Registration of microbiological products in Brazil

By Luis Paulo Fava

Toxicology coordinator of Bioagri Laboratórios Ltda.-Merieux Nutriscience

Contact info： 

Brazil: agro.br@mxns.com

China: kathy.zhu@mxns.cn

In recent years, biological and natural products for agriculture have been gaining strength and prominence in global agribusiness. One of the most challenging points for modern agricultural production is maintaining the activity financially profitable with the least possible impact on the environment. The indiscriminate use of chemical products is one of the points that attracts the most attention when talking about sustainable production. What is a fact is that there is a great appeal from society for the use of solutions that reduce the use of chemical products in crops. And the use of biological products is one of the most promising solutions to cooperate with this reduction. Biological products can be composed of microbiological agents (bacteria, fungi, protozoa and viruses), macrobiological agents (insects, mites and nematodes), semiochemical agents (pheromones and allelochemical) and biochemical agents (enzymes and hormones). Biological products are generally considered safer and more sustainable than chemical pesticides applied in agriculture. They help protect crops, restore and/or improve crop and soil biodiversity, are also used as bioremediators, can minimize anthropogenic environmental impacts, in addition to helping to produce healthier foods. The global adoption of biopesticides by farmers generated more than 5 billion dollars in 2020 and grew 16% from 2015 to 2020. This represented a much higher value than the chemical pesticides sector, which represented a growth rate of just 1% in the same period. The expectation is that the global biological control market will continue to grow, reaching a value of 11.1 billion dollars in 2025.

On April 10, 2023, the Ministério da Agricultura e Pecuária/Secretaria de Defesa Agropecuária - Brazil publishes the joint ordinance SDA/MAPA - IBAMA - ANVISA n° 1 which establishes procedures to be adopted for the registration of microbiological products used in the control of pests or as defoliants, desiccants, stimulators, growth inhibitors. This resolution highlights some points: It is prohibited to register products based on microorganisms that fall into biological risk classes 3 or 4; Products based on microorganisms, classified in biological risk class 2, may have their application rejected according to technical criteria defined by Anvisa; Technical product registration is not required for microbiological products; When more than one microorganism is an active ingredient, it’s necessary to carry out the required pathogenicity studies  for each of them or ensure that the appropriate concentration of microorganisms for each species and/or isolate tested was reached in the study carried out, according to the guidelines in the protocols; Studies that aim to evaluate the toxicity, infectivity and pathogenicity of the active ingredient may be carried out with the formulated product as long as they reach the concentration of the active ingredient required in the protocols.

Mérieux NutriSciences is an institution prepared with a specialized team and physical and technological structure to offer services with great quality standards in all its activities. This is achieved through the implementation of rigorous quality management systems, including compliance with recognized international standards. Additionally, Mérieux NutriSciences promotes a culture of continuous improvement, investing in research and development to constantly improve its testing methods and ensure the accuracy and reliability of results.

The tables below present the studies necessary for the registration of biological products in Brazil, which are divided into two categories, the ones based on inactivated microorganisms and on live microorganisms: