Considerations in Addressing Data Requirements for Bees
At Kerona Scientific’s Plant Protection Symposium, Markus Persigehl, Senior Study Director from tier 3 solutions GmbH, Germany, provided an in-depth view of the considerations required for addressing data requirements for bees.
Around 70% of plant species are pollinated by bees. Honeybees, bumble bees and solitary bees are the bee species considered for the approval of active substances and authorisation of PPPs under the Plant Protection Products Regulation (EC) No. 1107/2009.
In 2022, EFSA published a revision of the guidance on the risk assessment of plant protection products on bees. The original guidance was published initially in 2013 and not officially noted.
Compared to the previous SANCO 2002 guidance, the EFSA guidance provides different exposure scenarios including effects on larvae and chronic effects on adult bees. In the EFSA guidance 2013, the trigger value used for chronic effects (ETR = 0.03) was very conservative, resulting in unresolved adult chronic risk assessment for most of the products including herbicides and fungicides.
There is no harmonised approach amongst Member States on whether or not to use the new EFSA guidance. Some Member States rely on the SANCO guidance, whereas others use some parts of the EFSA guidance. The new draft EFSA guidance 2022 has proposed more realistic exposure parameters for the risk assessment, and refinement options based on field exposure and residue studies. It is expected that the EFSA guidance will be accepted this year, in 2023.
Please get in touch with Kerona Scientific at email@example.com if you need support with risk assessments for bees or any other issues relating to the authorisation of PPPs in the EU.