Case Law: Plant Protection Products

The General Court dismissed the appeal submitted by Pesticide Action Network Europe (PAN Europe) seeking annulment of the European Commission´s decision rejecting the request for internal review of the Commission's Implementing Regulation (EU) 2021/2049, which renewed the approval of the active substance cypermethrin as a candidate for substitution under Regulation (EC) 1107/2009 on the placing of plant protection products (PPPs) on the market. 

PAN Europe claimed that the Implementing Regulation was contrary to the precautionary principle and to the obligation of the EU to ensure a high level of protection of human health and the environment, as laid down in articles 9 and 11, articles 168(1) and 191(1) TFEU, and articles 35 and 37 of the Charter of Fundamental Rights and enshrined, as regards PPPs, in Regulation 1107/2009, in particular article 4. 

The Commission argued that it had a wide margin of discretion as risk manager under Regulation 1107/2009, and that it had considered the scientific risk assessment carried out by the European Food Safety Authority (EFSA) and the rapporteur Member State, as well as other legitimate factors, such as the availability of alternatives and the socio-economic impact of the renewal of the approval of cypermethrin. The Commission also maintained that it had applied the precautionary principle and ensured a high level of protection of human health and the environment by imposing strict risk mitigation measures in the Implementing Regulation, and by leaving the responsibility for the authorization of PPPs containing cypermethrin to the Member States, who had to carry out a comparative assessment under article 50 of Regulation 1107/2009. 

The General Court dismissed PAN Europe's plea in law and the action in its entirety. It held that the Commission had not committed any error of law or manifest error of assessment in its role as risk manager under Regulation 1107/2009, and that it had duly considered the scientific risk assessment and other relevant factors, as well as the precautionary principle and the high level of protection of human health and the environment. 

The General Court also rejected PAN Europe's arguments that the Commission had disregarded the criteria for approval set out in article 4 and Annex II of Regulation 1107/2009, that the risk mitigation measures imposed by the Implementing Regulation were unrealistic and ineffective, and that the Commission had shifted its responsibilities to the Member States.

But the greatest contribution that the General Court makes in this judgement refers to the precautionary principle, on which it concludes the following:

•  The authorization and approval procedures established by Regulation 1107/2009 for PPPs and their active substances are expressions of the precautionary principle.

• Where it proves impossible to determine with certainty the existence or scope of the alleged risk because of the inconclusive nature of the results of the studies carried out, but the likelihood of actual damage to the environment persists should the risk materialize, the precautionary principle justifies the adoption of restrictive measures.
• The precautionary principle justifies the adoption of restrictive measures only if they are non-discriminatory and objective and also proportionate.     

• Thus, the precautionary principle is directed at EU action and cannot be interpreted as requiring a EU institution, solely based on that principle, to adopt a specific measure such as refusing an authorization. While it is true that that principle may justify an institution adopting a restrictive measure, it does not make it mandatory in all circumstances.     

• When scientific assessment does not make it possible to determine the existence of a risk with sufficient certainty, whether or not the precautionary principle should be invoked generally depends on the level of protection chosen by the competent authority exercising its broad discretionary powers. This choice must, however, be consistent with the principle that the protection of public health, safety and the environment takes precedence over economic interests, together with the principles of proportionality and non-discrimination.   

• Scientific risk assessment does not necessarily have to provide institutions with conclusive scientific proof of the risk and its potential adverse effects should the risk materialize. The context in which the precautionary principle is applied corresponds by hypothesis to a context of scientific uncertainty.

• Finally, the adoption of a preventive measure, its withdrawal or relaxation, cannot be made conditional on proof of the absence of any risk, as such proof is practically impossible to provide from a scientific point of view, given that zero risk does not exist in practice. However, a preventive measure cannot validly be motivated by a purely hypothetical approach to risk, based on mere scientific suppositions that have not yet been verified.