Timeline: Developing Regulations for Biostimulants
The global biostimulant market has been growing steadily since 2015. It is estimated to be around $2.3 billion in 2020 and to reach $ 3.9 billion in 2025, according to several sources such as RB Desk Research, Mordor Intelligence, Markets and Markets, DunhamTrimmer 2020. These numbers represent an average of approximately 11.2% CAGR. The US represents a significant portion of the market, reaching $323 MM in 2019 and projected to grow to $576 MM in 2025 (Dunham Timmer, 2020). Products containing amino acids and protein hydrolysates, humic and fulvic acids, seaweeds and microorganisms represent the main classes of biostimulants.
With all this growth and with a high number of new products reaching the market every day, one would assume the framework to register these products is well-defined globally. This is not quite the case in many countries – most notably the US and Brazil. Europe, which captures a larger percentage of the biostimulant market is ahead on the development of a regulatory framework for these products.
In 2019, Europe published the European Fertilizer Regulation (EC) No. 2019/1009 which includes a definition for biostimulants and a regulatory path for registration of these products across the EU Member States. The new Regulation will come into effect in 2022 and new standards for processes and methods will be developed in the next three years.
Brazil does not yet have a definition for biostimulants. Currently, they are classified as biofertilizers and there is a proposal to simplify the registration of biofertilizers and biopesticides in the country, which was published on Decree, nº 10.375, May 26, 2020.
In the US, there is significant activity going on between government and industry organizations to develop and implement a framework that will harmonize registration within the country, while enhancing the quality and credibility of biostimulants in the market.
The US Farm Bill in 2018 recognized the need to develop a harmonized regulatory package for biostimulants in the US. The Farm Bill suggested a definition for biostimulants and tasked the USDA to submit a report to Congress and the President providing a biostimulant definition and recommendations for a path to market.
In December of 2019, the USDA submitted its report to Congress where it provided two alternatives for biostimulant definition, described the benefits of biostimulant use, the regulatory dilemma at Federal and State level and provided recommendations and conclusions. Since then, government and industry organizations have been working together to develop a regulatory framework for biostimulants in the US in the form of a Model Bill.
More specifically, AAPFCO (Association of American Plant Food Control Officials) has created a Biostimulant Committee with the goal to create a thorough biostimulant package with the support of regulators and industry, containing an official definition for biostimulants, standards for label formatting, efficacy data guidelines and laboratory methods. The Committee is considering USDA’s proposed Biostimulant Alternative Definition 2, which states that: “A plant biostimulant is a substance (s), microorganism (s), or mixtures thereof, that when applied to seeds, plants, the rhizosphere, soil or other growth media, act to support a plant’s natural nutrition processes independently of the biostimulant’s nutrient content. The plant biostimulant thereby improves nutrient availability, uptake or use efficiency, tolerance to abiotic stress, and consequent growth, development, quality or yield.”
The AAPFCO Biostimulant Committee includes representatives from TFI and BPIA. During the AAPFCO Annual Summer Meeting, which was held virtually on July 29, the committee proposed the formation of several Working Groups (WGs) to develop a Non-Plant Food Ingredient Model Bill that includes biostimulants. The proposed WGs will focus on the following areas: Scope, Label, Registration, Unlawful Acts, Compliance Inspections, and Left Overs. The goal is for each WG to have a first draft by December 2021.
Much work still needs to be done, and it is critical to have all stakeholders working together to develop the regulatory framework for biostimulants in the US. The ultimate goal is to create a comprehensive biostimulant package that will enable effective and efficient registration and review processes to the benefit of all stakeholders. Stay tuned for more updates!
_________________________________________ About the Author
This article is penned by Rejane R de Moraes, Ph.D, PMP, and Six Sigma Black Belt. Dr. Rejane de Moraes has over 20 years of experience in agriculture crop protection in a variety of technical and business roles. Rejane holds a BS degree in Agronomy, a Masters in Crop Production, both from the Federal University of Pelotas in her native country of Brazil, and a Ph.D. in Entomology from the University of Florida. Rejane’s passion for sustainable agriculture has been a common thread through the years. Dr. Moraes currently serves as General Manager & Managing Director for Regulatory Affairs at Global BioAg Linkages and Managing Director LATAM & Regulatory Affairs at Primary BioAg Innovations™.