GB active substance renewals: pesticides
GB Renewal process
The renewal process of pesticide active substances in Great Britain (GB) is given in assimilated regulation No 1107/2009 (legislation.gov.uk) and assimilated regulation No 844/2012 (legislation.gov.uk).
Guidance document SANCO/2012/11251 was formally withdrawn in November 2024.
It no longer applies to GB renewal applications.
Active substance renewal list
The GB pesticide active substance renewal list shows which active substances are being supported for renewal of approval. It gives further information and links to associated documents.
Approval expiry dates
Pesticide active substances that are approved for use in plant protection products in GB can be found in the GB pesticides approvals register.
The register includes the expiry dates for the approvals and other details.
Pre-submission meetings
A pre-submission meeting can be requested before the submission of any information that is needed to complete the renewal assessment. These meetings can help ensure common understanding of what is being submitted and why.
You can arrange a pre-submission meeting using form CRD 10.
HSE charges a fee for the meeting.
Supporting renewal
If supporting an active substance through the renewal process, your obligations relating to renewal under assimilated Regulation No 1107/2009 continue to apply.
To maintain support for your active substance in GB, you must apply to renew its approval 3 years before it expires.
How to apply
Email your application to [email protected].
Use the format given in the annex of the assimilated regulation No 844/2012.
Also include:
- a cover letter stating intention to support
- details of the GB representative uses
- details of any task forces
You must also submit a supplementary dossier 33 months before the approval expires. At this point HSE will charge you a sift fee.
If these steps are not completed for an active substance, its approval will not be extended beyond its expiration date, and it will not be eligible for renewal in GB.
We will contact you if you later need to supply further information to support your active substance.
If an active substance in GB is not supported, then its approval will expire and we will determine a period for withdrawing products which contain it.
Supplementary dossier requirements
The requirements for your supplementary dossier are given in assimilated regulation No 844/2012 and should include:
- a copy of the application sent previously to HSE
- a cover letter confirming your intention to support renewal of approval in GB that includes invoicing details for the sift fee
We will accept a copy of the dossier provided to support the active substance in the European Union (EU) so long as this contains details of a representative product and uses that are relevant to GB. If the EU product and uses are not relevant to GB, your cover letter should give details of the representative GB product and uses that will be supported.
Once GB renewal requirements are agreed, before beginning assessment, we may require that you update your supplementary dossier. Where this is the case we will contact you and agree a reasonable period to provide this update.
Admissibility
Before a renewal application is considered for admissibility, we will contact you to talk through the process and to explain how the assessment will be handled. We may also request specific additional information at this point and will agree a timetable for this to be provided.
If, following the admissibility consideration, we determine that a supplementary dossier meets the requirements for renewal assessment, we will declare it admissible and publish a redacted version of the supplementary summary dossier on our active substance renewal list. This will be accompanied by appropriate communication. We will charge a fee at this point based upon our estimate of the resource needed for the initial renewal work. Once you have received this information you may choose not to proceed with your renewal application. If this results in no one supporting the active substance for renewal then its approval will not be extended beyond its current expiry date.
Assessment
We will assess your active substance renewal application in line with the necessary regulatory processes and compile a suitable draft renewal assessment report.
First assessment of approval criteria
We will first establish whether the active substance meets certain hazard criteria. These are laid down in points 3.6.2 to 3.6.4 and 3.7 of Annex II to assimilated regulation No 1107/2009. Where these criteria are not satisfied, our assessment will consider whether the dossier demonstrates that under realistic conditions of use there is negligible exposure to the substance. Where that is not demonstrated, our draft renewal assessment report shall be limited to those parts of the assessment.
Assessment of the specification of the active substance
In principle, the minimum purity and maximum contents of relevant impurities as originally set for the first approval of the active substance will be kept. However, in justified cases we may amend them if we have safety concerns.
Assessment of remaining approval criteria
We will then consider the remaining approval criteria that are set out in the legislation. For each criterion, we will consider any new information necessary, that has come to light since the last approval or renewal decision. This may include, but is not limited to:
- newly published literature that relates to the active substance or the manner in which it is used
- newly accepted regulatory guidelines and standards
- newly generated studies or regulatory models that use the active substance, or which are relevant to its underlying risk assessment
- new assessments and regulatory decisions undertaken in other jurisdictions, where these are relevant to the approval criteria in GB
We will assess the necessary information and summarise our assessment in the draft renewal assessment report. If we need additional information, we will request this from you and set a suitable deadline for submission. We may also seek independent scientific advice during this period.
Public consultation
We will then publish our draft renewal assessment report on our website. This document is a summary of our evaluation of whether the approval criteria are met. We will invite you and the public to submit written comments on the assessment report within a period of 60 days.
We will charge a fee at this point.
Conclusion
We will then prepare a conclusion to our renewal assessment. This will summarise our evaluation, taking account of any comments and independent scientific advice that we have received. The conclusion will present our opinion as to whether the active substance can be expected to meet the approval criteria. Our conclusion will be published on our website and will be accompanied by appropriate communication.
Decision
In light of our conclusion, we will decide whether or not to renew the approval of the active substance. In certain cases, the respective governments of GB may wish to take the decision in light of our conclusion and any other matters they consider relevant in accordance with the Agency Agreements between them and HSE.
- Following a decision not to renew the approval of the active substance, we will remove it from the register of approved active substances and arrange a suitable use-up period for any products authorised in GB that contain it
- Following a decision to renew its approval, we will update the register of approved active substances. This will then trigger the start of the renewal process for products authorised in GB that contain the active substance
In both cases, we will publicise the decision as well as any necessary dates and actions.
GB Renewal programme
HSE is currently working with Defra, the Scottish Government and the Welsh Government to develop a revised independent GB process for Great Britain (GB) programme for the renewal of pesticide active substance approvals. Once this is agreed we intend to introduce an ongoing programme of renewal for GB pesticide active substances.
This page will be updated once that process is agreed and a programme is implemented.
In Northern Ireland, EU decisions that relate to the renewal of pesticide active substance approvals continue to apply directly.