EBIC says it supports a proposal to update the Component Material Category 7 (CMC 7), which is the category in the EU’s Fertilising Products Regulation (FPR) relating to microorganisms that can be used in microbial plant biostimulants.

Following the adoption of the FPR in 2019, EBIC has voiced its concerns over 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., and the lack of a dynamic mechanism for updating it. This restricts the use of many other microorganisms with demonstrated agronomic benefits, and the absence of a defined update process creates regulatory uncertainty, says EBIC on its website.

“While the Fertilising Products Regulation (FPR) foresees the addition of new microorganisms to Component Material Category 7 (CMC 7), it does not define a clear process for updating the list of microorganisms that can be used in microbial plant biostimulants, only criteria such as trade potential, safety and agronomic efficiency,” explains David Barton, Senior Consultant at Prospero & Partners, which provides the Secretariat for EBIC.

“The current reliance of the FPR on one-off technical studies to update positive lists creates delays, regulatory uncertainty, and puts EU companies at a competitive disadvantage. A technical study led by the Austrian Institute of Technology (AIT) is currently underway, but there is no clarity on when the next one will take place or whether there is a budget for it, adding further uncertainty. EBIC is advocating for a criteria-based approach that would remove the need for periodic technical studies and instead establish a dynamic, predictable, scientifically based process for adding new microorganisms. This would ensure regulatory oversight while keeping pace with scientific and market developments,” Barton told New AG International via email.

In its letter dated 31 January 2025 to DG GROW (Directorate General for Internal Market, Industry, Entrepreneurship), EBIC stressed the need for a streamlined process by which microbial plant biostimulants can gain market access while ensuring regulatory compliance.

EBIC has acknowledged the proposal put forward by the chair of the Coordination Group of Notified Bodies (NOBO) at the Commission Expert Group on Fertilising Products (CEG-FP) meeting in November 2024 as a means of creating a functional and dynamic regulatory system within the current FPR. Rather than relying on technical studies, the proposal seeks to establish a structured, transparent process that enables timely updates to CMC 7.

“In principle, the proposal from the chair of the Coordination Group of Notified Bodies (NOBO) offers a pragmatic interim solution by enabling third-party assessors to evaluate new microorganisms based on the methodology developed by AIT. These assessors would conduct evaluations under a structured, documented process, ensuring scientific rigor while maintaining confidentiality between applicants and assessors,” explained Barton.

“Importantly, these assessors do not have the authority to approve or deny a microorganism’s inclusion in CMC 7. Instead, they provide an ‘acceptance recommendation,’ which is then reviewed by the CEG-FP or a designated subgroup. The Commission retains final decision-making authority, ensuring that updates to CMC 7 remain within the established regulatory framework.

While certain legal aspects still need to be worked out, this proposal could make the FPR more viable, provide regulatory certainty, and ensure a structured approach to adding new microorganisms. Without such a mechanism, companies may be forced to go through national rules, leading to market fragmentation and regulatory inconsistency,” continued Barton.

In December 2023, the Austrian Institute of Technology (AIT) was contracted by the European Commission to assess microorganisms proposed for agronomic efficiency and safety.

“EBIC supports the proposal in principle as a means to provide a dynamic and transparent system that keeps pace with innovation while maintaining regulatory oversight. We look forward to further engagement with the CEG-FP to explore the legal and procedural aspects of this approach to ensure a viable option for CMC 7 updates. This process could also provide valuable insights to help shape future regulatory developments, ensuring the EU remains at the forefront of microbial biostimulant innovation,” said Barton.

Concluding its letter to DG Grow, EBIC said it would like to encourage further discussion of this proposal to develop a workable and effective solution.