Extract from Commission communication COM(2000)1 on the precautionary principle
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:
ï examination of the benefits and costs of action or lack of action
ï examination of scientific developments.
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 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.
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.
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
A comparison must be made between the most likely positive or negative 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.
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:
ï 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.
ï Research must be carried out to elicit the additional scientific data required for a more objective assessment of the risk.
ï 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.
ï 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.