Foreword
Recently (with the portal showing an update as of 9 April 2026), the Italian Ministry of Health published operational instructions on its institutional portal regarding the alignment of plant protection products with the requirements of Delegated Regulation (EU) 2023/707. This communication clarifies the administrative procedures for reclassifying authorised products, specifying the use of variation forms (such as model FTS-VAM-23b) for “deteriorating” (more severe) classification changes, and the procedure for the less common “improving” (less severe) changes, using the technical variation model FTS-VAM-20C.
Before delving into the bureaucratic details of the Italian procedure, it is essential to start from the beginning.
A Structural Revolution, Not a Simple Update
Regulation (EC) No 1272/2008 (CLP) has accustomed us to a constant stream of technical updates (ATPs – Adaptations to Technical Progress). However, Regulation 2023/707 is not “just another” revision: it represents an unprecedented structural change. For the first time since the inception of the CLP, the European legislator has not merely reclassified individual substances but has added entirely new regulatory “drawers” to Annex I, introducing new hazard classes to meet the objectives of the Chemical Strategy for Sustainability.
The New Hazard Classes: Criteria and Thresholds
The new regulatory framework introduces scientific definitions for hazards previously managed only on a “case-by-case” basis. Below are the details of the new classes and the concentration thresholds that trigger the classification of mixtures. It is worth noting that “mixture” refers to the finished product composed of two or more substances: in this context, the reference is to formulated products placed on the market. While current technical terminology prefers this term, many operators remain attached to the historical definition of ‘preparations’ (used in pre-CLP legislation), which perhaps more intuitively described the nature of these products.
- Endocrine Disruptors (ED). Substances that alter the human or animal hormonal system.
- Thresholds in mixtures: Classification is triggered if a component is present at a concentration ≥ 0.1%.
- Symbol: GHS08 (Human health) or GHS09 (Environment).
- PBT and vPvB Properties. Persistent, Bioaccumulative and Toxic (or Very Persistent and Very Bioaccumulative) substances.
- Thresholds in mixtures: Mandatory classification if a component is ≥ 0.1%.
- Symbol: GHS09 (Environment).
- PMT and vPvM Properties. Persistent, Mobile and Toxic (or Very Persistent and Very Mobile) substances. These aim to protect groundwater from contamination.
- Thresholds in mixtures: Again, the relevance limit is set at 0.1%.
- Symbol: GHS09 (Environment).
Note on symbols: Since these classes are a European initiative not yet adopted at a global level (UN GHS), there are no dedicated new pictograms. Existing symbols are used, accompanied by specific new risk phrases (EUH430 to EUH451).
Action Required in Italy: The Procedure for PPPs
Returning to the Ministry’s update, the procedure is strict. Companies holding authorisations for plant protection products must verify whether active substances or co-formulants fall into the new categories.
- Assessment: Analyse the formulation’s composition in light of the new 2023/707 criteria. If, as in most cases, the analysis reveals a more severe classification, an administrative path is followed. The note also mentions the case of “improving” classifications, which requires a different procedure.
- Variation Applications: If a new hazard is identified and the classification “deteriorates,” an administrative variation application must be submitted to the Ministry of Health. This follows the established “tacit consent” (silenzio/assenso) procedure, which does not require the issuance of a formal decree but involves the publication of the updated label on the Ministry’s portal 60 days after the application is received. In the case of “improving” variations, “tacit consent” does not apply, and a formal decree must be issued.
- Documentation: The guidelines detail the documents required. In summary: product composition, updated Safety Data Sheets (SDS) for components, administrative data, and the Excel form (a PDF example of which is available on the portal).
- Timeline: The Ministry recommends starting procedures promptly to avoid authorisation bottlenecks. From 1 May 2026, new products placed on the market must feature labels aligned with the new classifications. Products already on the market may retain the old label until 1 May 2028. Therefore, from 2 May 2028, non-compliant products cannot be traded. Given the seasonality of plant protection products, this could pose a significant challenge.
Find out more:
- Official source: Italian Ministry of Health Portal Page on PPP Classification Adjustment Applications. (Note: The page is in Italian. You can view theEnglish machine translation here)
Originally featured in Euregulator’s weekly column on AgroNotizie (Italian version).