Reg. (EC) No. 1107/2009 – Active Substance Renewals Dossiers required under AIR IV and V – Are you ready ?

The fourth programme of active substance renewals under the Plant Protection Products Regulation (EC) No. 1107/2009 was revised in January 2019. Submission dates for many of the originally postponed substances in Group 4 (1) and 4 (2) are now fast approaching in 2020 and 2021.

The fifth programme comprising of 66 active substances was published in June 2019. The deadlines for applications to be made and the supplementary summary dossiers to be submitted all fall between 2019 and 2024.

Our large and newly combined regulatory team (previously APC and Staphyt Regulatory) are ready and able to assist you in any aspect of the active substance renewal process.

In addition to chemical substances, we have significant experience in biological active substances (through our dedicated Bio team).

We can assist with:

  • Identifying any new data and updates needed to risk assessments
  • Task Force coordination
  • Pre-submission meetings with the Rapporteur Member State
  • Advising on representative product and uses (GAP)
  • The application, confirming your support for the substance
  • Study design, commissioning/monitoring
  • Preliminary risk assessment
  • Literature search and review
  • Assessment of endocrine disruption
  • Dossier preparation and submission
  • Ongoing support and guidance throughout the evaluation process

If you would like to find our more about our services and our team please get in touch: contact@staphyt.com