Environmental fate and behaviour specialist, Abdul Abu, reports back from this interesting Fresenius conference on behaviour of pesticides in air, soil and water.

The Fresenius conference provides an annual opportunity for representatives from EU regulatory agencies, industry, consultancy, academia and research institutions, as well as decision-makers to discuss the latest regulatory developments, advances in environmental fate and exposure, and recent developments in risk assessment and risk mitigation for plant protection products. Several useful 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.
    • July 2024: Publication of a non-exhaustive list of substances used as safeners and synergists.
    • December 2024: Interested parties to submit notification of further substances or preparations used as safeners and synergists in plant protection products.
    • June 2025: Interested party wishing to submit an application (re: Article 7, Regulation (EC) No 1107/2009) for the approval of a safener or synergist, to submit a request for inclusion in the work program for gradual review.
    • December 2025: Adoption of the work program for substances included in it.
    • June 2028: All applications for approval of safener and synergist shall be submitted.
    • Transitional period of 5 years from adoption of work program for products already on the market that contain these substances.
  • Other EU level regulatory updates and ongoing activities.
    • Expected updates of Regulation (EU) No 546/2011 as regards the uniform principles; Regulation (EU) No 283/2013 and Regulation No 284/2013 on the data requirements for active substances and plant protection products.
    • Amendment of Regulation (EU) No 547/2011 as regards the labelling requirements for plant protection products.
    • PBT, vPvB, PMT, vPvM: New RAR Vol 1 template (combined 1107/2009 assessment report and proposal for Harmonised Classification and Labelling (CLP) according to Regulation (EC) No 1272/2008) has been published by European Commission.
    • Guidance is being developed by ECHA/EFSA on the Regulation of Persistence, Mobile and Toxic and Very Persistent and Very Mobile (PMT, vPvM) substances, following the amendment of CLP Regulation (EC) No 1272/2008 on hazard classes and criteria for the Classification, Labelling and Packaging of substances and mixtures.
    • FOCUS surface water “repair action”. Stage 2 testing have begun with Step 3 tools in the FOCUS version control. Once completed, activity with Steps 1-2 and Step 4 tools will be required. Finalised tools for regulatory applications are not expected before 2026.
  • Regulatory updates from the UK HSE.
    • Final report of CRD project: An Investigation into additional risk mitigation measures to reduce environmental exposure of pesticides in surface water via drainflow and to groundwater has been published. HSE are reviewing actions and considering further research and development.
    • HSE have developed a new ArcGIS tool that maps soil, crop and weather data for the whole of GB, which has been used to determine updated crop statistics which will be published on the HSE website to assist with UKHTDF “Approach 2 – weighted level of exceedance” calculations.
  • Interzonal Steering Committee (izSC) agreement on Interim Working Document on interzonal core assessment of greenhouse uses – environmental fate, to be implemented from the 1st of September 2024. Applicants are required to submit 2 draft registration reports (dRR):
    • 1 dRR covering high-and low-tech greenhouses, evaluated at the interzonal level; and
    • 1 dRR covering walk in tunnels, open protective structures and field uses, evaluated at the zonal level.
  • Northern Zone Steering Committee are in the process of updating the Guidance Document on work-sharing with a view to further harmonisation. Swedish University of Agricultural Sciences has initiated an update of climate data for Swedish MACRO-in-FOCUS groundwater scenarios in light of climate change, with possible implementation in the regulatory procedure.
  • The SETAC Harmonised Framework for Spatially Distributed Leaching Modelling of Pesticides (SDLM) Initiative, which has been developed for FOCUS Tier 3B groundwater simulations with PEARL and PELMO models, are aiming to provide a draft report to EFSA in 2025. The time-lines to finalise the SDLM approach for regulatory application could extend beyond 2026.
  • OECD project on development of New Test Guideline to determine the uptake of chemicals by plant roots is still at the Round-robin testing stage. The OECD test guideline is not expected to be available for a few more years.
  • EFSA are finalising preparations to revise the Guidance Document on risk assessment for non-target arthropods to pesticides. Mandate is expected from the European Commission anytime soon. Considering other associated ongoing initiatives by EFSA, for example ongoing research by WUR, Shefield University and others on definition of Specific Protection Goals for NTTO, the Guidance Document is not expected to be finalised for regulatory applications before 2028.

Overall, the 26th 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.

If you require advice or guidance on aspects of environmental fate and exposure, please feel free to contact us.

Enjoyed this article? Avoid missing out on our future news articles by signing up – you can select which topics you are interested in and can unsubscribe at any time.