Just like your Spotify wrapped, here are your PPP regulatory ecotoxicology highlights for 2023…

2023 has been a busy year for EFSA with two revised guidance documents, an online calculator and many reports published. As we prepare for a new year, here is a re-cap of some of the biggest ecotoxicology regulatory changes and updates made for plant protection products (PPPs).

At the beginning of the year, EFSA released the final version of the revised guidance document on Risk assessment for Birds and Mammals and the associated online calculator (R4EU platform). The new guidance document outlines a tiered risk assessment scheme covering dietary exposure, exposure via secondary poisoning and exposure via intake of contaminated water. The guidance is not yet in force for pesticide authorisation, but it is expected to be noted in the EU in Spring next year.

The following month, EFSA published a scientific report on the use of Critical Appraisal Tool (CAT) for the evaluation of ecotoxicity studies that may not follow standard test guidelines. The aim of CAT is to provide a structured and transparent approach to assist regulators and EFSA experts in the evaluation of non-standard higher tier ecotoxicology studies included in the PPP data package, to increase transparency and consistency among dossiers.

Also in March, EFSA published the revision of the guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). The revisions presented follow a tiered approach for assessing both bees’ exposure to PPPs (via contact or diet) and the resulting effects. The document also provides recommendations for managing risks from metabolites and mixtures of PPPs. Similarly to the birds & mammals update, an online calculator tool to aid the assessment is planned, however it is currently at an early development stage so watch this space! More background information on the protection of bees in Europe can be found on the EC website.

Jumping to the end of the year, last month EFSA along with several national agencies and academic partners have developed an open-access platform ‘TKPlate’ that integrates a number of physiologically-based kinetic models and toxicokinetic-toxicodynamic models (TK-TD) used in ecological risk assessment, as well as assessing human and animal health. The integration of TK models into a user-friendly interface is an important step to implement their use in chemical risk assessment. We will keep a close eye on these developments and share relevant updates, but in the meantime take a look at our poster about the use of the TKTD model GUTS in the environmental risk assessment of PPPs presented at SETAC Europe 2022. The use of GUTS is supported by EFSA in the PPP acute risk assessment scheme for aquatic invertebrates and fish. Are your ecotoxicological endpoints showing potential concern for aquatic risk assessment? Contact our Senior Ecotoxicologist Alice Tagliati for advice about using GUTS model as Tier 2 refinement to predict survival rates under untested environmental conditions.

Finally, hot off the press, environmental scenarios were established for honey bee colony model ApisRAM. These scenarios represent the diversity of European environments in terms of risks for honey bees, and are crucial for the regulatory use of the model in the risk assessment of PPPs. Our team will keep a close eye on any further news being published on these scenarios or model in 2024. We will be sure to share further updates as and when they become available.

If you would like to discuss how any of these updates may affect your ongoing or future dossier submissions, contact us today.

We wish you a happy and prosperous 2024 from everyone here at Enviresearch.