LA CAMPAGNE
Court decisions
The Blaise Judgment confirms compliance of
EU pesticide regulation with the precautionary principle
Blaise Judgment, octobre 1st 2019, C-616/17
On 1 October 2019, the Court of Justice of the European Union (CJEU) issued a ruling (Case C-616/17) addressing preliminary questions raised by the Criminal Court of Foix regarding the validity of the EU regulation on pesticide evaluation methods. Regulation 1107/2009 requires manufacturers to prove that the products they intend to market have no immediate or delayed harmful effects on human health or the environment. Scientific evidence is verified by the European Food Safety Authority (EFSA) at the EU level for declared active substances, and by each Member State for products before their authorization.
1. Regarding the identification of active substances in a pesticide product
The Court confirmed that the obligations imposed on applicants to identify active substances in applications for marketing authorization (MA) for pesticide products are sufficient.
The data required for the approval of active substances (Regulation (EU) 283/2013) must be sufficient to identify each active substance and define its specifications and nature (point 56).
In an MA application, the applicant must disclose all substances composing the product and cannot discretionarily select which component should be considered an active substance.
Consequently, the Court emphasized that national authorities are responsible for ensuring compliance with the obligation to identify the active substances contained in the pesticide product covered by the authorization request, particularly verifying that these active substances have already been approved (point 59).
Furthermore, if these requirements are not met—for example, if the applicant fails to declare all active substances in a product—the authorization may be revoked.
2. Regarding the consideration of the cumulative effects of a product’s components
The Court stated that under Regulation 1107/2009, the procedure leading to the authorization of a pesticide “must necessarily include an assessment not only of the specific effects of the active substances contained in that product, but also of the cumulative effects of those substances and their effects combined with other constituents of that product” (point 75).
The interaction between active substances, safeners, synergists, and co-formulants must be considered both at the European level during the evaluation of an active substance (in at least one representative formulation containing it) and at the national level for each commercial product (point 65).
3. Regarding the reliability of scientific studies submitted by applicants for pesticide product authorization
The Court was asked whether relying on studies provided by manufacturers to demonstrate the absence of harm from pesticides complies with the precautionary principle, given the risk of bias.
The Court emphasized that the quality of tests and studies submitted to prove the absence of harm from products and active substances is strictly regulated (Regulations 284/2013 and 283/2013).
Furthermore, « the Member State to which an application is submitted must undertake an independent, objective and transparent assessment of that application in the light of current scientific and technical knowledge, while the Authority [EFSA] must adopt a decision in the light of current scientific and technical knowledge. » Point 88
« It is the duty of the competent authorities to take account of the most reliable scientific data available and the most recent results of international research and not to give in all cases preponderant weight to the studies provided by the applicant. » (Point 94)
4. Regarding the disclosure of the authorization application file
The Court questioned whether the confidentiality of certain elements of applicants’ dossiers conflicts with the precautionary principle.
« While it is not inconceivable that increased transparency in those procedures may be such as to permit an even better assessment of the risk to health resulting from the use of a plant protection product, by enabling the public concerned to put forward arguments opposing the grant of the approval or authorisation sought by an applicant, it must, in any event, be held that that regulation permits, to a great extent, the public to obtain access to the dossier lodged by the applicant ». Point 102
« Member States may not provide that a request for access which concerns information on emissions into the environment should be refused on grounds based on protection of the confidentiality of commercial or industrial information. » (Point 107)
5. Regarding the absence of carcinogenicity and toxicity studies for product authorization
Only the declared active substance undergoes long-term toxicity and carcinogenicity testing. Given that commercialized products can be up to a thousand times more toxic than their active substance, the tribunal questioned whether the authorization process complies with the precautionary principle.
The Court reiterated that under Article 4(3)(b) of Regulation 1107/2009, a pesticide cannot be authorized if it exhibits carcinogenicity or long-term toxicity.
“It is therefore the task of the competent authorities, when examining an application for the authorisation of a plant protection product, to verify that the material submitted by the applicant, and primarily the tests, analyses and studies of the product, is sufficient to exclude, in the light of current scientific and technical knowledge, the risk that that product exhibits such carcinogenicity or toxicity. In that context, the ‘cursory tests’ mentioned by the referring court would not suffice to perform that verification properly.” (Point 116)
The Court clarified that long-term toxicity and carcinogenicity analyses should be conducted not only during the approval of active substances but also when evaluating market authorization applications.
However, in practice, market authorizations are granted without long-term toxicity and carcinogenicity testing of the final commercialized products. This is a failure to properly implement EU regulations.
[1] Un produit phytopharmaceutique, dans des conditions d’application conformes aux bonnes pratiques phytosanitaires et dans des conditions réalistes d’utilisation, satisfait aux conditions suivantes : […] il n’a pas d’effet nocif immédiat ou différé sur la santé humaine, y compris les groupes vulnérables, ou sur la santé animale, directement ou par l’intermédiaire de l’eau potable (compte tenu des substances résultant du traitement de l’eau), des denrées alimentaires, des aliments pour animaux ou de l’air, ou d’effets sur le lieu de travail ou d’autres effets indirects, compte tenu des effets cumulés et synergiques connus lorsque les méthodes d’évaluation scientifiques de ces effets, acceptées par l’Autorité, sont disponibles; ou sur les eaux souterraines […] » article 4, paragraphe 3, sous b).
The CJEU Confirms European Case Law on Pesticide Marketing Authorization (MA)
In 2019, PAN Europe filed three complaints with a Dutch court against the reauthorization of Closer (Sulfoxaflor), Dagonis (Difenoconazole), and Pitcher (Fludioxonil). The Dutch pesticide authorization agency (CTGB) failed to use the most recent scientific knowledge and the latest guidelines for evaluating endocrine-disrupting effects or toxicity to bees for risk assessment. The CTGB rejected PAN’s request to challenge its decision to authorize the marketing of these three pesticides.
In 2022, the Dutch court referred preliminary questions to the Court of Justice of the European Union.
The three CJEU judgements confirm the Blaise case-law: risk assessment of pesticides must be based on the most reliable available scientific or technical data at the time of marketing authorization.
The most reliable available scientific or technical data can be used to challenge the marketing authorization of a pesticide in national courts, particularly when the risk assessment by the rapporteur Member State is insufficiently justified.
The major contribution of Judgment C-308/22 is to clarify that the available data is not limited to EFSA guidance documents adopted by the European Commission and Member States at the time of the MA application. Instead, it includes « the most reliable scientific or technical data… regardless of their source or when they became accessible » (see point 92).
Thus, the risk assessment conducted by the Member State prior to granting a MA cannot be limited to following EFSA guidance documents when these have become outdated due to advances in scientific knowledge. The Member State deciding on the MA for a pesticide is therefore not bound by the initial assessment of the rapporteur Member State. Although Member States cannot re-evaluate the approval of an active substance when reviewing the MA of a product containing it, the authorization of the product is not an automatic implementation of the approval of its active substance (see Granosalus, C-313/19).
Therefore, a Member State is not obliged to grant MA to a pesticide containing active substances that, although approved, pose an unacceptable risk to health if there is scientific evidence to that effect.
“[…] in order to challenge the authorisation for placing a plant protection product on the market in the territory of the Member State taking a decision concerning such authorisation under the latter provision, the most reliable scientific and technical data available may be raised before the authorities or the courts of that Member State with a view to demonstrating that the scientific risk assessment of that plant protection product, carried out by the Member State examining the application under Article 36(1) of that regulation, is insufficiently reasoned.” (point 110)
