The Cost and Complexity Behind Biostimulant Claims

Biostimulants are increasingly central to agricultural innovation, supporting nutrient efficiency, stress tolerance, and crop performance. As demand for sustainable solutions grows, so does interest in positioning products within this category. 

However, bringing a biostimulant to market is not simply a matter of product performance. Regulatory classification, claim substantiation and technical documentation can quickly become resource-intensive and may significantly affect both timelines and market access. 

Companies developing biostimulants in Europe face a key challenge: meeting regulatory requirements while making compliant product claims. Under the EU Fertilizing Products Regulation (EU) 2019/1009, rules on classification, data and claim substantiation directly affect how quickly products reach the market.

Getting classification right from the start

A critical first step is ensuring that your biostimulant product is positioned correctly. In practice, this means avoiding two common pitfalls: 

• making claims that classify the product as a plant protection product

• having the product classified as a conventional fertilizer due to its nutrient content 

Correct classification directly affects regulatory requirements, time to market, and the claims you can make.  

Data and Technical Documentation

Establishing a biostimulant claim requires a structured technical documentation package, including:

• Product composition and manufacturing process
• Safety considerations
• Efficacy data supported by robust, reproducible evidence to substantiate claims

Generating efficacy data is particularly resource-intensive. Field trial data must comply with the EN 17700 standard, which sets strict requirements for trial numbers, controls, replicates, and statistical analysis. Meeting these requirements demands significant time and R&D investment: validating claims across all crop groups typically requires 12–20 field trials, costing approximately €100–300k in total and contributing to long development timelines and delayed market access.

Claims

A biostimulant is distinct from conventional fertilizers and pesticides in that its primary function is to improve one or more of the following, regardless of its nutrient content:

• Nutrient use efficiency: The ability of a plant to take up and utilise available nutrients from the soil or applied fertilizers.
• Tolerance to abiotic stress: The plant's capacity to withstand environmental pressures such as drought, extreme temperatures, salinity, or mineral toxicity.
• Quality traits: The physical and chemical characteristics of the harvested crop, including colour, flavour, sugar content, and nutritional value.
• Availability of confined nutrients: The ability to make nutrients in the soil or rhizosphere more available to the plant. 

The biostimulant registration defines the scope of permissible claims, linking product performance directly to regulatory compliance.  Environmental and field conditions can influence biological performance, meaning supporting efficacy data plays a critical role in substantiating biostimulant claims.

Strategic Considerations for formulators

In practice, developing and registering a biostimulant requires substantial time, technical expertise, regulatory resources, and financial investment. Companies must generate robust efficacy data, ensure ingredient compliance, prepare technical documentation, and align claims with evolving regulatory definitions. These requirements often involve extensive field trial programs, contributing to high development costs, long timelines, and potential delays in market access or product claims. 

One way to reduce this complexity is to build on an already compliant and well-documented biostimulant product. At Borregaard, this approach is reflected in Activance NUE, which is supported by extensive technical documentation and efficacy data demonstrating performance in areas such as nutrient use efficiency.