The biostimulants market is experiencing spectacular growth: estimated at nearly $4 billion in 2024, it is growing at an average rate of +12% per year (EBIC, 2023). This momentum reflects their central role in the agroecological transition: improving nutrient use efficiency, strengthening plant resilience, and reducing environmental footprint.
But such growth requires safeguards. For a long time, the lack of a specific regulatory framework encouraged heterogeneity: some products were based on solid scientific validation, while others were not, which undermined farmers' confidence and slowed adoption. To meet this need for transparency, the European Union introduced Regulation (EU) 2019/1009, which came into force in July 2022. This text now serves as the benchmark for the marketing of biostimulants within the EU.
Definition and regulatory status
Regulation (EU) 2019/1009 defines biostimulants as products " that stimulate plant nutritional processes independently of their nutrient content, with the aim of improving nutrient use efficiency, abiotic stress tolerance, crop quality characteristics, or nutrient availability in the rhizosphere."
This definition marked a major step forward, as it gave biostimulants official status at the European level, classifying them in category PFC 6 – Plant Biostimulants. It also clarifies their place in relation to other inputs:
- fertilizers (PFC 1), whose function is to directly provide nutrients to the plant,
- plant protection products (PPPs), which target pathogens and claim to protect against biotic stress.
This distinction, which is essential from a regulatory standpoint, remains limited from a scientific perspective.
Many natural substances and microorganisms have what are known as "mixed" effects: they improve nutrition and growth, but also indirectly strengthen resistance to disease. Mycorrhizal fungi, for example, stimulate root exploration and nutrient absorption, while occupying the rhizosphere space in such a way as to limit the establishment of soil pathogens.
However, current regulations require that claims be limited to abiotic stresses only. A product cannot therefore be classified as a biostimulant if it explicitly claims to protect against a pathogen. This boundary, which is clear from a legal standpoint, remains biologically porous in reality, sometimes fueling debates between manufacturers, scientists, and regulatory authorities.
From a national approach to European harmonization
Before Regulation (EU) 2019/1009 came into force, the regulation of biostimulants was based on fragmented approaches at national level. Each Member State had its own framework:
- In France, biostimulants were classified as Fertilizing Materials and Growing Media (MFSC). Their commercialization required a Marketing Authorization (MA) issued by ANSES. The application included a complete analysis of the product (composition, agronomic efficacy, safety). The AMM, valid for ten years, guaranteed a certain level of credibility, but was a cumbersome and costly procedure.
- An alternative route existed via mutual recognition: a product already authorized in one EU country could be placed on the market in another with a simplified application. In practice, this mechanism was widely used: in 2019, 75% of new marketing authorizations for biostimulants in France came from mutual recognition applications, which were considered faster and less costly.
- At the same time, some manufacturers have circumvented the lack of a specific framework by using the "DSM" (Designation, Specification, Marking) declaration system. This mechanism, designed for products that are already standardized (such as conventional fertilizers), was based on a simple declaration of conformity by the manufacturer. In the absence of a standard adapted to biostimulants, this practice led to the marketing of products with sometimes misleading claims, which contributed to tarnishing the image of the sector.
The adoption of Regulation (EU) 2019/1009 has laid the foundations for a common, harmonized framework for all Member States, a first in the sector. This mechanism aims to ensure that biostimulants marketed in Europe meet the same standards of quality, safety, and efficacy, regardless of their country of origin.
However, in practice, the European system still coexists with national systems. In France, for example, it is still possible to market a biostimulant via a Marketing Authorization (MA) issued by ANSES in the MFSC category, particularly for products targeting a national market or awaiting CE marking. This dual system creates a certain degree of complexity, but it also reflects a period of transition, while notified bodies and European procedures become fully operational.
The role of CE marking
One of the most significant contributions of Regulation (EU) 2019/1009 is the introduction of CE marking for all fertilizer products covered by this framework, including biostimulants. Since July 2022, this marking has become an essential requirement for marketing throughout the European Union.
The CE marking is not just a simple logo on packaging: it is official recognition of conformity. It certifies that the product meets three fundamental requirements:
1. Safety: The product must not pose any risk to human or animal health or to the environment. This includes the absence of chemical contaminants (cadmium, lead, arsenic, mercury, dioxins, hydrocarbons), pathogenic microbial strains, or physical risks related to the formulation (foreign bodies, stability).
2. Agronomic effectiveness: The effects claimed by the manufacturer must be scientifically demonstrated through standardized tests, according to protocols recognized at the European level.
3. Traceability and production quality: The manufacturer must prove that each batch produced corresponds to the declared formulation and has the same efficacy. Regular audits and comprehensive technical documentation ensure this quality.
Each CE marking dossier is assessed by an independent notified body accredited by the European Commission. This body audits the manufacturer's quality system, verifies the conformity of the composition, analyzes the scientific evidence provided, and inspects the production chain. This external control reinforces market reliability and guarantees transparency for both distributors and end users.
PFC and CMC: a dual classification for greater clarity
To enhance clarity and harmonization, the regulation is based on a dual categorization:
- PFCs (Product Function Categories) define the main function of the product. For example:
- PFC 1: Fertilizer
- PFC 2: Basic mineral amendments
- PFC 3: Soil amendments
- PFC 4: Growing media
- PFC 5: Inhibitors
- PFC 6: Plant and microbial biostimulants
- PFC 7: Fertilizer mixtures
- CMCs (Component Material Categories) specify the nature of the raw materials used.
| CMC | Description |
| CMC 1 | Substances and mixtures based on virgin materials |
| CMC 2 | Plants, parts of plants, or plant extracts |
| CMC 3 | Compost |
| CMC 4 | Digestate from plant crops |
| CMC 5 | Digestate other than from plant crops |
| CMC 6 | By-products of the food industry |
| CMC 7 | Microorganisms |
| CMC 8 | Nutritive polymers |
| CMC 9 | Polymers other than nutritive polymers |
| CMC 10 | Derived products within the meaning of Regulation (EC) No. 1069/2009 |
| CMC 11 | By-products within the meaning of Directive 2008/98/EC |
| CMC 12 | By-products of the food industry |
| CMC 13 | Microorganisms |
| CMC 14 | Nutritive polymers |
This dual classification provides greater clarity: it allows farmers to understand both what the product does (PFC) and what it is made of (CMC). It facilitates comparison between product ranges, limits gray areas, and promotes fair competition between manufacturers.
Assessment procedures: Modules B-C and D
To obtain CE marking, the manufacturer must undergo an assessment procedure. Two main modules apply to biostimulants:
- Module B-C: combines an examination of technical documentation (test reports, safety analyses, proof of effectiveness) with an examination of representative samples of the production. This procedure is validated by a notified body, ensuring comprehensive external control.
- Module D: this is based on a manufacturer's declaration of conformity, supported by a certified quality management system (e.g. ISO 9001). The manufacturer then undertakes to maintain the conformity of its processes over time and to provide complete quality documentation.
These two approaches allow the regulatory burden to be tailored to the profile of the companies: Module B-C is preferred for new products requiring a full assessment, while Module D can be used by manufacturers who are already certified and have robust quality processes in place.
Strict technical requirements
The regulation imposes a series of technical criteria aimed at ensuring the safety, consistency, and effectiveness of biostimulants:
Chemistry: strict thresholds for heavy metals (Cd, Pb, As, Hg) and organic contaminants (dioxins, aromatic hydrocarbons).
Biology: only certain microbial strains listed in the regulations may be used (e.g., Rhizobium, Azotobacter, Trichoderma, mycorrhizae), and their safety must be proven by toxicity and non-pathogenicity tests.
Physical properties: the stability of formulations (liquid, powder, granules) must be demonstrated in order to guarantee efficacy and safety throughout storage and application.
But the key point remains agronomic effectiveness. Claims must be justified by reproducible tests conducted according to standardized methods.
The CEN (European Committee for Standardization) has published a series of standards (EN 17700-1 to 5, followed by 33 specific methods in 2022) for measuring:
- improving nutrient use efficiency,
- increased tolerance to abiotic stresses (drought, heat, salinity),
- improving the qualitative characteristics of crops (yield, homogeneity, nutritional quality),
- increased availability of nutrients in the rhizosphere.
These standards represent a major step forward: they establish a uniform scientific framework at the European level, reducing differences between countries and strengthening market credibility.
Finally, traceability requirements complete the system: manufacturers must demonstrate the consistency of their batches, keep detailed technical documentation, and be able to trace the origin and processing of each component.
Distinction from other "bisolutions"
The term biosolutions is widely used by manufacturers and distributors, but it remains primarily a marketing concept. It covers several families of products of natural origin or derived from biological processes, of which biostimulants are just one type of product.
Biosolutions include:
Biocontrol products: these are natural agents (microorganisms, macroorganisms, natural substances, pheromones, etc.) used to combat pests.
Legally, they are classified as plant protection products (PPPs) and subject to the same lengthy and costly authorization procedures as chemical pesticides. However, certain organisms such as Trichoderma spp. can be used in both contexts: biocontrol (claiming to combat pathogens) or biostimulant (claiming to improve tolerance to abiotic stress).
PNPP and SNUB (Natural Preparations of Low Concern and Natural Substances for Biostimulant Use): these are traditional preparations such as liquid manure, macerations, or decoctions (nettle, horsetail, etc.).
Since 2016, they can be marketed without marketing authorization, but their claims are limited and are based mainly on empirical knowledge. They do not offer the same level of scientific validation or the same prospects for innovation as industrial biostimulants.
Organic fertilizers: their main function is to directly provide nutrients (nitrogen, phosphorus, potassium, trace elements).
Unlike biostimulants, their effectiveness depends solely on this nutrient supply. Regulation CEN/TC 17700-1 (2022) also requires verification that a biostimulant does not simply act as a disguised fertilizer.
Agronomic additives: this concept, specific to French law (standards NF U 44-204 and 551/A4), refers to substances added to a fertilizer to give it a new fertilizing property.
Regulation (EU) 2019/1009 follows this logic via category PFC 7 (mixtures), allowing several types of inputs to be combined in a single product.
In summary, biostimulants are part of the broader landscape of biosolutions, but they are distinguished by a clear regulatory status, harmonized at the European level, and by claims limited to abiotic stresses. This clarification avoids frequent confusion with biocontrol, PNPPs, or fertilizers.
To better understand this distinction, it is useful to place biostimulants within the regulatory classification of fertilizers in France.
There are two main categories: Plant Protection Products (PPP), which aim to protect crops against pests, and Fertilizing Materials, which aim to improve plant nutrition and soil properties.
Biostimulants belong to this second category, alongside soil amendments, growing media, fertilizers, and adjuvants, while PPPs include plant protection products and PNPPs.
Conclusion
The implementation of Regulation (EU) 2019/1009 marked a decisive step in the structuring of the biostimulant market. By introducing CE marking, defining a dual PFC/CMC classification, and setting strict requirements for safety, efficacy, and traceability, the European Union has provided these solutions with a clear, consistent, and credible framework.
Biostimulants are therefore no longer simply emerging innovations. They are now fully-fledged, regulated and scientifically validated tools that can support European agriculture in its transition towards greater sustainability, resilience to climate hazards, and transparency towards society.
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Disclaimer
The aim of this series is to share practical information on biostimulants. Each month, a new topic will be covered, based on our expertise and research.
