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HSE Pesticides eBulletin

Issued: 19 April 2021

An independent pesticides regulatory regime is in operation in Great Britain (England, Scotland and Wales).

This eBulletin includes information on the Plant Protection Products (PPP) regulation in Great Britain.

GB renewal: Clarification of the requirement for Supplementary Dossiers

HSE's Pesticides eBulletin issued 9 March 2021 set out the deadlines for the submission of an application and a supplementary dossier (SD) to support the renewal of an active substance in GB.

We committed to providing further clarification in relation to the submission of SDs in particular.

HSE has already indicated that at the application stage, we require:

• A copy of the application for renewal in the EU. This will be accepted by HSE as an application for renewal in GB
  
  
• A cover letter stating your intention to support renewal of approval in GB
  
  
• If the EU representative use or uses are not relevant to GB, the cover letter should also indicate details of a representative GB use or uses that will be supported

HSE can now confirm that, in preparing for GB active substance reviews, we will require an SD to be submitted in order to meet the legal requirement in the retained EU legislation.

Timings

SDs are required to be submitted:

• 30 months prior to the expiry date of the approval of the active substances that expire before 13 May 2026
  
  
• 33 months prior to the expiry date of the approval for active substances that expire on or after 13 May 2026

Content

The future GB programme may specify additional or alternative data requirements to address GB conditions. Further information will be provided with the detailed arrangements for the GB review programme, which is now beginning to be considered. In the meantime:

• Until the future GB programme is developed and the timetable for introducing any material changes to the requirements for the SDs have been publicised in advance, all that will be required to be submitted at the deadline in order to fulfil the legal requirement will be an electronic copy of the SD submitted to the EU

• A sift fee only will be charged at this stage for the receipt and acceptance of copies of EU SDs.  Further information about evaluation fees will then be provided with the detailed arrangements for the GB review

Once the future GB review programme has been established, further deadlines will be set for the provision of updated dossiers to support the review of active substances in GB.  Further details will also be provided at that point with regard to the content of those updated GB dossiers.

Contact us

If you have any questions relating to this eBulletin, please contact us.