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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.

Dossier submitted by producer (applicant) to HSE.

More on the submission of application and supporting dossier[9]

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).

More on the admissibility check[10]

Evaluation completed within 12 months.

Applicant has 6 months to provide additional information.

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

More on evaluation[11]

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 required.

More on consultation and ISA[12]

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

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

More on conclusion[13]

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

HSE seeks prior approval from GB ministers to carry out the decision-making function as delegated to HSE.

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

GB approvals register updated.

More on the decision[14]

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.

Find out more in our guide on phased submission[15]

Link URLs in this page

  1. Step 1: Pre-submission meetinghttps://www.hse.gov.uk/pesticides/active-substances/pre-submission-meeting.htm
  2. Step 2: Submission of application and supporting dossierhttps://www.hse.gov.uk/pesticides/active-substances/submission-application-supporting-dossier.htm
  3. Step 3: Admissibility checkhttps://www.hse.gov.uk/pesticides/active-substances/admissibility-check.htm
  4. Step 4: Evaluationhttps://www.hse.gov.uk/pesticides/active-substances/evaluation.htm
  5. Step 5: Public consultation and independent scientific advicehttps://www.hse.gov.uk/pesticides/active-substances/consultation-and-independent-scientific-advice.htm
  6. Step 6: HSE conclusionhttps://www.hse.gov.uk/pesticides/active-substances/hse-conclusion.htm
  7. Step 7: Approval decisionhttps://www.hse.gov.uk/pesticides/active-substances/approval-process.htm
  8. More on pre-submission meetinghttps://www.hse.gov.uk/pesticides/active-substances/pre-submission-meeting.htm
  9. More on the submission of application and supporting dossierhttps://www.hse.gov.uk/pesticides/active-substances/submission-application-supporting-dossier.htm
  10. More on the admissibility checkhttps://www.hse.gov.uk/pesticides/active-substances/admissibility-check.htm
  11. More on evaluationhttps://www.hse.gov.uk/pesticides/active-substances/evaluation.htm
  12. More on consultation and ISAhttps://www.hse.gov.uk/pesticides/active-substances/consultation-and-independent-scientific-advice.htm
  13. More on conclusionhttps://www.hse.gov.uk/pesticides/active-substances/hse-conclusion.htm
  14. More on the decisionhttps://www.hse.gov.uk/pesticides/active-substances/approval-process.htm
  15. Find out more in our guide on phased submissionhttps://www.hse.gov.uk/pesticides/active-substances/phased-submission.htm
  16. Next page Step 1: Pre-submission meeting (optional) https://www.hse.gov.uk/pesticides/active-substances/pre-submission-meeting.htm
  17. View a printable version of the whole guidehttps://www.hse.gov.uk/pesticides/active-substances/print.htm

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Updated 2024-03-25->->->->->