Under the Biocidal Product Regulation (BPR) and Plant Protection Products (PPP) Regulation, it results in the non-approval/renewal of an active substance.
ED assessment has been a required endpoint for the approval of biocides and plant protection products in the EU since 2018; that same year, EFSA and ECHA published a guide on how to fulfil the requirements for both the BPR and PPP. In order to be considered an ED, a substance has to show three key features: observed adverse effects, an endocrine mode of action and a causal relationship between the two.
All (ongoing) active substance registrations and renewals under the BPR and PPP require a full ED assessment. Co-formulants present in formulated products should be screened for ED and replaced if ED properties are confirmed. Furthermore, the European Commission is currently evaluating the idea of updating the REACH annexes to include an ED assessment requirement.
TRISKELION can assist you in the complete assessment of ED properties for your products, such as:
- The preparation of registration/compliance strategies for relevant legislations (e.g. BPR, PPP, REACH), with an eye on the latest regulatory developments
- The performance of a detailed literature search, customized to your needs and available information
- The assessment of available data (literature, studies, QSAR data) for ED properties
- The preparation of weight-of-evidence approaches to assessing the ED potential of a substance
- The reporting of available data using the EFSA/ECHA Excel template
- The development of testing strategies for ED data generation
- Study contracting and the monitoring of ED-related studies
- The drafting of expert statements on ED
- Interactions with other registrants/consortia, authorities and downstream users on the impacts of ED