Efficacy framework of the Regulation (EC) 1107/2009
In order to decide whether the benefits from the of use of a plant protection product outweigh any disadvantages, Regulation (EC) 1107/2009 requires that a product should be sufficiently effective. We will therefore focus on the notion of Acceptable Efficacy.
Then, as the Efficacy of a product can vary within the same regulatory zone according to many parameters, we will look at the notion of climate comparability.
Then, in terms of presentation, the Efficacy Section of the product dossier has a particularity. We will explain the difference between the Biological Assessment Dossier and the dRR.
Finally, we will discuss efficacy in the active substance approval dossier. The requirements for a new active substance differ from those of a product registration dossier.
The product requirements will be addressed in subsequent modules.
Objectives and skills
Understand three essential aspects of Regulation (EC) 1107/2009 in terms of efficacy through the notion of acceptable efficacy, the difference between regulatory zones and EPPO climatic zones and the place of the Efficacy Section in the plant protection product registration dossier.
Understand the efficacy requirements for the approval dossier of a new active substance.
Public and prerequisites
- Any actor needing to understand the efficacy section of a PPP dossier.
- Basic knowledge of Regulation 1107/2009 is an asset.
Program/Content
- Definition of Acceptable Efficacy
- Regulatory zones vs climatic EPPO zones
- The place of Efficacy in a PPP dossier : difference between BAD and concise dRR
- Efficacy data requirements for new active substance approval: the efficacy summary dossier
Details and technical aspects
- Date: March 20th, 2025
- Time: 9h30 - 11h30
- Training duration: 2 hours
- Language of presentation : English
- Language of training material : English
- Online training
- Cost : 300€
- Minimum number of participants : the training will be held based on a minimum of 5 participants.
- Participation fee is for ONE participant (Fees are to be paid individually for each participant).
- A 10% discount will be applied to the price from the second participant from the same company in the same training.
20.03.25
English
English
Online
2 hours
300.00€ Excl. Tax
