June 18
Anjum Shabbir
Anjum Shabbir
11th May 2021
Consumer, Health & Environment Justice & Litigation

Analysis: “The Precautionary Principle Defeats all Challengers: The Court of Justice’s ruling in the Bayer case” by Elijah Granet

An appeal is always a roll of the dice, but in Case C-499/18, Bayer CropScience AG (‘Bayer’) had a particularly unlucky run at the Luxembourg casino.  Their appeal against the General Court’s judgment (T‑429/13 and T‑451/13) failed not merely on all its (rather weak) grounds, but they managed the notable and hapless feat of having the Court of Justice vitiate part of the appealed judgment in favour of the respondents (the Commission), while upholding the legal effect of the unfavourable first-instance holding.  In its ill-fated appeal, Bayer, rather altruistically, managed to helpfully clarify and confirm the extraordinary width of the discretion afforded to the Commission both under the review of measures under Regulation No 1107/2009 (the Plant Protection Product Regulation – ‘PPPR’), and when applying the precautionary principle generally.  This Analysis examines how Bayer’s disastrously weak appeal shone light onto just how strong the precautionary principle is in interpreting the PPPR.

At first-instance, the General Court had held that the Commission, when reviewing the approval of plant protection products under the powers delegated to it under Article 21(1) PPPR was limited to  situations where ‘new scientific knowledge’ had arisen.  As Advocate General Kokott had pointed out in her Opinion, this reading was simply untenable given the plain language of the EU legislature (‘The Commission may review the approval of an active substance at any time’); the Court agreed (even if it let the General Court’s ruling stand notwithstanding this error). This holding notably widens the scope of the powers of the Commission to engage in review of product approvals, and will provide a powerful shield against future legal challenges to reviews.  The Court’s finding at paragraph 50 is clear: the review of approval is not contingent on any threshold criterion.  Bayer’s case was noticeably weak on this point; it attempted to avail itself of one of the recitals to the PPPR, but ignored the overriding teleological force of the  precautionary principle in interpreting the Regulation, which, as the Court made clear in this case, is normatively superior to legal certainty in applying the PPPR.

In this respect, it is possible to have some sympathy for the appellant corporation’s misunderstanding. The ‘precautionary principle’ is an infamously empty turn of phrase which always begs further questions, because while risk and uncertainty are quantifiable, precaution is always a matter of subjective judgment rather than objective science. This is why questions of the application of the precautionary principle fall ultimately to be decided by lawyers and politicians rather than scientific experts (and, indeed, why this analysis focuses entirely on questions of law rather than reviewing staid studies of the apiary impacts of clothianidin, thiamethoxam and imidacloprid).  Bayer tried to plead what we can call the ‘weak’ version of the precautionary principle, in which the general principle of precaution (that a given product is guilty until proven safe) provides only limited discretion and can be displaced by other values, like legal certainty (much like the force of gravity can be displaced by that of magnetism). This argument comprehensively failed, and the Court weighed, on each ground of appeal, on the side of the ‘strong’ version of the principle, in which the discretion implied by precaution is both exceptionally wide and can overcome other countervailing legal considerations..

A paradigmatic example of the strong principle in action can be seen in this judgment at paras 75 et seq. Bayer attempted to argue that the PPPR limited the Commission’s discretion to review pre-existing decisions by requiring a comprehensive assessment (whatever that may mean) of the risks at hand. The Court made very clear that such a proceduralist view of the PPPR was axiomatically contrary to the strong precautionary principle, because the precautionary principle mandates action first, science later. In this reading, mandating a risk assessment would emasculate the precautionary principle by putting procedure ahead of precaution. Instead, the only prima facie safeguard (in the absence of convincing scientific proof of safety) is the uniform standard set by the General Court and confirmed by the Court of Justice: the Commission must ‘provide, in accordance with the general rules of evidence, solid and convincing evidence which, without resolving scientific uncertainty, gives rise to reasonable doubt as to whether the active substance in question satisfies the approval criteria laid down in Article 4 [of the PPPR]’.

As Bayer’s attempts to find exceptions and loopholes in this wide legal standard found no purchase at the Court, it is worth considering just how much leeway this gives to the Commission with regard to plant protection products.  As any common law lawyer can attest, the plain meaning of the English words (the authentic language of this case is English) ‘reasonable doubt’ set a punishingly high threshold.  In light of this case, it is difficult to see, absent truly bizarre circumstances or unusually bulletproof scientific rebuttal evidence, how a successful challenge to a precautionary-minded Commission decision on a plant protection product could proceed in the short term (before the new risk could be comprehensively assessed). On the one hand, it is reasonable to see this wide discretion as fitting the legislature’s intention – made clear in, inter alia, recital 8 of the PPPR – that the approval of plant protection products be highly limited by the overriding teleological imperatives (well-founded in primary legislation) of the protection of humans, animals, and the environment. On the other hand, this case provides a reminder of the problems inherent in throwing scientific epistemology to lawyers.  All the advances in the quantification of risk and uncertainty, and all the voluminous scientific literature on the methodology of risk assessment, are irrelevant here; instead, the question ultimately becomes, in true lawyer fashion, a matter of semantic interpretation about the true meaning of ‘reasonable doubt’, ‘sufficiently documented’, and ‘uncertainty’. The great science fiction writer Isaac Asimov once bemoaned that lawyers are the only high-ranking profession who do not regularly use mathematics (or, at any rate, mathematics that are more complex than the adding up of a client’s bills). As our ability to define, model, quantify, and risk advances thanks precisely to the rigorous application of mathematics and math-adjacent fields (from economics to plant science), the lawyerly insistence that abstract legal norms like the precautionary principle can override our increasingly skilled ability to assess risk may become increasingly untenable.


Elijah Granet is a law lecturer and PhD candidate at Universität Bayreuth in Germany.


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