Vigna Brazil: How to accelerate the registration period of Brazilian technical preparations?

In the past two years, despite the significant challenges caused by the coronavirus pandemic, agriculture is the only one of the three large sectors of the economy (services and industry) that showed growth in 2020. 

It is estimated that Brazil will reach record levels in grain production in 2020-21 harvest, which is expected to reach 252.3 million tons. 

To give you an idea, the agricultural sector’s GDP (Gross Domestic Product) grew 14.46% in the first six months of 2021, with important increases for all segments. 

The “Agrochemicals” sector, following the same path, has a growth prediction of more than 10% in 2021, as compared to 2020. The anticipated sales of agrochemicals for 2021-22 is a sign of bullishness in this healthy market. It has already reached between 20 and 30%, well above the 10% historically achieved by the end of January. 

This increase in the agriculture sector is attracting even more national and foreign companies that want a share of the Brazilian agrochemicals market. However, the regulatory system for this segment in Brazil is one of the most rigorous, bureaucratic, and time-consuming in the world, considering that it involves the individual assessment of the Ministries of Agriculture (MAPA), Health (ANVISA) and Environment (IBAMA), each one with their specific requirements. Therefore, to speed up the submission of the process and the consequent assessments made by the government, we must consider some strategies before and during the preparation of the registration dossier and even after the Brazilian government evaluates it. 

THE FIRST ISSUE TO BE CONSIDERED 

For the registration of agrochemicals in Brazil, the first issue to be considered is the company. The registration holder must be a company regularly established in Brazil and authorized by the federal and local authorities to operate with pesticides (import and/or manufacture and commercialize). 

Every company established in Brazil must respect a specific regulatory system at the federal and municipal levels, depending on the segment in which it operates, because the regulatory system for the companies working with agrochemicals in Brazil is very well regulated and bureaucratic. 

Before operating, it is necessary to pay attention to the registration requirements and licenses and whether these are compliant with the legislation, which involves several government bodies, coordinators, institutes, and regulatory agencies, responsible for overseeing the correct conduct of activities according to their respective segment. Registering the company requires a few steps. In summary, you will need: 

a.Delineate the business model and company´s name; 

b.Have a reliable accounting office available; 

c.Choose if your business will be registered as MEI, ME, EPP, medium or a large company; 

d.Define the legal framework of the company: EI, EIRELI, or LTDA; 

e.Choose the activities that are going to be performed (CNAEs); 

f.Define the taxation regime: “Simple National”, “Presumed Profit” or “Actual Profit”; 

g.Prepare the Articles of Incorporation with the participation of the business partners; 

h.Submit the necessary documents to be registered at the Commercial Board; 

i.Obtain the location and operating permits from the City Hall 

j.State Registration, etc. 

After completing all the steps required for starting a business, it is possible to initiate the regularization with the regulatory bodies, namely Environmental Agencies (locals and IBAMA), Professional Councils, Health Agencies (ANVISA), MAPA (Agriculture Ministry), and municipal Agriculture Agencies. 

The company must have a qualified professional to assume technical responsibility for the activities that will be performed, being civilly and criminally responsible for all activities and products from the company. Depending on the company's segment, this professional maybe an agronomist, and if it involves industrial activities, it maybe necessary to have other professionals. 

Another extremely relevant point, which must be accomplished at the beginning of the project, is the evaluation of the product (origin, production process, mode of action, indication of uses) for its correct classification into the pesticides macro-legislation (agrochemicals, microbiologicals, macrobiologicals, biochemicals, semiochemicals, phytochemicals, stimulants, and atypicals), as there are different regulatory requirements for each one of the categories. 

This correct classification is essential, considering the different requirements for the laboratory studies to be presented at the dossier, about assessing physicochemical, toxicological, mutagenic, and ecotoxicological characteristics. Thus, the prior evaluation of these studies by specialized professionals is a very important step, to verify if they meet the parameters recommended in the guidelines and the requirements of the Brazilian authorities. Also, it is important to ensure they are not preventing some studies from being accepted or causing delays in evaluating the process or even its rejection. Studies performed in foreign countries could be accepted, provided they are performed under international GLP (Good Laboratory Practices). 

In general, the basic agrochemicals legislation requires end-use product registration and the corresponding Technical Product (TP or TGAI). However, considering some product categories, the need for registration of the Technical Product would be discussed by the authorities case by case and could be waived in specific situations. 

GENERATING DATA 

It is necessary to get an Experimental Use Permit (EUP or RET, in Portuguese) to import samples and contract any study in Brazil (field and/or laboratory). 

The sample import process is essential for the company that wants to operate with agrochemicals, their components, and similar products in Brazil. In general, according to Article 8 of Decree No. 4.074/2002, "Agrochemicals, their components, and similar products can only be produced, handled, imported, exported, marketed, and used in the Brazilian territory if previously registered with the competent federal agency, in compliance with requirements of the Federal Agencies responsible for the agriculture sectors, (MAPA) Health (ANVISA) and the environment (IBAMA)." 

To prepare a registration dossier, it will be necessary to present several laboratory studies and information proving the product’s safety (health and environmental) and the efficacy and residues trials performed in Brazil, of course attending to all the requirements and criteria required by the Local Authorities. It will be necessary to have feasible samples of the product(s) to have these studies performed locally. 

Through the RET (EUP) issuance, the company will obtain authorization to import and carry out experiments in the national territory. The RET is valid for three years and allows the import or local manufacture of samples for development and perform any research and study to compose the product´s registration process in Brazil. The main legislations detailing these procedures are INC nº 25/2005 and MAPA Ordinance 24/2016, depending on each product. The guidelines for the RET submission, evaluation by the authorities, and the approval period vary depending on the legislation that will be used. 

The import process must be conducted formally, avoiding shipment by express companies or door-to-door courier service, as these are products that necessarily require previous approval from the authorities. It is important to highlight that many documents must be provided to have a successful formal import of the samples, such as the "Shipment Acknowledgment", Invoice, Packing List and Certificate of Analysis (CofA), besides the labeling following the local legislation, according to the information described in the RET Certificate and others requested by the IN 39/2017. 

As the RET is also a (temporary) registration, the authorities require information about the samples, as their uses, custody network, and disposals.

FIELD TRIALS FOR AGROCHEMICAL'S REGISTRATION: EFFICACY AND RESIDUES 

For the registration dossier, besides all the information and GLP laboratory studies, it will also be necessary to perform the efficacy and residue trials locally with the formulated product the company wants to register in Brazil. 

It requires three (3) efficacy trials per target, per crop, and four (4) residue trials per crop. Both residues and efficacy trials must be performed in Brazil and under GAP/GLP, but the residue trial could not be requested for some product categories. 

Of course, the efficacy report must demonstrate the agriculture objectives, claims, and field application recommendations. 

There are specific legislations, with documental and technical guidelines to conduct the tests, giving special attention to the main ones, which are the IN36/2009 and IN42/2011. 

One must follow several steps during this part of the process for a successful outcome with the trials, which we briefly describe below: 

PROTOCOL 

The protocol is the primary step, which will determine how the tests should be performed and must contain at least the following information: crop, target, treatments, period, number and application intervals, the volume of the agrochemical mixture, when applicable, the mode of application, parameters to be evaluated and guidelines used for writing the final report. This previous step becomes even more critical when tests are performed at different locations by different CROs. 

PRODUCT 

The product to be tested must have the EUP/RET before obtaining the product samples and installing the trials. The experimental products can only be stored in official experimental stations, accredited by MAPA to conduct field trials. 

RESEARCHERS AND CROS (CONTRACT RESEARCH ORGANIZATIONS)

In Brazil, there are about three hundred official CROs able to conduct field trials officially. Choosing the best CRO (and Researcher), according to its experience, considering the type of product, best location, and a very well-prepared protocol, are critical issues for the success of the field trials performance and the obtainment of good reports for the dossier. 

CONDUCTING THE TRIALS

The agronomic efficiency and practicality trials for the same crop and or the same target should be conducted in different representative regions of the crop or in the same region in different crop seasons. As described in the experimental project, the tests must be conducted by entities accredited by MAPA, presented on the respective RET dossier. The experimental design must provide conditions for an adequate statistical analysis of the results. In general, a minimum of six treatments and four repetitions should be used, including treatment with the standard product, a control treatment without application, and other four treatments with different doses of the product. The trials should have at least seven treatments with four replicates when considering the herbicides, with a clear definition of the dose that does not control the pest, a minimum dose for pest control, and a higher dose with control statistically similar to the control provided by the minimum dose of control. In the evaluations, one must present the level of incidence or infestation and severity of the pest. For fungicides, one must also offer the evolution of the severity of the disease, assessed by using data from the area under the disease progress curve (AUDPC), accompanied by statistical analysis. 

REPORT

The agronomic efficiency and practicality reports must be based on technical and scientific information and present clear data proving the benefits to which the tests carried out were proposed. In general, these data are described in the Normative Instructions (IN) mentioned above. The results and discussion section must present the absolute efficiency data (contrasted by referenced statistical analysis) and the relative efficiency data in percentage values (using statistically referenced formulas). 

HOW TO ACCELERATE THE SUBMISSION OF THE EFFICACY TRIALS: 

According to Fabio Domingues, director of Vigna Brasil Group, “Considering the fact that for the registration of biological products, the Brazilian government requires efficacy trials performed for the target, regardless of the culture, we recommend that the company, speed up the assembling of the registration dossier, choose short-cycle crops, whose target is a problem, aiming to accelerate the achievement of final results in the field, thus not delaying the submission of the process. 

This strategy of using short-cycle crops is also important for regular agrochemical products, where the recommendation of use is made by crop/target; as for this type of product, the registration process currently takes about five years. Any time that can be reduced during the assembling of the dossier would already be valid. During this long wait, the company will be able to generate studies with other crops of greater interest, targeting to subsequently submitting these efficacy trials for approval as a post-registration process, which is much faster, to have the label extended.” 

The registration of regular agrochemical products takes around five years, from the date of the dossier´s submission, assuming the government will not perform any additional complex requirement. However, for biopesticides (biologicals, pheromones, biochemicals, natural PGR, and plant extracts), there is a fast-track based on the low toxicity profile. The registration process approval can take about 10 to 12 months. 

These deadlines are mainly due to a large number of processes in the evaluation queue waiting for analysis. Thus, one of the most important points that the company must observe is the quality of the dossier to be submitted. It should reduce as much as possible the possibility of receiving complex requirements from the authorities, which will require more time for the company to meet them and also for the government to analyze it or even, with the chance of having the process rejected due to the lack of inconsistent documents, studies and information. 

ABOUT

Vigna Brasil Group is a 25-year-old CRO that work as a facilitator in Brazil, rendering services as a “one-stop-shop”. Being a full services provider, offering any kind of support, starting from the establishment of a legal entity in Brazil; company licenses and products registrations (Regulatory Affairs); strategic and operational affairs and market intelligence studies (Business Intelligence); execution and management of field trials performed with crop protection products, fertilizers, inoculants, and GMO (Field Management). After having all the licenses and registrations available, we help the company and product in operate fully, maintaining all the mandatory documents and reports in force.

This article was initially published in AgroPages' '2021 CRO & CRAO Manual' magazine.

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