European Union: The Court Of Justice Of The EU Rules That The Pre-Market Approval Regime Set By EU Plant Protection Products Regulation Is Compatible With The Precautionary Principle

Last Updated: October 11 2019
Article by Ruxandra Cana, Eléonore Mullier and Filippo Mattioli

By a preliminary ruling request sent by French courts, the Court of Justice of the European Union was asked to rule on whether specific aspects of the EU Plant Protection Products Regulation (Regulation (EC) 1107/2009) were compatible with the precautionary principle. The request was sent to the EU Court as part of pending criminal proceedings before a French Court in which a number of individuals were subject to criminal proceedings for having damaged glyphosate-containing products. In their defence, the individuals had invoked the precautionary principle and questioned whether Regulation 1107/2009 fully ensured the protection of human health in light of the precautionary principle. 

The Court judgment addresses points which are regularly raised against various EU law instruments governing chemicals. It looks at the fact that an applicant has discretion in identifying an active substance to undergo the substance approval process, and it looks at whether the applicable procedures take into account the cumulative effects of constituents of a plant protection product. The judgment also looks at the fact that the evidence supporting the application is for the most part based on studies generated by the applicant itself. The Court also reviewed the rules which prevent full public disclosure of the evidence supporting an application for approval, and the rules imposing (or not) specific tests for the approval of plant protection products. 

For each of these points, the Court finds that the procedures in place under Regulation 1107/2009 are compatible with the precautionary principle – and that, as a result, the EU legislature has not committed a manifest error of assessment. 

The ruling is significant because the elements, and principles, reviewed in the context of the EU Plant Protection Products Regulation are also relevant for other EU chemicals regimes (such as REACH or biocides) – and these elements are now confirmed to be compatible with the precautionary principle and lawful under EU law.  

Specifically, the Court was asked to address four questions, each of them asking if a specific aspect of the Regulation was compatible with the precautionary principle. It answered all questions in the positive – the regime put in place by Regulation 1107/2009 is compatible with the precautionary principle, and the EU legislature has not committed a manifest error of assessment. 

Before dealing with the specific questions, the Court assessed whether the EU legislature has an obligation to comply with the precautionary principle when adopting rules such as Regulation 1107/2009. It found that the obligation is incumbent on the EU legislature, and a correct application of the precautionary principle presupposes, first, the identification of the potentially negative consequences for health, and, second, a comprehensive assessment of the risk "based on the most reliable scientific data available and the most recent results of international research" (paragraph 46). It then considered whether it had to look into the specifics of the approval process for glyphosate, or into the characteristics of the relevant provisions themselves – and found for the latter. Importantly, the Court's judicial review in this matter had to "necessarily be limited to whether the EU legislature, in adopting Regulation 1107/2009, committed a manifest error of assessment" (paragraph 51). 

In response to the specific questions: 

  • Addressing the question as to whether the discretion allowed to the applicant to identify the active substance subject to approval would be incompatible with the precautionary principle, the Court held that the criteria set out for the identification of an active substance by the applicant, and the obligations imposed on the applicant to identify the active substance, do not give the applicant the option of choosing at his discretion the scope of the active substance and found that there was no manifest error of assessment.
  • Addressing the question as to whether the Plant Protection Products Regulation takes sufficiently into account the cumulative effects of substances in a product, the Court identified all the instances in which such cumulative effects are actually considered, and found that there was no manifest error of assessment.
  • Addressing the question as to whether the fact that the tests and analyses submitted by an applicant would be incompatible with the precautionary principle, because they "may be biased" (paragraph 30), the Court assessed in detail all the provisions related to the validity of the tests, methods of analysis, evaluation by Member States and other provisions requiring a high level of scientific basis and found no manifest error of assessment.
  • Addressing the question as to whether the authorisation dossier should be made public, the Court found that the rules related to the public access to information (as interpreted by the Court in particular in Case C-442/14 Bayer CropScience and Stichting De Bijenstichting but also in Case T-545/11 RENV Stichting Greenpeace Nederland and PAN Europe v. Commission) are suitable, and as a result, there is no manifest error of assessment.
  • Finally, addressing the claim that no studies of carcinogenicity and toxicity are required for the authorization procedure, the Court found that the applicable rules do not exempt the applicant from submitting such tests, and accordingly that there is no manifest error of assessment. 

The Court concludes, to the point, that "an examination of the questions referred for a preliminary ruling has revealed nothing capable of affecting the validity of Regulation (EC) No 1107/2009." (operative part of the judgment). 

The judgment and the opinion of Advocate General Sharpston can be found here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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