One Concept, Two Paths: How Do China and the EU Regulate Biostimulants?

China's chemical fertilizer application rate vastly exceeds the global average. Annual fertilizer use per hectare stands at approximately 75 kg in the EU and 119 kg globally, while China uses around 319 kg—roughly 2.7 times the world average. Prolonged overuse of chemical fertilizers contributes to soil acidification, nutrient leaching, and greenhouse gas emissions, posing a serious threat to sustainable agriculture.

In response, the Chinese government has introduced a series of policy measures to curb fertilizer use. China's 2024 No. 1 Central Document called for advancing green agricultural development, while the Action Plan for Fertilizer Reduction by 2025 set concrete reduction targets. Against this backdrop, biostimulants—products that can enhance nutrient use efficiency, improve crop tolerance to abiotic stress, and boost produce quality—have attracted increasing attention from both industry and policymakers.

The Current State of China's Biostimulant Market

According to registration data from the Department of Crop Production, Ministry of Agriculture and Rural Affairs of China (MARA), a total of 18,372 biostimulant-containing products registered between 2005 and 2025 remain on the market. Of these, 11,175 (approximately 61%) are microbial biostimulant products and 7,197 (approximately 39%) are non-microbial products. The market is overwhelmingly domestic, with 97.2% of registered products originating from Chinese manufacturers and only 2.8% being imported.

Among non-microbial products, humic acid and amino acid products hold the largest market shares, followed by other categories such as seaweed extracts and chitosan. The dominance of humic acid products is closely tied to China's global leadership in the extraction, importation, and consumption of lignite—the primary raw material source for humic acids. As early as 1974, the State Council issued a directive promoting the development of humic acid fertilizers, laying the historical foundation of the industry. Chinese researchers have co-authored 22.9% of all global publications on amino acid fertilizers and 39.61% of those on humic or fulvic acid fertilizers (Web of Science, 2000–2025), attesting to China's strong research footprint in the field.

Within the microbial segment, bacterial products far outnumber fungal ones. The most commonly used bacterial genera include Bacillus, Trichoderma, Rhizobium, Azospirillum, Pseudomonas, Glomus, Streptomyces, and Azotobacter. Notably, approximately 49.3% of microbial products contain only a single species, while 38.7% contain two. Products incorporating three to eight species—so-called Synthetic Communities (SynComs)—have begun to appear on the market,representing a frontier direction in product development.

The global biostimulant market is projected to grow steadily, with China, Europe, and North America all recording compound annual growth rates of approximately 12.16%, 8.17%, and 12.16%, respectively (Mordor Intelligence, 2025).

China's Regulatory and Standardization Framework

China currently has no dedicated biostimulant legislation. Relevant products are primarily registered as fertilizers through MARA. The overarching legal basis is the Agricultural Law of the People's Republic of China, with the Administrative Measures for Fertilizer Registration serving as the key implementing regulation, and the Requirements for Fertilizer Registration providing technical guidance.

China's standardization architecture operates across five levels:

• National Standards (GB/GB/T/GB/Z): Issued by the State Administration for Market Regulation; can be mandatory (GB), recommended (GB/T), or guidance-oriented (GB/Z).

• Industry Standards: Issued by relevant departments of the State Council; can be either mandatory or recommended.

• Provincial Standards: Issued by provincial and district-level standardization authorities.

• Group Standards: Issued by social organizations such as industry associations, societies, and alliances; recommended in nature.

• Enterprise Standards: Issued by individualcompanies; recommended in nature.

The term "biostimulant" was formally incorporated into Chinese industry standards in 2021. In 2025, the China Inorganic Salts Industry Association (CISIA) published the first group standard T/CISIA 015-2025 specifically dedicated to biostimulants: Biostimulants—Terminology and Classification. This marked a significant milestone in China's biostimulant regulatory development. Nevertheless, inconsistencies in terminology and overlapping classification categories across different standards remain issues that need to be addressed.

The EU Regulatory Framework

In contrast, the EU leads the world in biostimulant regulation. The EU Fertilizing Products Regulation (FPR, EU 2019/1009), published in 2019 and entering into application in 2022, established a unified legal definition and registration pathway for plant biostimulants. In 2024, the European Committee for Standardization (CEN) published the EN 17700 series of standards, further strengthening the technical framework.

Under the EU FPR, raw materials are organized into Component Material Categories (CMCs). Microbial biostimulants fall under CMC 7. Regarding agronomic efficacy claims, the EU requires them to be substantiated by scientific evidence, covering nutrient use efficiency, tolerance to abiotic stress, quality traits, and the availability of confined nutrients in the soil or rhizosphere (guidance principles proposed by Ricci et al., 2019). Risk assessment requirements include strict limits on heavy metals (As, Cd, Cr, Hg, Pb, etc.) and pathogenic microorganisms (Listeria monocytogenes, Salmonella spp., E. coli, Enterococci, among others).

Comparison of Active Compound Categories

Microbial Categories: Both China and the EU recognize microorganisms as important functional components of biostimulant products; however, they differ in the scope of microorganisms permitted. Under the EU’s Fertilising Products Regulation (FPR), specifically Component Material Category 7 (CMC 7), only four groups of microorganisms are currently authorized: Azotobacter, Azospirillum, mycorrhizal fungi, and Rhizobium. In contrast, China does not restrict the types of microorganisms that may be used. In addition to the four categories recognized by the EU, China also includes microalgae within its microbial category.

Non-Microbial Categories: The fundamental difference between the two systems lies in their classification logic. The EU classifies materials by origin (CMC), while China classifies products primarily by their functional active compounds. In terms of correspondence, China's recognized humic substances can be mapped to multiple EU CMCs (CMC 2 plant extracts, CMC 3 compost, CMC 5 digestate, CMC 6 food industry by-products, CMC 10 animal by-products, etc.), while seaweed extracts correspond mainly to CMC 2. Amino acids and derivatives can be traced to several CMCs. It is important to note that a single raw material may contain multiple functional substances, and a single functional substance may derive from multiple material sources—meaning no simple one-to-one equivalence exists between the two systems.

Challenges and Outlook

A comparative analysis of biostimulant policies in China and the EU reveals several key challenges and opportunities:

Systematic Standardization: China urgently needs to build a more comprehensive biostimulant standard system. While the publication of the terminology and classification group standard in 2025 was an important step forward, further standards covering product requirements, safety assessment, and technical guidelines are still needed. Resolving inconsistencies in terminology and overlapping classifications across existing standards is equally pressing.

Public Awareness: Consumer and farmer awareness of biostimulants in China remains relatively limited. Expanding education and outreach is a foundational requirement for the healthy development of the industry.

Towards a Unified Global Regulatory Framework: ISO/TC is actively developing international standards for beneficial substances, including biostimulants, presenting an important opportunity to harmonize regulatory approaches globally. China's meaningful participation in the international standard-setting process is both a strategic necessity and a pathway to aligning its domestic regulatory framework with international norms—creating favorable conditions for Chinese biostimulant products to enter global markets.