Brazil establishes new rules for registration of agrochemicals

The Brazilian government has revised the rules on the production, research, registration, use, import, and export of agrochemicals. 

The main objectives of Decree No. 10.833, published on October 8, are to reformulate the process of analyzing registers, facilitate research on pesticides, enable technological innovations, and implement actions to protect applicators.

According to the Brazilian government, the changes were necessary “to update the outdated legislation, due to practical and technological advances and in science that took place in the sector.”

There were rules for prioritizing the registration of new products and longer deadlines for the analysis of each type of registration, according to the specific complexity of each claim, providing for speed in cases of priority processes. The objective is to increase competition in the agrochemical market, enable the registration of more modern and less toxic products, and reduce costs for the producer.

The new text of the law unifies the analysis between the bodies responsible for the control and regulation of pesticides in the country: Anvisa (National Health Surveillance Agency), Ibama (Brazilian Institute for the Environment and Renewable Natural Resources), and MAPA (Ministry of Agriculture, Livestock and Supply).

The updated regulation provides for permission to use different brands for the same registration number. It intends to reduce the number of requests to register products with the exact specifications by the same applicant.

The registration criteria for generic products will also be modified, reducing the need to deliver studies solely related to the proof of agronomic efficiency when dealing with a product that contains an active ingredient already registered. The submission of environmental and toxicological studies is still mandatory.

The new rules facilitate research and experimentation activities with registered active ingredients, carried out by an educational, extension, and research company or entity or by an accredited entity. The Temporary Special Registration (RET) will not be required for these activities. However, it will still be maintained in the case of research projects involving use in water environments or native forests.

The text also brings changes regarding the application of fines for non-compliance with the sector"s legislation. The current text allows the assessment to be made regardless of previous notice and does not exempt the application of penalties if the company comes to remedy the irregularities. This measure guarantees the possibility of punishment and penalising of violators, consequently increasing compliance with regulations and guidelines.

The new decree includes the definition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), for toxicological classification and communication of health hazards in the labeling. The GHS, already incorporated by Anvisa since 2019, is an internationally agreed system created by the United Nations (UN) to harmonize classification criteria and labeling standards used in different countries.

Finally, the new text determines the creation of applicator records, with mandatory training for professional applicators in the field. The decree also allows recommending organic agriculture in registered products, as long as they are approved and evaluated as suitable for the purpose. In addition, phytosanitary products approved for use in organic agriculture can also be produced for their own use in conventional agriculture without the need for registration.