Last 23d October 2018, in the Annual Biocontrol Industry Meeting, ABIM, International Biocontrol Manufacturer’s Association, IBMA, presented IBMA Whitepaper: A New EU Regulatory Framework for Bioprotection Agents, as a proposal to improve regulation in the European Union towards biocontrol products and techniques.
The purpose of this document is to persuade the EU authorities to develop a new, more appropriate legislative framework, with simplified provisions and with a centralized regulatory body dedicated to the evaluation of bioprotection products, which should be operational by 2021.
Bioprotection technologies, or biological tools for the protection of plants for the management of pests, weeds and diseases, are of natural origin or identical to those found in nature when they are synthesized, and generally have a low impact on the human health and the environment. Although the term biopesticide is often used, IBMA pleads to use the term bioprotection agents, since the suffix "cidal" often does not describe the true mechanisms of these substances, as they do not kill directly, but rather protect the plant.
Current mechanisms for bioprotection technologies approvals have evolved from regulations for conventional chemical pesticides and this approach is not working well in Europe, despite guidance produced for use in Reg. (EC) 1107/2009 for these types of technologies, and its regulation processes are still very long and expensive. The nature and particularities of bioprotection technologies should not be treated as chemical pesticides, the current procedures are unproductive and hinder the success of Sustainable Use of Pesticides (SUD, Dir. 128/2009/EC) in order to reach the UN Sustainable Development Goals, that heighten a healthy and productive environment and wills to decrease the impact of agricultural intensification.
The IBMA whitepaper explains how other countries like the US take us a competitive advantage in this sense. EPA has a procedure and regulatory body exclusively for this type of products since 1994, and has a history of approvals of new products through a rigorous and solid review, with a deadline of one year since its submission, and follows a step-by-step approach with evaluators dedicated exclusively to this type of product. To date, the US has approximately four times more biocontrol or bioprotectant products available in the market compared to EU. In addition, FAO is recommending similar regulatory approaches that are already being adopted by other countries such as Australia, Brazil, Canada and China, being also promoted by the OECD.
Clearly, european farmers and companies dedicated to developing agricultural inputs for plant protection of low environmental impact are staying behind because we do not have a more effective and specific regulatory system for this kind of products, already considered of low risk and with many advantages that respond to an emerging and global need.
What makes the difference of bioprotection products versus conventional chemical pesticides?
Bioprotectants are of natural origin, produced from renewable resources and support holistic agro-ecosystems-based approaches for growing food with negligible harm to the environment. Examples of bioprotection agents are microorganisms, semiochemicals, plant extracts (botanicals) or natural substances. These products and by-products are already present in nature and belong to species whose bioprotectant activity has been already referenced as efficient and harmless to the environment, human and animal health.
The next step is to make these bioprotectants available for the global market, a challenge of companies that manufacture biocontrol products, which have to produce them on an industrial scale and make them widely available. This is very difficult if the active ingredients are treated as new synthetic chemicals, without a history of scientific and low scale use by farmers as they really do have, and considering them per se of risk, having to demonstrate the opposite with long and expensive procedures, and without a fluent and constant communication with the regulatory body.
Advantages of new regulatory solutions for bioprotectants
Finding new regulatory solutions for bioprotectants would reduce disproportionate costs, compared to the risks that these technologies represent; it would allow to evaluate the risk specifically related to this kind of products and would reduce the resources required, adequately addressing the potential risks and providing shorter evaluation periods. The result would be a greater offer of bioprotection products, quickly placed on the market, replacing the products deemed to be of concern.
Easing Bioprotection technologies in the framework suggested by IBMA in its whitepaper would also provide social and competitive benefits,suchas delivery of safe food without residues and with minimal impact for the environment in compliance with SUD Directive 128/2009/EC. It would also support the sustainable goals of phytosanitary protection of the EU Council, and promote renewable systems within the circular economy. It would contribute to creating an economy based on biological products with job and business opportunities for both SMEs and EU farmers, to be competitive in the global market.
IBMA Whitepaper also states that the model proposed would be applicable for bioprotection agents as well as other categories of products for use and release in the environment (e.g. biocides, biostimulants and organic inputs).