It is now two years since the Fertilising Products Regulation (2009/1009 - FPR) was applied across 27 EU member states in July 2022. This was a major achievement for the European Biostimulants Industry Council (EBIC) and the industry, when for the first time, plant biostimulants were recognised by regulators. Importantly, the FPR sets out specific safety and quality requirements which ensure that all CE-marked plant biostimulants are subject to a thorough conformity assessment process. The assessment process is managed by a number of Notified Bodies and eliminates inappropriate or false product claims, giving growers and advisors the confidence that plant biostimulants are safe, effective and reliable.
As the trade association for plant biostimulants in Europe, EBIC’s mission is to ensure that plant biostimulants are valued as integral to sustainable agriculture and to secure an enabling regulatory framework for all of them. Whilst EBIC sees the inclusion of plant biostimulants in the FPR as a major milestone in the development of the plant biostimulants industry, in reality it is just a starting point. There are a number of outstanding issues that EBIC continues to work on, including a range of microbials being omitted, prohibitive mitigation measures for some animal byproducts, and disproportionate data requirements related to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
To truly enable the development of the plant biostimulants industry in a harmonised European market, several key issues must be addressed by regulators.
Whilst some manufacturers are now succeeding in obtaining the CE mark for their plant biostimulants, many are still encountering obstacles. EBIC continues to advocate for changes and improvements and has recently set out its manifesto calling for the new European Parliament to embrace innovation in agriculture, reduce regulatory barriers and facilitate the uptake of beneficial products such as plant biostimulants.
EU decision-makers have started to address some of those, but many products are blocked within the FPR, hindering efforts to transition to sustainable agriculture and preventing European farmers from competing fairly with other regions. EBIC believes that it is only by incentivising and enabling growers to use innovative technologies that Europe will achieve sustainablefood systems.
REACH+ requirements overly onerous and limiting The FPR cross-references the REACH Regulation (EC 1907/2006) but imposes stricter requirements for substances produced in amounts less than 10 tonnes per year if they are used in EU fertilising products. EBIC has coined the term REACH+ to reflect the FPR requirement for a Chemical Safety Report and data equivalent to that specified in Annex VIII of REACH, even for substances that are already approved for use in food and/or feed, or those produced in amounts under 10 tonnes per year.
EBIC believes these requirements are onerous in terms of both time and cost for manufacturers, especially smaller companies and those producing innovative substances with less opportunity to offset data costs against profits. They will also increase requirements for animal testing, without any gain in terms of health and safety.
Years of work inside EBIC on REACH+ culminated in a workshop in May 2023 to discuss and understand the difficulties companies were having meeting the requirements with policymakers. It has now convened a joint industry task force to establish a common position on REACH+ and propose amendments to the FPR to address industry’s concerns while respecting the need to ensure safety of the food chain.
Microorganisms in CMC 7 should be criteria-based Component Material Category (CMC) 7 of the FPR lists only four types of micro-organisms that may be used in microbial plant biostimulants. Since the FPR was created, EBIC has challenged this limited positive list on the basis that there are many other micro-organisms that are already being used as components of microbial-based plant biostimulants or are in the research and development stage.
Despite a consultation submitted to Member States in 2021 to gather information about microbial plant biostimulants already on the market under national rules, the EU then launched a survey to allow stakeholders to submit proposals for the future development of FPR Annexes, which closed on 16 September 2022. Around 56 proposals for microorganisms were submitted, which are now going to be considered in a technical study. This study will be undertaken by the Austrian Institute of Technology (AIT) and will evaluate the safety and agronomic efficiency of these micro-organisms for microbial plant biostimulants. A workshop is planned this month for stakeholders, but it is still unlikely that AIT will make recommendations to EU decision makers before the end of next year.
EBIC remains extremely concerned about these timelines, which are blocking access to the EU market and delaying the establishment of harmonised rules for microbial plant biostimulants. This allows divergent national rules to dictate investments in innovation under uncertain circumstances for too many years despite these solutions being desperately needed by EU growers. However, EBIC is actively engaged in the process, providing guidance to those members who submitted proposals and is in regular contact with the AIT to offer its expertise. EBIC continues to reiterate its preference for a criteria-based approach to CMC 7 instead of a positive list.
No CE-marking opportunity for animal byproducts (ABPs) Since the FPR’s adoption in 2019, no animal byproducts have been listed in CMC 10, meaning that ABPs commonly used in plant biostimulants (hydrolysed proteins and insect frass) are unable to go through the CE-mark process. As required by the FPR, a first list of end-points in the manufacturing chain were determined by a Regulation adopted in 2023. That was a first step, however, and the future list requires a technical study similar to that for microorganisms. This was contracted to Qlab in 2023 and is expected to conclude by October
2024. The results of this study will then be examined by EU decision-makers and should lead to further amendments to the FPR Annexes.
EBIC is working with QLab to provide expertise as well as offering guidance to members. However, EBIC is concernd that the Commission’s mandate for the study focuses on processes used for animal feed and ignores the transformation processes used for fertilising products.
On top of this, EBIC has coordinated an open joint letter with other 15 organisations, calling for a fundamental review of the EU’s approach to the regulation of materials from animal origin in the food chain, which is not compatible with the Circular Economy. Read the open letter HERE.
FPR evaluation should lead to improvementsAs required by Article 49 of the FPR, by 16 July 2026, the European Commission must submit to the European Parliament and to the Council a report assessing the application of the FPR and its overall impact as to the attainment of its objectives, including its impact on small- and medium-sized enterprises. The two studies on CMC 7 and CMC 10 will contribute to that assessment, along with a further technical study relating to new materials and processes in the FPR Annexes which will be completed by the end of 2025.
The FPR assessment report must include an assessment of the functioning of the internal market for fertilising products. It will consider conformity assessment and market surveillance effectiveness as well as an analysis of the effects of optional harmonisation on production, market shares and trade flows of EU fertilising products and fertilising products placed on the market under national rules.
The report must take due account of technological progress and innovation as well as standardisation processes affecting production and use of fertilising products. It must be accompanied, if appropriate, by a legislative proposal from the European Parliament and the Council. This report is likely to be conducted either by an external party, or by the Joint Research Center of the European Commission, with the tender process happening this year.
EBIC calls for transformative action by the next EU parliamentPart of EBIC’s role is to identify, prioritise and manage regulatory challenges as they emerge. Since the implementation of the FPR, its advocacy work has already led to some concrete steps to improve the regulatory framework, and alongside its members EBIC continues to work on these key issues. EBIC believes that all plant biostimulant technologies should have equal access to the market as the FPR is implemented and its strategy is built on that premise.
As new technologies are developed, more issues will come to the surface and EBIC will work with decision-makers to overcome them. EBIC’s manifesto makes its requests of parliament very clear: policymakers must provide an innovation-friendly environment for plant biostimulants. To make their full contribution to more sustainable agriculture,plant biostimulants needenabling regulation but alsoenabling policies.
To ensure farmers can access and benefit from the proven advantages of using plant biostimulants, regulatory barriers to placing these innovative products on the single market must be reduced. To achieve this, EBIC is calling for EU policymakers to speed up routes to market for biostimulant technologies. Additionally, EU policy must incentivise and facilitate the uptake and application of beneficial products such as plant biostimulants to make the transition to sustainable food systems a reality. ●
EBIC remains extremely concernedabout these timelines
On May 24, the U.S. House of Representatives Committee on Agriculture released a “Discussion Draft” of a 2024 Farm Bill. Subtitle C (Regulatory Reform), of Title X (Horticulture, Marketing, and Regulatory Reform) of the bill, proposes several amendments to FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act), the U.S. pesticides law. Pertinent to this article, proposed FIFRA amendments impacting plant biostimulants would (1) exclude certain plant biostimulants from the definition of “Plant Regulator”, thereby precluding their regulation as pesticides in the U.S., and (2) enact a U.S. statutory definition of plant biostimulants.
Taking these provisions in reverse order, the definition of plant biostimulant is unremarkable. The bill proposes to define “plant biostimulant” as:
any substance or mixture of substances that, when applied to seeds, plants, the rhizosphere, or soil or other growth media, acts to support a plant’s natural nutrition processes independently of the nutrient content of that substance or mixture of substances, and that thereby improves—
(1) nutrient availability, uptake, or use efficiency;
(2) tolerance to abiotic stress; or
(3) consequent growth, development, quality, or yield.
Close observers will recognize this as a reasonably similar analogue to definition 1 from the USDA’s 2019 Report to Congress on Plant Biostimulants. As I have noted on a number of occasions in various writings and speaking engagements, the myriad definitions of plant biostimulants that have been proposed over the years in various contexts have been, for the most part, substantively consistent, notwithstanding slight variations in how they have been phrased. The Farm Bill definition similarly is similar: a plant biostimulant is a substance or mixture of substances that act to affect the plant’s physiology in a way that improves plant nutritional processes (e.g., uptake, use efficiency, or availability of plant nutrients); enhances tolerance to abiotic stress; or improves the growth, development, quality, or yield of plants. Excluding such products from the requirement of FIFRA regulation would be a very welcome change, because these are exactly the types of claims that plant biostimulant product developers and producers want to make – but not if they have to register their products as pesticides to do so.
As for the other statutory change, removing certain biostimulants from the FIFRA definition of pesticides, this would be a significant improvement in the current regulatory posture of these substances. A quirk of U.S. pesticide law is that FIFRA defines as a “pesticide” not only substances that are intended to prevent, repel, destroy, or mitigate pests, but also substances that are intended to alter the rate of growth or maturation of plants, or to otherwise alter the behaviour of plants. Substances that have these latter effects are termed plant growth regulators and are regulated as pesticides. Given the substantial costs, time, and ongoing obligations associated with pesticides regulation, most, if not all, plant biostimulant product developers and distributors desire to avoid characterization of their products as a pesticide by any workable means.
If enacted into law, the Farm Bill provisions would do that – at least for plant biostimulants that (1) have a “lowrisk profile” in relation to humans and other organisms, as determined by EPA; and (2) are of biological origin or include chemical compounds that are synthetically derived, but structurally similarand functionally identical to, biological substances.
That said, it will be interesting to see how the ‘as determined by EPA’ provision is implemented. Will EPA require pre-market review of biostimulants prior to determining that a particular biostimulant is low-risk, or will it issue categorical exclusions of certain chemical substances or mixtures that it presumptively deems to be low-risk, or will its regulatory approach be a mix of both options? Bottom line, even if the House Farm Bill plant biostimulants provisions are enacted into law, there will remain anelement of ‘stay tuned’.
Keith Matthews has practiced environmental law focusing on the regulation of chemicals, biopesticides, and genetically engineered organisms for over 25 years. He has practiced in the private sector, and for over 13 years was a staff attorney and assistant general counsel in the Office of General Counsel at the U.S. Environmental Protection Agency. He then served for four years as the Director of the Biopesticides and Pollution Prevention Division (BPPD) in EPA’s Office of Pesticide Programs (OPP). Today, Keith is principle at Matthews Law LLC, where he counsels clients on the regulation of biopesticides, biostimulants, and genetically engineered organisms regulated by the EPA, FDA, and the U. S. Department of Agriculture. ●
Keith Matthews, Matthews Law LLC
The Fertilizer Institute (TFI) announced that its newly launched Certified Biostimulant program has awarded the first two certifications for a biostimulant product.
The first, AgroLiquid’s PrimAgro C-Tech, is described as a Bacillus species-containing fertilizer that combines organic acids and live strains of bacteria.
“Upon thorough review of their data, research and methodology, we have confirmed their adherence to industry-established standards, ensuring that among other criteria, proper experimental protocols were followed during efficacy testing,” said TFI president and CEO Corey Rosenbusch.
The second product certified by TFI is Hello Nature’s PSP 5-0-0 biostimulant product.
Rosenbusch said that agricultural retailers are “excited to get these innovative products into the hands of growers so they can maximize the efficiency of their fertilizer while also protecting the environment.
“But because biostimulants are a relatively new innovation there was a lack of a standard when assessing new products and determining which to recommend to growers,” he noted. “The Certified Biostimulant program was created to provide that standard and give confidence to both retailers and growers that they are choosing the right products that fit with their existing nutrient stewardship plans.”
TFI’s Certified Biostimulant initiative aligns with the United States Biostimulant Industry Guidelines, which set forth criteria for comprehensive documentation supporting efficacy testing methods, composition, and safety measures. Upon certification, a product is granted a distinctive label, signifying to agricultural retailers and consumers that it has undergone the necessary steps to meet the outlined standards in the guidelines.
Learn more about the TFI’s certification process from Ed Thomas, vice president of government affairs. ●
Finland-based UPM Biochemicals haslaunched a new range of bio-based plant stimulants, UPM Solargo.
The company stated that inlong-term testing, UPM Solargo products have been shown to increase crop yield and quality, and to reduce demand for classical nitrogen-, phosphorus-, and potassium-based fertilizers.
UPM Solargo biostimulants are natural products containing plant-based polyphenols from renewable sources. They are derived from lignin, a bio-based, non-toxic raw material. The company said test marketing has been finalized with great success in main European markets and the process of rolling out UPM Solargo at full industrial scale has started.
New AG International spoke with Suvi Pietarinen, PhD, manager business development, UPM Biochemicals. When discussing the mode of action, Pietarinen said: “We were interested about the role of lignin in nature; we knew that it is slowly biodegraded by soil microbiota and forms humic substances in soil. With our collaboration partner Green Innovation GmbH, we were discussing this process and started to talk about Trichoderma, which is a main wood decaying fungi. This led to cooperation with Prof. Matteo Lorito in University of Naples. He helped us in finding the synergy between lignin and Trichoderma, which is purely biostimulating.
“The Trichoderma biodegrades lignin, and the produced humic acids chelate micronutrients and boost root growth of plants,” added Pietarinen. “Trichoderma helps the plant make most of the nutrients that are in the soil or givenas fertilizers.”
Request a copy of the New AG International Yearbook 2023 for full interview. ●
UK-based IntraCrop’s plant biostimulant Status has been awarded CE Mark Certification for use on a wide range of broad acre crops and woody perennials.
Status is a pure plant biostimulant containing the molecule MTU and pidolic acid, which is designed to
influence plant physiology to maximize nutrient uptake and assimilation, mitigate environmental stress factors, and improve crop yield and quality.
The CE Mark certification has been granted under PFC 6 (B) of the European Union’s new Fertilising Products Regulation (EU 2019/1009
– the FPR). This means it is now available for use by growers across all 27 member states.
“The new FPR requires manufacturers to provide clear efficacy data to prove that the product meets its label claims,” noted Dr. Mark Palmer, commercial director for IntraCrop. “Status is one of very few products that has been able to evidence label claims for all three key biostimulant effects: stress tolerance, nutrient use efficiency and quality traits including yield.”
Palmer added that in trials of Status, improvements in chlorophyll production and photosynthetic activity typically range from 20-50 percent depending on circumstances, which translate into yield benefits of five to 20 percent.
IntraCrop’s plant biostimulant offers complementary modes of action to increase plant response by combining the effects of MTU on photosynthesis and pidolic acid on nitrogen assimilation. In healthy conditions, Status increases green leaf retention and improves nutrient use efficiency, resulting in higher yield and quality. The company added that in stressed conditions, Status protects the photosynthetic apparatus and improves plant resilience, resulting in quicker stress recovery, protecting yield.
Hailed as a ‘new generation of biostimulants’, Status has undergone more than a decade of stringent trials. Its specific mode of action is well understood, and dose rates have been clearly defined, providing growers with realistic expectations of what it will deliver.
According to Dr. Jaroslav Nisler, of the Czech Academy of Science who led the development of MTU, “MTU achieves remarkable results at very low dose rates (0.5g/ha), which is unique. Status helps a variety of crops cope better with challenging climates by improving nitrogen use efficiency. It builds the resilience required to deal with abiotic stresses which, sadly, are becoming increasingly common in crop production,” he said. “In trials in wheat for example, leaves exposed to periods of drought, heat or salinity remained green for longer and recovered more quickly when treated with Status.” ●
Read more about MTU
Controlled-release fertilizer (CRF) specialist Pursell Agri-Tech has filed a non-provisional patent with the US Patent and Trademark Office for its biodegradable coating components and application process.
Founded in 1904 and based in Sylacauga, Alabama, Pursell
Agri-Tech has a history in fertilizer coating, beginning with sulphur-coated urea in the 1960s to becoming a market leader in polymer-coated fertilizer granules.
The company says it is in end-stage research and development for a coating technology that will enable commercialization of CRF products
meeting European Union biodegradability standards.
The low-temperature process enables the incorporation of biostimulants and microbes, stated the company in a news release. “This unique capability allows Pursell to deliver a biodegradable CRF product with nutrient uptake and a
biostimulant package tailoredto a crop’s specific needs.
“Our current coating technology utilizes an extremely thin membrane, which already decreases the amount of polyurethane used in the process. This biodegradable technology, coupled with biostimulant inclusion, has the potential to be a true game-changer for both Pursell and the fertilizer industry at large,” said Joe Brady, Pursell CFO and Sustainability Initiatives Lead. “When introduced, our biofortified, biodegradable CRF products will offer the broad benefits of our current products, without any of the potential effects of non-biodegradable coatings.” ●
Read the exclusive interview with Taylor Pursell, chairman of Pursell Agri-Tech, in NAI’s SCRSF e-book.
New Zealand-based startup Metrovate announced a NZ$1 million (US$610,000) capital raise by Sprout Agritech LP to fund the development of a biostimulant for agriculture.
Using molecular biology, Metrovate has isolated the natural signalling molecules needed for a precision targeted biostimulant that only affects the intended partsof the target crop.
“By marrying molecular biology with cutting-edge technology models that allow us to predict how the molecules we’re designing will interact with the native machinery of plants, we’ve been able to achieve a level of accuracy we believe is unique in industry,” explains Metrovate’s founder and chief scientific officer Nikolai Macnee. “Driven by machine learning and artificial intelligence, our platform technology employs unique computational techniques that allow us to design and refine biostimulants which can both broadly improve growth and, where applicable, achieve some of the highest specificity in the world.”
Targeting a broad range of growing styles – from traditional broadacre crops to high tech projects such as indoor growing and vertical farms – Macnee said Metrovate’s proprietary formulas can be applied via fertigation systems or throughfoliar spray.
Metrovate has a purpose-built lab facility that is housed in the Newmarket Innovation Precinct. Initial funding, augmented by an Agricultural and Marketing Research and Development Trust (AGMARDT) grant, will be used to validate efficacy and refine an initial targeted product. Further field trials and R&D will follow the initial screening underway before the startup can scale a commercial solution. ●
BASF Agricultural Solutions and Anhui Huaheng Biotechnology (AHB) have signed an agreement to jointly explore and develop the agriculture nutrition segmentin China.
Under the agreement, both parties will work together to develop biostimulant products. In addition, the jointly established Plant Nutrition Application R & D Institute will serve as innovation hub for the two companies providing support in new product development, formulation development, bio-measurement experiments and field trials. Moreover, both parties will collaborate closely in various fields, such as research on mode of action and digital farming.
BASF Agricultural Solutions has already launched several plant nutrition products in China, including WANGQIU leaf fertilizer, WANGQIU aminoacid, WANGQIU seaweed, WANGQIU Fruit and WANGQIU Root.
“Over the decades, BASF has been a dedicated partner in China’s agriculture industry. Our comprehensive agricultural innovations portfolio, spanning seeds and traits, chemical and biological crop protection products, soil management, as well as professional and specialty solutions (P&SS) products, are designed to empower Chinese growers, enhancing their crop management efficiency and quality,” said Jackson Wang, vice president, BASF Agricultural Solutions Greater China. “We are confident that our locally co-developed plant nutrition product will enhance the value of our existing BASF Agricultural Solutions and contribute more to new quality productivity in China.”
Anhui Huaheng Biotechnology is a synthetic biotechnology company focused on green technology innovation and sustainable value creation. Its main products include amino acids, vitamins, and bio-based intermediates and monomers, serving as global partner in various fields such as biomaterials, animal nutrition, beauty and care, plant nutrition, human nutrition and flavour.
According to Fan Yi, board director and vice president of AHB, the company has been focusing on empowering biotechnology in agriculture. “AHB and BASF have a long history of cooperation. We are looking forward to working with BASF to pursue long-term value in the field of agriculture.” ●
BioPrime AgriSolutions, an India-based ag-biotech start-up, is partnering with Yara India on a new biostimulant, Chiron.
Developed by BioPrime, Chiron leverages the SNIPR (smart nanomolecule induced physiological response) technology, utilizing small molecules to modulate plant responses effectively.
BioPrime states this fast-acting formulation is designed to enhance flower count and improve flower-to-fruit conversion, resulting in a “significant increase in crop yields.”
"Together with Yara India, we have the huge opportunity to cater to the unmet needs of the farmers facing the brunt of weather uncertainties leading to loss in yield," said Dr. Renuka Diwan, CEO of BioPrime. ●
