November 19, 2019
Final judgment
France, Melun

Economic stakeholders
ULD Europe LTD, represented by SCP Célice, Texidor et Périer.
ANSES (Agency for Food, Environmental and Occupational Health & Safety)
No description

Carbamate, Fungicide, Mancozeb
Annul the ANSES decision refusing to grant marketing authorization for "Mastana SC" by mutual recognition of the authorization issued by the UK authorities. Order ANSES to pay the company the sum of 1,830,000 euros for the damage it considers it has suffered.
Administrative Court of Melun, France
First instance

November 30, 2023
Application rejected.

On November 30, 2023, the Administrative Court of Melun rejected UPL Europe LTD's application to overturn the decision of ANSES, the French agency responsible for the approval of plant protection products. In this decision, ANSES refused to authorize the marketing of "Mastana SC", by mutual recognition of the authorization issued by the UK authorities.

On August 3, 2018, UPL Europe LTD submitted a marketing authorization (MA) application for "Mastana SC", a fungicide based on mancozeb (an active substance belonging to the carbamate family), for use on wheat, triticale and spelt, under the mutual recognition procedure provided for in articles 40 to 42 of Regulation (EC) no. 1107/2009 of October 21, 2009. ANSES refused this request on the grounds that the assessment carried out by the reference country, the UK (Northern zone), did not meet the regulatory requirements for the Southern European zone (to which France is partly attached). These regulatory requirements were those concerning pesticide residues in or on foodstuffs, as well as those set out in the current guide documents for the environmental and ecotoxicology sections.

According to the applicant company, ANSES failed to justify its decision in the light of Regulation (EC) no. 1107/2009. Under this regulation, any Member State receiving an MA application for a plant protection product that has already been approved by another Member State is required, in accordance with the principle of mutual recognition, to issue the authorization under the same conditions as those of the MA granted by the reference State, unless it imposes specific conditions of use in application of articles 36 § 3 and 31 § 3 and 4, or demonstrates that the plant protection product presents an unacceptable risk to human or animal health or to the environment.
In addition, the company criticized ANSES for not having asked it to complete the dossier after its refusal.

After outlining the general scheme of European regulations on plant protection products, the Administrative Court provides some useful clarifications on the conditions for recognizing in France the authorization of a plant protection product granted in another zone of the European Union.

First of all, in the case of an interzonal MA application (two different zones), the Court emphasized that ANSES's power of judgment is more extensive than in the case of an intrazone application. In this second case (intrazone application), there is a presumption of comparability in terms of agricultural, phytosanitary, environmental and climatic conditions, which limits the margin of maneuver of the State receiving the application. It will thus be necessary for this State to justify any refusal by proof of particular "circumstances" or "characteristics".

Furthermore, the Court notes that ANSES is only required to "examine" the product data evaluated by the reference Member State, and not to re-evaluate these data or additional data when the evaluation is incomplete.

Accordingly, the Court ruled that ANSES could legally refuse to issue authorization for the whole of France, on the grounds that there had been no assessment of the chemical residues resulting from the intended uses of this product in the Southern European zone to which the South of France belongs, even though such an assessment existed for the Northern European zone to which the North of France belongs.