What Does It Take to Launch a New Biostimulant?

Providing rigorous safety and performance evaluations

Our expertise in agronomic study design, chemical analysis, risk assessment, and regulatory guidance helped our sector-disrupting client go to market with evidence-based product claims.

THE CHALLENGE

When a producer of innovative, “clean” charcoal, sourced from sustainable forest biomass, needed to prove the efficacy and safety of two primary byproducts — pyroligneous acid (wood vinegar) and charcoal dust (biochar) — intended for biostimulant and soil improver uses, Exponent provided data-driven solutions for successful regulatory approval of a product that pushes the envelope on sustainable agriculture.

EXPONENT’S MULTIDISCIPLINARY SOLUTION

Exponent’s agrichemical, environmental, health science, risk and safety, and regulatory experts oversaw crop trials, evaluated product safety, vetted lab and glasshouse data, and helped the client navigate the complex EU fertilizer approval process.

Study Design
Agrichemical experts oversaw the retained contract research organization’s soil and crop trials, performing careful trial design and assessment to fit with specific biostimulant claims, including fine-tuning dosage recommendations and application specifications, and provided ongoing monitoring to support robust, evidence-backed studies for regulatory approval.

Claim Substantiation
Our European team leveraged Exponent’s agronomic, health sciences, analytical chemistry, and regulatory expertise to rigorously evaluate field trial, laboratory, and glasshouse trial data, demonstrate improved nutrient availability, and validate nutrient use efficiency in various crops and soils.

Risk Assessment
Agricultural experts evaluated the crop safety risks associated with pyroligneous acid’s low pH and acetic acid content; assessed the biostimulant for possible phytotoxic effects; and validated the safety of different application methods and their suitability for different soil types and crops.

Regulatory Support
Exponent’s regulatory team guided our client through the high-complexity EU fertilizer regulatory process and registration dossier preparation, including comprehensive documentation, risk assessment data production, and compliance with labeling standards.

OUR IMPACT

Exponent’s rigorous analysis and deep regulatory expertise enabled our client to evaluate, validate, and go to market with credible, defensible product claims aligned with the EU agricultural market’s sustainability goals. Leveraging our multidisciplinary expertise, Exponent helps clients with bespoke risk assessments, claim substantiation, and regulatory guidance for unique, complex agronomic challenges — including the validation of a first-of-its-kind process for a circular economy.

What Can We Help You Solve

Exponent’s multidisciplinary consultants have extensive experience helping clients navigate regulatory requirements for novel biostimulants and fertilizers. We support risk assessments, field trial data review, toxicity evaluations, and regulatory processes, including product dossier submissions and more.