There is no factor affecting the validity of the PPP Regulation (1107/2009) concerning the placing of plant protection products on the market, said Advocate General Eleanor Sharpston in conclusions delivered on Tuesday, 12 March (Case C-616/17).
Several environmental activists belonging to the ‘Faucheurs volontaires anti-OGM ariégeois’ movement are being prosecuted in France for having damaged Roundup weedkiller cans containing glyphosate in private commercial premises. They are calling for the Court of Justice of the European Union to be questioned as to the validity of the PPP Regulation, specifically with regard to the precautionary principle in TFEU (Article 191). In their opinion, if products containing glyphosate have been proven to pose risks to human health and the environment, such a finding could remove the legal foundation on which the proceedings against them were based.
The Foix Criminal Court (Tribunal correctionnel de Foix) is consulting the Court of Justice regarding: - the excessive margin of discretion that a manufacturer would have to define the active substance of a plant protection product to be placed on the market when the final product marketed is composed of several substances; - the rules that allow producers to conduct the tests, analyses, and evaluations contained in the marketing dossier themselves and to invoke confidentiality to prevent an independent counter-analysis of that dossier; - whether sufficient testing is required to determine the potential cocktail effect (exposure to different plant protection products containing the same active substance or different active substances in the same product) of a plant protection product containing glyphosate.
For the Advocate General, the essential issue raised is whether the general provisions of the PPP Regulation are flawed in such a manner as to render the legislation invalid. Her answer to this question is ‘no’.
Ms Sharpston notably asserts that the PPP Regulation itself is a precautionary measure that introduces a system of prior approval affecting the general category of plant protection products.
If a particular approval process for a product does not sufficiently take the cocktail effect into account, safety nets exist permitting restrictive measures to be taken on the basis of the precautionary principle, the Advocate General also points out. In addition, the competent authorities of the European Union and the Member States may invoke other assessments to justify such measures.
Moreover, it is clear that the PPP Regulation imposes objective conditions as for the quality of the data to be provided, states Ms Sharpston. In her opinion, EU law prevents an applicant from conducting the necessary studies itself according to its own (biased) protocols and (partial) standards and from choosing the data it prefers to submit in its dossier.
As for the confidentiality rules in the regulation, they constitute an exception to the general principle of access to information and should be interpreted and applied restrictively. Consequently, according to the Advocate General, the provisions of the PPP Regulation on public access to data are not vitiated by manifest errors.
Finally, the Advocate General considers that, if an assessment demonstrates the existence of a risk to human health due to the long-term toxicity of a pharmaceutical product without being able to clearly determine how serious this risk is, nothing in the PPP Regulation prevents the relevant authorities from rejecting the application for authorisation of a plant protection product, in application of the precautionary principle.
However, Ms Sharpston emphasises that a balance should be struck between two concerns, namely an appropriately high level of protection for humans, animals, and the environment and the possibility for products that increase agricultural productivity to be placed on the market.
Last week, the General Court ruled in favour of greater transparency in the procedures leading to the authorisation of glyphosate in the EU (see EUROPE 12209/21). (Original version in French by Mathieu Bion)