Application of the Precautionary Principle in the European Union – What Will Change

Ursula Schliessner
Oppenheimer Wolff & Donnelly LLP
Brussels, Belgium

Editor’s Note: There have been a series of decisions taken by the Court of First Instance (the "CFI") and the European Court of Justice (the "ECJ") in the last two years interpreting the Precautionary Principle (the "PP"). Moreover, the European Commission (the "Commission"), the European Union’s ("EU") executive body, issued a policy paper at the beginning of 2000 on the same subject outlining its future day-to-day application of the PP. This article examines these recent developments and draws conclusions of their impact to EU policy.

Introduction
The PP is explicitly mentioned in the EC Treaty only once, in relation to the European Community ("Community") policy on the environment. (Although previously used, the PP was finally recognized as a principle of international environmental law with its incorporation as Principle 15 of the 1992 Rio Declaration, which reads: "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.") Article 174 (2) EC Treaty specifies that "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." The PP is not defined in the EC Treaty. Over and above its application in environmental policy, the EU has more recently also introduced the PP into other areas of Community policy, namely those relating to human, animal and plant health. See, e.g., Commission White Paper on Food Safety (COM (1999) 719 (Final).

Case Law of the European Courts
The ECJ and the CFI have recently had several opportunities to express themselves on the PP. Some of the major rulings are reviewed briefly below. Additional cases not discussed here include T-199/96 Laboratoires pharmaceutiques Bergaderm SA; and Jean-Jacques Goupil v. Commission of the European Communities; C-157/96 (BSE); T-70/99 (order on application for interim relief in Alpharma Inc. v. Council of the European Union – withdrawal of bacitracin zinc (antibiotic) from the list of authorized additives for feedingstuffs).

The British BSE Case
The first landmark decision – though it did not actually mention the term PP – was the ECJ’s judgment of May 5, 1998 in the British BSE case in which the United Kingdom contested the legality of the Commission’s decision to ban British beef for intra-Community trade pending the U.K.’s implementation of hygiene measures. Case C-180/96 United Kingdom of Great Britain and Northern Ireland v. Commission of the European Communities. The Commission had argued, on the basis of the opinions of its Scientific Committee, that a ban was justified pending further examination of the facts and that it could not be excluded that BSE was linked to the outbreak of Creutzfeldt-Jakob disease in the U.K. The U.K. argued, among other points, that the Commission had misused its powers, that the principle of proportionality was breached and that the Commission decision did not respect the principle of legal certainty.

The ECJ held that under the secondary Community legislation in question, the Commission was entitled to adopt safeguard measures in response to the publication of new information despite the fact that the disease had been in existence for a long time. On the basis of this new information, the link between BSE and Creutzfeldt-Jakob disease had become a possibility. The ECJ recalled that in the present case the Commission enjoyed a wide measure of discretion and that in such case, the ECJ must restrict itself to examine whether the Commission has committed, in exercising such discretion, a manifest error, or a misuse of powers, or whether the Commission clearly did exceed the bounds of its discretion – which the ECJ denied in the present case in view of the uncertainty of the adequacy and effectiveness of the U.K. measures and the seriousness of the public health hazard. As to the proportionality of the Commission measures, the ECJ argued that in the case at hand, the Community legislature had a discretionary power corresponding to the political responsibilities given to it in the Treaty. Consequently, the measure adopted would only be illegal if it had been manifestly inappropriate. The ECJ held that where there is uncertainty as to the existence or extent of risks to human health, the institutions could take protective measures without having to wait until the reality and seriousness of those risks become fully apparent.

The ECJ argued that this approach is borne out by Article 174 (1) EC Treaty which states that the Community environmental policy – which shall be based on the principle that preventative action should be taken and that environmental protection requirements should be integrated into the definition and implementation of other Community policies – has as its objective, amongst others, the protection of human health. The conclusiveness of this reasoning is doubtful. First, it is unclear why the ECJ made reference to the other principles of Article 174 rather than to the PP. Second, the mere fact that the Community environmental policy is based upon the principle that preventative action should be taken, does not make this principle applicable to other policy areas, i.e., to public health policy. Third, this gap can also not be closed by arguing that environmental protection requirements should be integrated into other Community policies. The more appropriate justification is given by the ECJ in the same case in the Order on application for interim relief of July 12, 1996. The Court argues in this instance (para 63 of the Order) that Article 3 (p) of the EC Treaty requires the Community to contribute to the attainment of a high level of health protection (see also Article 152 (1) EC Treaty). However, there is no explicit mention of the PP in either Article 3 (p) or Article 152 EC Treaty.

Finally, the ECJ held that a dissenting opinion of one of the members of the Commission’s Scientific Committee was sufficient to plead scientific uncertainty in the given case.

Virginiamycin
In the case involving the withdrawal of Virginiamycin from the list of authorized additives under Council Directive 70/524 (additives in feedingstuffs), Case T-13-99 R Pfizer Animal Health SA/NV v. Council of the European Union, the CFI issued an order (later confirmed by the ECJ) rejecting the interim relief – to suspend the withdrawal until the decision in the main proceedings – requested by the applicant. According to the CFI, the assessment of the urgency of the matter and the balancing of interests did not justify interim relief. The CFI did not accept Pfizer’s economic argument that its sole facility producing Virginiamycin would have to be closed following the ban of Virginiamycin, or that the ban, pending a decision in the main proceedings, would have other significant economic impacts on Pfizer’s operations.

In any event, even if Pfizer had succeeded in establishing the existence of serious and irreparable damage, the CFI indicated that it would still not have arrived at a different outcome. The CFI weighed the interest of the applicant against the interest of the other parties. The CFI held that in the case at hand, the damage to the commercial interests could not outweigh the damage to public health which would be liable to be caused by the suspension of the ban and which could not be remedied if the main proceedings were subsequently dismissed. The CFI reiterated its previous case law that the protection of public health must take precedence over economic considerations. The CFI stated that where there is uncertainty as to the existence or extent of risks to human health, the institutions might take protective measures without having to wait until the reality and seriousness of those risks become fully apparent. The CFI held that the risk of increased antimicrobial resistance in humans is based on the assumption that bacteria resistant to Virginiamycin in animals are transmissible to humans. The CFI cited scientific findings according to which the magnitude of the medical and public health impact of antimicrobial use in animal feed production is not known. Despite this uncertainty, however, there is enough evidence to cause concern. In addition, the duration of exposure to and concentration of the antimicrobials seem to play a role. Therefore, the CFI held that "in those circumstances, without prejudging the examination by the Court of the assessment of the extent of the risk, which must be established by the institutions concerned when adopting a precautionary measure, the mere existence of the risk so identified is enough in itself to justify taking into account, in the balancing of interests, the protection of human health." (Emphasis added).

Bt 176
In Case C-6/99 Association Greenpeace France and Others v. Ministère de l’Agriculture et de la Peche and Others, the French Conseil d’Etat had referred a case for a preliminary ruling to the ECJ in which the ECJ had to examine whether a Member State had to authorize the placing on the market of a genetically modified organism (Bt 176 maize/corn) in accordance with Part C of Directive 90/220 once the Commission had handed down a favorable decision in this respect, or whether rather the Member State has discretion – on the basis of the PP – not to do so. The ECJ responded that the PP was already built into Directive 90/220, namely into its Articles 12 (1) (full risk assessment required), 11 (6) (notifier must immediately submit new information on the genetically modified organism) and 16 (possibility for the Member States to invoke safeguard measures if new information becomes available) and that, therefore, France would not be entitled to invoke the PP independently.

Trichloroethylene
In Case C-473/98 Kemikalieinspektionen v. Toolex Alpha AB, the Swedish authorities had prohibited the marketing and use of products containing trichloroethylene for industrial purposes in Sweden subject to exemptions to be granted on a case-by-case basis. As there is no Community secondary legislation on this subject, the ECJ had to assess the case on the basis of Articles 28 and 30 EC Treaty (free movements of goods). Once more the ECJ held that health and life of humans ranked foremost among the interests protected in Article 30 EC Treaty and that the measure was proportional to the aim pursued. The ECJ concluded that "taking account of the latest medical research on the subject, and also the difficulty of establishing the threshold above which exposure to Trichloroethylene poses a serious health risk to humans, given the present state of the research, there is no evidence in this case to justify a conclusion by the Court that national legislation such as that at issue in the case in the main proceedings goes beyond what is necessary to achieve the objective in view." While the case focused on an assessment of the issue of proportionality, it is noteworthy that the underlying assumption for the conclusion that the Swedish measures were considered necessary and thereby proportional was the difficulty of establishing a safety threshold for exposure to trychloroethylene. The ECJ decided that in such a case, the Swedish government was entitled to adopt the most stringent, i.e., the most precautionary, of all measures, namely a marketing ban – rather than establishing a (low) threshold.

Commission Communication
As there is no conclusive definition of the PP either in the EU Treaty or in secondary Community legislation, the Commission, in its long awaited Communication of February 2000 (the "Communication"), attempted to (i) give a definition and the scope of application of the PP, and (ii) define the criteria for application of the PP. See COM (2000) 1 Final (Unless a Communication is a disguised binding legal measure (e.g., a Directive, Decision, or Regulation) for which the wrong form was used, a Communication is a non-binding policy paper that may set out the Commission’s thinking in certain areas). The PP and its scope are defined as follows: "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 plant health may be inconsistent with the chosen level of protection." The Communication concludes that recourse to the PP presupposes: (a) the identification of potentially negative effects resulting from a phenomenon, product or procedure; as well as (b) 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.

Once the scientific evaluation mentioned above has been performed, the so-called "triggering" factor for a decision based on the PP is given. According to the Commission, the absence of scientific proof to the existence of a cause-effect relationship, a quantifiable dose-response relationship, or a quantitative evaluation of the probability of adverse effects following exposure should not be used to justify inaction. Scientific advice supported only by a minority segment of the scientific community, provided the credibility and reputation of this segment is recognized, is sufficient. The above "fact finding" phase is classified as risk assessment. The actual administrative follow-up, a decision based on the PP, is classified as risk management.

Once the risk management process comes to the conclusion that action is deemed necessary on the basis of the PP, the measures – according to the Communication – must meet the following parameters:

• be proportional to the chosen level of protection (notion of the least restrictive measure);
• be non-discriminatory in their application;
• be consistent with similar measures already taken;
• be based on an examination of the potential benefits and costs of action or lack of action (including where appropriate and feasible a cost/benefit analysis);
• be subject to review in the light of new scientific data; and
• be capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment (issue of burden of proof).

The last bullet point is quite controversial. Currently, the burden of proof as to whether a particular substance or product is safe lies with the producer in those cases in which the substance or product is subject to a pre-market approval procedure, whereas it lies with the public authorities or other stakeholders where products or substances may be marketed without pre-market approval. The Communication argues that measures based on the precautionary principle will be able to reverse the burden of proof in the latter instance.

Issues and Concerns
There are two principal issues of concern in relation to the use of the PP, the scope of its use, and the possibility of a judicial review of the use of the PP. As to the first issue, in view of the case law of the European courts (see BSE, Virginiamycin, Trichloroethylene), it has to be taken as a given that the PP’s scope has been extended from purely environmental policy to human and potentially animal health policy. Although the PP is not explicitly mentioned in those EC Treaty provisions relating to human health, it is indeed arguable that the PP is indirectly built into Articles 3 (p) "preventing human illness" and 152 EC Treaty "attainment of a high level of health protection." However, the way of extrapolation of applicability of the PP, as the ECJ inferred in the BSE case, appears far-fetched. If indeed it is taken as a given that the PP is recognized both for environmental as well as for health policy, then the next step would be to examine whether the PP can be used directly – either on the basis of the EC Treaty or on the basis of national law where existent – to justify legislative action and determine whether there are limits to its use. It is arguable that where the PP enters into "competition" with other high-ranking environmental principles, such as the polluter-pays principle or the principle that preventative action should be taken (see Article 154 EC Treaty), there is no compelling reason – and no case law yet – to the extent that the PP should take precedence over these other principles. It is noted, however, that with regard to the principles enshrined in the EC Treaty following standing case law, protection of human health – and application of the PP thereto – prevails over economic and property considerations. See CFI in Virginiamycin and ECJ in Trichloroethylene. Further, where the PP is incorporated into secondary legislation (e.g., in the form of a risk assessment and risk management procedure such as in Directive 90/220), it would be illegal to apply the PP independently or a second time. See ECJ in Bt 176. Hence, the PP may only be applied in those cases in which it is not yet incorporated into secondary legislation.

As to the second issue, that of judicial review, the Commission submits in its Communication that application of the PP is a measure of risk management. Risk management is considered a typical political/legislative issue in which the legislator has large discretion. Following the case law of the European courts, use of the PP – that is the choice of the precautionary level – would hence be subject to limited judicial review only, namely in relation to (i) misuse of powers (e.g. an arbitrary measure); (ii) manifest error (e.g. wrong facts); or (iii) exceeding bounds of discretion. The actual measure adopted to achieve the chosen precautionary level of protection would be subject to judicial review against the six criteria that the Commission has committed to apply in its Communication.

Conclusion
The PP is recognized as a principle of international and European environmental law. Its scope has recently been extended by the European courts to human health policy. Where the PP is incorporated into secondary Community legislation, either explicitly or implicitly, there is no scope for a second application. Following the case law of the European courts, use of the PP by European or national legislators is subject to only limited judicial review. The legislator has large discretion as to the choice of the level of health or environmental protection required. Once this level of protection is chosen on the basis of the PP, the actual measures taken could be assessed in court against the six criteria to which the Commission has committed in its recent Communication.

Given the limited mechanisms for judicial review and the European and national legislator’s tendency to apply the PP in all cases of scientific uncertainty, including on the basis of minority scientific opinions, it is likely that more and more EU and national measures will be based on the PP. Adding the sketchy European interim relief mechanisms to this picture, it is very likely that many products will be withdrawn or banned from use on the European market on the basis of the PP in the near future.