Plant biostimulants and the FPR: examining the work still ahead
August 2024
It has been two years since the Fertilising Products Regulation (FPR 2009/1009) was implemented across the 27 EU member states in July 2022. This marked a significant achievement for the European Biostimulants Industry Council (EBIC) and the broader industry, as it was the first time that plant biostimulants gained formal recognition from regulators. The FPR establishes clear safety and quality standards, ensuring that all CE-marked plant biostimulants undergo a comprehensive conformity assessment. This process, overseen by several Notified Bodies, helps eliminate misleading or false product claims, providing growers and agricultural advisors with the assurance that plant biostimulants are both safe and effective.
As the representative body for plant biostimulants in Europe, EBIC’s mission is to ensure these products are acknowledged as crucial to sustainable agriculture and to establish a supportive regulatory framework for them. While the inclusion of plant biostimulants in the FPR represents a major milestone for the industry, EBIC views it as just the beginning. There are several outstanding issues that EBIC is actively working on, including the exclusion of certain microbial products, restrictive mitigation measures concerning some animal by-products, and excessive data requirements related to the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH).
For the plant biostimulants industry to truly thrive in a unified European market, several critical issues still need to be addressed by regulators.
Although some manufacturers are now able to obtain the CE mark for their plant biostimulants, many continue to face challenges. EBIC is steadfast in advocating for reforms and enhancements and has recently released a manifesto urging the new European Parliament to embrace agricultural innovation, lower regulatory hurdles, and promote the adoption of beneficial products like plant biostimulants.
EU policymakers have begun to tackle some of these issues, but numerous products remain hindered within the FPR, obstructing efforts to transition to sustainable agriculture and disadvantaging European farmers in comparison to other regions. EBIC contends that only by encouraging and enabling growers to adopt innovative technologies will Europe be able to develop sustainable food systems.
REACH+ requirements: excessively burdensome and constraining
The FPR references the REACH Regulation (EC 1907/2006) but enforces even stricter conditions for substances produced in quantities under 10 tonnes annually if used in EU fertilising products. EBIC has coined the term REACH+ to describe the FPR’s demand for a Chemical Safety Report and data equivalent to that in Annex VIII of REACH, even for substances already approved for food and feed or those produced in smaller amounts.
EBIC argues that these requirements are overly demanding in terms of both time and financial resources for manufacturers, particularly for small enterprises and those developing innovative substances with limited opportunities to recoup data costs. Furthermore, these requirements will increase animal testing without yielding any additional health and safety benefits.
EBIC’s extensive work on REACH+ led to a workshop in May 2023, aimed at discussing the challenges companies face in meeting these requirements with policymakers. As a result, a joint industry task force has been established to form a unified stance on REACH+ and propose amendments to the FPR that address the industry’s concerns while maintaining the necessary safety standards for the food supply chain.
Microorganisms in CMC 7 should follow a criteria-based approach
The Component Material Category (CMC) 7 of the FPR currently permits only four types of microorganisms to be used in microbial plant biostimulants. Since the FPR’s inception, EBIC has challenged this restricted positive list, arguing that numerous other microorganisms are either already utilised in microbial plant biostimulants or are in the research phase.
Despite a consultation with Member States in 2021 to gather data on microbial plant biostimulants already available under national regulations, the EU initiated a survey to allow stakeholders to submit proposals for the future development of FPR Annexes, which concluded on 16 September 2022. Approximately 56 microorganism proposals were submitted, which are now under consideration in a technical study. This study, led by the Austrian Institute of Technology (AIT), aims to assess the safety and agronomic efficiency of these microorganisms for use in microbial plant biostimulants. A stakeholder workshop is planned for this month, but it is still unlikely that AIT will provide recommendations to EU policymakers before the end of next year.
EBIC remains highly concerned about these timelines, which are restricting access to the EU market and delaying the establishment of standardised regulations for microbial plant biostimulants. This situation permits varying national regulations to influence investments in innovation under uncertain conditions for too long, despite the urgent need for these solutions by EU growers. Nevertheless, EBIC is actively involved in the process, offering guidance to members who submitted proposals and maintaining regular communication with the AIT to share its expertise. EBIC consistently advocates for a criteria-based approach to CMC 7 instead of a restrictive positive list.
No CE-Marking pathway for animal by-products (ABPs)
Since the FPR’s adoption in 2019, animal by-products have not been included in CMC 10, preventing ABPs commonly used in plant biostimulants (such as hydrolysed proteins and insect frass) from going through the CE-mark process. As stipulated by the FPR, a preliminary list of endpoints in the manufacturing chain was established by a Regulation adopted in 2023. Although this was a preliminary step, the forthcoming list necessitates a technical study akin to the one for microorganisms. This study, contracted to Qlab in 2023, is expected to be completed by October 2024. The findings will then be reviewed by EU decision-makers, potentially leading to further revisions of the FPR Annexes.
EBIC is collaborating with QLab to provide expertise and guidance to its members. However, EBIC is apprehensive that the Commission’s mandate for the study focuses on processes used for animal feed while neglecting those relevant to fertilising products.
Additionally, EBIC has orchestrated an open joint letter with 15 other organisations, urging a comprehensive review of the EU’s approach to regulating materials of animal origin within the food chain, as the current approach is not aligned with the principles of the Circular Economy. You can read the open letter here.
Evaluating the FPR to drive improvements
As mandated by Article 49 of the FPR, by 16 July 2026, the European Commission must present a report to the European Parliament and the Council assessing the FPR’s application and its impact on achieving its goals, including its effects on small and medium-sized enterprises. The studies on CMC 7 and CMC 10 will contribute to this assessment, alongside an additional technical study on new materials and processes within the FPR Annexes, scheduled for completion by the end of 2025.
The FPR evaluation report must include an analysis of the internal market for fertilising products, considering the efficacy of conformity assessments and market surveillance, as well as the implications of optional harmonisation on production, market shares, and trade flows of EU fertilising products and those sold under national regulations.
The report must account for technological advancements and innovation, as well as standardisation processes affecting the production and use of fertilising products. It should also be accompanied, if necessary, by legislative proposals from the European Parliament and the Council. This evaluation is likely to be conducted by an external party or the Joint Research Centre of the European Commission, with the tender process taking place this year.
EBIC advocates for transformative action by the next EU Parliament
EBIC’s role involves identifying, prioritising, and addressing regulatory challenges as they arise. Since the FPR’s implementation, EBIC’s advocacy efforts have already resulted in several steps to enhance the regulatory framework, and together with its members, EBIC continues to work on these critical issues. EBIC believes that all plant biostimulant technologies should have equitable access to the market as the FPR is implemented, and its strategy is centred on this principle.
As new technologies emerge, additional challenges will inevitably arise, and EBIC is committed to collaborating with decision-makers to resolve them. EBIC’s manifesto clearly outlines its requests to parliament: policymakers must create an environment conducive to innovation in the plant biostimulants sector. To fully contribute to sustainable agriculture, plant biostimulants require not only supportive regulation but also enabling policies.
To ensure farmers can access and benefit from the proven advantages of plant biostimulants, regulatory barriers to bringing these innovative products to the single market must be minimised. EBIC is therefore urging EU policymakers to expedite market entry pathways for biostimulant technologies. Additionally, EU policy should encourage and facilitate the adoption and application of beneficial products like plant biostimulants to make the transition to sustainable food systems a reality.