle must not be
disproportionate to the desired level of protection and must not aim at zero risk,
something which rarely exists. However,
in certain cases, an incomplete
assessment of the risk may considerably limit the number of options available to
the risk managers.

In some cases a total ban may not be a proportional response to a potential risk.
In other cases, it may be the sole possible response to a potential risk.

Risk reduction measures should include less restrictive alternatives which make
it possible to achieve an equivalent level of protection, such as appropriate
treatment, reduction of exposure, tightening of controls, adoption of provisional
limits, recommendations for populations at risk, etc. One should also consider
replacing the products or procedures concerned by safer products or procedures.

The risk reduction measure should not be limited to immediate risks where the
proportionality of the action is easier to assess. It is in situations in which the
adverse effects do not emerge until long after exposure that the cause-effect
relationships are more difficult to prove scientifically and that – for this reason –
the precautionary principle often has to be invoked. In this case the potential
long-term effects must be taken into account in evaluating the proportionality of
measures in the form of rapid action to limit or eliminate a risk whose effects

17

will not surface until ten or twenty years later or will affect future generations.
This applies in particular to effects on the eco-system. Risks that are carried
forward into the future cannot be eliminated or reduced except at the time of
exposure, that is to say immediately.

Measures should be proportional to the desired level of protection.

6.3.2. Non-discrimination

The principle of 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.

Measures taken under the precautionary principle should be designed to achieve
an equivalent level of protection without invoking the geographical origin or the
nature of the production process to apply different treatments in an arbitrary
manner.

Measures should not be discriminatory in their application.

6.3.3. Consistency

Measures should be consistent with the measures already adopted in similar
circumstances or using similar approaches. Risk evaluations include a series of
factors to be taken into account to ensure that they are as thorough as possible.
The goal here is to identify and characterise the hazards, notably by establishing
a relationship between the dose and the effect and assessing the exposure of the
target population or the environment. If the absence of certain scientific data
makes it impossible to characterise the risk, taking into account the uncertainties
inherent to the evaluation, the measures taken under the precautionary principle
should be comparable in nature and scope with measures already taken in
equivalent areas in which all the scientific data are available.

Measures should be consistent with the measures already adopted in similar
circumstances or using similar approaches.

6.3.4.

Examination of the benefits and costs of action and lack of action

likely positive or negative
A comparison must be made between the most
consequences of the envisaged action and those of inaction in terms of the
overall cost to the Community, both in the long- and short-term. The measures
envisaged must produce an overall advantage as regards reducing risks to an
acceptable level.

Examination of the pros and cons cannot be reduced to an economic cost-benefit
analysis. It is wider in scope and includes non-economic considerations.

18

However, examination of the pros and cons should include an economic cost-
benefit analysis where this is appropriate and possible.

Besides, other analysis methods, such as those concerning the efficacy of
possible options and their acceptability to the public may also have to be taken
into account. A society may be willing to pay a higher cost to protect an interest,
such as the environment or health, to which it attaches priority.

The Commission affirms, in accordance with the case law of the Court that
requirements linked to the protection of public health should undoubtedly be
given greater weight that economic considerations.

The measures adopted presuppose examination of the benefits and costs of
action and lack of action. This examination should include an economic
cost/benefit analysis when this is appropriate and feasible. However, other
analysis methods, such as those concerning efficacy and the socio-economic
impact of the various options, may also be relevant. Besides the decision-
maker may,
in certain circumstances, by guided by non-economic
considerations such as the protection of health.

6.3.5.

Examination of scientific developments

The measures should be maintained as long as the scientific data are inadequate,
imprecise or inconclusive and as long as the risk is considered too high to be
imposed on society. The measures may have to be modified or abolished by a
particular deadline, in the light of new scientific findings. However, this is not
always linked to the time factor, but to the development of scientific knowledge.

Besides, scientific research should be carried out with a view to obtaining a
more advanced or more complete scientific assessment. In this context, the
measures should be subjected to regular scientific monitoring, so that they can
be reevaluated in the light of new scientific information.

The Agreement on Sanitary and Phytosanitary Measures (SPS) provides that
measures adopted in the context of inadequate scientific evidence must respect
certain conditions. Hence these conditions concern only the scope of the SPS
Agreement, but the specific nature of certain sectors, such as the environment,
may mean that somewhat different principles have to be applied.

Article 5(7) of the SPS agreement includes certain specific rules:

• The measures must be of a provisional nature pending the availability of
more reliable scientific data. However this provisional nature is linked to the
development of scientific knowledge rather than to a time factor.

• Research must be carried out to elicit the additional scientific data required

for a more objective assessment of the risk.

19

• The measures must be periodically reviewed to take account of new
scientific data. The results of scientific research should make it possible to
complete the risk evaluation and if necessary to review the measures on the
basis of the conclusions.

• Hence the reasonable period envisaged in the SPS Agreement includes the
time needed for completion of the necessary scientific work and, besides, the
time needed for performance of a risk evaluation based on the conclusions of
this scientific work. It should not be possible to invoke budgetary constraints
or political priorities to justify excessive delays in obtaining results, re-
evaluating the risk or amending the provisional measures.

Research could also be conducted for the improvement of the methodologies
and instruments for assessing risk, including greater integration of all pertinent
factors (e.g. socio-economic information, technological perspectives).

The measures, although provisional, shall 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.

Maintenance of the measures depends on the development of scientific
knowledge, in the light of which they should be reevaluated. This means that
scientific research shall be continued with a view to obtaining more complete
data.

Measures based on the precautionary principle shall be reexamined and if
necessary modified depending on the results of the scientific research and
the follow up of their impact.

6.4.

The burden of proof

• Community rules and those of many third countries enshrine the principle of
prior approval (positive list) before the placing on the market of certain
products, such as drugs, pesticides or food additives. This is one way of
applying the precautionary principle, by shifting responsibility for producing
scientific evidence. This applies in particular to substances deemed "a priori"
hazardous or which are potentially hazardous at a certain level of absorption.
In this case the legislator, by way of precaution, has clearly reversed the
burden of proof by requiring that the substances be deemed hazardous until
proven otherwise. Hence it is up to the business community to carry out the
scientific work needed to evaluate the risk. As long as the human health risk
cannot be evaluated with sufficient certainty, the legislator is not legally
entitled to authorise use of the substance, unless exceptionally for test
purposes.

•

In other cases, where such a prior approval procedure does not exist, it may
be for the user, a private individual, a consumer association, citizens or the
public authorities to demonstrate the nature of a danger and the level of risk
the head of the
posed by a product or process. Action taken under

20

precautionary principle must in certain cases include a clause reversing the
burden of proof and placing it on the producer, manufacturer or importer,
but such an obligation cannot be systematically entertained as a general
principle. This possibility should be examined on a case-by-case basis when
a measure
the precautionary principle, pending
supplementary scientific data, so as to give professionals who have an
economic interest in the production and/or marketing of the procedure or
product in question the opportunity to finance the necessary research on a
voluntary basis.

adopted under

is

based

Measures
assign
responsibility for producing the scientific evidence necessary for a
comprehensive risk evaluation.

principle may

precautionary

on the

7.

CONCLUSION

This Communication of a general scope sets out the Commission's position as
regards recourse to the precautionary principle. The Communication reflects the
Commission’s desire for transparency and dialogue with all stakeholders. At the
same it is provides concrete guidance for applying the precautionary principle.

The Commission wishes to reaffirm the crucial importance it attaches to the
distinction between the decision to act or not to act, which is of an eminently
political nature, and the measures resulting from recourse to the precautionary
principle, which must comply with the general principles applicable to all risk
management measures. The Commission also considers that every decision must
if
be preceded by an examination of all the available scientific data and,
possible, a risk evaluation that is as objective and comprehensive as possible. A
decision to invoke the precautionary principle does not mean that the measures
will be adopted on an arbitrary or discriminatory basis.

This Communication should also contribute to reaffirming the Community's
position at international level, where the precautionary principle is receiving
this
increasing attention. However the Commission wishes to stress that
Communication is not meant to be the last word; rather, it should be seen as the
point of departure for a broader study of the conditions in which risks should be
assessed, appraised, managed and communicated.

21

ANNEX I

LEGAL AND OTHER BASES FOR EC DECISIONS ON PRECAUTIONARY MEASURES

The legislative texts

Ref. 1

The EC Treaty, incorporating provisions already introduced by the Maastricht Treaty of
1992, and more specifically Article 174 thereof, states:

"2. Community policy on the environment shall aim at a high level of protection
taking into account the diversity of 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 …

3. In preparing its policy on the environment, the Community shall take account
of:

available scientific and technical data, …

the potential benefits and costs of action or lack of action …"

–

–

–

Ref. 2

Article 6 of the EC Treaty provides that "environmental protection requirements must be
integrated into the definition and implementation of the Community policies and
activities referred to in Article 3, in particular with a view to promoting sustainable
development".

Ref. 3

Hence, Article 95(3) of the EC Treaty provides that: "The Commission, in its proposals
envisaged in paragraph 1 concerning health, safety, environmental protection and
consumer protection, will take as a base a high level of protection, taking account in
particular of any new development based on scientific facts. Within their respective
powers,
the European Parliament and the Council will also seek to achieve this
objective".

Ref. 4

The first paragraph of Article 152 of the EC Treaty provides that: "A high level of human
health protection shall be ensured in the definition and implementation of all Community
policies and activities".

22

Case law

Ref. 5

In its judgement on the validity of the Commission's decision banning the exportation of
beef from the United Kingdom to reduce the risk of BSE transmission (Judgements of 5
May 1998, cases C-157/96 and C-180/96), the Court held:

"Where there is uncertainty as to the existence or extent of risks to human health, the
institutions may take protective measures without having to wait until the reality and
seriousness of those risks become fully apparent." (Grounds 63). The next section fleshes
out the Court's reasoning: "That approach is borne out by Article 130r(1) of the EC
Treaty, according to which Community policy on the environment is to pursue the
objective inter alia of protecting human health. Article 130r(2) provides that that policy is
to aim at a high level of protection and is to be based in particular on the principles that
preventive action should be taken and that environmental protection requirements must
implementation of other Community
be
policies."(Grounds 64).

definition and

integrated

into the

Ref. 6

In another judgement concerning protection of consumer health (Judgement of 16 July
1998, case T-199/96), the Court of First Instance cites the above passage from the BSE
judgement (see Grounds 66 and 67).

Ref. 7

Recently, in the Order of 30 June 1999 (Case T-70/99), the President of the Court of First
Instance confirmed the positions expressed in the abovementioned judgements. Note that
this judgement contains an explicit reference to the precautionary principle and affirms
that “requirements linked to the protection of public health should undoubtedly be given
greater weight that economic considerations.”

Policy orientations

Ref. 8

In its Communication of 30 April 1997 on consumer health and food safety (COM(97)
183 final), the Commission states: "the Commission will be guided in its risk analysis by
the precautionary principle, in cases where the scientific basis is insufficient or some
uncertainty exists".

Ref. 9

In its Green Paper on the General Principles of Food Law in the European Union of 30
April 1997 (COM(97) 176 final), the Commission reiterates this point:

"The Treaty requires the Community to contribute to the maintenance of a high level of
protection of public health, the environment and consumers. In order to ensure a high
level of protection and coherence, protective measures should be based on risk
assessment, taking into account all relevant risk factors, including technological aspects,
the best available scientific evidence and the availability of inspection sampling and

23

testing methods. Where a full risk assessment is not possible, measures should be based
on the precautionary principle."

Ref. 10

In its Resolution of 10 March 1998 on the Green Paper, the European Parliament states:

“European food law is based on the principle of preventive protection of consumer
health;

stresses that policy in this area must be founded on a scientifically-based risk analysis
supplemented, where necessary, by appropriate risk management based on the
precautionary principle;

invites the Commission to anticipate possible challenges to Community food law by
WTO bodies by requesting the scientific committees to present a full set of arguments
based on the precautionary principle.”

Ref. 11

The Joint Parliamentary Committee of the EEA (European Economic Area), adopted a
Resolution on Food Safety in the EEA on 16 March 1999. In this connection, on the one
hand, it “emphasises the importance of application of the precautionary principle” (point
5) and, on the other, “reaffirms the over-riding need for a precautionary approach within
the EEA to the assessment and evaluation of applications for the marketing of GMOs
intended to enter the food chain…” (point 13).

Ref. 12

On 13 April 1999, the Council adopted a Resolution urging the Commission, inter alia,
"to be in the future even more determined to be guided by the precautionary principle in
preparing proposals for legislation and in its other consumer-related activities and
develop as a priority clear and effective guidelines for the application of this principle".

24

ANNEX II

THE PRECAUTIONARY PRINCIPLE IN INTERNATIONAL LAW

The environment

Although applied more broadly, the Precautionary Principle has been developed primarily
in the context of environmental policy.

Hence,
the Ministerial Declaration of the Second International Conference on the
Protection of the North Sea (1987) states that "in order to protect the North Sea from
possibly damaging effects of the most dangerous substances, a precautionary approach
is necessary which may require action to control inputs of such substances even before a
link has been established by absolutely clear scientific evidence". A new
causal
Ministerial Declaration was delivered at
the Third International Conference on the
Protection of the North Sea (1990). It fleshes out the earlier declaration, stating that "the
participants ... will continue to apply the precautionary principle, that is to take action to
avoid potentially damaging impacts of substances that are persistent, toxic and liable to
bioaccumulate even where there is no scientific evidence to prove a causal link between
emissions and effects"

The Precautionary Principle was explicitly recognised during the UN Conference on
Environment and Development (UNCED) in Rio de Janeiro 1992 and included in the so-
called Rio Declaration. Since then the Precautionary Principle has been implemented in
various environmental instruments, and in particular in global climate change, ozone
depleting substances and biodiversity conservation.

The precautionary Principle is listed as Principle 15 of the Rio Declaration among the
principles of general rights and obligations of national authorities:

“In order to protect the environment, the precautionary approach should 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 is reproduced in similar wording in:

1. The preamble of the Convention of Biological Diversity (1992):

(…) Noting also that where there is a threat of significant reduction or loss of biological
diversity, lack of full scientific certainty should not be used as a reason for postponing
measures to avoid or minimise such a threat (…)

2. In article 3 (Principles) of the Convention of Climate Change (1992):

(..)The Parties should take precautionary measures to anticipate, prevent or minimise the
causes of climate change and mitigate its adverse effects. Where there are threats of serious
or irreversible damage, lack of full scientific certainty should not be used as a reason for
postponing such measures, taking into account that policies and measures to deal with
climate change should be cost-effective so as to ensure global benefits at the lowest possible
cost. To achieve this, such policies and measures should take into account different socio-

25

economic contexts, be comprehensive, cover all relevant sources, sinks and reservoirs of
greenhouse gases and adaptation, and comprise all economic sectors. Efforts to address
climate change may be carried out cooperatively by interested Parties.

In the Paris Convention for the protection of the marine environment of the north-east
Atlantic (September 1992), the precautionary principle is defined as the principle "by
virtue of which preventive measures are to be taken when there are reasonable grounds
for concern that substances or energy introduced, directly or indirectly, into the marine
environment may bring about hazards to human health, harm living resources and
marine ecosystems, damage amenities or interfere with other legitimate uses of the sea,
even when there is no conclusive evidence of a causal relationship between the inputs
and the effects."

Recently, on 28 January 2000, at the Conference of the Parties to the Convention on
Biological diversity, the Protocol on Biosafety concerning the safe transfer, handling and
use of living modified organisms resulting from modern biotechnology confirmed the
key function of the Precautionary Principle. In fact, article 10, paragraph 6 states: “Lack
of scientific certainty due to insufficient relevant scientific information and knowledge
regarding the extent of the potential adverse effects of a living modified organism on the
conservation and sustainable use of biological diversity in the Party of import, taking
also into account risks to human health, shall not prevent that Party from taking a
decision, as appropriate, with regard to the import of living modified organism in
question as referred to in paragraph 3 above, in order to avoid or minimize such
potential adverse effects”.

Besides, the preamble to the WTO Agreement highlights the ever closer links between
international trade and environmental protection.

The WTO SPS Agreement

Although the term „Precautionary Principle“ is not explicitly used in the WTO
the
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS),
Appellate Body on EC measures concerning meat and meat products (Hormones) (AB-
1997-4, paragraph 124) states that it finds reflection in Article 5.7 of this Agreement. Art
5.7 reads:„In cases where relevant scientific evidence is insufficient, a Member may
provisionally adopt sanitary or phytosanitary measures on the basis of available
scientific information, including that from the relevant international organizations as
well as from sanitary and phytosanitary measures applied by other Members. In such
circumstances, Members shall seek to obtain the additional information necessary for a
more objective assessment of risk and review the sanitary or phytosanitary measure
accordingly within a reasonable period of time.“

The Appellate Body on Hormones (Paragraph 124) recognises….” that there is no need
to assume that Article 5.7 exhausts the relevance of a precautionary principle”.
Moreover, Members have the “right to establish their own level of sanitary protection,
which level may be higher (i.e. more cautious) than that implied in existing international
standards, guidelines and recommendations”. Furthermore, it accepts that “responsible,
representative governments commonly act from perspectives of prudence and precaution
where risks of irreversible, e.g. life-terminating, damage to human health are concerned.”
The Appellate Body on Japan-Measures affecting agricultural products (AB-1998-8,
paragraph 89) clarifies the four requirements which must be met in order to adopt and

26

maintain provisional SPS measures. A Member may provisionally adopt an SPS measure
if this measure is:

imposed in respect of a situation where „relevant

1)
insufficient“; and

scientific information is

2) adopted “on the basis of available pertinent information“.

Such a provisional measure may not be maintained unless the Member which adopted the
measure:

1) „seek(s) to obtain the additional information necessary for a more objective risk
assessment“; and

2) „review(s) the … measure accordingly within a reasonable period of time“

These four requirements are clearly cumulative and are equally important for the purpose
of determining consistency with the provision of Art 5.7. Whenever one of these four
requirements is not met, the measure at issue is inconsistent with Art 5.7. As to what
constitutes a „reasonable period of time“ to review the measure, the Appellate Body
points out (Paragraph 93), that this has to be established on a case-by-case basis and
depends on the specific circumstances of each case, including the difficulty of obtaining
the additional
information necessary for the review and the characteristics of the
provisional SPS measure.

27

ANNEX III

THE FOUR COMPONENTS OF RISK ASSESSMENT

An attempt to complete as far as possible these four components should be performed
before action is taken.

Hazard identification means identifying the biological, chemical or physical agents that
may have adverse effects. A new substance or biological agent may reveal itself through
its effects on the population (illness or death), or on the environment and it may be
possible to describe the actual or potential effects on the population or environment
before the cause is identified beyond doubt.

Hazard characterisation consists of determining, in quantitative and/or qualitative terms,
the nature and severity of the adverse effects associated with the causal agents or activity.
It is at this stage that a relationship between the amount of the hazardous substance and
the effect has to be established. However, the relationship is sometimes difficult or
impossible to prove, for instance because the causal link has not been established beyond
doubt.

Appraisal of exposure consists of quantitatively or qualitatively evaluating the
probability of exposure to the agent under study. Apart from information on the agents
themselves (source, distribution, concentrations, characteristics, etc.), there is a need for
data on the probability of contamination or exposure of the population or environment to
the hazard.

Risk characterisation corresponds to the qualitative and/or quantitative estimation, taking
account of inherent uncertainties, of the probability, of the frequency and severity of the
known or potential adverse environmental or health effects liable to occur. It
is
established on the basis of the three preceding and closely depends on the uncertainties,
variations, working hypotheses and conjectures made at each stage of the process. When
the available data are inadequate or non-conclusive, a prudent and cautious approach to
environmental protection, health or safety could be to opt for the worst-case hypothesis.
When such hypotheses are accumulated, this will lead to an exaggeration of the real risk
but gives a certain assurance that it will not be underestimated.

28