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Brazil establishes new rules for pesticide registration and research

The measure provides more security to applicators and incentives for scientific research.

10/11/2021

Brazilian crop field.

This Friday, October 8, the Brazilian federal government published Decree No. 10,833, which changes the rules on production, research, registration, use, import and export of pesticides in the country. The main objectives are to reformulate the log analysis process, facilitate pesticide research to enable technological innovations, and implement actions to protect pesticide applicators.

This Friday's decree modifies Decree 4,074, of 2002, which regulates Law 7802, of 1989. The changes were necessary to update provisions of the legislation that were already out of date, due to the practical, technological and scientific advances that occurred in the sector.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.

In one of the main advances, 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 about the risks, as well as 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 they are approved and evaluated as suitable for this purpose. Furthermore, 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.

Clarifications on crop protection records

Rules were also established to prioritize the registration of new products and longer periods for the analysis of each type of registration, compatible with the specific complexity of each claim, providing agility in the 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.

The new text eliminates the duplication of document analysis between the organisms 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 the 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 deliver studies related only to the agronomic efficiency test in the case of a product that contains 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 regulations facilitate research and experimentation activities with already registered active ingredients, carried out by a company or teaching, extension and research entity or by an accredited entity. The Special Temporary Registry (RET) will no longer be required for these activities, but the requirement will be maintained in the case of research projects that involve use in aquatic environments or in native forests.

The registration of pesticides destined 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 exclusive production for export, but the need for the active ingredient and other components to be approved for use in Brazil still remains. 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, in a second moment, it was found that the irregularities had not been corrected. The current text allows the assessment to be carried out 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 sanctions to offenders, consequently increasing compliance with the rules and guidelines.

The new decree includes the definition of the Globally Harmonized System of Classification and Labeling of Chemical Products (GHS), for the purposes of toxicological classification and communication of health hazards on 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 consistent parameters at a global level. . It also allows the implementation of risk assessment by Anvisa, in line with international commitments. The change will bring users, especially rural producers, a greater knowledge about the products used.

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 the 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 current decree brings a high cost of control by the government in activities that do not present justifiable risk, while other activities with higher risk could be better carried out. There is also a concern to reduce pests resistant to active ingredients available in the market, through the availability of new technologies that allow 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 promote research on pesticides for use already authorized in the country.

What changes to the pesticide registration analysis process?

The decree reformulates the record analysis process, establishing a division of administrative routines, to avoid reworking between three bodies in charge of analyzing pesticide records: Ministry of Agriculture, Ibama and Anvisa, maintaining technical rigor in the evaluation of these products. . The objective is to reduce redundancies in the delivery of documents and the repetition of administrative efforts between the three different agencies. In this way, it is expected that the servers linked to the registry activities can be released to act in the inspection and in important activities of re-evaluation of pesticides.

The period for analyzing the product records, which is currently set at 120 days, will be defined based on the criteria of technical complexity and the prioritizations established by the technical bodies of the Bodies, which can vary from 12 months to 36 months. In some priority cases, defined by the Ministry, the term may be six months. The objective of the change is to make the deadlines more viable and compatible with the complexity of each type of claim and, at the same time, expedite the 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 the health security of field workers?

Yes. The decree creates a requirement for a registration 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 the training courses for the approval of the pesticide applicator registration, including the technical-operational requirements for application safety. The measure is important to raise awareness about the risks and educate on the importance of the correct and appropriate use of pesticides.

How does the decree affect small crops?

The new text allows the government to modify, on its own initiative, the recommendations for use in already registered products, based on official recommendations previously approved by agricultural, health and environmental organizations. Currently, these recommendations can only be made by the companies that own the records. The objective is to harmonize existing registries, in addition to offering solutions for crops of low attractiveness to 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 legislation of the sector. Now, the fine can be applied independently of the prior notification and the measures to correct the irregularities carried out by the offender. The new text is stricter, guaranteeing punishment and the application of sanctions to offenders. Also, when there are any unauthorized changes, the product registration may be canceled.

Does the decree change the way pesticides are classified?

The decree includes the definition of the Globally Harmonized System of Classification and Labeling of Chemical Products (GHS), and communication of health hazards on pesticide labeling. It also allows 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 already registered active ingredients, carried out by a company or teaching, extension and research entity or by an accredited entity. The bureaucratic measure aims to reduce the emission of TERs for conducting research with active ingredients that are already registered and that are carried out in regulated and controlled environments.

The requirement will be maintained in the case of research projects that involve use in aquatic 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, provided they are approved and evaluated as suitable for this purpose. In this way, several biological and microbiological products can be evaluated and, if they are considered suitable, they will be given the designation of use for organic agriculture.

The text also makes 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 raised doubts for producers. The objective is to promote the use of these biological and organic-based products both by certified and organic rural producers and by those who practice conventional agriculture.

The more rural producers use phytosanitary products authorized for organic agriculture, the greater the tendency to adhere to good production practices and the use of biological control methods and technologies, which will consequently further increase the degree of sustainability of national agriculture. .

What changes to the registration of products to be exported?

For the granting of the 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 creating jobs. On the other hand, the decree requires a greater number of documents for the granting of the export registration in order to ensure that the agencies have knowledge of the product manufactured in the national territory.

Will pesticide records continue to be published?

Advertising of pesticide registers is still mandatory, but can be done through the Pesticide 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 efficient and friendly to citizens.


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