Amend the conditions of approval for a pesticide active substance
An active substance approval may be subject to conditions and restrictions as outlined in Article 6(1) of retained Regulation (EC) No 1107/2009.
Conditions or restrictions may include:
- minimum degree of purity of the active substance
- designation of areas where the use of plant protection products containing the active substance may not be authorised
- risk mitigation measures
The GB Approvals Register details the conditions or restrictions for approved active substances in GB.
If you produce a pesticide active substance in GB, you can make an application to amend the conditions of its approval.
It is the same process as when you apply for a new active substance in GB.
The same timelines and fee structure apply.
You must still provide a summary and a complete dossier with your application.
As an amendment, you may present your dossier in the form of an addendum to the current DAR/RAR. You can then make reasoned justifications under Article 7(1D) rather than submitting sections that are not affected by your change.
The active substance application process is described in Articles 7-13 of Retained Regulation (EC) No 1107/2009.
Publishing your dossier
If HSE confirm your application is admissible, we will publish your summary dossier on the website. You should set out the reasons for the requested change in your dossier.
To keep certain parts of your dossier confidential, you must separate this information and present your case for confidentiality in your cover documents.
An active substance must be approved in EU before it can be included in any PPP authorised for use in Northern Ireland. You must approach an EU Member State to make an application for amendment.