Brazil's new regulations on biological inputs: Changes in registration pathways, opportunities and risks for market entry

Brazil has introduced its first dedicated regulatory framework for biological inputs, marking a pivotal shift in the country's agricultural regulatory landscape. In this interview, Daniela Maia, Head of Regulatory Affairs at Staphyt Brazil, and Andréia Shiwa, Regulatory Affairs and Product Registration Manager at SynTech Research Brazil, provide in-depth insights into how the new regulations will impact registration pathways and data requirements in practice. They also offer strategic guidance on how companies can capture emerging opportunities while effectively managing related risks.

What are the latest changes in Brazilian biological registration regulations? How do these changes impact application strategies for biologicals companies?

Staphyt: In December 2024, Brazil published a new law that specifically governs ″bio-inputs″, that includes biopesticides (e.g., microbiological, macrobiological, semiochemicals, biochemical, plant extract), biostimulants and fertilizer (e.g., biofertilizers and inoculants). It means an integration of bioinputs into a single new law, excluding products of biological source from the fertilizer and pesticide laws. 

One of the main changes is the possibility of registering the same product with different functions. (e.g., plant protection + nutrition) under a single pathway. This presents product portfolio opportunities to package combined benefits.

The National Programme for bioinputs offers potential access to credit/funding, support for building bio-input manufacturing (means potential access to R&D), and Brazilian companies should tap into those mechanisms.

We know that this law is still being implemented and regulated in detail, and the government is working on it. Having modern legislation built exclusively for biological products, and therefore a more favorable regulatory environment, will certainly help to further boost the growth of this sector.

Syntech: Published on December 24th, 2024, the Law No. 15.070, creates Brazil’s first comprehensive framework for agricultural bioinputs for agricultural, livestock, aquaculture, and forestry use, as follows:

- Considering the application to all farming systems (conventional, organic, agroecological).

- Covering all bio-inputs used in agricultural activity, such as biostimulants or growth or performance inhibitors, semiochemicals, biochemicals, phytochemicals, metabolites, organic macromolecules, biological control agents, soil conditioners, biofertilizers, and inoculants.

- Establishing the mandatory registration of bio-inputs or bio-input inoculum produced or imported for commercial purposes, as well as the registration of bio-factories, importers, exporters, and traders of this type of product.

- Exempting the registration requirement for semiochemical bio-inputs used in plates, traps, and as food attractants with active ingredients derived solely from the biological fermentation of food and its residues, or for bio-inputs produced exclusively for on-farm use, with the latter being prohibited from being used for commercial purposes.

- Supporting financial incentives for R&D and simplifying procedures for low-risk products

Impacts on registration application:

- Redefining and unifying the regulatory framework

- Classifying products under new categories and adapting the dossiers accordingly

- Accelerating the compliance and market entry

What are the key differences in registration requirements across different categories of biological inputs?

Staphyt: Based on the new law, only new biopesticides (new active ingredients) will continue to be evaluated by the three Brazilian authorities (MAPA – Ministry of Agriculture, ANVISA – Ministry of Health and IBAMA – Ministry of Environment), with the need to submit toxicological, ecotoxicological and physicochemical studies, in addition to those on agronomic efficiency. 

Biopesticides with active ingredients already registered will have a simplified process, evaluated only by MAPA.

Products previously classified under the fertilizer law will continue to be evaluated solely by MAPA, as is currently the case.

Syntech: The key differences are related to the source (product, process or technology of plant, animal, or microbial origin, including a biotechnological process, or structurally similar and functionally identical to that of natural origin), or the mode of action of the product.

Is the registration pathway for combined biological and chemical products more complex?

Staphyt: Yes, it is more complex when compared to registering just a biological product, since when it comes to a combination of biological and chemical, the product must meet the requirements of the most restrictive of the categories. 

There are some differences in the list of required studies to meet both legislations, but the main issue is the timeframe for obtaining registration. Currently, registration for a biological product is approved approximately 1 year after submission, while for a chemical product, the average time is 5 years.

What factors are most likely to cause registration delays, and how can companies proactively avoid them?

Staphyt: The main reason is the quality of the dossier submitted to the authorities (incomplete or weak dossier/data submission). Sometimes due to lack of knowledge, or simply to speed up the submission deadline.

The quality of the studies is also a very relevant point.

Laboratory: when we talk about microbiological products, for example, there are specific methodologies for this type of product (mostly from the EPA), and they generally have a longer duration (and consequently are more expensive) to allow for the evaluation of the microorganism's interaction with the test system. However, some companies perform studies using methodologies designed for chemical products, which do not allow for a correct assessment of the product's impact on human health and non-target organisms, generating the need to conduct new studies.

Field: efficacy trials must be performed in Brazil, usually, in three different regions (representative of the crop). These regions are not very clear in the Brazilian legislation, and sometimes, the company does not choose the best region for that pest and/or crop, and MAPA asks for new studies. 

It means back-and-forth with the agencies, and for performing new studies, sometimes it takes a lot of months. 

To avoid this situation, we recommend conducting a Data Gap Analysis (DGA) of Brazilian requirements, to monitor the studies according to local requirements and prepare a high-quality dossier.

Once the dossier is submitted, monitor status frequently and maintain good communication with the agencies. 

Syntech: The Bio-inputs law is still under transition, and other regulations cannot be reviewed yet.

So, it is expected to have some uncertainties in the current regulatory framework, which can cause some misalignment in some processes. However, since the Brazilian approach is First In First Out with Biologicals having a priority fast-track, it is recommended to apply for registration as soon as the company is ready to enter the Brazilian market.

What are the most common reasons for the rejection of company registration applications in recent years?

Staphyt: It is not common for authorities to reject applications. Generally, they request additional information from the company or new studies, if necessary.

If studies clearly required by law are missing, without proper technical justification, the authorities may reject the process without initiating the evaluation (checklist phase).

Talking about bioinputs, considering that we have innovative products and technologies, and it is not uncommon to have different modes of action, the incorrect categorization of a product can lead to the non-acceptance of the process (for example claiming biostimulant when pesticidal).

Thus, it is important to decide clearly whether the product will be marketed as a biopesticide, a biostimulant, or biofertiliser, etc, since the claims determine regulatory pathway and data burden.

A pre-submission meeting or informal consultation to clarify expected data and potential issues with the Brazilian authorities is a good alternative for specific products. 

Syntech: Probably, lack of technical data expected, or some misalignment in the product category classification in submissions.

However, some delay is expected during this transition period and implementation of new legislation, while new technologies are being developed and evaluated.

We expect several issues to be clarified with the implementation of the new decree and in the upcoming legislative revisions.

What are the main components of registration costs, and what is the approximate range?

Staphyt: The main costs are related to the laboratory studies (toxicological and ecotoxicological studies) when applicable, and the efficacy trials. 

There are some fees that are required from Brazilian Governments to register products in Brazil that are around USD 4,000.00 - ANVISA (Toxicological Evaluation) and IBAMA (check list and Evaluation).

For products that are evaluated only by MAPA, there is no official fee.

What are the main differences in data requirements between Brazilian companies and foreign companies seeking registration? What advantages or challenges exist for international applicants?

Syntech: We note that the understanding and demands related to biostimulants are different compared to, for example, the USA and Europe. There is still no clear definition, for example, regarding the minimum requirements for the registration of proteins, peptides for pest biocontrol, and also related to seed coating, soil conditioners, soil improvers...

Current evaluation processes have proven to be more demanding in the requirements necessary for the registration of new inoculants and biofertilizers compared to other countries.

As an advantage, I understand that there is an effort by the Brazilian government to propose new legislation, encouraging research and development of low-risk technologies, aiming for greater sustainability in food production and less impact on human health and the environment.

The challenge will be to meet the new demands during this period of transition and implementation of new legislation.

Staphyt: There is no difference in data requirements between Brazilian and foreign companies. The process is the same for everyone. 

Considering all registration processes (regardless of category), it must be submitted by a Brazilian company, legally authorized to operate with pesticides and/or fertilizer, this process can be easy for local companies. But, for sure, foreign companies can get support from a local company (consultants, partners, distributors) to help with their operations. Staphyt teams can assist you in developing your projects.