HomeProgressBiopreparations based on microorganisms, regulation and benefits

Biopreparations based on microorganisms, regulation and benefits

Microorganisms, such as bacteria, fungi, viruses and protozoa, play a crucial role in plant protection. In particular, they are often parasites or pathogens for insects or other harmful organisms. In fact, these microorganisms, naturally present in the environment (1), are used in biological control to combat parasites and diseases in crops. (2) On the other hand, this sustainable approach to plant protection has introduced new challenges especially related to the safety and regulation of agricultural products.

1) Microorganisms useful in agriculture

In the environment, heterotrophic microorganisms also play a key role, especially in biogeochemical cycles and soil health, by providing essential nutrients to plants. (3)

These organisms, for example, contribute to soil fertility, regulate the greenhouse gas emissions, contrast i pathogens of plants and promote the plant growth. Preserving soil biodiversity is fundamental to ensuring food and nutritional security for future generations. (4)

2) Role of fungi and useful bacteria

The mushrooms and bacteria used in agriculture perform crucial functions in biological control.

The mushrooms, with mechanisms such as hyperparasitism and antibiotic production, help protect plants from pathogens.

Rhizosphere bacteria, known as PGPR (Plant Growth-Promoting Rizhobacteria) (5), promote plant growth without necessarily establishing close symbioses.

Microorganisms they play a fundamental role in protecting the root system and assimilating nutrients in the soil. (6)

3) Biopreparations based on microorganisms

Biopreparations based on microorganisms (BBM) represent a crucial piece in the management of integrated pest control (IPM, Integrated Pest Management) and embody the cutting edge of agricultural sustainability. (7)

The European Union, through Directive 2009/128/EC, required Member States to implement protocols that include the use of BBMs. Italy has implemented this directive through the Legislative Decree of 14 August 2012, n. 150. (8,9) Certainly, this orientation towards BBM is a symptom of a consolidated evolutionary trend, highlighted by the growing adherence of agricultural operators, both in the conventional and organic production system, to the growing use of microbial inoculants. (10)

This evolution it is fueled by a series of driving forces, including the need to increase agricultural production to meet growing food demand.

According to estimates of the United Nations, the world population will exceed 9 billion by 2050, making it even more essential to adopt sustainable agricultural approaches to feed the planet in a safe and environmentally friendly way. (11) As well as the growing effort to reduce, if not completely eliminate, pesticide residues in foods, making microorganism-based biopreparations (BBMs) an attractive choice for conscious growers and consumers.

4) A growing market

The current market of biopreparations and biostimulants shows tangible signs of growth, with a CAGR (Compound annual growth rate) (12) above 10%. This increase is supported thanks to continuous scientific research which has improved and stabilized the effectiveness of biopreparations. Additionally, BBM formulas vary, including individual species and combinations of beneficial microorganisms and bioactive molecules.

On the other hand, these biopreparations not only offer biocontrol solutions, but also biofertilization and biostimulation functions, thus helping to optimize agricultural productivity in a sustainable way. (13)

Global Biostimulants Market Trends from 2017 and Forecast to 2029 with a CAGR (Compound Annual Growth Rate) of 12,5% ​​[Source: MMR]
Figure 1. Global biostimulants market trends from 2017 and forecast to 2029 with a CAGR (Compound Annual Growth Rate) of 12,5% ​​[Source: MMR]

5) New rules and sustainable perspectives

From November 2022, the European Union has introduced new regulations to facilitate the approval of microorganisms in plant protection products. These regulations, certainly aligned with the objectives of the European Green Deal, allow farmers to access organic alternatives to chemical pesticides. The safety and sustainability-focused approach aligns with the “Farm to Fork” strategy and will certainly contribute to greener and more sustainable agriculture. (14)

  • Commission Regulation (EU) 2022/1438. Amendments to Annex II of Regulation (EC) no. 1107/2009 for the specific criteria for the approval of active substances which are microorganisms. (15)
  • Commission Regulation (EU) 2022/1439. Amendments to Regulation (EU) no. 283/2013 for the information to be submitted for active substances and specific data requirements for microorganisms. (16)
  • Regbody of the Commission (UE) 2022/1440. Amendments to Regulation (EU) no. 284/2013 for the information to be submitted for plant protection products and specific data requirements for plant protection products containing microorganisms. (17)
  • Commission Regulation (EU) 2022/1441. Amendments to Regulation (EU) no. 546/2011 for the specific uniform principles for the evaluation and authorization of plant protection products containing microorganisms. (18)

Two Communications of the Commission list test methods and guidance documents relevant for the harmonized implementation of Part B of the Annex to Regulation (EU) No. 283/2013 and Part B of the Annex to Regulation (EU) no. 284/2013. (19,20)

Test methods and documents Guidelines listed were selected based on validation and their relevance for the approval of microorganisms. Furthermore, they include in vitro approaches, computational models and other alternative methods to minimize testing on vertebrate animals.

6) Conclusions

The new rules he EU guidelines certainly represent a significant step forward in the innovative use of microorganisms in plant protection products. Biopreparations based on microorganisms stand as fundamental innovations in the contemporary agricultural context, above all promoting environmental sustainability and ensuring food security for future generations.

The research still continues in this sector, and is essential to maximize the potential of BBMs by fully integrating them into global agricultural practices. However, these advances not only offer safer and more effective organic solutions for farmers, but also help reduce the environmental impact of chemical pesticides.

This approach focused on safety and sustainability aligns perfectly with the European Union's broader goals for greener agriculture and a globally sustainable future.

Gabriele Sapienza


(1) Thompson, L., Sanders, J., McDonald, D. et al. A communal catalog reveals Earth's multiscale microbial diversity. Nature 551, 457–463 (2017). https://doi.org/10.1038/nature24621

(2) Pal, K.K. & McSpadden Gardener, Brian. (2006). Biological Control of Plant Pathogens. The Plant Health Instructor. 2. https://doi.org/10.1094/PHI-A-2006-1117-02

(3) Wilpiszeski, Regina & Aufrecht, Jayde & Retterer, Scott & Sullivan, Matthew & Graham, David & Pierce, Eric & Zablocki, Olivier & Palumbo, Anthony & Elias, Dwayne. (2019). Soil Aggregate Microbial Communities: Towards Understanding Microbiome Interactions at Biologically Relevant Scales. Applied and Environmental Microbiology. 85. https://doi.org/10.1128/AEM.00324-19

(4) Micro-organisms used in plant protection products, EU report 2023, https://food.ec.europa.eu/plants/pesticides/micro-organisms_en

(5) Vincenzo Michele Sellitto, Useful microorganisms in agriculture, Edagricole, 2020, https://www.lafeltrinelli.it/microrganismi-utili-in-agricoltura-libro-vari/e/9788850655885

(6) Gabriele Sapienza, Useful microorganisms in agriculture, Microbiologia Italia, 2022, https://www.microbiologiaitalia.it/ecologia/i-microrganismi-utili-in-agricoltura/

(7) Giulia Pietrollini, Biofertilizers to Fight Climate Change. GIFT (Great Italian Food Trade).

(8) Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 EUR-Lex – 32009L0128 – EN – EUR-Lex (europa.eu)

(9) Legislative Decree 14 August 2012 n. 150, LEGISLATIVE DECREE 14 August 2012, n. 150 – Regulations

(10) Kallenbach, C., Frey, S. & Grandy, A. Direct evidence for microbial-derived soil organic matter formation and its ecophysiological controls. Nat Commun 7, 13630 (2016). https://doi.org/10.1038/ncomms13630

(11) United Nations Regional Information Centre, UN 75 – The big issues: A changing demography, 2020,UN 75 – The major themes: A changing demography – UN Italy (unric.org)

(12) Maximize Market Research, Biostimulants Market- Global Industry Analysis and Forecast (2022-2029) https://www.maximizemarketresearch.com/market-report/biostimulants-market/604/

(13) Thakore, Yatin. (2006). The Biopesticide Market for Global Agricultural Use. Industrial Biotechnology. 2. https://doi.org/10.1089/ind.2006.2.194

(14) Dario Dongo. From Farm to Fork to Farm to War, Science's Call for a Resilient Food Strategy. GIFT (Great Italian Food Trade).

(15) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009, EUR-Lex – 02009R1107-20221121 – EN – EUR-Lex (europa.eu)

(16) Commission Regulation (EU) No 283/2013 of 1 March 2013, EUR-Lex – 02013R0283-20221121 – EN – EUR-Lex (europa.eu)

(17) Commission Regulation (EU) No 284/2013 of 1 March 2013, EUR-Lex – 02013R0284-20221121 – EN – EUR-Lex (europa.eu)

(18) Commission Regulation (EU) No 546/2011 of 10 June 2011, EUR-Lex – 02011R0546-20221121 – EN – EUR-Lex (europa.eu)

(19) Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 283/2013, EUR-Lex – 52023XC0609(02) – EN – EUR-Lex (europa.eu)

(20) Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 284/2013, EUR-Lex – 52023XC0609(01) – EN – EUR-Lex (europa.eu)

Trainee Assistant Researcher | Website

Graduated in Agriculture, with experience in sustainable agriculture and permaculture, laboratory and ecological monitoring.

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