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How is the marriage between biologicals and chemicals really going?
by Jan Mostert, Portfolio Lead Biorationals and Horticulture, and Sue Young, Regulatory Affairs Manager, Certis
It is therefore intriguing to examine where are we now in practical terms in this world? These expensive acquisitions were not made just to create solo biorational products. The companies invested in this way to do something synergistic, maybe to create ready-mixed products or rotational programs at least. Realistically we might expect to find a first wave of integrated or combination products coming through to the market five years on. One of the first of such ready-mix products is Xanthion which was launched by BASF in North America in 2014, a fungicide mixed with Bacillus to be used in maize. However, if we look for other products in this category we find little evidence of successful introductions to the market. The desire was certainly to develop new biorational mixtures or rotation solutions in the major outdoor crops but, seeing the limited solutions coming to market, it doesn’t seem to be that easy. These biorational solutions tend to be more expensive than conventional products and it is a bit more complicated to position them successfully. As a result the successes that have been seen are mainly in certain high value niche crops, like fruiting vegetables and fruit crops.
Unlike conventional chemical products, microbiologicals are living organisms and need the right conditions to work. For example, in northern European countries with lower temperatures and different climatic features, these microbiologicals were not always as effective as anticipated, based on information from laboratory tests.
From a regulatory point of view there was a perception that the process for biorationals would be easier than for chemical products; that if the product is seen as lower risk there should be less requirement to go through all the same regulatory hurdles. However, although less data may be needed, most authorities view the dossier for a biorational product or active substance as they would that of a conventional product, expect to see similar argumentation for approval and, in many cases, demand similar data. A number of companies have found biorationals that work in the laboratory but they frequently have neither knowledge nor experience of the regulatory system and often do not even know the mode of action. The larger companies who take them over then find themselves lacking the information they need to prove what a product is, how it works and that it does not have undesirable effects. Furthermore, in Europe it is still necessary to prove efficacy for biorationals so trials data over several years is required and for biorationals this is not always consistent.
The shortage of new active substances coming through provides a further limitation. Indeed only a small number of new ‘low-risk’ active substances have been applied for since the introduction of the European Union 1107/2009 regulations and some of those will be new strains of previously registered actives. In addition there is now a stricter requirement for the renewals of previously approved, well-established actives. Most of the substances for this type of product were on List 4 of 91/414 and received blanket approval in 2009 prior to subsequent review. They are now to be fully reviewed over the next few years and will need a modern dossier with additional data. This means that the cost of preparing such dossiers may become prohibitive and some of these substances could even be lost.
So the main successful developments with biorationals still seem to be in the niche markets of horticulture or organic production. It may be that we can expect launches in larger markets such as the USA or Brazil where regulatory requirements are slightly less demanding than in Europe. However, it seems fair to say that, so far, this whole area has been moving forward much more slowly than the industry was expecting. The anticipated new era of biorational compounds and mixes seems not to have come to fruition, perhaps because it is not as easy as many expected to achieve such mixes or rotations.
In Certis Europe we have been working with both biorationals and conventional chemistry for some time and have created integrated programs using both these products. We have built up extensive knowledge in the sector and are perhaps better placed than some of the larger companies, not least because we do not expect it to be simple. We are still investing in the purchase and development of biorationals that could be used in outdoor crops and we believe that some of them will come to market, albeit mostly in niche situations. We have selected a few for development that we consider have a strong prospect of being effective, but they are not major game-changers on crops such as wheat, maize, corn or soya, where conventional measures tend to be relatively cheap. We are now making our first investments into the development of hybrid products that we believe can be successful.
Are the difficulties mainly regulatory or technical? It is difficult to say but, as we move forward on our own journey of biorational developments, we shall learn more. Logically regulatory limitations should be minimal for these types of developments, but to date we are not aware of any hybrid products registered in Europe and we would expect some visibility by now if others were being successful in the market. For the moment we do not see a wave of hybrid products on the horizon: progress seems to be slow in this marriage of biorational and chemical products and thus the ‘greening of the world’ is not going as fast as many would probably like.
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