Fieldfisher secures key regulatory victories for Philagro France and Suterra in market access disputes

Philagro France is a crop protection company specialising in the distribution of herbicides, fungicides and insecticides tailored to French agricultural needs. It operates autonomously in France as part of a broader international network focused on innovation and sustainable farming.

Suterra Europe Biocontrol S.L. is a global innovator in biocontrol technologies. The company develops environmentally responsible alternatives to traditional pesticides, with a strong focus on pheromone-based products that support integrated pest management.

The victories, handed down by the Tribunal Administratif de Lyon and the Tribunal Administratif de Melun, and which are very rare against ANSES, ensure that Philagro France’s herbicide PLEDGE and Suterra’s biocontrol product Subvert remain available to agricultural producers in France. 

Philagro

In the case of Philagro France, the Lyon court ruled in an emergency proceeding in favour of the company, suspending ANSES’ decision to deny the renewal of PLEDGE’s marketing authorisation (MA). PLEDGE is a pre-emergent herbicide used in fruit and vine cultivation to prevent weed growth, with its active ingredient, flumioxazin, already approved in multiple EU jurisdictions. Despite this, ANSES sought to block its continued use, citing unproven risks.

Fieldfisher successfully argued that ANSES had failed to meet the legal standards under EU law, particularly those outlined in Article 36 of Regulation (EC) No 1107/2009, which requires regulators to accept approvals from other EU reference Member State unless they can demonstrate a specific, evidence-based health or environmental risk.

The court found that ANSES had not met this threshold, allowing PLEDGE to remain on the market pending a final ruling. Partner Olivier Lantres led the Fieldfisher team in France alongside Associate Charlotte Delcamp, supported by the regulatory Partner Koen Van Maldegem from the firm's Brussels office.

Suterra

Meanwhile, the Tribunal Administratif de Melun ruled on the merits that ANSES acted unlawfully in rejecting the MA for Subvert, an innovative pheromone-based biocontrol solution developed by Suterra Europe Biocontrol S.L. to combat the grapevine moth (Lobesia botrana). Suterra had sought MA in France through the EU mutual recognition procedure, leveraging an existing approval granted by Maltese regulatory authorities (reference Member State). However, ANSES refused to recognise this authorisation, prompting a legal challenge. 

The court found that ANSES had failed to properly assess the scientific evidence supporting Subvert and had exceeded its regulatory authority by re-evaluating the product’s safety and efficacy instead of adhering to the mutual recognition framework.

The ruling annuls ANSES’ refusal and mandates that the agency reassess Suterra’s MA application within 120 days (which is very rare), reinforcing the need for a harmonised, science-driven approach to regulatory decision-making across the EU. The Brussels team (namely Partner Claudio Mereu and Counsel Simon Englebert) and the Paris team (partner Olivier Lantrès) teamed up to achieve this result. 

Olivier Lantres, Co-Head of Life Sciences at Fieldfisher, commented: 
"These rulings, highly relying on regulatory aspects and administrative knowledge, send a strong message about the importance of regulatory consistency and scientific rigour in the EU, in particular in France. Companies investing in sustainable and innovative solutions must have confidence in a fair and predictable regulatory process, in all the sectors like the phytopharmaceutical field and the pharmaceutical field, among others. Our international regulatory team was pleased to have supported both Philagro France and Suterra in defending their market access and protecting users’ ability to rely on proven products."