TRADE AND MARKET I NG ‘A sustainable potato sector requires a stable EU policy’ There is currently a lot of discussion about the re-registration of active substances in potato cultivation. Why is it precisely now that crop protection products are being re-registered? ‘To understand this, we first need to go back to the early 1990s. At that time, there were several major food scandals and there were concerns about the quality of the food in the shops. In response to this pressure from the public and from political opinion, legislation and regulations were tightened up. This certainly applies to residues of synthetic products used in cultivation and ranged from crop protection to fertiliser. At the time, it was already established that this regulation cannot be achieved at a national level in the internationally-operating agricultural sector. That’s why the authorities have chosen to regulate this at European level by means of EU Directive 91/414. The purpose of this Directive was to re-register products in order to harmonise the evaluation of plant protection products in Europe. This was done according to the latest scientific research and on the basis of common protocols, all of which had yet to be developed. The Directive was finally implemented from around 2001, but bear in mind that paper is patient and practice is difficult to manage. In fact, the implementation of the Directive failed to take account of the cartloads of documents with new data that manufacturers had to submit for assessment. It appeared that the authorising organisations were unable to cope with the amount of work, which delayed the assessment of the products for many years. Because the Directive was incorporated into national laws by all the countries in their own way, each country also continued to operate according to its own rules. That’s why those involved decided to proceed with the re-registration in stages. Subsequently, four categories were defined, whereby the group with the most critical products were dealt with first. Before the evaluation of all the existing active substances under 91/414 had been completed, a new European law came into force: 1107/2009. This law was intended to enable countries to cooperate more closely and make use of each other’s evaluations. At the same time, the authorising organisations such as Ctgb (Board for the Authorization of Plant Protection Products and Biocides) in the Netherlands had to assess all new substances in accordance with this new Directive.’ This sounds really awkward, but what exactly is the big problem for the potato sector? ‘The first problem is that the standards are constantly being tightened during the race. This means that we build up a dossier for a product for potatoes, for example, and carry out additional tests. The government then confronts us with new insights during or at the very end of the process. Then we’ll need even more time to generate the data, or we’re in a stage of the process where we’ll no longer be able to submit new studies. We’re therefore faced with an unexpected question, to which we’re no longer allowed to reply, resulting in a ‘data gap’, which may lead to rejection. Maybe there’s nothing wrong at all, but the authorisation process no longer permits a response. This is a different method from that used by the United States, which is the biggest competitor of our potato processing industry. In the US, the Environmental Protection Agency (EPA) draws up an inventory and evaluates the products and lists the new insights about the active ingredient. The EPA then indicates what data is missing for re-registration. The manufacturer must then supply the requested test data within ‘If the range of products is narrowed, this will lead to increased production costs’ a certain period of time. We as manufacturers can then decide whether or not to do so, based on estimates of the market value and Return on Investment (ROI). The most important thing is that you know how long research will take and what it’s going to cost. Unfortunately, this isn’t the case in Europe, because insight in regard to the authorisation of active substances is constantly changing. In addition, in Europe, we’re moving away from a risk-based approach. This means that, in an increasing number of areas, the actual risk of substance use is not taken into account, but rather the intrinsic risk, or the potential hazard. This is also called a hazard approach and is equivalent to the government no longer allowing table knives to cut meat, because in principle you could kill someone with them. This puts science at risk. Our scientific experts can no longer even submit a number of important aspects, because agreed protocols are not (yet) available. This can be seen, for example, in the subject of the breakdown of active substances in the soil. As manufacturers, we make synthetic compounds from natural substances, giving them improved phytopharmaceutical properties. For example, think of pyrethroids: mimicked from pyrethrines, natural insecticides found in garden plants such as the Pyrethrum Daisy. The natural active ingredient can be extracted from it, but it’s not ideal for agricultural use. The question at stake here is: how and to what extent do synthetic variants of substances such as pyrethroids break down in the environment? It’s a race between risk assessment and the state of analytical techniques. In the past, for example, we talked about parts per million (particles per million), but today we’re already talking about parts per billion (particles per billion). The question that arises is: what is the relevance of these figures? This is why I’m calling for greater harmonisation and agreement between public authorities. Only then can we discuss or investigate in a transparent way what is scientifically sound and relevant. Only then will we be able to work together to substantiate the political requirements with scientific methods in order to ensure that the research is consistently completed and translated into practice.’ Potato World 2017 • number 4 5 Pagina 4

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