FRANCE: Guidance on extensions for minor uses (Article 51)

The French procedure for the authorisation of minor uses under Article 51 of  Regulation (EC) No.1107/2009 was published in the Official Bulletin of the Ministry of Agriculture on 27 April 2018 as a Note of information.

Article 51 of  Regulation (EC) No.1107/2009 sets that not only the authorisation holder but also official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation. The corresponding extensions of authorisation shall  be granted provided that they are in the public interest and that they do not present harmful effects to human or animal health or inacceptable effects on the environment.

The intended extension is in the public interest when it fulfills at least one of the following criteria:

• it is intended to fill gaps of uses  with no or few alternatives
• it is a low risk product (Art. 47 of Reg. 1107/2009)
• it is a biocontrol plant protection product (list set in accordance with Article L 253-5 of French Rural Code)
• it is a protective measure against categories 1 and 2 phytosanitary dangers (French Decree of 15 December 2014 concerning the list of categories 1 and 2 phytosanitary dangers for plant species)

The content of the application dossier is set by the French Decree of 30 June 2017 and is to be sent to Anses.

The application goes through Anses scientific evaluation. When possible the request is to be identified as part of the inventory tasks for technical gaps performed by the Commission of orphan uses (‘Commission des usages orphelins’ or ‘CUO’). This is a Commission of consultation and expertise of the Ministry of Agriculture constituted by representatives of stakeholders and ANSES. Efficacy and crop safety data are not mandatory for such applications. The ‘public interest’ status is evaluated by the Ministry of Agriculture.

In order to fasten the evaluation process, the data used to demonstrate that the application fulfills the eligibility criteria of Article 51 procedure can be transmitted to the CUO secretariat prior to the application to ANSES.

When the extension of authorisation is granted, the administrative decision is sent to the authorisation holder and, if different, to the applicant. The minor use extension shall be separately identified on the product label if the authorisation holder accepts to revise it. In any case, information regarding the specific conditions of uses of the product for this extension is available for users in the Anses List of marketing authorisation decisions and on E-Phy website.

To download: Note de service DGAL/SDQSPV/2018-344 (in French)

Lynxee consulting’s team is at your disposal if you need support for your applications

Contact us! https://lynxee.consulting/en/contact/