EUROPE – COM: Feedback open on new harmonised classification and labelling of endocrine disruptors & persistent pollutants
28 October 2026
The Ministry of Agriculture has published a service note on the procedure for applying for and granting marketing authorisations for plant protection products (PPPs) under Article 53 of Regulation (EC) No 1107/2009, also known as 120-day derogations.
This instruction repeals the previous information note on this subject, which dated from 2012.
The document first outlines the context and legal basis for these authorisations. It then describes the procedures for submitting and processing an application, and for granting an authorisation.
The following information are provided in the Annexes:
- The application form to be completed by the applicant
- The prior agreement document from the product holder
- Clarifications on the information to be submitted, as mentioned in the prior agreement document
The application form includes, in particular, the technical and economic justification for the application and an analysis of existing alternatives.
In the prior agreement document, the product holder lists the recommended conditions of use for the intended uses, including all protective measures for the operators, workers, residents and bystanders, and the environment. The product holder must also certify that they have provided the DGAL with all the information justifying the absence of harmful effects on human health and unacceptable risks to the environment, for all uses covered by the application.
These elements can take different forms: zonal or national assessment report of the most recent product authorisation, Anses conclusions, study reports, exposure reports based on the OPEX model, risk assessments, etc. They must cover:
- Compliance with applicable maximum residue limits and the consumer risk assessment
- Risk to human health (operators, workers, residents and bystanders) and the environment
- Risk to bees and other pollinating insects
The document specifies that, in case of a renewal of the application, these elements must be resubmitted.
Upon receipt of a complete application, an acknowledgement of receipt is sent to the applicant. Requests for additional information may be made to the applicant or the holder of the product concerned, during the admissibility or assessment steps.
Note that, in 2025, the Ministry published guidelines specifying, among other things, the principles adopted for the assessment of these applications under Article 53.
When the required conditions are met, a marketing authorisation is granted for a maximum period of 120 days. The applicant and the marketing authorisation holder of the product implement the necessary actions to ensure that the conditions of use specified in this decision are communicated to users. The actions implemented must be documented. At the end of the authorisation validity period, information on the surfaces treated and the quantities of product used under this authorisation must be sent to the DGAL, together with any other information required by the decision.
To download (in french):
See also our previous articles:
Lynxee consulting’s team is at your disposal to answer your questions.
Contact us! https://lynxee.consulting/en/contact/
