Decree establishes new rules for the registration and research of agrochemicals

The federal government published this Friday (08/10) Decree No. 10.833, which changes the rules on production, research, registration, use, import and export of agrochemicals in the country. The main objectives are to reformulate the records analysis process, facilitate research with agrochemicals to enable technological innovations and implement actions to protect agrochemical applicators.

The decree published today amends Decree 4.074, of 2002, which regulates Law 7.802, of 1989. The changes were necessary to update provisions of the legislation that were already outdated, due to practical, technological and scientific advances occurring in the sector. The previous decree itself has already been amended over the years to adapt to the new realities and demands of Brazil's agricultural sector.

In one of the main advances, the new text determines the creation of applicator records, with mandatory training for professional applicators in the field. The measure will be important to increase awareness of risks, as well as guide appropriate application aimed at protecting the environment, food safety and best practices for human health.

The decree also allows the inclusion of recommendations for organic agriculture in products already registered, as long as they are approved and assessed as suitable for this purpose. Furthermore, phytosanitary products approved for use in organic agriculture can also be produced for their own use in conventional agriculture without the need for registration.

Rules were also established for prioritizing 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 for speed in cases of priority processes. The objective is to increase competition in the agrochemicals market, enabling the registration of more modern and less toxic products, and also reducing costs for the producer.

The new text eliminates the duplication of documentary analyzes between the bodies responsible for the control and regulation of agrochemicals in the country (Anvisa, Ibama and the Ministry of Agriculture, Livestock and Supply), maintaining technical rigor for the evaluation of these products. It also provides for the permission to use different brands for the same registration number, which will reduce the number of requests for registration of products with the same specifications by the same applicant. 

The registration criteria for generic products will also be modified, reducing the need to submit studies solely related to proving agronomic efficiency when dealing with a product that contains an already registered active ingredient. It is important to clarify that the exemption does not apply to environmental and toxicological studies.

The new rules 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. Special Temporary Registration (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 water environments or native forests.

The registration of agricultural pesticides intended exclusively for export – and which, therefore, will not be sold and 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 still maintaining the need for the active ingredient and other components to be approved for use in Brazil. This will increase the attractiveness of investments in industrial production plants for export.

The text also brings changes in relation to the application of fines for non-compliance with sector legislation. In the previous text of the Decree, the fine could only be applied if the offending company had been previously notified and if, subsequently, it was found that the irregularities had not been remedied. The current text allows for assessments regardless of previous notice and does not exempt the imposition of fines if the company corrects the irregularities. This measure guarantees the possibility of punishing and applying penalties to offenders, consequently increasing compliance with regulations 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 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 alignment with international commitments. The change will bring users, mainly rural producers, greater knowledge about the products used. 

Questions and answers about the new Decree for agrochemicals

Why is it important to update agrochemical standards?

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 for harmonization with internationally adopted advances in science. The last update was in 2009. Maintaining the decree in force brings a high cost of control by the government in activities that do not present a justifiable risk, while other activities with greater risk could be better performed. There is also concern about reducing pests resistant to active ingredients available on the market, through the availability of new technologies that will allow adequate pest management.

Among the objectives of the new decree are to increase competition in the agrochemicals and related markets, improve the safety of applicators and stimulate research into products already authorized for use in the country.

What changes in the process of analyzing agrochemical records?

The decree reformulates the registration analysis process, establishing a division of administrative routines, to avoid rework between three bodies responsible for analyzing agrochemical registrations: Ministry of Agriculture, Ibama and Anvisa, maintaining technical rigor for evaluating these products. The objective is to reduce redundancies in document deliveries and the repetition of administrative efforts between the three different bodies. In this way, it is expected that employees linked to registration activities can be freed to carry out inspection and important agrochemical reevaluation activities.

The deadline for analyzing product registrations, which is currently fixed at 120 days, will be defined according to technical complexity criteria and the prioritizations established by technical bodies, and may vary from 12 months to 36 months. In some priority cases, defined by Mapa, the deadline may be six months. The change aims to make deadlines more feasible and compatible with the complexity of each type of claim and, at the same time, speeds up priority processes.

With the decree, it will be allowed to have more than one different brand for the same registration number. The change should reduce the number of requests to register products with the same information.

Does the decree increase health security for field workers?

Yes. The decree creates the requirement for a registry of agrochemical 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 approval of agrochemical applicator registration, including technical-operational requirements for safe application. The measure is important to increase awareness of the risks and educate on the importance of correct and appropriate use of agrochemicals.

How does the decree affect small crops?

The new text allows the government to change, on its own initiative, recommendations for use in already registered products, based on official recommendations previously approved by agriculture, health and environmental 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 agrochemical industries, known as “minor crops”.

Will there be more rigor for those who break the rules?

Yes. The text also brings changes in relation to the application of fines for non-compliance with sector legislation. Now, the fine may be applied regardless of prior notification and measures to remedy irregularities carried out by the offender. The new text is more rigorous, guaranteeing the punishment and application of penalties to offenders. Furthermore, when there is any unauthorized change, the product registration may be canceled.

Does the decree change the way agrochemicals are classified?

The 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 in the labeling of agrochemicals. It also allows the implementation of risk assessment by Anvisa, in alignment with international commitments.

What changes for research activities?

The new decree exempts the presentation of the Temporary Special Registration (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 issuance 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 that involve use in water environments or native forests.

What changes for the registration of products for organic agriculture?

The decree allows the inclusion of recommendations for organic agriculture in products that are already registered, as long as they are approved and assessed as suitable for this purpose. In this way, several biological and microbiological products can be evaluated and, if considered suitable, will be designated for use in 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 phytosanitary products authorized for organic agriculture, the greater the tendency will be 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?

To grant registration for products manufactured exclusively for export, it will no longer be necessary for the product to be registered for use in Brazil. The change aims to stimulate investments in new industrial plants producing pesticides for export in Brazil, stimulating the economy and creating jobs. On the other hand, the decree now requires a greater number of documents to grant export registration in order to ensure that agencies have knowledge about the product manufactured in national territory.

Will agrochemical records continue to be disclosed?

Publicity of agrochemical registrations continues to be mandatory, but may be done through the Pesticide Information System (SIA), instead of through the Official Gazette of the Union. The idea is that the system is an active transparency tool for disclosing registrations , being more effective and friendly to citizens.