EU Regulation (EC) No 1107/2009 regulates the placing on the market of crop protection active substances and products 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 & environmental safety. Product approval or renewal is done at Member State level and the system is aimed at the safe and sustainable use of plant protection products.
The entry into force of Regulation 1107/2009 has resulted in a precautionary, complex, and increasingly politicized regulatory environment. As a consequence, the outcome of reviews has become more difficult to predict, and this has had a significant impact on crop protection companies.
Since the implementation of approval at EU level (Directive 91/414/EEC, the forerunner of Regulation (EC) No 1107/2009) approximately 900 compounds have been removed from the farmer’s toolbox. Currently, active substances 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 average 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 substances & products is critical to manage resistance and meet pest/disease challenges 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 complicated & 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 current 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.