Insight 8: Strategic planning and early preparation enable a smoother regulatory journey for EU PPP
Earlier this year our Plant Protection Products (PPP) team published a series of insights on the sector’s regulatory landscape. This legislative environment can be difficult to navigate, especially in the European Union (EU) with its complex processes and rigorous requirements.
TSG’s PPP team explored three areas where clients often require support: active substance (AS) renewal, products’ renewal of authorisation and the approval of biopesticides. A common theme running through all the articles is that strategic planning and early preparation enable a smoother regulatory journey. Scroll down to read the summaries of the articles and click on the links to read them in full.
Active substance renewals: a taskforce approach
In the first article, Iain Watt, Head of Plant Protection, wrote about the difficulties facing PPP AS renewals in the EU. Since renewal generally happens on a 10-15 yearly cycle, regulatory requirements can change significantly in the interim. For instance, increased emphasis on environmental impact may necessitate new studies to generate the data needed for Rapporteur Member State (RMS) evaluation.
To reduce the administrative burden of AS renewals, the EU encourages multiple entities that share a common AS to collaborate over renewal dossiers. However, the set-up and ongoing coordination of taskforces to handle this can be a challenge.
Iain has experience on both sides of the fence, having worked as a participant and a technical advisor for AS renewal taskforces. His article offers advice on how to ensure all parties work constructively and effectively. It addresses key questions such as ‘Who should be involved in a taskforce?’, ‘How do we coordinate new studies?’ and ‘How do we determine the best representative use of the AS?’. The article also covers areas such as IP and confidentiality as well as the use of existing data held by taskforce members.
Read the full article: Five common questions about taskforces for PPP active substance renewals
Streamlining PPP renewal of authorisation
Once AS renewal is granted, applications must be made to renew the authorisation of products that contain it within three months. Since PPP renewal of authorisation dossiers can take around 400 hours to prepare, it’s clearly advantageous to begin the process as early as possible.
Our PPP regulatory experts recommend starting the initial groundwork for a PPP renewal of authorisation at least a year before its AS renewal date. This upfront planning should include data gap analysis and preliminary risk assessments based on known changes to scientific and technical guidance related to PPP use.
Following the progress of the AS renewal is critical, the applicant is deeply involved in this process. Once it has been reviewed by the appointed RMS, it is peer reviewed by the European Food Safety Authority (EFSA). EFSA then publishes its conclusions before handing over to the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) for a final decision.
The EFSA conclusions are likely to be reflected in any conditions set down by SCoPAFF, so they can be used to predict new requirements and their scientific parameters with a fairly good level of accuracy. Harnessing this information enables product owners, outside of the AS renewal process to get a head start generating data to support renewal of product authorisation applications.
Click the link for the full article: Renewal of authorisation for plant protection products: three ways to help it run smoothly
Biopesticide approvals in the EU
Last year the European Commission announced its intention to reduce the use and risk of chemical and more hazardous pesticides by 50% by 2030. However, as we explained in the third article in the series, this doesn’t necessarily pave the way for easier biopesticide approvals.
As it stands, biopesticide ASs must fulfil approval criteria and, for the most part, general data requirements, devised for conventional chemicals. It’s widely acknowledged that the system needs to adapt, and the Commission and EFSA are engaging with working groups on this matter.
In the meantime, biopesticide AS manufacturers wanting to target the PPP market in the EU must work within the existing parameters of Regulation (EC) No 1107/2009. The approval procedure is as lengthy and stringent as it is for any other AS for PPP applications, so thorough planning and preparation is key.
The article compares the EU situation to that in the US, and outlines measures that can be taken to help streamline the approval process in the EU. We suggest taking a strategic approach to identify and engage with an RMS that has specialist understanding of particular biopesticides.
Read the article in full here: Biopesticide active substances in the EU: navigating approval
The convoluted nature of PPP regulations makes their fulfilment time-consuming and onerous for any organization. For smaller companies that don’t handle these matters on a regular basis, the processes and stipulations can be confusing and it’s easy to make mistakes. TSG’s dedicated PPP team has a wealth of experience and expertise in this space; get in touch if your company could benefit from practical support or expert guidance at [email protected]