On October 8, 2021, Brazil’s federal government published a new decree that changes the rules on the production, research, registration, use, import and export of pesticides in the country. The main objectives of Decree No. 10,833 are to reformulate the registration analysis process, facilitate pesticide research to enable technological innovations and implement actions to protect pesticide applicators.
Decree No. 10,833 amends the 2002 decree regulating Law 7802 of 1989. The changes were necessary to update provisions of the legislation that were already outdated, due to the practical, technological and scientific advances that occurred in the sector. The previous decree itself has been modified over the years to adapt to the new realities and demands of the agricultural sector in Brazil.
The new text determines the creation of applicator registries, with mandatory training for professional applicators in the field. The measure will be important to raise awareness of the risks, as well as to guide the correct application aimed at protecting the environment, food safety and best practices for human health.
The decree also allows the inclusion of a recommendation for organic agriculture in already registered products, provided that they are approved and evaluated as suitable for that purpose. In addition, plant protection products approved for use in organic agriculture can also be produced for their own use in conventional agriculture without the need for registration.
In addition, rules have been established to prioritize the registration of new products and longer deadlines for the analysis of each type of registration, compatible with the specific complexity of each claim, providing agility in cases of priority processes. The objective is to increase competition in the pesticide market, allowing the registration of more modern and less toxic products, and also reducing costs for the producer.
On the other hand, the new decree eliminates the duplication of document analysis between the agencies responsible for the control and regulation of pesticides in the country (Anvisa, Ibama and the Ministry of Agriculture, Livestock and Supply), maintaining the technical rigor for the evaluation of these products. It also provides for permission to use different trademarks for the same registration number, which will reduce the number of applications for registration of products with the same specifications by the same applicant.
The criteria for the registration of generic products will also be modified, reducing the need to submit studies related only to the agronomic efficiency test in the case of a product containing an active ingredient that has already been registered. It is important to clarify that the exemption does not apply to environmental and toxicological studies.
The new regulation facilitates research and experimentation activities with already registered active ingredients, carried out by a company or educational, extension and research entity, or by an accredited entity. The Temporary Special Registration (RET) will no longer be required for these activities, but the requirement will be maintained in the case of research projects involving use in aquatic environments or native forests.
The registration of pesticides intended exclusively for export and which, therefore, will not be sold or used in the country has been simplified. Now, it will no longer be necessary for these products to be registered for use in Brazil when their purpose is production exclusively for export, but the need for the active ingredient and other components to be approved for use in Brazil is still maintained. This will increase the attractiveness of investments in industrial production plants for export.
The text also brings changes regarding the application of fines for non-compliance with the legislation of the sector. In the previous text of the Decree, the fine could only be applied if the offending company had been previously notified and if, at a later stage, it was found that the irregularities had not been remedied. The current text allows the assessment to be made independently of prior notice and does not exempt from the application of fines if the company proceeds to correct the irregularities. This measure guarantees the possibility of sanctioning and applying penalties to violators, thus increasing compliance with the rules and guidelines.
The new decree includes the definition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), for the purposes of toxicological classification and communication of health hazards in labeling. The GHS, already incorporated by Anvisa since 2019, is an internationally agreed system created by the United Nations (UN), designed to harmonize the classification criteria and labeling standards used in different countries, through the use of globally consistent parameters. It also enables the implementation of risk assessment by Anvisa, in line with international commitments. The change will bring users, especially rural producers, greater knowledge about the products used.
Questions and answers about the new Decree on pesticides
Why is it important to update pesticide regulations?
Decree 4,074, of 2002, has undergone changes over the years to adapt to the new realities of demands of the Brazilian agricultural sector and the need to harmonize with the advances in science adopted internationally. The last update was in 2009. The maintenance of the decree in force brings a high cost of control by the government in activities that do not present justifiable risk, while other activities with greater risk could be performed better. There is also a concern to reduce pests resistant to active ingredients available on the market, through the availability of new technologies that will allow an adequate pest management.
Among the objectives of the new decree are to increase competition in the pesticide and related markets, improve the safety of applicators and encourage research on pesticides for use already authorized in the country.
What changes in the process of analyzing pesticide records?
The decree reformulates the process for analyzing records, establishing a division of administrative routines, to avoid reworking between three bodies responsible for analyzing pesticide records: Ministry of Agriculture, Ibama and Anvisa, maintaining technical rigor in evaluating these products. The objective is to reduce the redundancies of document deliveries and the repetition of administrative efforts between the three different agencies. In this way, it is expected that servers linked to registration activities can be released to act in inspection and in important pesticide re-evaluation activities.
The deadline for analyzing product registrations, which is currently set at 120 days, will be defined according to technical complexity criteria and the prioritizations established by the technical bodies, which may vary from 12 months to 36 months. In some priority cases, defined by the Ministry, the deadline may be six months. The purpose of the change is to make deadlines more feasible and compatible with the complexity of each type of claim and, at the same time, speed up cases of priority processes.
With the decree, it will be allowed to have more than one different brand for the same registration number. The change is expected to reduce the number of product registration requests with the same information.
Does the decree increase health security for field workers?
Yes. The decree creates a requirement for a register of pesticide applicators, to facilitate the implementation of health and education programs on the correct use of these products. The Map will define the minimum guidelines for training courses for the approval of pesticide applicator registration, including technical-operational requirements for safety in application. The measure is important to raise awareness about the risks and educate about the importance of correct and appropriate use of pesticides.
How does the decree affect small crops?
The new text allows the government to change, on its own initiative, recommendations for use in products already registered, based on official recommendations previously approved by agriculture, health and environment bodies. Currently, these recommendations can only be made by the companies holding the records. The objective is to harmonize existing records, in addition to offering solutions for crops with low attractiveness for the pesticide industries, known as “minor crops”.
Will there be more rigor for those who break the rules?
Yes. The text also brings changes regarding the application of fines for non-compliance with the sector’s legislation. Now, the fine can be applied regardless of prior notification and measures to remedy the irregularities carried out by the offender. The new text is stricter, guaranteeing the punishment and application of penalties to offenders. In addition, when there is any unauthorized change, the product registration may be cancelled.
Does the decree change the way pesticides are classified?
The decree includes the definition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), for the purposes of toxicological classification and communication of health hazards in the labeling of pesticides. It also allows for the implementation of risk assessment by Anvisa, in line with international commitments.
What changes for research activities?
The new decree dispenses with the presentation of the Temporary Special Registry (RET) for research and experimentation activities with active ingredients already registered, carried out by a company or entity teaching, extension and research or by an accredited entity. The bureaucratic measure aims to reduce the emission of RETs for conducting research with active ingredients that are already registered and that are conducted within regulated and controlled environments.
The requirement will be maintained in the case of research projects involving use in water environments or in native forests.
What changes for the registration of products for organic agriculture?
The decree allows the inclusion of a recommendation for organic agriculture in products that are already registered, as long as they are approved and evaluated as suitable for this purpose. In this way, several biological and microbiological products can be evaluated and, if considered adequate, they will be given the designation of use for organic agriculture.
The text also makes it clear that phytosanitary products approved for use in organic agriculture can also be produced for their own use in conventional agriculture without the need for registration. Previously, the legislation did not have this explicit authorization, which caused doubts for producers. The objective is to encourage the use of these biological and organic-based products both by rural producers certified as organic and by those who practice conventional agriculture.
The more rural producers use authorized phytosanitary products for organic agriculture, the greater will be the tendency to adhere to good production practices and use of biological control methods and technologies, which will consequently further increase the degree of sustainability of national agriculture.
What changes for the registration of products that will be exported?
For the granting of registration of products manufactured exclusively for export, it will no longer be necessary for the product to be registered for use in Brazil. The purpose of the change is to encourage investments in new industrial plants for the production of pesticides for export in Brazil, stimulating the economy and generating jobs. On the other hand, the decree requires a greater amount of documents for the granting of export registration in order to ensure that the agencies have knowledge about the product manufactured in the national territory.
Will pesticide records continue to be released?
Advertising of pesticide records is still mandatory, but it can be done through the Pesticides Information System (SIA), instead of the Federal Official Gazette. The idea is that the system is an active transparency tool for the disclosure of records , being more effective and friendly to the citizens.