Conventional regulatory assessment often starts with a data requirement: which study has not yet been submitted?

For complex biological substances, that may not always be the best scientific starting point.

With Clitoria ternatea extract, we have multiple lines of evidence relevant to mammalian safety: no adverse effects noted, low oral bioavailability of cyclotides, a membrane-mediated mode-of-action with evidence of insect selectivity, and a substantial history of human and livestock exposure.

So when considering additional mammalian assessments, including reproductive and developmental toxicity, the key question should be:

What credible pathway to harm remains unresolved?

For target arthropods, that pathway is clear: exposure, susceptible membranes and observed biological effects.

For mammals, the pathway is much weaker when exposure, systemic availability, susceptibility and existing toxicology are considered together.

That does not mean uncertainty disappears. It means testing should be directed at the uncertainty that matters.

The goal is not less evidence. It is the right evidence.

If you have any queries relating to the botanical biopesticide characterisation or risk assessment, our team of biopesticide regulatory experts are ready to help. Call or email and speak directly with one of our biopesticide consultants.