The Fresenius conference on “Behaviour of Pesticides in Air, Soil and Water” provides an annual opportunity for representatives from regulatory agencies, industry, consultancy, academia and research institutions, to discuss latest regulatory developments, advances in environmental fate and exposure, as well as global developments in the risk assessment and risk mitigation for plant protection products. Some important regulatory updates to note include:

 

  • Regulation (EU) 2024/1487 of 29 May 2024 defining data requirements for approval of safeners and synergists and the establishment of a work program for the gradual review of safeners and synergists in accordance with Regulation (EC) No 1107/2009. Important timelines to note:
    • 19 June 2024: Entry into force.
    • 19 June 2028: First dossier submissions.
    • Transitional period of 5 years (to 19 December 2030) from adoption of Work Program for products already on the market that contain safeners and synergists.
  • Co-formulants and Plant Protection Products (PPP). Ongoing work by European Commission, EFSA and Member States to:
    • Establish a common database of co-formulants.
    • Development of guidance document on assessment of PPP including co-formulants. Workshop planned for 20 June 2024.
  • Updates of Regulation (EU) No 546/2011 regarding the Uniform Principles; Regulation (EU) No 283/2013 and Regulation No 284/2013 on the data requirements still ongoing. Key changes to:
    • Reflect new guidance on bees, birds and mammals, and water treatment processes.
    • Improve information requirements for co-formulants.
    • Two-year transitional measures.
  • FOCUS surface water repair action. Discussion between EFSA and Member States ongoing on selection of a suitable temporal percentile as the basis for risk management decisions on the exposure assessment goal.
  • PFAS and TFA.
    • 1st mandate sent to EFSA to review health-based reference values for TFA – outcome expected in Q1 2026.
    • 2nd mandate concerning environmental aspects under preparation.
    • Products containing trifluoro-pesticides (CCF3 pesticides) shown to form TFA in soil are being reevaluated in Denmark following the TriFluPest project which investigated the extent to which trifluoro-pesticides can be converted to TFA in agricultural soils.
  • Regulatory updates from the UK HSE.
    • CRD is supporting CropLife Europe to develop additional guidance on aged sorption.
    • CRD are developing guidance on impact of water treatment processes on residues of active substances or their metabolites in water abstracted for production of drinking water. CRD technical assessment in progress with reporting deadline of March 2026.
    • CRD have developed a replacement for SEISMIC to assist with UKHTDF “Approach 2 – weighted level of exceedance” calculations. Report is available on HSE website and a zip folder containing the new v2.2 of UKHTDF model as well as additional tools for processing results.
    • CRD have updated PEC soil, surface water/sediment spray drift and tier 1 drainflow spreadsheet calculators, also available on the HSE website.

 

Other initiatives by industry groups such as CropLife Europe highlighted the challenges inherent in the implementation of the Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for production of drinking water; and proposals for the consideration of a weight-of-evidence approach in the assessment of hazard classes and classification of Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM) properties.

 

Overall, the 27th International Akademie Fresenius AGRO Conference provided useful regulatory updates and developments in environmental risk assessment of plant protection products and point to some challenging few years ahead. CEA have the expertise and considerable experience of applying standard and higher tier risk assessment approaches to demonstrate safety of active substances of plant protection products on the EU and global market. If you would like to learn more about how CEA can support your products, please feel free to contact us directly.

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