Dive into our team’s expertise on the Plant Protection and Plant Nutrition markets.
Once a month, our experts will gather all the news and updates in PPP and PNP markets. They will select major news to help you navigate in the regulations framework.
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Plant Protection
1. Northern Zone Steering Committee – Guidance Document on work-sharing for the authorisation of plant protection products – version 14
Key updatesinclude:
- Updated details on the composition statement, including the non-significant formulation changes.
- Updated details on bridging statement (Toxicology and Ecotoxicology)
- Toxicology : The Guidance on the Application of the CLP Criteria has been included to be used for the assessments
2. French decree No. 2025-629 of 8 July 2025 on PPP authorisation
ANSES has issued guidance implementing Decree No. 2025-629, introducing a prioritization system for PPP authorisations in France. A Ministerial Order (6 March 2026) identifies over 120 “listed uses” of critical agronomic importance with limited or threatened control options (including fruit crops, vegetable crops, ornamental crops, arable crops, seed crops, grapevines, spices, aromatic herbs and medicinal crops.) which will be assessed as a priority. Applicants must clearly flag these uses in their submissions. The guidance also reiterates strict requirements for mutual recognition applications, limiting submissions to RMS-aligned data compatible with the 120-day timeline, with only limited contextual information allowed.
3. French Note on Implementation of regulatory provisions regarding prohibited co-formulants as provided for by Regulation (EU) 2026/1120
In the Reg EU 2026/1120, 12 new co-formulants were listed as unacceptable (see our recent LinkedIn breaking news). The purpose of this new French note is to present the implementation procedures by ANSES.
For AMM requests submitted before June 16, 2026 and currently under instruction, for products containing a co-formulant newly added to Annex III, requests for non-significant changes in composition must be submitted as soon as possible and no later than December 16, 2026.
As soon as possible, and no later than July 31, 2026, holders of AMMs for plant protection products, adjuvants, and mixed products containing one or more co-formulants newly added to Annex III are invited to declare them to ANSES via email.
4. EFSA recommendation on how to perform the consumer risk assessment for commodities with no consumption data in PRIMo has been published on the EFSA website
It is an Excel file listing the instructions on how to perform acute consumer risk assessments (IESTI) for 18 food commodities for which no consumption data have been added to PRIMo (either PRIMo 3.1 or 4, as indicated in the Excel file). In summary, EFSA recommends either using available consumption data from another model (PRIMo 3.1 or 4 or JMPR IESTI tool) if available, or using consumption data available for similar commodities. Also, the relevant variability factor, IESTI case, large portion and unit weight are given for each concerned commodity. This guideline helps dietary safety experts to choose the correct strategy for food commodities without consumption data and increases the confidence of regulatory approval.
Plant Nutrition
1. Cadmium in Phosphate Fertilisers: How National Exceptions Impact Market Access
The regulatory landscape for phosphate fertilisers is shifting rapidly. With France recently lowering its cadmium thresholds, compliance is becoming a moving target for manufacturers and distributors across Europe.
Under the EU FPR, the baseline limit stands at 60 mg Cd/kg P₂O₅. However, through Article 3(2), several Member States have already introduced stricter national restrictions to address environmental and health concerns:
With growing political and public pressure, more countries are expected to adopt similar restrictions.
2. Participation in ABBA Working Groups to Accelerate Market Access
Market authorisation processes for complex biologicals can be a maze. That’s why Staphyt Regulatory is thrilled to be collaborating with ABBA (the French Biocontrol and Biostimulation Association for Agroecology) in two newly formed regulatory working groups aimed at streamlining market access:
- Working Group 1: Registration of Microbial Consortia – Addressing the complex regulatory hurdles of multi-strain biological products to establish clearer evaluation standards.
- Working Group 2: Secondary Metabolites Production – Creating actionable methodologies to address the characterization, safety data, and registration requirements for microbial products.
Through this collaboration, we are leveraging our day-to-day consulting experience to build clearer, more efficient regulatory pathways for the entire industry.
In need for personalized regulatory advice to meet your specific needs? Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support: Geoffroy Moulin | Evelyne Güsken | Asha Hoque | Romain Galy | Jeanne Millan Bernal | Caroline Pigeat
Contributors: Pierre LAURENT | Manisha Armoogum | Matthew Burns | Elodie Belmas | Dorothee Michelet | Ismael Sánchez | Pérez Liis Teubner
Contact us or visit our website for more information: contact@staphyt.com
