Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 5232 I EUROPEAN SEED I EUROPEAN-SEED.COM INSIDERS ADVICE FROM INDUSTRY EXPERTS INSIDERS — Here, experts from across the industry will discuss issues that are top-of-mind, share technical advancements, talk about tips for success and provide perspective on policy. Readers can hone in on areas that are of particular interest and get a snapshot of what’s happening and how it impacts the seed industry. EU Regulation (EC) No 1107/2009 reg- ulates the placing on the market of crop protection active substances and prod- ucts which contain them. It specifies that active substances which are used as crop protection must be approved or renewed at EU level. The objective is to safeguard human and animal health & environmen- tal safety. Product approval or renewal is done at Member State level and the system is aimed at the safe and sustaina- ble use of plant protection products. The entry into force of Regulation 1107/2009 has resulted in a precaution- ary, complex, and increasingly polit- icized regulatory environment. As a consequence, the outcome of reviews has become more difficult to predict, and this has had a significant impact on crop pro- tection companies. Since the implementation of approval at EU level (Directive 91/414/ EEC, the forerunner of Regulation (EC) No 1107/2009) approximately 900 com- pounds have been removed from the NEIL GREENER Regulatory Lead for Seedcare in EAME for Syngenta SEED TREATMENT AND STEWARDSHIP The EU regulatory system for pesticides farmer’s toolbox. Currently, active sub- stances are disappearing at a rate 4 times faster than at which new innovation is coming to the market. Also, the more stringent requirements have led to rising costs of bringing new active substances to market, and are estimated at an aver- age of $286 million and 10 years of R&D per product. The regulatory component accounts for 40% of the total cost and although the process has strict timelines, outcomes are not predictable. In addition, once the review process has started the notifier has very limited opportunities to respond to questions and any changes in requirements. Large R&D companies are the only ones capable of taking on the investment risk and therefore play a critical role in maintaining and bringing new innovation to the market. The investment decisions can only be based on best assessment of the concerns that will be driving the regulatory questions during the review; and once a submission has been made, opportunities to address any changes are very limited. It is important to underline that the efficient approval of new active sub- stances & products is critical to manage resistance and meet pest/disease chal- lenges in order to make sure that the grower has the tools she/he needs to effectively grow the crops. Unfortunately however, the current process for new active substances and products is com- plicated & slow. In the same way, the renewal of active substances and products is equally important for the maintenance of a full range of solutions in the market, but is similarly complex and slow. We need to ensure that farmers and growers have a wide choice of providers of crop protection solutions, but the cur- rent regulation is making this more and more difficult to achieve. There are far fewer active substances to choose from compared with 25 years ago. And this makes the job of the farmer a whole lot more difficult.