Potato Review

crop protection products, he said the EU registration reviews had started in 1991, and are still running. “The timeline is not manageable. Moreover, new data requirements are likely to result in more losses of products. There are conclusions still pending for 40 active substances, and a ‘first’ non-approval for over 60% of these. The problem gets worse too, as the products that were re-registered then, are now coming up to the end of their registration period.” The approvals process The core legislation for the EU market is Regulation (EC) No 1107/2009 sets EU-wide requirements for registration, and is applied directly in the Member States, Albert told delegates. “The process in Europe is quite complicated, with different authorities being involved in registration. First, the company chooses the EU member where to makes the submission, and submits the relevant material to the authority. A draft assessment report is then compiled, which is commented on then sent back to the European Food Safety Authority (EFSA) where preliminary results are peer reviewed and decisions made on approval or non-approval. “The information is then considered by the European Commission’s Standing Committee on the Plant, Animal, Food and Feed. This is then followed by registry in each Member State.” This can be very time-consuming; on paper the time estimated is 27 months, he said, but in reality it is closer to 46 months. “It is so hard, which explains why there are hardly any new products coming to Europe.” Comparing legislation in Europe and the US, he noted that in the US, 73 new actives were submitted, of which 35 were approved, 30 have a maximum residue limit (MRL). In the same timeframe in the UK, only six received registration, and two of these are relevant to potatoes, whereas in the US there are 12 new active substances relevant to potatoes. He attributed the difference to the science-based risk: Benefit analysis as used in the US similar to the regulatory system the EU used to have before 2011. The EU legislation is very firm and there is no support to make use of phytosanitary needs to keep crop protection products in the market. Changes in the process impacted the registration, and resulted in some of the new active substances not receiving registration in the EU, he said. There is, of course, now a new Commission, and there are rumours of the possibility of accepting new technologies. “What this will mean we do not know, and we shall have to wait for the European Green Deal to be published.” Schirring believes there are also opportunities from stakeholder engagement, and EFSA has stated it wants more dialogue with the industry and the agro food sector. “In agriculture, unlike other biosciences, we do not have a joint platform to talk about these issues and reach compromise on the path forward.” Looking at the current situation, he pointed out that EU-based farmers have fewer solutions for crop protection than they had in 1993. By comparison, those in the US still have approximately the same number. “The next challenge will come from the re-registration of the available actives being used in the EU region following the new legislation.” www.potatoreview.com POTATO REVIEW MARCH/APRIL 2020 15