Biostimulants – Navigating the United States regulatory landscape

Biostimulants are an emerging class of products that indirectly impact soil quality and provide plant nutrition. At present, there is no specific biostimulant regulatory framework in the US, meaning that these types of products need to ‘fit’ into the existing regulatory landscape. With each state having its own set of rules and regulations, navigating this landscape can be a challenge for companies wanting to sell their products on the US market. In this paper, experts at TSG Consulting give an overview of biostimulants and how they are regulated in the USA.

With the world’s population anticipated to reach 10 billion by 2050, the agricultural sector faces challenges to feed our growing population. The need to use arable lands more efficiently and increase productivity while also managing recurring environmental stresses, such as drought, heat, and salinity, has become more apparent.

Although abiotic stresses may be mitigated by providing water, nutrients and other treatments, these may not be sufficient to achieve the desired output. Plant biostimulants have been described as a promising category of products to improve yield and quality of the crops and other soil/plant characteristics, by both the scientific community and the industry. There is mounting interest in these products across the world but navigating through the regulatory landscape can be challenging. Companies need to be aware of the ever-changing rules associated with this emerging category of products as they consider bringing them to the United States market.

What is the definition of ‘biostimulant’?

Many countries are tackling this question and trying to craft a definition for biostimulant. Europe recently published the new European Fertilizer Regulation (EC) No. 2019/1009 which includes a definition for biostimulants and a regulatory path for registrations of these products across the EU Member States. The EU regulation will become effective in 2022 and in the next three years, new standards for processes and methods will be developed.

In the US, 18 H.R. 2: Agriculture Improvement Act of 2018 (formerly referred to as the Farm Bill) defines a biostimulant as ‘a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield’.

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