Globally aligned regulations, standards critical to role of biologicals in sustainable agriculture

The global market for biostimulants and biological control agents is witnessing dynamic growth and evolution, with a concerted effort to promote an increase in the uptake of biologicals products in agricultural programs in 2024.

Biostimulants, such as seaweed extracts, animal and plant residues as well as liquid manure composting of soil, are agricultural products that enhance plant growth, nutrient uptake and stress tolerance. BCAs, on the other hand, are a type of pesticide derived from natural materials or living organisms -- such as plants or microbes -- that control pests, including insects, weeds and plant diseases. BCAs are an alternative to conventional chemical pesticides, which are typically synthetic and often have a broader environmental impact.

Market growth for biostimulants and BCAs is driven by a convergence of technological advancements, consumer preference for zero or minimal residue in food, an increasingly tough regulatory climate for chemical pesticides, the need for climate-resilient solutions and a growing political emphasis on sustainable agricultural practices. In addition, there is mounting pressure on conventional crop protection products, such as those used for insect-, disease- and weed-resistance. This pressure is increasing due to the diminishing efficacy of some conventional products in the field, driving the search for more viable alternative treatments.

Regulatory challenges and initiatives

Regulations play a critical role in creating a favorable environment for biological purposes. However, while some countries, such as Brazil and the US, have preferential and fast track systems for biologicals, others have no special provisions. The area of regulation is highly complex and technical. Not only do regulations differ widely between countries, but within countries they vary depending on the product group. The international standards for BCAs are not comprehensive. Similarly, there is a lack of harmonized standards covering biostimulants at the international level.

Inadequate regulation of BCAs and biostimulants is a major barrier to the successful commercialization of such products. In most countries, BCAs are regulated under the same regulatory frameworks as conventional chemical pesticides. The shortcomings of this approach are well recognized, presenting issues such as inappropriate data requirements and risk assessment procedures, as well as complex and unpredictable review processes.

Biostimulant regulatory frameworks are just getting established, with the EU leading the way. Attempts to make regulatory frameworks for BCAs and biostimulants proportionate, risk-based as opposed to hazard-based, transparent and predictable are expected to intensify.

The drive to align and standardize regulations for biostimulants and BCAs is likely to gain momentum over the next decade. Collaborative initiatives between regulatory bodies, industry stakeholders and research institutions aim to streamline evaluation processes, facilitate global trade, and ensure consistent standards of safety and efficacy. Policies promoting sustainable agriculture will add urgency to harmonization efforts.

Growing recognition of the importance of microbial diversity in biostimulants and BCAs is likely to drive regulations toward strain-specific evaluations. Tailoring regulations to account for the unique characteristics and interactions of individual strains will become increasingly important. Some agencies, for example, the Environmental Protection Agency in the US, already require detailed strain-specific data as part of the registration process.

Rapid progress in analytical techniques, including omics technologies and advanced modeling, will further enhance the scientific evaluation and risk assessment of biostimulants and BCAs. This will help in making their application to crops in the field more sustainable for farmers and allow for more precise and comprehensive assessments of their safety, efficacy and environmental impacts.