Regulatory

Regulatory

EBIC is committed to harmonising the regulatory landscape for plant biostimulants in Europe. A key achievement was the inclusion of biostimulant products into the EU Fertilising Products Regulation (FPR), which sets out the rules for placing fertilising products, including biostimulants, on the market. This regulation, in force since 2022, categorises biostimulants by their functional claims and requires manufacturers to provide evidence supporting these claims.

Read more about our work on the FPR

EBIC actively engages with policymakers and regulatory bodies to address challenges and facilitate smoother market entry for biostimulants. This includes working on issues related to animal by-products, microbials, and multiple use. Regular workshops and discussions with European Commission representatives and notified bodies ensure that the biostimulant industry’s concerns are heard and addressed. With climate change and soil degradation posing a very real threat to food security and farmer livelihoods, EBIC’s 2024 manifesto puts forward a vision that leverages the power of plant biostimulants to address these issues head-on.

Read more about our manifesto

Additionally, EBIC collaborates with the Committee for European Standardisation (CEN) to develop standards for verifying biostimulant claims. This ongoing work is crucial in establishing clear and consistent guidelines for product approval and market placement, ultimately fostering innovation and growth in the biostimulant sector.

Read more about our efforts in Conformity Assessment

 

European Regulation

Plant biostimulants are emerging as a crucial category in agricultural inputs, promising enhanced plant growth and resilience through natural processes. However, as these products gain traction, the regulatory landscape around them has also become increasingly complex.

The EU has pioneered the regulation of plant biostimulants, recognising them as a distinct product category under the FPR, officially Regulation (EU) 2019/1009. Adopted on June 5, 2019, and applicable from July 16, 2022, this regulation marked a significant shift from previous frameworks, specifically Regulation 1107/2009, which grouped biostimulants under plant protection products (PPPs).

The FPR defines plant biostimulants as products that stimulate plant nutrition processes independently of their nutrient content, with the primary aim of improving nutrient use efficiency, abiotic stress tolerance, quality traits, or the availability of nutrients in the soil or rhizosphere.

Plant biostimulants are categorised as PFC 6, with sub-categories for microbial (PFC 6(A)) and non-microbial (PFC 6(B)) biostimulants. The regulation outlines specific Component Material Categories (CMCs) that are permissible in plant biostimulants. These include natural substances, plant extracts, composts, and specific microorganisms like Azotobacter spp. and Mycorrhizal fungi.

While the FPR provides a comprehensive framework, several challenges persist in ensuring compliance and smooth market access for plant biostimulants.

 

Borderline Cases:

• Products that serve dual purposes, such as those with both biostimulant and pesticidal functions, create regulatory ambiguities. Under the FPR, if a product contains a substance with pesticidal properties, it is classified as a PPP, which entails a different regulatory pathway.
• Conformity Assessment: The FPR requires a rigorous conformity assessment process, which includes an EU-type examination (Module B) and conformity to type based on internal production control (Module C). This process is essential for ensuring that products meet safety and efficacy standards.

Safety and Quality Requirements:

• The FPR sets stringent safety requirements, including limits on heavy metals, pathogens, and other contaminants, particularly for microbial biostimulants. Manufacturers must demonstrate compliance through detailed technical documentation and periodic audits by notified bodies.

What work is needed to further develop EU regulation around biostimulants?

The regulatory landscape for plant biostimulants is continuously evolving. Key ongoing initiatives include:

1. Amendments to the FPR:

The European Commission is actively working on amendments to include new materials and processes under the existing CMCs. This includes expanding the list of permissible microorganisms and refining criteria for polymers used in plant biostimulants.

2. Standardisation Efforts:

The EU has initiated several standardisation projects to create harmonised standards for plant biostimulants, with the first set of standards expected by the fourth quarter of 2024. These efforts aim to streamline the regulatory process and ensure consistent product quality across the EU.

3. Digital Labelling:

The introduction of digital labelling for EU fertilising products, including plant biostimulants, represents a significant shift towards more transparent and accessible product information. This initiative is part of the broader digital transformation in the EU’s regulatory approach.

Beyond the EU, other regions are also grappling with the regulation of plant biostimulants. However, the EU’s framework is currently the most advanced and may serve as a model for other jurisdictions. As global trade in agricultural products grows, the harmonisation of biostimulant regulations will become increasingly important to facilitate market access and ensure consistent standards worldwide.