The Note of 5 April 2022 has been published on the portal of the Ministry of Health, updating the national procedure for the management of applications for authorization of plant protection products for plant health emergencies, in accordance with Article 53 of Regulation EC 1107/2009.
The Article of the Regulation provides that a Member State may authorise the placing on the market of a plant protection product, for a maximum period of 120 days and for a limited and controlled use, when such a measure is necessary to contain a serious hazard (plant pest or disease) that cannot be controlled with the means of defence already available on the market.
This is a regulatory tool that has been considered indispensable and widely used since the introduction of the Regulation.
Over the years, due to the gaps in pest management resulting from the progressive exclusion of many active substances from the market without balancing the approval of substitutes, there has been an increasing use of the possibilities provided by Article 53, which – although useful – still represents a significant environmental burden.
The Commission therefore intervened to provide guidance to Member States in order to streamline procedures and avoid an overlap in the number of applications, with the aim of harmonising the application of the Article across Europe.
In accordance with the indications of the Commission, the General Directorate for Hygiene and Food Safety of the Ministry of Health has updated its procedure for the management of applications for derogation under Article 53.
In the interests of transparency and more efficient sharing of available data, before being formally addressed to the Ministry of Health, applications will have to be entered in the Commission’s PPAMS, the Community computerised system for managing applications.
The Italian Authority undertakes to provide, in the event of a positive evaluation of the application, an authorisation that is temporally appropriate to the expected treatment with the product.
The new procedure reiterates several times the strong limitation for the use of candidate substances for substitution and specifies that applications for emergency authorisation of products containing unapproved active substances “must be a last resort, only when no other possibilities exist”.
Ministerial documents at: