Microbial plant biostimulants play a crucial role in improving crop tolerance to abiotic stress, enhancing crop quality, and increasing nutrient availability and efficiency. Expanding the list of approved microorganisms could contribute significantly to the EU Green Deal targets and enhance food security under current challenging conditions.
EBIC supports the European Commission’s initiative to collect data on candidate materials and microorganisms for future revisions of Annex II in the Fertilising Products Regulation (FPR). However, it expresses significant concerns about the current limitations and proposed timelines for updating Component Material Category (CMC) 7, which impacts the market access for microbial plant biostimulants. Read our position paper on simplification for microbial plant biostimulants and on Rhizobia.
Since the adoption of the FPR in 2019, EBIC has highlighted the narrow scope of the positive list under CMC 7, which only includes four genera of microorganisms: Azotobacter spp., mycorrhizal fungi, Rhizobium spp., and Azospirillum spp. This limitation restricts the use of many other microorganisms with proven benefits for microbial plant biostimulants.
The European Commission had previously consulted Member States and stakeholders in 2021 regarding microorganisms for inclusion in the FPR. Now, the Commission is conducting a new study on microbial plant biostimulants, which is being run by the Austrian Institute of Technology (AIT). The study is developing new methodologies for their assessment and registration under the EU Fertilising Products Regulation (FPR). The aim is to create a robust, flexible system that supports innovation while ensuring safety.
1. Prescreening for Positive List Inclusion: AIT is developing criteria and methodologies to assess 56 proposals submitted during the EU survey, aiming to include prescreened, safe microorganisms on the CMC 7 list. The goal is to maintain an open framework at the CMC 7 level while applying an asterisk for those that need further product-level testing by NoBos. This approach ensures proportionate risk assessment and allows for the real-world application of these microorganisms to be fully evaluated.
2. Criteria-Based Assessment: New and existing microorganisms could be evaluated against predefined safety and efficacy criteria. Applying an asterisk would signal the need for further NoBo assessment at the product level. This continuous, criteria-based approach would support faster market access and ongoing innovation, avoiding delays associated with periodic technical studies.
Under the FPR, a “product” is broadly defined, including not just the microbial component (CMC) but also factors such as dosage, concentration, application timing, pattern of use, and formulation. These factors are crucial to the product’s safety and efficacy, making product-level assessments essential. For instance, microbial consortia, which involve multiple microorganisms, are best assessed at the product level to understand their combined effects in real-world conditions.
Agronomic efficiency under the FPR assesses the “potential” of a biostimulant to enhance nutrient use efficiency, tolerance to abiotic stress, quality traits, and availability of confined nutrients. This is based on literature and trial data, with the “actual” efficiency evaluated at the product level by NoBos.
1. Immediate Inclusion of Proven Microorganisms: Allow microorganisms that have demonstrated their trade potential, safety, and agronomic efficiency under national regulations to be included in the positive list for CMC 7. This approach would enable the industry to continue investing in microbial plant biostimulants while the full study of new microorganisms and materials progresses.
2. Ongoing Comprehensive Study: Continue with the planned comprehensive study of new microorganisms and materials, ensuring that these are thoroughly evaluated and included in the FPR in a timely manner. EBIC is prepared to collaborate with the Commission and the Commission Expert Group on Fertilising Products (CEG-FP) to facilitate the inclusion of these microorganisms within a reasonable timeframe.
A delay of up to six years for most microbial plant biostimulants to reach the EU market would hinder significant investments in this sector. The negative consequences of such delays would be felt across the EU, impacting both agricultural innovation and the availability of effective plant biostimulants for farmers.
EBIC advocates for a balanced approach to updating CMC 7 in the FPR, which includes both the immediate incorporation of proven microorganisms and a comprehensive study of new candidates. This strategy would support ongoing innovation in microbial plant biostimulants and align with the broader goals of the EU Green Deal and food security objectives.