Efficacy Testing for Biostimulants
Efficacy Testing for Biostimulants
Biostimulant Efficacy Testing was explored in Kerona’s very first Dublin FPR Symposium on the Fertilising Products Regulation (FPR, Regulation (EU) 2019/1009) on the 28th of September 2023. In fact, the plethora of questions received from the attendees showed that there is a lot of uncertainty around the standards for designing efficacy testing trials and evaluating the claims of biostimulants. Our guest speaker Jose Giner, from GMW Bioscience in Spain, was very keen to answer these questions and to showcase the extensive trial work he and his team have been performing since 2007.
Jose started his presentation by talking about the biostimulant claims, which can include, among other things, tolerance to abiotic stress, improved nutrient use efficiency, reduction of required fertiliser inputs, and improved crop quality. To evaluate these claims, trials should be set up under a suitable environment. Jose presented many examples of trials his team has performed and listed the advantages each trial environment offers. For example, according to his experience, abiotic stress claims are better evaluated under controlled conditions, because stress can be artificially induced more easily, than in the field, and external variability can be minimised. This type of trial is accepted by the authorities and can be used to support a claim if the results are statistically significant. Of course, each case is unique for marketing reasons, there might be the need to also set up abiotic stress trials in field conditions.
To increase the chance of success with statistically significant results, Jose stressed the importance of having well defined claims, but at the same time not limiting the scope of the trials, especially when the biostimulant mode of action is not fully understood. Examining multiple parameters of crop development, yield, or quality, increases the chances of discovering at least one positive effect for the test product on the crop. Jose explained how external heterogeneity is the worst enemy of biostimulant trials and he gave many suggestions on how to avoid it. Finally, he focused on the importance of the accuracy of assessments which can be achieved by using the appropriate scientific equipment and methodologies.
Lastly, Jose highlighted the importance of designing the trial programme as early as possible and in consultation with a contracted research organisation that has previous experience in biostimulant trials. This experience will allow them to make the right choices for the trial design and conditions, the crop type, and assessments to be taken. According to Jose, all the above will increase the chance of observing statistically significant effects on the crop, which is the only way to support a claim on a biostimulant label. In addition, effective planning can allow for more trials to be performed within a single season / year, which can lead to a faster authorisation of a biostimulant product. Unlike Plant Protection Product efficacy testing trials, there is no requirement for biostimulant trials to be performed over a certain number of years, so depending on the claims to be tested and the available resources within a CRO, a full trial programme can be executed within a single year / season.
If you missed the FPR Symposium, a copy of all the presentations is available on the publications section of the Kerona website at https://kerona.ie/product/fpr-symposium-presentations/
If you need assistance with registration of fertilising products in the EU, please do not hesitate to contact the experts at Kerona info@kerona.ie