Application for Active Substance
Only approved active substances are permitted to be used in plant protection products. An active substance will be approved when it complies with the obligations and conditions of the Regulation.
Do you want the Netherlands to act as Rapporteur Member State to assess your application for an active substance (in EU)? Please contact our account manager at the earliest stage to discuss this.
In certain approval implementing regulations for active substances, a restriction has been included, for example for the field of use (insecticide , herbicide, fungicide, etc.). To remove a restriction the active substance approval has to be amended. The process for an amendment of the conditions of an approval is identical to the process for approval of an active substance.
For regulations and guidance documents regarding pesticide evaluations: please refer to this page on the EFSA website.
From 27 March 2021 onwards the Transparency Regulation is applicable to all applications for active substances and MRL’s. Please visit our page on the Transparency Regulation and EFSA for more information about the consequences.
EFSA provides training and instruction sessions to guide users in the use of IUCLID:
- Transparency Regulation Implementation Training Programme,
- Transparency Regulation Implementation and Stakeholder engagement
EFSA Toolkit provides an overview of all EFSA portals that are of interest to applicants: pre-submission activities gateway, e-submission system, EFSA’s scientific assessment work portal.
EFSA provides a table with detailed crosswalks from the EU Table of Contents (SANCO/10181/2013) for plant protection product (PPP) dossiers to IUCLID 6.6 as well for chemical substances as for microorganisms. Missing and/or additional information should always be submitted in the form of an updated dossier in IUCLID
On January 1st, 2021 our e-mailaddress for EU active substances for plant protection products will be activated. From this moment on all communication regarding your application(s) for approval, amendment and/or renewal of active substances for plant protection will go via this e-mail box. We kindly ask you to send all e-mail messages regarding the applications for approval, amendment and/or renewal of active substances for plant protection to this e-mail address. The messages will be handled by the EU active substance project managers. The e-mail box will help to secure a swift and evenly communication in your application process. The project manager in charge will be recognizable in the e-mail messages. Every application will keep the current project manager as a first point of contact. Messages regarding service desk requests /questions, still have to be send to the service desk.
The registration manual contains information on:
- Application active substance NL = RMS
- Assessment of equivalence active substance or additive
- Renewal approved active substance
- Confirmatory data
- Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances applicable to applications submitted before 27 March 2021)
- Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances and on the maximum residue level (MRL) application procedure (applicable to applications submitted on or after 27 March 2021)