Training

Biological Assessment Dossier & Efficacy Data Management (Part 1/2)

The purpose of the Biological Assessment Dossier is to justify the uses proposed on the product label and for this, each data requirement must be properly met. A good introduction is key because it will set the framework necessary for the proper understanding of the dossier.

Then, any preliminary data and those demonstrating the dose and direct efficacy of the product will be discussed. We will show you a way to present and summarize them.

We will consider the management of minor uses and possible extrapolations.

Biological Assessment Dossier & Efficacy Data Management (Part 2/2)

The purpose of the Biological Assessment Dossier is to justify the uses proposed on the product label and for this, each data requirement must be properly met.

We will see how to present and summarize data on the possible adverse effects of the product on the treated and harvested plants (yield and quality), on non-target plants as well as on beneficial organisms. We will consider the risk analysis to be carried out in terms of the development of resistance and following and adjacent crops.

Efficacy data: The case of adjuvants requirements.

Adjuvants are not plant protection products, but they influence their behaviour. The regulatory requirements for adjuvants vary from one Member State to another, including in terms of efficacy.

For Member States requiring efficacy data, we will review the reference documents. We will investigate possible extrapolations that will allow us to define the representative uses to be tested. We will also focus on the modalities to be tested in the trials.

Efficacy data: The case of biostimulants requirements

In this module, we will discuss the new European regulatory framework 2019/1009 for biostimulant products. As the 17700 standards are now finalized and available since November 2024, we will present you the essential points to take into account when setting up efficacy trials for biostimulant products. We will also see for each type of biostimulant claim, the points of attention when setting up the efficacy trials.