Strategic advice

The registration of pesticide active ingredient and plant protection product in EU is subject to regulations (1107/2009/EC), procedures and guidelines warranting a high level of safety for the environment and human health. However, it is at the cost of expensive scientific dossiers, heavy administrative burden, and ultimately high financial risk to the industry.

ENC helps the Agrochemicals Industry finding its way through this labyrinth and advice on the best strategy to develop.

Strategic advice will explore the best approach to lead your project depending on your business objective, the regulatory status of the active substance concerned and the investment you are ready to engage into the project.

Strategical consideration are indispensable ahead of any project to define the right regulatory objective. These considerations will question:

• the registration status of the active substance;
• the registrability of the targeted active substances (are there threads on this molecule that jeopardize its EU authorisation?);
• if it is best to defend the active substance as main applicant or as a generic company;
• the best registration process for your PPP.
  • Is it Art 33 for a zonal application? Or is it Art 40 for mutual recognition?
  • Should we refer to Art 34 for unprotected studies?
  • When and how to prepare for renewal under Art 43?
  • How to handle modification of your existing registration such as label extension?
• And more.