Review of pesticide active substance approvals
Outside of the routine renewal of approval process, HSE may review the approval of a pesticide active substance at any point if new scientific or technical knowledge indicates that it may no longer meet the approval criteria.
The review will follow the process described in Article 21 of retained Regulation (EC) No 1107/2009 and will result in one of the following:
- reassurance that the approval continues to meet the criteria
- withdrawal of the approval
- amendment to the conditions or restrictions of the approval
HSE will notify the producers of the active substance of the reasons for the review.
Initiation of the review
Producers will be invited to submit comments before a set deadline. If you wish to refer to studies, data, or third-party assessments, you must supply them alongside your comments. This will be your only opportunity to contribute information to the review.
HSE’s review will consider your comments as well as any other relevant information. The timeline for reaching a decision will vary depending upon the quantity and nature of the information to be reviewed. HSE will prioritise the review. HSE may obtain independent scientific advice from the UK Expert Committee on Pesticides (ECP) on specific points where it considers this appropriate.
HSE’s review may indicate that amendment or withdrawal of the approval is appropriate. If such a change is likely to have a significant effect on trade, then the final decision may be subject to consultation through the World Trade Organisation (WTO). The consultation includes a minimum 60-day commenting period. In these cases, HSE will update the GB Pesticide Approvals Register to give advance notice of the consultation on HSE’s proposed decision. This update will acknowledge the ongoing review. HSE will also issue an e-bulletin.
Results of the review
Once concluded, HSE will inform producersof the outcome of the review, the reasons for that outcome, and, if needed, the details of any grace period. Where necessary, HSE will then update the GB Pesticide Approvals Register. This update will acknowledge the review as the reason for the change and be notified using an e-Bulletin.
If the active substance approval is withdrawn as a result of the review, HSE will withdraw the authorisations of the affected plant protection products in GB. These withdrawals will include a suitable grace period to use up and dispose of existing stock.
If the active substance approval is amended as a result of the review , HSE will consider the impact of the change on the currently authorised plant protection products in GB and take any necessary action.
If the review concludes that the approval continues to meet the criteria without amendment, HSE will check that the product authorisations continue to meet the requirements.
If you hold an authorisation for a pesticide product, you have an obligation under Article 56 of retained Regulation (EC) No 1107/2009 to immediately notify HSE of any new information regarding the product or the active substance (including metabolites) that suggests it may no longer comply with the authorisation/approval criteria.