skip to main content

First PPP Active Substance Approval Confirmed under the Great Britain PPP Regulatory Framework

Earlier this month saw the first new PPP active substance approval granted in Great Britain under the retained Regulation (EC) No 1107/2009.

The herbicidal active substance, cinmethylin, supported for approval by BASF plc, was formally approved in Great Britain on 7th June 2022 following the Health and Safety Executive’s (HSE) risk assessment of the substance and conclusion that it is expected to meet the criteria for approval.

With close attention being paid by the agrochemicals industry as to how the GB regulatory framework for PPPs will operate in practice, the approval of cinmethylin provides the first insights. The UK government and HSE no doubt have aspirations to demonstrate that an independent GB regulatory framework operating outside of the EU system will allow independent regulatory decisions to be made more efficiently and hence within short timeframes.

In practice, the approval process for cinmethylin has taken a little over 4 years from submission of notifier’s supporting summary dossier (April 2018) to the final approval entering into force. Much of this time appears to have been required for HSE to complete the substance assessment and preparation of the Draft Assessment Report (DAR), first published in May 2021. From the point of publication of the DAR however, it is perhaps pertinent to note that the subsequent procedural steps covering the 60-day public consultation, requests for further independent scientific advice from the Expert Committee on Pesticides (ECP), publication of HSE’s final decision on recommendation for approval and the approval entering into force took little over 1 year in total.

In the context of timelines to approval, it can be tentatively noted that cinmethylin is currently also undergoing assessment for approval in the EU, with the RMS (Netherlands) having reported the admissibility of the supporting summary dossier to move to full assessment in October 2018. To date, there appears no sign of the EU assessment process being close to completion.

Whilst they are some encouraging signs with respect to efficiency of the GB approval process (at least from the publication of the DAR onwards) it will be important to see how active substances navigate through the process to gain more clarity on whether an independent GB regulatory framework is being implemented effectively in a manner that is providing benefits of faster, more decisive regulatory decisions being made. All eyes will no doubt be on the next new active substance, dimpropyridaz, that HSE also understood to currently be in the process of assessing to make a decision for GB approval.

Further information on the assessment and approval of cinmethylin in Great Britain can be found on the HSE website

If you would like to be kept up-to-date with news on the GB PPP Regulation or have enquiries for support with submission applications for active substance approvals or PPP authorisations in Great Britain, contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Herbicide RHS

Contact

Enviresearch Ltd
34 Grainger Park Road
Newcastle upon Tyne NE4 8RY

Telephone: +44 (0)191 243 0687
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Further Information