13 Apr 2021
By Rob Gladwin, Head of Technical Management
Leaving the EU has brought both uncertainty and opportunity for the farming sector. As we look forward to how new innovations will be approved for use by British producers – and how these fit in to future trade agreements - it’s important to look at how the regulatory environment will operate post-Brexit. At the heart of the debate is the recent loss of a number of important Plant Protection Products (PPP) and the need for new technologies to support farmers and growers.
Active Substances (ASs) are approved - or renewed for continued use - by the Chemicals Regulation Division (CRD); prior to Brexit these decisions were made in the context of wider EU decisions. CRD continues to operate under the same rules as they were in the EU, however, how this government department decides to interpret and implement these rules going forward will be decided nationally.
CRD has earned a strong international reputation for taking a pragmatic, science-based approach to regulatory approvals; it is also known for being one of the most efficient regulatory agencies in the world. It has some vacancies to fill – as do many government departments – but if these are done quickly and with the right people, then this shouldn’t hinder CRD’s delivery.
Our hope is that politics won’t get in the way of CRD’s science-led pragmatism, and that the British approvals process could be established as one of the fastest in the world – possibly seeing consents achieved 24 months after the initial application by a manufacturer. The current view is that CRD wants to function without political interference - a position that we wholeheartedly support. What the industry needs is a predictable British regulatory system, that is independent, that the industry understands and can work with.
Historically, under the EU system, there are areas where CRD wanted more supporting studies than the EU, for example, related to when birds are nesting or foraging and surface water impact; these are likely to remain key areas of scrutiny. The endocrine disrupters (EDs) also remain under the spotlight; it will be interesting to see how these are dealt with by GB. Bees are another area where the guidance is still in preparation in the EU, so we will have to see how CRD positions itself on this in the future, now we are outside the EU.
The Revysol® approval is a good example of the CRD approach to the PPP approvals process. Very early on in the Brexit negotiations, after BASF had made the EU application for Revysol’s approval, we had discussions with CRD who decided to run the EU and UK approvals in parallel with the EU process. They weren’t able to make any decisions on Revysol’s GB approval until we had left the EU, Brexit was delayed and Revysol was registered within the EU process as a result. CRD was pragmatic and were able to show flexibility in the way that they approached the whole process.
CRD is still to define how they will handle Active Substance and product renewals. CRD has indicated that they will push forward renewals by giving extensions of three years (for active substances with expiry dates up to the end of 2023), to give their team some space to get the process in place. However, it is uncertain if the full three-year period will be allowed, particularly where a decision on non-renewal is made by a third country, e.g. the EU. A worked example of this is mancozeb which was voted for non-renewal at the end of December but hadn’t come into effect when we had exited the EU, so it is still approved in GB.
CRD has already said that they will review the approval for mancozeb, but also haven’t said when they will look at it, which makes it difficult for industry to plan, particularly where decisions on production are made a year or two in advance. How they handle active substance renewals will be critical to the toolbox that is available in the medium term. What they might do is look at what comes out of the EU and decide whether to grant the renewal based on the EU decision; or, if the EU has decided not to renew, how does CRD consider the conclusions made by the EU?
The watch out here is that the EU process is politically charged, and if there is a political issue, then the science goes out the window, and this is where we might get a deviation, and GB might take a different view in the future.
The scrutiny of PPPs will remain high – and rightly so – but having domestic responsibility for the approval of all technologies could give us new opportunities.
The current government, as well as the shadow team, are interested in the use of innovation in agriculture to deal with challenges like climate change and the need for food production while making room for nature. Even when you dig into the individual topics such as genetics and gene editing; both the industry and the regulatory/policy makers are interested in the debate.
This is important context, because we need to broaden the genetic base, especially in cereals, because diseases like rusts rely on a very narrow lineage. Anything that we do to broaden the genetic base and rigour is important.
Big questions are being debated, for example, could we overcome some big issues like using gene editing to tackle cabbage stem flea beetle? The regulatory environment is central to encouraging investment in these new technologies, and if regulated in the right way, small pioneering start-ups will also invest and innovate which is good news for us all.
And going forward, trade negotiations will play a central role in what technologies British farming can use alongside what is registered in GB, particularly when the produce is traded with the EU or internationally, and for IPM to be truly effective ; we need a wide range of tools available for farmers to use – cultural control alongside genetics, chemistry, digital - they all work very much together and are inextricably linked– essentially having the biggest toolbox possible and allowing the grower to select the right tools for the job. Regulation needs to allow for these innovations to develop and be applied in best way possible.
Revysol® is registered trademark of BASF. Revysol® is contained in Revystar XE® mefentrifluconazole. Always read the label and product information before use. For further product information including warning phrases and symbols, you can refer to agricentre.basf.co.uk
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