The EU’s (Not-So) Fast Track for Biocontrols
With each passing year, it seems regulatory agencies around the world have made it more difficult for manufacturers to introduce traditional crop protection chemicals, which in part, has led to wider research into and acceptance of biocontrol solutions. The challenge for many companies, though, is that in several countries and regions those regulatory agencies treat biocontrol products the same way they have traditional chemistries, meaning it can take years to bring a product to market.
In countries that do offer a fast track for biocontrol products, companies can cut the time it takes to bring products to market, sometimes by years. While high-value specialty crops have employed biocontrols for decades, growers of row crops have begun embracing them as part of their crop protection strategies.
“Biocontrol has been standard in greenhouse crops for 30 to 40 years, and biopesticides are readily used in IPM programs,” says Willem Ravensberg, president of the International Biocontrol Manufacturers Association (IBMA). “In outdoor crops they are more recent and less well known and accepted. But issues with the conventional chemicals such as resistance, residue limits, honey bee problems, and political programs focusing on reduction of the use of chemicals bring changes and give options for biopesticides.”
Of course the pressure to move from traditional crop protection products is not only from regulators. There is pressure from consumers and retailers to produce food with less residue, which more or less forces growers to choose alternatives.
“Slowly biopesticides are being used more by growers, but it takes time before they understand them and rely on them,” Ravensberg says. “It is part of a changing crop protection to IPM, which needs more knowledge of pests and diseases and the way to control them. But every grower sees that this is the way the future crop protection will go.”
It’s for reasons like that IBMA is working with the EU Commission to rewrite the rules on biocontrol registration.
In the EU
In a nutshell, the EU has a two-tiered system. First a substance must be approved EU level. Second, each member state (country) has the opportunity to approve it.
“There is a fast-track system for low-risk products based on low risk substances,” Ravensberg says. A member state then has 120 days to decide whether to approve an application for low-risk plant protection products.
“The problem, however, is that the initial list of criteria for low-risk substances are not appropriate for biopesticides (because they were designed for chemicals),” Ravensberg says. “Since the publication of this law in 2009, IBMA has been trying to get this changed, and the expectation is now that low-risk criteria for biopesticides will be approved late this autumn, after so many years.”
Ravensberg says that beginning in 2017, companies will know the criteria and then can develop active substances that will meet these criteria.
“After approval of such a low-risk active substance, which still takes three to four years, the authorization of a low-risk product may take place and companies will benefit from the 120-days procedure.”
Still, each member state has the opportunity to make its own decision.
“This is an issue, for sure, for product authorizations,” Ravensberg says. “Countries may have so-called national requirements. This is not often the case for biologicals. But the way evaluators make their assessments varies per country because of different levels of experience with biopesticides, level of understanding of these products, and one of the issue areas is evaluation of efficacy.”
This means that products with the same dossier could have different approved labels in different countries. There is hope that a coordinated effort will lead to the development of a guideline for evaluation of efficacy trials both for the applicant as well as the evaluators, which should give a more harmonized approach. That is something IBMA is working on with regulators.
“Mutual recognition of product approvals should provide this harmonization already, but lack of confidence, etc. often leads to a repeat of dossier evaluations and consequently more time and expenses,” Ravensberg says.
One other factor could help lead to greater acceptance of these products throughout the EU.
The interest of the large multinationals that acquired biopesticide companies and are now gradually bringing biopesticides to the market could have an impact on grower acceptance, Ravensberg says.
“Growers have a long history with those companies and this may help building more trust in bio,” he says. “And the direction our societies are developing towards a more sustainable, durable and bio-based economy, towards more green. This changes the consumer needs, and retailers and NGOs further develop that. Further the pace with which new biopesticides are developed, their numbers, and research in this area and new technologies will offer many new possibilities for the grower in the
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