Overview

An active substance can only be used within a plant protection product (PPP) in Great Britain if it's approved. 

You can apply for approval if you're the producer of the active substance.

Process steps

These give a summary of the process steps and link to further guidance.

Step 1: Pre-submission meeting

Optional meeting where HSE will provide advice and identify potential issues.

Step 2: Submission of application and supporting dossier

Dossier submitted by producer (applicant) to HSE.

Step 3: Admissibility check

Admissibility check will be completed within 45 days.

Admissibility reported to applicant and GB Competent Authorities.

Applicant has 3 months to address missing elements.

Summary dossier made publicly available (excluding confidential information).

Step 4: Evaluation

Evaluation completed within 12 months.

Applicant has 6 months to provide additional information.

Draft assessment report (DAR) circulated to applicant and GB Competent authorities.

Step 5: Public consultation and independent scientific advice (ISA)

ISA sought from the Expert Committee on Pesticides (ECP) if required.

Draft assessment report (DAR) made publicly available (excluding confidential information). Public have 60 days to comment.

Additional information may be required based on feedback from the ISA and consultation. Further ISA of consultation may be undertaken.

Step 6: HSE conclusion

Conclusion prepared within 120 days of end of consultation on whether the active substance meets the approval criteria.

If independent scientific advice (ISA) is obtained, 90 more days are allowed for preparation of the conclusion.

Step 7: Approval decision

Competent Authorities decide on approval of the substance within 6 months.

Conclusion documents and final Assessment Report (AR) made publicly available (excluding confidential information).

GB approvals register updated.

Phased submissions

Phased submissions are a type of procedure for new active substances. They include a pre-application study evaluation that recognises that many studies are available ahead of a planned submission. They're optional and acceptance is subject to HSE agreement.

Updated 2023-02-28->->->->->