Italian Authorization Procedures for Plant Protection Products
Italian Authorization Procedures for Plant Protection Products
At Kerona Scientific’s virtual Plant Protection Symposium in November 2022, Dra Elisabetta Garatti from Expedia MRCC Srl, spoke about the procedures in the authorization process of Plant Protection Products (PPP) in Italy.
After a quick review of the European System of Zonal Authorization, Elisabetta explained the Italian authorization procedures. Article 75 of Regulation (EC) No. 1107/2009 states that each Member State (MS) designates a competent authority to carry out the obligations of the evaluation procedures and designates a national authority to coordinate with applicants, other MS and the Commission. In the case of Italy, the competent authority is The Ministry of Health (MOH) in Rome. The MOH is formed by one Secretariate General and 12 Directorates General. The Directorate responsible for the authorization and control of the marketing of Plant Protection Products and for the planning of official control on residues in vegetables is the Directorate-General for hygiene, food safety and nutrition (DGISAN).
DGISAN delegates the evaluation activity of the risk assessment of active substances and PPP to evaluation bodies such as Universities, Scientific Institutes and National Research bodies specialized in the PPP sector. The MOH allocates the evaluation through annual contracts called “Convenzioni”. These official bodies are included in the list established on the basis of the Directorial Decree reviewed annually and posted on the Ministry’s website.
This system has some critical points to be aware of, firstly that as the Convenzioni are renewed annually and the allocations are decided in the last quarter of the year it makes it difficult to allocate all Convenzioni by 31st of December. Related to this the timing established by Regulation (EC) No. EC 1107/2009 starts when the Convenzione is established, not from the submission date of the application. It is also important to know that the DGISAN does not refuse any pre-notification of PPP authorization.
The applications that can be submitted to the DGISAN related to PPP are:
- Applications of new active substances and Renewals (with Italy as a zRMS)
- Applications of new PPP
- Technical changes for authorized PPP
- Administrative changes such as adding new packaging sizes or changing the tradename.
More information about the procedures and the necessary documentation can be found on the website of DGISAN (https://www.salute.gov.it/portale/fitosanitari/homeFitosanitari.jsp)
Kerona Scientific’s Southern European Regulatory Team based in Spain can help you with the authorization of Plant Protection Products in the Southern Zone. Please contact our PPP team at info@kerona.ie