On 6 May 2021, the Court of Justice of the European Union (First Chamber) (“CJEU”) gave judgment in Case C-499/18 P Bayer CropScience AG and Others v European Commission. The case is the culmination of long-running litigation concerning neonicotinoid pesticides and their alleged effects on bees. The judgment is significant for what it says about the effect of the precautionary principle in the context of regulatory action to withdraw an existing approval.
The appeal concerned the application of Article 21 of Regulation (EC) No 1107/2009 (the “Plant Protection Product Regulation”), which governs the Commission’s ability to review the approval of active substances in cases where there is reason to believe that the criteria for approval are no longer satisfied. The main issue on the appeal was how the precautionary principle should be applied in the context of a regulatory structure itself expressly stated to be an application of that principle.
The CJEU’s judgment confirms that there is a low bar on the initiation of a review, and a high bar on challenging restrictive measures taken as a result of such a review. The appeal had criticised the methodology and slender evidential basis for the review process, saying that more solid scientific reasons should have been shown before an existing approval was withdrawn. The CJEU held that the precautionary principle did not require an exhaustive risk assessment to be undertaken. Nor did it require the Commission to provide the producer of the substance under consideration an opportunity to carry out new studies in order to fill any gaps identified in the available data. The Commission was entitled to take action where a risk could not be ruled out. In application of the principle of proportionality, even if a requirement for an impact assessment could be implied, it could be satisfied by a high-level review.
The CJEU gave guidance as to the application of the burden of proof. It held that the precautionary principle applies even where it proves impossible to determine with certainty the existence or extent of the alleged risk; and clarified that the initial burden of proof reverts to the party concerned upon production of solid and convincing evidence which gives rise to reasonable doubt as to whether an active substance satisfies the approval criteria.
A copy of the Judgment can be found here.