Is the EU Regulatory Framework Providing a Benefit Yet for Biological Companies?
Editor’s note: Each year, 2BMonthly’s State of the Industry feature includes a Q&A with executives from leading biocontrol and biostimulants companies worldwide. The 2023 feature touched on a wide range of prevailing topics including the biologicals M&A climate, critical success factors for scaling biologicals companies, and growers’ buying intentions for biologicals in 2024. In the excerpt below, experts offered their insight on the regulatory progress for biologicals in the EU.
Q: The biologicals regulatory situation in the EU remains murky. Some contend we are making progress with regulators to improve the process; others assert that no real progress is being made. What is your position?
Ashish Malik, President & CEO, Bee Vectoring Technologies: The industry spent a lot of energy trying to advance legislation that would limit the amount of chemical pesticides used on-farm in Europe. Ultimately this legislation did not pass, indicating that the market (which includes farmers and the chemical companies) is not ready for this. In other words, a positioning that states biologicals should be used at the expense of chemicals will not work. So, I believe we need to go back and work with regulators to figure out what has to happen in order for biologicals to get a more favorable, quicker, and predictable regulatory outcome. I think if we focus on this, which is a more positive approach than trying to get chemicals banned, then eventually we will achieve a good outcome.
Salman Mir, Chief Operating Officer, Valent BioSciences: We recognize the new EU rules were put into place with the intention of reducing the regulatory burden for companies and speeding up regulatory approvals for biopesticides. In our experience, these new rules have instead increased the demand on registrants. Although the addition of scientific peer-reviewed literature data is a positive development, it creates a significant demand on preparing the literature and determining which data should be included in the dossier.
As a consequence of these factors, we expect the regulatory environment in the EU to continue to be challenging, but we look forward to working closely with regulators to clarify their expectations and ensure we are continuing to put effective biorationals in the hands of the growers who need them.
Bénédicte Flambard, Vice President, FMC: As the demand for sustainable agriculture continues to rise, one of the biggest challenges the biological crop protection industry faces is the pace at which some regulatory bodies approve products. The EU is still lagging behind countries such as the U.S., Brazil, and Japan in facilitating the registration of new technologies such as biochemicals like peptides, pheromones, and RNA technologies. While challenges persist, ongoing initiatives and dialogue between regulators, industry stakeholders, and the scientific community indicate a positive shift towards fostering innovation while ensuring the safety of these products. Securing a resilient and sustainable future for agriculture requires EU policymakers and legislators to continue to engage with farmers and CropLife Europe members to support faster approval timelines at the EU or country level. The balance between regulatory rigor and support for sustainable solutions will be crucial for the future of agriculture in the EU.
Pam Marrone, Co-founder & Executive Chair, Invasive Species Control Corporation: I do not see progress being made. I think it is time to align with and organize growers to have them lobby the EU to change the regulations for biologicals.
Eduard Vidal, CEO, Sustainable Agro Solutions (SAS): Being it in progress or not, what is clear to us is that the movement in the regulation is slow, especially comparing to the speed of other changes such as some phytosanitary products removal or other countries’ regulation approval for biologicals. We need a faster movement from the regulation bodies in the EU, and a realistic approach to the sustainable agriculture needs. We must have a regulation that protects the environment, people’s health, and sustainability. All these values are core in our company. At the same time this regulation must be clear, reasonable in terms of costs and requirements for registration, and flexible to adapt to innovation made by the industry.
Peter Maes, Chief Strategy Officer, Koppert: The response varies significantly when considering microbials and macrobials in the EU regulatory landscape. When addressing microbials, progress is evident, yet it’s slow-paced due to systemic challenges. Authorities, facing staffing shortages and limited biological understanding, hinder approvals. Initiatives like the Green Team at CTGB emphasize the need for knowledge-building efforts. Harmonization among member states is crucial but challenged by differing requirements. Current advancements merely patch up systemic flaws. Biologicals are different from synthetic chemicals, and they should not be treated in the same regulation. Until this distinction is addressed, progress remains slow and minimal.
In the macrobial domain, regulatory authorities intend to meet the 2030 Green Deal objectives. However, same capacity shortages impede knowledge development and approvals, particularly against invasive pests. The inconclusive European Commission study on macrobials leaves a void in shaping EU-wide regulations. Recurring inconclusive studies translate to stagnant local regulations, hindering progress where policy needs more sufficiency. While glimpses of progress exist, regulatory hurdles persist in both microbials and macrobials within the EU. A unified, harmonized approach acknowledging the uniqueness of biologicals is imperative to pave the way for sustainable agricultural solutions.
Daniel Zingg, CEO, Andermatt Group: The regulatory situation in the EU is a challenge for companies. And unfortunately, the discussion on SUR, which would have been a milestone for the development of the biologicals market, is off the table. This means that further detailed discussions will be necessary in order to achieve improvements.
Loading ...Jim Thompson, Director of Business Development, Portfolio Management Biologicals and Non-Crop, AMVAC: To date, we have not seen a tangible change in the EU regulatory framework that provides a benefit yet for biological companies. AMVAC has chosen to focus more resources on the North American and South American markets as well as the Asia-Pacific region. We have seen noticeable improvement in the regulatory processes in Brazil, and some of the other LATAM countries, which has allowed to us grow our businesses there.
Carlos Rodríguez-Villa Förster, Managing Director, AlgaEnergy: No doubt that we’ve made progress, despite the recent SUR bill rejection. If we look 10 years back, it’s evident. For example, we now have a regulation in place for biostimulants, and one that defines them by their claim and benefit, which needs to be evidenced in the field according to specific standards that are assessed in great depth. Today, any farmer purchasing a CE marked biostimulant can be sure that it’s no snake oil, because of the harmonized regulation. That said, there is plenty of work to be done, the regulations are far from perfect… but the progress can’t be questioned.
Amy O’Shea, President & CEO, Certis Biologicals: The regulatory landscape for biologicals within the EU is intricate and constantly evolving. The Farm to Fork strategy announced by the European Commission aimed to simplify the biological pesticide regulation process and align it more effectively with scientific principles. Although the announcement generated optimism, subsequent progress has been less noticeable. Steps toward progress have led to new data requirements for microorganisms. At the same time, the issue of long timelines and uncertainty during assessments has yet to be resolved.
I remain cautiously optimistic about the ongoing efforts to enhance communication channels between industry stakeholders and EU regulatory bodies. It is imperative to shift focus toward understanding the science and efficacy of biological products. This involves gaining insights into biologicals’ impact on the agricultural industry’s ability to combat pest and disease resistance, providing a separate track for biological products and adapting to changing consumer preferences. Prioritizing these changes will be what allows the agricultural industry to continue sustainably and effectively nourishing the growing global population.
Vladyslav Bolokhovskyi, CEO, BTU-Center: The situation is not easy. In some groups, the situation is uncertain. We see that Europe is trying to differentiate the registration processes of biologicals from chemical ones, but it is not very fast. The law that allows the registration of biostimulants at the EU level includes only four microorganisms, which greatly limits the potential of this law for us. In addition, some countries, such as the Netherlands, take this law as a basis for national registration. Thus, the shortcomings of this legislation exclude decisions on registrations at the national level. It is critical for us to expand the list of microorganisms able to be registered at the EU level.
Currently, out of 60 BTU-CENTER biologicals, only two products may be suitable for this law. As for biocontrol, the situation was and remains difficult. The possibility of registering biopesticides does not exist for small and medium-sized companies. We have got really vast experience in the use of biological crop protection products across hundreds of thousands of hectares, which we would like to share by presenting our products in Europe.
View more expert insight on the state of the biologicals industry here.
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