FRANCE – Ministry of Agriculture: Public consultation on the draft guideline for Article 53 marketing authorizations.

The Ministry of Agriculture has opened a public consultation concerning a draft guideline on marketing authorizations for plant protection products granted under Article 53 of Regulation (EC) No. 1107/2009.

Article 53 of Regulation (EC) No. 1107/2009 allows Member States to authorize, in special circumstances, the placing on the market of plant protection products by way of derogation from the standard authorization procedure, when there is no other reasonable way to control a plant health hazard. The validity period of these authorizations, known as “emergency exemptions”, cannot exceed 120 days. In France, in accordance with article R. 253-6 of the Rural Code, it is the ministry in charge of agriculture which is responsible for issuing these authorizations. If necessary, an opinion from ANSES may be requested.

The guideline specifies the approach followed and the principles retained for the examination of demands made under Article 53 of Regulation (EC) No 1107/2009. It also details the required documents and data for such demands, as well as the content of the authorizations which may include restrictions on use to ensure the protection of health and the environment.

The consultation is open since 13 January and until 3 February 2025.

To download (in French): 

Projet de lignes directrices pour la délivrance des autorisations de mise sur le marché des produits phytopharmaceutiques au titre de l’article 53 du Règlement (CE) n°1107/2009 du 21 octobre 2009

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