CJEU ruling: PAN Europe vs Dutch Authorities on pesticide approvals

In 2019, the Dutch pesticide authorization agency (CTGB) agreed to authorize the placing on the Netherlands market of three plant protection products containing the active substances sulfoxaflor, difenoconazole and fludioxonil. PAN Europe lodged objections against such decisions, which were rejected as unfounded by the CTGB. As a consequence, PAN Europe sought annulment of these decisions before the Dutch Court.

PAN Europe claimed that the CTGB had failed to use the most updated scientific knowledge available within the framework of the risk assessment of pesticides, as well as the fact that the most recent guidelines to evaluate endocrine disruption or the toxicity to bees had been disregarded by the CTGB. The Dutch Court referred questions for a preliminary ruling to the Court of Justice of the EU, which resulted in two rulings delivered by the latter last April 24, 2024.

In these two rulings, the Court of Justice of the EU has declared the following:

• The Member States concerned may depart from the scientific risk assessment of a product carried out by the zonal Rapporteur Member State examining the application for an authorization to place such product on the market, in the situations referred to in Regulation No 1107/2009, in particular where such Member States concerned have available the most reliable scientific and technical data – which was not taken into account by the zonal Rapporteur Member State when preparing its assessment – which identifies an unacceptable risk to human or animal health or to the environment (case C-308/22).

• 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. This implies that the wording of Article 29(1)(e) and of Article 36(2) of Regulation No 1107/2009 -which refer to the need for a plant protection product to be authorized 'in the light of current scientific and technical knowledge'- does not preclude the most reliable scientific and technical information available -irrespective of the source of that information or the time when it became available -being raised before the authorities and courts of a Member State concerned, with a view to challenging the authorization of such a product in the territory of the Member State concerned (case C-308/22).
• While Article 36(1) of Regulation No 1107/2009 refers to the use of 'guidance documents available at the time of application' it cannot be inferred from that provision that the Member State examining an application must limit itself to basing its risk assessment solely on the guidance documents available, where it considers that such documents do not sufficiently reflect current scientific and technical knowledge in the light of which it is required to carry out its assessment (case C-308/22).
• Point 3.6.5 of Annex II to Regulation No 1107/2009, lays down  the specific criteria that determine whether an active substance is to be considered as having endocrine disrupting properties that may cause adverse effect in humans. The intervening parties in the proceedings, the Commission and certain Member States consider that the endocrine disrupting properties that an active substance may present are not to be assessed as part of the examination at national level of an application for authorization to place on the market a plant protection product containing that active substance.

However, in its ruling, the General Court declares that the competent authority of a Member State assessing an application for authorization to place a plant protection product on the market is required, as part of such examination, to take into account the adverse effects that the endocrine disrupting properties of an active substance contained in that product may cause for human beings, considering the relevant and reliable scientific or technical knowledge available at the time of that examination and which is, in particular, reproduced in the criteria laid down in point 3.6.5 of Annex II of Regulation No 1107/2009 (joined cases C-309/22 and C-310/22).

While the intervening parties claim that the principle of legal certainty requires that the examination of an application for authorization of a plant protection product should be carried out by reference to the scientific and technical knowledge existing at the time when that application was made, this principle must be weighed up against the precautionary principle on which Regulation No 1107/2009 is based to ensure a high level of protection of human and animal health and the environment. Therefore, taking into account relevant and reliable scientific or technical knowledge which was not yet available at the time when the application for authorization for placing a plant protection product on the market was made cannot be regarded as being contrary to the principle of legal certainty (case C-308/22 and joined cases C-309/22 and C-310/22).