FRANCE – ANSES: Withdrawal of tritosulfuron-based products
15 May 2025
The French Ministry of Agriculture published guidelines on marketing authorisations (MA) for plant protection products (PPP) granted under Article 53 of Regulation (EC) No. 1107/2009.
Article 53 allows Member States to respond to an emergency situation by authorising, by way of derogation and for a maximum of 120 days, the placing on the market of PPPs when there is no other reasonable way to control a plant health hazard.
The document sets out the requirements for a MA application made under Article 53, the approach followed and the principles adopted for its assessment, as well as the content of the authorisation where applicable.
Applications must be sent to the French Ministry of Agriculture by a technical institute or by a producer or producer’s representative, and must include :
- the application form drawn up by the DGAL (Directorate General for Food), including detailed justification of the plant health hazard,
- information on the PPP, its active substance(s) and intended uses, the desired authorisation period (maximum 120 days) and an estimate of the treated area,
- the agreement of the PPP marketing authorisation holder or the manufacturer, with all the relevant data needed to assess the risks to human and animal health and to the environment. If the product is already authorized, or if a zonal assessment report is available, these documents must be enclosed to the application. In addition, if the target crop is a foodstuff, residue data must be provided to ensure compliance with maximum residue limits.
When examining applications, the authorities check :
- the existence of a plant health hazard,
- the existence of special circumstances,
- the need for a derogation to manage the hazard, and
- the absence of other reasonable means of managing this hazard.
If the examination of the application leads to the conclusion that the use of the PPP is necessary, it may be authorised under Article 53.
However, authorisation can only be granted for a PPP whose active substance does not meet the exclusion criteria set out in Annex II of Regulation (EC) No 1107/2009 (carcinogenic, mutagenic or reprotoxic category 1, endocrine disruptor, PBT and vPvB) and has not been refused approval or renewal of approval by the European Commission (unless special conditions have been duly justified).
Furthermore, in accordance with the judgment of the Court of Justice of the European Union of 19 January 2023, the conditions of use defined by the authorisation decision may not run counter to restrictions on use set out in the European approval of the active substance (for example, use only in greenhouses).
If necessary, the French Ministry of Agriculture may request an opinion from Anses.
The authorisation specifies the conditions and restrictions on the use of the product during the approved period. This decision is sent to the MA holder and to the applicant and published on the French Ministry of Agriculture website. It is also notified to the other Member States and to the European Commission, and is made available on its website.
These guidelines apply to all article 53 applications from 02 May 2025.
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