Transition metals can be used as active substances in plant protection products (PPPs). Due to their specific behaviour in the environment, they are not fully covered by existing risk assessment guidances.
EFSA was thus asked by the European Commission to prepare a statement that provides a framework for conducting the environmental exposure, hazard characterisation and risk assessment for transition metals when used as active substances according to Regulation (EC) No 1107/2009.
The statement and the outcome of the public consultation performed form 3 August to 21 September 2020 were published on 29 March 2021.
In this statement, the EFSA’s PPR panel proposes to start with a preliminary phase in which monitoring data of transition metals in environmental compartments are compiled. Then a first assessment step is performed considering metal natural background and anthropogenic residue levels and assuming fully bioavailable residues. If higher assessment steps are performed, reduced bioavailability of residues from past applications could be considered. However, for freshly added transition metals such as PPP, equilibrium cannot be assumed.
For addressing speciation and bioavailability issues, models and scenarios including environmental processes and parameters relevant to the fate and behaviour of transition metals in water, sediment and soils would need to be adapted or developed. Care should be taken to avoid unnecessary complexity. All developments should follow current EFSA guidance documents.
If refined approaches have been used in the risk assessment of PPPs containing metals, post-registration monitoring and controlled long-term studies should be conducted and assessed.
Lastly, the statement highlights that the prospective risk assessment of metal-containing PPPs can only cover a defined period as there are limitations in the long-term hazard assessment due to issues of non-degradability. It is therefore recommended to consider these aspects in any risk management decisions and to align the environmental risk assessment with the goals of other overarching legislative frameworks.
Outcome of the Public Consultation on the draft statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP)
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