Opinion of the Economic and Social Committee on 'Use of the precautionary principle'
Date: 2000-07-12
Institutions: European Economic and Social Committee
Subjects: consumer protection, health risk, industrial hazard, public health, public safety

C 268/6

EN

Official Journal of the European Communities

19.9.2000

Opinion of the Economic and Social Committee on ‘Use of the precautionary principle’

(2000/C 268/04)

On 2 March 2000 the Economic and Social Committee decided to draw up an opinion, under Rule 23(3)
of its Rules of Procedure, on ‘Use of the precautionary principle’.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 21 June 2000. The rapporteur
was Mr Bedossa.

At its 374th plenary session (meeting of 12 July 2000) the Economic and Social Committee adopted the
following opinion by 101 votes to two, with one abstention.

1.

The Commission communication

1.1. Summary

At Community level, the only legal reference to the
1.1.5.
precautionary principle is to be found in Article 174 of the
Treaty (environment). However, the Commission considers
this a more general principle which should be taken into
consideration in risk management in the fields of health and
consumer safety.

On 13 April 1999, the Council asked the Com-
1.1.1.
mission ‘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’. Among other things, this Com-
mission communication responds to that request.

1.1.6.
There are more legal references at international level.
They are to be found inter alia in the Rio Declaration, the
United Nations’ Framework Convention on Climate Change,
the Convention on Biological Diversity and the Protocol on
Biosafety. Within the WTO, the principle is given practical
expression in the Agreement on Sanitary and Phytosanitary
Measures (SPS) and the Agreement on Technical Barriers to
Trade (TBT).

1.1.2.
The purpose of the communication is to set out the
Commission’s intended approach to the application of this
principle, both within the European Union and internationally.
It also seeks to provide an input to the ongoing debate on the
principle, both within the Community and at international
level.

The precautionary principle must be considered
1.1.3.
within a structured approach to the analysis of risk which
comprises three elements: risk assessment, risk management,
risk communication.
In the Commission’s view, the pre-
cautionary principle is particularly relevant to the management
of risk. Faced with a situation in which potentially dangerous
effects deriving from a phenomenon, product or process have
been identified, and preliminary scientific evaluation does not
allow the risk to be determined with sufficient certainty, it is
up to political decision-makers to judge what is an acceptable
level of risk for society. In such situations, decision-makers
may invoke the precautionary principle, which may involve a
decision to act or a decision not to act.

1.1.4. Where action is deemed necessary, measures based
on the precautionary principle must meet a series of con-
including, among others, proportionality, non-dis-
ditions,
crimination, consistency and an examination of benefits and
costs and of scientific developments.

In connection with the Codex Alimentarius, a
1.1.6.1.
debate is under way, with the active involvement of the
Commission, on laying down risk analysis criteria in the food
sector, including, among other things, arrangements for use of
the precautionary principle.

2.

Preliminary comments

2.1.
On the eve of the 21st century, risk acceptability
requires new types of rules. Fear is generated by danger, but
risk is not the same thing as danger. We take a risk, while we
can avoid danger. In western culture, the emergence of the risk
concept testifies to a profound change in the relationship with
danger. We can decide in a completely rational way to expose
ourselves to danger or certain dangerous situations. Risk does
not equate with fear, but with courage.

The current situation may be considered in two ways.
2.2.
The contemporary risk indicator is the notion of disaster. The
19th and 20th centuries were preoccupied with the idea of
accident. Today, the nature of risks has changed, with a shift
from accident to disaster. These include natural and climate-
related disasters,
increasingly,
disasters with an impact on health.

technological disasters and,

19.9.2000

EN

Official Journal of the European Communities

C 268/7

2.3.
It is remarkable to note how far environmental issues
now focus on health concerns rather than the defence of
nature.

2.11.
elements:

The precautionary principle has three substantive

2.4.
The change in the nature of risk also has an impact on
the nature of damage. Not only is disaster-level damage now
uninsurable, but, above all, it is not subject to compensation.
This calls into question the principle underpinning the major
social pact of the 20th century, namely that an acceptable risk
is a risk which can be compensated.

2.5.
Risks go beyond the bounds of compensation, but also
involve an element of irreversibility. The concept of sustainable
development stipulates that nothing should be done which
cannot be undone. Nothing we do should be definitively
binding on future generations.

2.6.
Fear raises the question of social relationships in a
society experiencing severe asymmetry in the technologies it
deploys. Technology makes relationships unequal; that means
that a system of collective bargaining cannot be the point of
reference for the technological society. We live in an unequal
society in which risk creates asymmetry. The issue of the
responsibility — and trustworthiness — of those who handle
risk is thus particularly acute.

2.7.
The first point to be made here concerns decision-
making. The Commission communication asks what consti-
tutes acceptable risk and when a risk can be taken. The key
term here is now precaution. Precaution is not the same thing
as prevention. A preventive stance requires a measurable risk;
prevention relates only to measurable or controllable risks.

2.8.
People are asked to exercise precaution when, over and
above risks which have to be controlled and measured, they
are required to take risks which they cannot yet comprehend
but which are likely to be revealed at some future stage of
scientific development. Contemporary risk has an extraordi-
narily long timeframe. Technical safety issues thus give way to
issues of ethical security.

2.9.
The quest to find an ethical and legal framework for
the emerging new world of the 21st century is being conducted
— in more and more cases — through the courts, as well as
via contemporary attitudes to the risk issue and debates which
would benefit from a little scientific rigour.

— Firstly, precaution involves stepping up the drive to boost

knowledge.

— Secondly, it means establishing scientific and technologi-
cal monitoring schemes to identify new knowledge and
understand its implications.

— Thirdly, precaution means staging a wide-ranging social

debate on what is desirable and what is feasible.

2.12.
Confidence can be restored by setting up a watertight
system for monitoring knowledge. Scientific-monitoring
schemes must seek to identify weak signals. Without the
capacity to deal with weak signals, decision-makers can offer
only an ‘all-or-nothing’ response. This means, in the current
public health climate, that they are likely to take action, since
the public, while not calling for zero risk, does demand that
information on risk factors be taken into account without
delay.

It

2.13.
is up to the public authorities to create an
environment for debate in which the social players can address
(i) objective health risk data, (ii) forecasts of the effectiveness
of preventive action and (iii) the concerns of the public at
large. This social dimension is an integral part of any sound
application of the precautionary principle. It is here that the
‘consensus conferences’ come in.

2.14.
The value of quantitative risk analysis and cost-benefit
analysis schemes must not be overrated. Nor must the figures
involved be exaggerated. Risk assessment must be fostered as
part of the negotiation mechanism on social issues. Its actual
role in society is to provide the bases for dialogue.

2.15.
The public needs to know exactly whom to contact
on perceived threats. To build up confidence, arrangements
must be set in place for this purpose as part of a European
mechanism. Such a mechanism — which is social, organis-
ational and scientific — is subsumed in the precautionary
principle.

2.10.
Precaution is essential to any risk analysis ‘process’.
As part of this process, the precautionary principle is an
approach to risk management applied in cases where there is
an unknown and potentially highly dangerous risk — pending
scientific research findings at a later stage.

The

2.16.
advancement of democracy requires new
decision-making processes. Decisions will have to be taken on
the basis of uncertain and extremely complex data rather than
scientific certainties. This is a major volte-face. Subject to this
condition, the demand for health security, far from nurturing
totalitarian ideas, will help promote democracy.

C 268/8

EN

Official Journal of the European Communities

19.9.2000

3. General comments

3.1.
The precautionary principle extends what is known
under public law as the ‘policing powers’ of the authorities. To
this end, the State, which is traditionally in charge of health,
safety and order, can and must take measures which run
counter to, curb, limit and suspend the right to free expression,
demonstration and trade and the freedom to engage in
entrepreneurial activity. The precautionary principle seeks to
extend these powers of intervention, not as a target per se, but
in their practical application.

3.2.
This new responsibility has major implications at
international level. It enables countries to temporarily suspend
their free trade commitments. The precautionary principle
gives countries a sovereign right — and makes them the sole
arbiter — on matters affecting the safety of their nationals.
There is thus a stark contradiction with the EC Treaty.

3.3.
This purpose of the Commission communication is to
iron out that contradiction: once the principle is recognised
as applying in a European and international context, the
Commission is seeking to lay down a common definition, so
that each country is no longer able to prescribe a definition of
its own. It is a way of invoking a public policy exception.

4.1.3.
The Economic and Social Committee agrees that the
policy framework is now a matter for political decision-makers
and ultimately the courts.

4.1.4.
At international level, recognition of the precaution-
ary principle has been a long process, starting with the 1982
World Charter for Nature. Recognition has continued apace in
various different conventions,
leading to the progressive
consolidation of the principle in international environmental
law. It has thus become a fully-fledged and general principle
of international law.

4.1.5.
needs of
protection.

Under WTO agreements, this law is adapted to the
to environmental
international

linking it

trade,

4.1.6.
In terms of WTO agreements, the SPS and TBT
agreements make it possible to regulate trade in the light of
the aims of protection of the public. The SPS agreement covers
sanitary and phytosanitary measures to protect human, animal
and plant health based purely on scientific grounds. The TBT
agreement covers all technical barriers to trade (labelling,
standards, composition etc.) Its purpose is to reduce unwar-
ranted technical obstacles to trade. The SPS and TBT agree-
ments ensure that the precautionary principle is appropriately
enforced in this legal order (WTO) without, however, men-
tioning it specifically.

3.4.
The precautionary principle is only the State’s responsi-
bility. Under this principle, the State must act in line with
certain hypotheses. The precautionary principle also makes
the State responsible for abstention from action. Such failure
to act jeopardises the State’s own national producers in relation
to other EU and non-EU countries, which can then take
advantage of the situation. The precautionary principle is a
principle of action, not inaction.

4.1.7.
The Economic and Social Committee shares the
Commission’s view that the EU must be entitled to prescribe
an appropriate level of protection within a suitable framework
— when this is justified — in all areas, i.e. the environment as
well as human, animal and plant health. The EU will thus be
widening the stance which it will have to defend at inter-
national and multilateral level.

3.5.
State action will apply to the decision-makers con-
cerned, but it is not up to them to make the first move. That is
in any case impossible given the vagueness of the precautionary
principle. How can a decision-maker reasonably determine
what constitutes a risk of serious damage, an effective and
proportional measure or economically viable cost?

4.

Legal bases

4.1.1.
At European level, the Economic and Social Com-
mittee notes that there are as yet few legal bases for a
precautionary principle and that case law is still in its infancy.

5.

Specific comments on the guidelines set out in the
communication

5.1. Why the need for guidelines?

5.2.
Guidelines are needed in an attempt to provide a fuller
picture of this principle. Its application must be dynamic
and subject to variation over time and in accordance with
circumstances. It is necessary to try (i) to identify the main
the principle needed to establish increasingly
features of
objective data, based on the broadest possible legal
infor-
mation, (ii) to derive, if possible, sound case law and (iii) to
arrive at policy orientations.

4.1.2.
Explicit and implicit allusion to this principle does
not provide a solid base, and the Economic and Social
Committee would ask the Commission to submit a concrete,
viable case soon.

5.3.
The Economic and Social Committee shares the Com-
mission’s view that the precautionary principle has become
in particular to environmental
a general axiom applying,
protection, and gradually being extended to human, animal
and plant health.

19.9.2000

EN

Official Journal of the European Communities

C 268/9

5.4.
Noting that the precautionary principle originated at
both national and international level, not least in the WTO
agreements, the Economic and Social Committee agrees with
the Commission that
the European Community has the
absolute right to establish whichever level of protection it
wishes in the areas covered by this principle. It is particularly
important to have arrangements in place for applying the
precautionary principle, since this principle will have reper-
cussions on the EU’s room for manoeuvre and on the stances
it defends at international and/or multilateral level in relation
to risk management.

Two kinds of measures arise out of the use of the

5.5.
precautionary principle:

Decision-makers alone — in this case the appropriate
5.5.1.
political and/or administrative authority — chose whether or
not to act.

The Economic and Social Committee also considers
5.5.2.
that the precautionary principle can be applied in various
different ways, in response, among other things, to sectoral
difficulties, without necessarily going as far as to involve the
adoption of legal instruments, which may always be subject to
judicial review.

7.

The triggering factor

The communication states that all partners should be
7.1.
involved in the study of various risk management options
which may come to light once the results of risk assessment
are available and that the procedure must also be as transparent
as possible.

7.2.
In this way, risk assessment can be made more
transparent and assessment quality can be improved by
gathering additional knowledge and/or information. It can also
help reinforce the credibility and acceptance of risk assessment.

The triggering factor is likely to be scientific uncer-

7.3.
tainty, rather than certainty.

Decision-makers alone determine whether action is to

7.4.
be triggered.

7.5.
In the interests of transparency, the options proposed
must be clear, accessible and generally understandable; the
complete file must be available (risk assessment, scientific data,
options taken into account). There must be complete openness
except in duly clarified individual cases.

6.

Implementation

8.

Proportionality

6.1.
The communication states that the implementation of
an approach based on the precautionary principle should start
with an objective assessment of the risks, identifying wherever
possible the degree of scientific uncertainty at each stage.

There is however a fundamental difference between
6.2.
risk assessment and risk management. Risk assessment must
be conducted by independent specialist scientists or must at
least be open to independent examination. Risk management,
on the other hand, is a matter for decision-makers, and it is
also up to them to decide whether there is a need for recourse
to the precautionary principle and how that principle is to be
applied.

The preventive element of

6.3.
reinforced only by:

this principle can be

— making the decision-making process as open and trans-

parent as possible

— educating and communicating in the clearest of terms by

way of extremely broad-based consultation.

6.4.
In the absence of certainty, the precautionary principle
must provide guidance for the decision-making process: in the
interests of efficiency and utility, formal risk assessment —
together with the analysis of scientific uncertainties — should
have a timeframe and be subject to deadlines.

8.1.
The Commission states that measures based on the
precautionary principle must be proportional to the desired
level of protection and to the risk to be reduced or eliminated.

8.2.
The fact that negative impact often comes to light only
after long exposure makes it more difficult to establish cause
and effect. Consequently, the precautionary principle must be
invoked and applied all the more frequently, not least in cases
where the risk is not directly perceptible.
In such cases,
consideration must be given to the proportionality of measures
taken in respect of a risk the potential impact of which may lie
in the distant future.

9. Non-discrimination

The communication states that measures should not

9.1.
be discriminatory in their application.

The Economic and Social Committee endorses this
9.2.
point on the basis of the objectively warranted principle of
treating comparable situations in a comparable way.

10. Consistency

The communication states that measures should be
10.1.
consistent with the measures already adopted in similar
situations or using similar approaches.

C 268/10

EN

Official Journal of the European Communities

19.9.2000

10.2.
The Economic and Social Committee naturally
endorses this point. Precautionary measures must be compar-
able in type and scope with the measures taken in equivalent
fields in which all the scientific data are available.

11. Examination of the benefits and costs

11.1.
The communication states that measures based on
the precautionary principle must include a cost-benefit analysis
in order to reduce the risk to a level acceptable to all concerned.

It is not possible to quantify adverse consequences
11.2.
for society, human health and the environment in exclusively
financial terms or to assess economic and moral impact purely
on the basis of a cost-benefit analysis.

11.3.
This examination of benefits and costs takes place
between the scientific evaluation and the choice of risk
management. It comprises cost-benefit analyses and must take
account of related non-economic considerations (social and
cultural acceptability, organoleptic properties etc.). This exam-
ination must in no way impact on the level of protection set
by society for its citizens but must be an aid in selecting the
best form of risk management for society as a whole.

12. The burden of proof

12.1.
The Commission states that measures based on the
precautionary principle must assign responsibility to the party
who must produce the scientific evidence necessary for full
risk evaluation.

12.2.
The Economic and Social Committee shares the
Commission’s view that the clause reversing the burden of
proof and placing it on the producer, manufacturer and
importer cannot be turned into a general principle. However,
the ESC feels that such a reversal of the burden of proof is
possible where a predetermined ‘positive’ list is available, inter
alia in the case of substances deemed a priori to be dangerous
or which may be dangerous at certain absorption levels.

13. Examination of scientific developments

13.1.
The communication states that measures based on
the precautionary principle must be provisional pending the
outcome of research designed to provide missing information
and achieve more objective risk assessment.

The Economic and Social Committee endorses this
13.2.
principle, particularly where more complete scientific research
is required to provide the fresh results needed to ensure
ongoing objective risk assessment. As it is, further periods of
research and development are often needed without entailing
long and complicated legal and political procedures.

11.4.
Economic cost-benefit analyses must reflect the costs
and benefits of risk management arrangements for the Euro-
pean Union as a whole and for each individual socio-economic
sector involved in risk management. Costs and benefits must
not thereby be measured solely in budgetary terms but must
take account of a range of indicators such as employment,
competitiveness and markets.

At the end of this process, the appropriate authority
11.5.
will be in a position to select the risk management option
most suited to its political priorities and obligations. The
authority should also be aware of the impact of its decision on
all the socio-economic players (stakeholders) involved so that,
where appropriate, they can be offered compensatory measures
under the risk management scheme.

14. Conclusion

14.1.
The Economic and Social Committee is pleased that
the Commission intends to establish specific guidelines for the
application of the precautionary principle.

14.2.
The Economic and Social Committee shares the
Commission’s view that it is a matter for political decision-
makers to determine whether or not to act, and that action
must be triggered on the basis of a codex (set of rules) as
described above. The Committee would ask the Commission
to clarify the risk analysis procedures and to ensure that the
guidelines for applying the precautionary principle fall within
a framework which incorporates management systems, inter-
action among the appropriate institutions and, in particular,
the involvement of all the players concerned (stakeholders).

19.9.2000

EN

Official Journal of the European Communities

C 268/11

14.3.
In conclusion, the Economic and Social Committee
feels it is essential for the European Union to reach, if possible,

an international consensus on arrangements for applying the
precautionary principle.

Brussels, 12 July 2000.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI

Opinion of the Economic and Social Committee on the ‘Proposal for a European Parliament and
Council Decision establishing the list of priority substances in the field of water policy’

(2000/C 268/05)

On 13 March 2000 the Council decided to consult the Economic and Social Committee, under
Article 175 of the Treaty establishing the European Economic Community, on the above-mentioned
proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 21 June 2000. The rapporteur
was Mrs Sa´nchez Miguel.

At its 374th plenary session (meeting of 12 July) the Economic and Social Committee adopted the
following opinion by 114 votes to one with one abstention.

1.

Introduction

One of the main obstacles to achieving the objectives
1.1.
set out in the WFD (Water Framework Directive)
is the
presence of increasing quantities of — and ever more diverse
— chemical substances in water, posing a serious risk to the
balance of eco-systems, the environment and human health.
The European Inventory of Existing Commercial Chemical
Substances (EINECS) has more than 100 000 entries and is
growing yearly.

1.2.
Despite the slowness with which risks are assessed,
there is increasingly firm evidence that exposure to even small
quantities of these substances is dangerous. At the moment
there is considerable concern over those substances which act
as endocrine disrupters and affect, among other functions, the
reproductive capacity of
including human
beings.

living species,

1.3.
Accordingly the primary objective of the Commission
proposal is to establish a new list of priority substances to
replace the list established under Directive 76/464/EEC, in
accordance with the proposed WFD.

1.4.
The method used for establishing this list combines
a procedure known under the abbreviated title COMMPS
(combined monitoring-based and modelling-based priority
the
setting) and an open and transparent discussion of
substances or groups of substances selected, culminating in
the list of priority substances.

The objective of establishing a new list is totally
1.5.
justified on account of the crucial role in future monitoring to
be played by the WFD, basically because:

1.5.1.
In the considerable time which has elapsed since the
adoption of Directive 76/464/EEC we have become more
knowledgeable — and socially concerned — about the effects
of new and historic substances in the aquatic environment,
especially those regarded as endocrine disrupters, which are
currently being regulated (including the UNEP-POP Conven-
tion).

1.5.2.
The WFD establishes a ‘combined approach’ requir-
ing harmonised quality standards and substance emission
limits to tackle the problems arising from point and diffuse
pollution of water bodies. This approach increases the number
of substances or groups of substances requiring more inspec-
tions and monitoring.